RU2304400C2 - Consumable food product containing food fat complexing agent (versions) and method for utilizing the same - Google Patents

Abstract

FIELD: production of consumable foods containing fat and α-cyclodextrin.

SUBSTANCE: consumable food product contains α-cyclodextrin and fat used in the ratio of from 1:20%/% to 1:3%/%. Said food product contains less than 9%/% of total cyclodextin. Method for enhancing organoleptical properties of fat-containing food product and method for reducing biological value of fat in fat-containing product involves adding α-cyclodextrin to fat-containing product in such a manner that α-cyclodextrin to fat ratio in food product is 1:20-1:3. Methods for increasing the level of high-density lipoprotein cholesterol, reducing the levels of leptin, levels of insulin in case individual is insulin resistant, and also method for diminishing diarrhea involves administering α-cyclodextrin to individual in an amount sufficient for obtaining of α-cyclodextrin to fat ratio of from 1:20 to 1:3%/% in food product consumed by individual. Also described are methods for reducing individual's cholesterol to high-density lipoprotein ratio, stimulating individual's body weight losses and reducing triglycerides levels, said methods involving introducing α-cyclodextrin in amounts providing α-cyclodextrin and fat ratio in consumable product to constitute from 1:20 to 1:3%/%. Methods allow food product having above useful properties to be obtained.

EFFECT: increased organoleptical properties, reduced biological value and reduced cholesterol to high-density lipoprotein ratio in food product obtained by above methods.

58 cl, 11 dwg, 5 tbl, 6 ex

Description

This application claims priority for provisional US patent application registration No. 60/486440 registered July 14, 2003, US patent application registration No. 60/461847 registered April 11, 2003, and US patent application registration No. 60/404366, registered August 19, 2002, all of which are incorporated herein by reference in their entirety.

Field of Invention

This invention relates to consumable products, in particular fat-containing consumable products containing α-cyclodextrin, and methods for their use. The invention also relates to methods for reducing the biological value of fats in fat-containing consumed products, and methods for improving the organoleptic properties of fat-containing consumed products.

BACKGROUND OF THE INVENTION

Attempts to control body weight through diet, exercise, and drugs have only limited success. Obesity continues to remain epidemic in the United States. It was estimated that in 2000 more than 64.5% of the US adult population was overweight or obese and 30.5% of the US population was obese (Flegal et al., JAMA 288: 1723-1727 (2002)). It also turns out that there is an epidemic of diabetes in the United States, 7.3% of the US population has diabetes (Mokdad et al., JAMA 286: 1195-1200 (2001)). Although doctors advise their patients to combat weight gain, obesity and diabetes, exercise and regulate the quality and quantity of food eaten, the results suggest that the majority of the population is unable or unwilling to make significant changes in lifestyle that may be necessary to reduce their body weight.

Strategies recommended by health care professionals to reduce and / or maintain weight often include lifestyle changes and, in some cases, additional use of drugs or food additives. Those individuals who are able to support weight loss (defined as a decrease of> 10% of their initial body weight after one year) usually use all of these strategies or at least some combination of these strategies (McGuire et al., "Behavioral strategies of individual who have maintained long-term weight losses "Obes Res 7: 334-341 (1999)). However, despite all the attempts made by obese individuals and the government, the degree of success in maintaining mass is disappointingly low. A meta-analysis showed that self-medication success rates ranged from 9% to 43% after one year of self-medication (Bartlett et al., "Is the prevalence of succesful weight loss and maintenance higher in the general community than the research clinic?" Obes Res. 7: 407-413 (1999)). National Weight Control Registry reported that 47% -49% of obese patients maintained at least 10% weight loss after one year, and 25-27% maintained this level of weight loss for 5 years (McGuire et al. , "The prevalence of weight loss maintenance among American adults" Int J Obes Metab Disord 23: 1314-1319 (1999)). However, after 5-15 years, only 5% of obese patients were able to maintain weight loss (Drenick and Jonson, Weight reduction by fasting and semistarvation in morbid obesity: long term follow-up. "Int. J. Obes. 2: 25-34 (1978) and Sarlio-Lahteenkorva and Rissanen "A descriptive study of weight loss maintenance: 6 and 15 years follow-up of initially overweight adults" Int J Obes 24: 116-125 (2000)).

The development of pharmaceutical methods for treating obesity has been observed, but their use has been limited. Currently, there are only two Food and Drug Administration (FDA) approving anti-obesity, orlistat and sibutramine drugs. Orlistat inhibits pancreatic lipase activity in the small intestine. Pancreatic lipase breaks down triglycerides into fatty acids and monoglycerides, which are then absorbed into the body. Thus, inhibition of lipase activity effectively reduces fat absorption. However, if the patient fails to adhere to a low-fat diet, which is recommended for his drug therapy, the fat is metabolized by intestinal bacteria and causes an osmotic shift and gas formation, which leads to diarrhea and flatulence, which are rather unpleasant side effects of this drug therapy. Thus, although this drug can cause moderate weight loss and better weight maintenance than a single diet, in the absence of major nutritional changes, the negative effects of the gastrointestinal tract, discomfort, diarrhea, and flatulence limit its use (Heck et al., "Orlistat, a new lipase inhibitor for the management of obesity." Pharmacotherapy 20: 270-279 (2000)).

Sibutramine is an inhibitor of the reuptake of serotonin and norepinephrine and reduces body weight by reducing appetite (Bray G., Drug treatment of obesity. Rev Endocr Metab Disord 2: 403-418 (2001)). The FDA has recommended it for the treatment of obesity for up to 2. However, sibutramine inhibits the reabsorption of norepinephrine and, thus, can increase blood pressure. Therefore, this drug is contraindicated for use by some obese patients (Bray 2001 supra and Sramek et al. "Efficacy and safety of sibutramine for weight loss in obese patie nts with hypertension well controlled by beta-adrenergic blocking agents: a placebo-controlled, double-blind, randomized trial "J Hum Hypertens 16: 13-19 (2002)). Other side effects of sibutramine include increased heart rate, insomnia , constipation, headache, abdominal pain, etc. For patients with normal blood pressure, sibutramine in combination with diet and behavioral changes showed beneficial effects (Astrup and Toubro "When, for whom and how to use sibutramine?" Int J .Obes Relat Metab Disord 25 (suppl 4): S2-S7 (2001)), but such data were not obtained in a study of people who used only sibutramine, that is, without changing the lifestyle. In addition, in one animal study, the effects of sibutramine on appetite reduction were reduced over several days of administration (Strack et al. "Regulation of body weight and carcass composition by sibutramine in rats" Obes Res 10: 173-181 (2002)).

Nutritional supplements have also been used to reduce weight gain, to maintain weight, and to treat certain metabolic abnormalities associated with obesity. For example, omega-3 fatty acids and linolenic acid have been shown to reduce weight gain and affect triglyceride levels and / or insulin resistance. Omega-3 fatty acids are known to lower blood lipids in individuals with normal sugar content, in hyperlipidemic and diabetic individuals and, as described, reduce body weight. Diabetic patients without hyperlipidemia consumed food containing fish oil, which is known to have a high content of omega-3 fatty acids, but does not show the ability to lower blood lipids, although blood pressure in these patients was reduced. However, diabetic patients with hyperlipidemia had significantly lower blood triglycerides and lower blood pressure after eating fish oil with omega-3 fatty acids (Kasmin et al. J. Clin Endocrinol Metab 67: 1-5 (1988)) . The effect of feeds containing fish oil given to Zucker genetically obese rats and their nonfat counterparts showed that both obese rats and normal rats had a decrease in body weight and blood lipid levels compared to controls (Jen. Et al ., Nutrition Research 9: 1217-1228 (1989)). High-fat foods made with fish oil caused at least a slight decrease in weight gain and insulin resistance compared to high-fat foods, but obtained with other types of oil (Pellizzon et al., Obesity Res. 10: 947 -955 (2002). It appears that omega-3 fatty acids also have beneficial effects on insulin resistance. Rats fed a high-fat fish oil diet had less insulin resistance than rats fed other oil oils. nap Emer, lard, corn oil, or triglycerides of medium chain length (Hill et al Int J.Obesity, 17:.. 223-236 (1993)).

Linolenic acid added to feeds has also been found to reduce body fat and promote β-oxidation of fatty acids in the liver (Takada et al., J. Nutr. 124: 469-474 (1994)). Old rats were fed food with various fatty acids, i.e. α-linolenic acid (n-3 PUFA) or gamma-linolenic acid (n-6 PUFA) (10% w / w), to which cholesterol was added, over a period of 15 weeks, and it was found that the feed was as with α -, and with gamma-linolenic acids inhibit the increase in total blood cholesterol, cholesterol VLDL + IDL + LDL in rats fed high cholesterol (Fukushima et al. Lipids 36: 261-266 (2001)). Similar results were found in obese Zucker rats that had reduced weight gain and body fat when they were fed daily through a gastric tube with gamma-linolenic acid (Phinney et al. Metabolism 42: 1127-1140 (1993)). In women, a mixture of n-3 PUFA and gamma-linolenic acid also favorably altered blood lipid and fatty acid profiles after administration for approximately 28 days (Laidlaw and Holub, Am. J. Clin. Nutr. 77: 37-42 (2003)) .

Lifestyle changes to stimulate weight loss and other health benefits include, for example, increased physical activity, reduced caloric intake, and reduced-fat food intake. In the United States, there has been a gradual decrease in percent of fat intake in food from 43.7% in 1965 to 33.1% in 1995 (Kennedy et al., “Dietary-fat intake in the US population” J Am Coll Nutr 18: 207- 212 (1999)), however, the average calorie intake increased more than the increase in fat intake. Thus, even though the percentage of fat intake in food was reduced, total fat intake increased from 1995 to 100.6 g (in men). Due to the relative lightness with which the fat of the food is transformed into adipose tissue, foods with a high fat content lead to increased weight gain compared to foods with a lower fat content, even though the calorie intake is comparable. This phenomenon has been described in both humans and rats (Astrup et al., "Obesity as an adaptation to high-fat diet: evidence from a cross-sectional study" Am J Clin Nutr; 59: 350-355 (1994)); (Jen "Effects of diet composition on food intake and carcass composition in rats" Physiol Behav 42: 551-556 (1988) and Jen et al., "Long-term weight cycling reduces body weight and fat free mass, but not fat mass in female Wistar rats "Int J Obesity 19: 699-708 (1995)).

Various low fat and / or low calorie foods have been developed in an attempt to stimulate weight loss or inhibit weight gain. Many of the "low fat" foods get lower percent fat, but the percentage of carbohydrates in foods is increased to make foods tastier by compensating for their loss of taste and consistency due to reduced fat. By increasing the amount of carbohydrates, for example, sugars, a “low fat” food product is often obtained in a food product, but its calorie content may not decrease and in many cases it actually increases. Many low-calorie food products are obtained by simply replacing the high-calorie components of the food product with a non-caloric filler, such as dietary fiber. However, replacing significant amounts of carbohydrates with fiber fillers often changes the taste and texture of the food product, making the food product less tasty for some consumers. In addition, the consumption of large amounts of dietary fiber often has undesirable side effects, such as flatulence, and foods containing more than approximately 60 g of fiber can lead to deficiencies of calcium, iron, zinc and an increased risk of bowel obstruction. Although high fiber foods containing approximately 25-35 g / d are considered beneficial foods, such as lowering triglycerides and blood cholesterol, many people should not take large amounts of fiber, such as older people, growing children and people suffering from certain medical conditions, for example, acute or super-acute diverticulitis and acute phases of certain inflammatory bowel conditions, for example, ulcerative colitis or Crohn’s disease. After some types of intestinal surgery, for example, colostomy or ileostomy, a low fiber, low toxin diet is preferably used as a transition to a normal diet. Thus, it is desirable to develop a food product that has a taste and texture that is desirable for consumers but also reduces body weight gain, triglycerides and cholesterol levels in the blood, and for which a high fiber content is optional.

Cyclodextrins are a family of cyclic glucose polymers produced by enzymatic processing of corn starch by cyclodextrin-glyceryl transferase. α-, β- and γ-cyclodextrins contain 6, 7 and 8 glucose molecules and have the conformation of a toroidal or truncated cone in an aqueous solution. Molecules have inner pores that form a hydrophobic inner side and a hydrophilic outer side. Polymers of different lengths form pores of different sizes.

The unusual properties of β- and γ-cyclodextrins have been used in various fields. For example, they were used to stabilize and solubilize drugs, as well as to increase the aromas of food products. Although β- and γ-cyclodextrins find significant use in the pharmaceutical and food industries, α-cyclodextrin finds relatively weak use in these industries due to its small pore size and the fact that it turned out to not be metabolized by pancreatic amylase or intestinal flora (Suzuki and Sato, "Nutrinional significance of cyclodextrins: indigestibility and hypolipemic effect of α-cyclodextrin" J Nutr Sci Vitaminol (Tokyo) 1985; 31: 209-223), although this latter aspect was disputed by one of the manufacturers of this material (Antlsperger G SG. "Toxicol ogical comparison of cyclodextrins ", presented in the 8 ^th International Cyclodextrin Symposium in Budapest 1996: 1-7). α-Cyclodextrin effectively forms complexes with free fatty acids (FFA) in solution (McGowan et al. "A peroxidase-coupled method for the colorimetric determination of serum triglycerides" Clin. Chem. 29 (3): 538-542 (1983)) and has been used to eliminate clouding caused by FFA in a number of clinical diagnostic reagents (Morgan, Artiss and Zak "A study of turbidity in hypertriglyceridemic specimens" Microchem. J. 64: 147-154 (2000)). α-Cyclodextrin has also been used to specifically and selectively remove free fatty acids from used cooking oil (US Pat. No. 5,560,950).

Previous studies have described that α-cyclodextrin is essentially indigestible and can affect weight gain only if it exceeds approximately 20% of total food intake, as determined by the rat model. Japanese Patent Application JP 05-298849 (Pub. No. 07115934) analyzes the effects of linolenic acid and α-cyclodextrin on weight gain in rats. This application reports that food fed to rats containing either 16% α-cyclodextrin or 1% linolenic acid gave a mass increase of approximately the same as that of rats fed control food. In contrast, this Japanese Patent Application discloses that rats receiving food containing a combination of 14% α-cyclodextrin and 2% linolenic acid exhibit significant weight loss. Japanese patent application S60-149752 also analyzes the effect of linolenic acid in combination with α-cyclodextrin on body weight gain in rats. This application describes that a feed containing 14% w / w% α-cyclodextrin has little effect on weight gain in rats, while a combination of 14% w / w% α-cyclodextrin and 0.5% w / w .% linolenic acid causes significant weight loss. Japanese Patent Application H5-298850 analyzes the effects of feed containing linolenic acid (1.5-2% w / w) and α-cyclodextrin (14% w / w) and a green barley element. This application describes that feeds containing 14% w / w% α-cyclodextrin in combination with 1.5-2% w / w linolenic acid cause only a slight increase in body weight, while the addition of a green barley element to linolenic acid and cyclodextrin leads to a significant reduction in weight gain. This application does not report the effect of feeds containing only α-cyclodextrin as an additional component. None of these applications describe the fat content in feed and the value of the additional ingredients and / or inefficiency of α-cyclodextrin alone.

In Japanese Patent Application P4-333575, rat food was supplemented with certain total amounts of linolenic acid and / or α-cyclodextrin and / or peptide hydrolyzate by feeding the rats through a probe wheat starch compositions containing either 0.9% w / w only linolenic acid, 9% w / w% α-cyclodextrin only, or 100% w / w compositions having a low molecular weight protein hydrolysis products with a high molecular weight or compositions containing combinations of these three components. The fat content in the feed was not indicated. Only feed containing a combination of linolenic acid, α-cyclodextrin and peptide hydrolyzate caused a significant change in the rate of weight gain in rats over time.

Japanese patent applications JPO5-113603 (Pub. No. 08187060) and JP05-164024 (Pub. No. 06343419) analyzed the effect of a mixture of approximately 15% α-cyclodextrin and 1.5% linolenic acid on human body weight gain. These applications describe that subjects taking α-cyclodextrin / linolenic acid compositions in an amount based on their body weight, so that the daily dose of the composition is about 0.015 g / kg body weight when administered three times a day, which is 1.37 g / 91 kg (200 pounds) for an individual when administered three times a day, corresponding to 4.11 g of the total composition per day or 0.62 g of α-cyclodextrin per day (0.21 g / meal) and 0.068 g of linolenic acid per day (0.023 g / meal), show a significant increase in weight loss compared with subjects who did not take this composition. However, these applications did not analyze the effect of only one α-cyclodextrin or only one linolenic acid and did not describe the fat content in foods. It is well known that linolenic acid reduces fat mass and growth in studies of both animals and humans (Jen et al., Nutri. Res 9: 1217-1228 (1989) and Takada et al., J. Nutri. 124: 469- 474 (1994) and Couet et al. Int. J. Obes. 21: 637-643 (1997)) and are likely to be the component that actually stimulates the observed weight loss, as indicated in these applications.

US Pat. No. 4,880,573 describes a method for removing cholesterol from fatty substances of animal origin, for example lard, deposits of fat on the inner surface of the body or oil. The method includes mixing α-cyclodextrin with a liquefied fatty substance in a non-oxidizing atmosphere and then removing complexes of cholesterol and cyclodextrin, as a result of which the fatty substance is freed from cyclodextrin and has a low cholesterol content.

US Pat. No. 5,189,149 discloses the use of complexes of long chain cyclodextrins and fatty acids, their salts and esters, including fish oil and vegetable oil glycerides, for delivering long chain fatty acids to a subject and eliminating the oiliness characteristics associated with fish oil and vegetable oil glycerides, and their unpleasant taste and smell.

US Pat. No. 5,232,725 relates to lowering cholesterol and free fatty acids in a fat-containing material, such as fresh cream, mixing water, a fat-containing material and cyclodextrin under conditions suitable for forming a thin oil-in-water emulsion that promotes formation complexes of cyclodextrin and cholesterol or free fatty acids. The complexes are then mechanically separated to obtain a fat-containing material with lowered cholesterol and free fatty acids. US Pat. No. 5,232,725 does not describe a food product that contains complexes of triglyceride and α-cyclodextrin and whose biological value of fat in the food product is reduced, as described herein.

U.S. Patent No. 5,560,950 relates to a method for reducing the free fatty acid content of a used oil by mixing the used oil with cyclodextrin, preferably with an absorbent, for example silica, under conditions in which agglomerates of cyclodextrin / absorbent and fatty acids are formed, and then removing agglomerates of cyclodextrin from the oil. This method provides an oil that does not contain cyclodextrin and has a reduced level of free fatty acids.

US Pat. No. 5,571,554 relates to a method for reducing triglycerides in an egg yolk by preparing a mixture of egg yolk with water or a salt solution and mixing the mixture with cyclodextrin and then removing cyclodextrin and added water or salt solution. The method allows to obtain an egg yolk without cyclodextrin with reduced triglycerides.

US patent 5738898 relates to a method for reducing cholesterol in egg yolk by preparing a mixture of egg yolk, water and cyclodextrin at a pH between 7.5 and 12. The cyclodextrin and cholesterol complexes are removed and the pH adjusted to 6-7. The method allows to obtain an egg yolk product without cyclodextrin with low cholesterol.

Many consumers, including obese individuals, appear to prefer foods that are high in fat (Mela and Sacchetti, "Sensory preferences for fats: relationships with diet and body composition" "Am J clin Nutr 1991; 53: 908-915). Therefore, for many individuals, especially obese individuals, it is very difficult to reduce their fat intake in order to reduce their body weight and the negative health effects associated with increased body weight gain. Therefore, a substance that reduces the absorption of edible fat without unpleasant The tricky action of modern drugs is highly desirable, and could have significant health benefits in reducing obesity and related disorders, such as type II diabetes (NIDDM). It would be desirable to develop a food product that promotes weight loss, reduces levels lipids and weaken the symptoms of other disorders associated with weight gain / obesity, and yet it has the desired organoleptic properties. Fatty consumable products having organoleptic properties, such as taste, texture and moisture, which are desirable for consumers but still stimulate weight loss and have other beneficial health effects, are described herein.

Summary of the invention

This invention relates to a fat-containing consumed food product that contains α-cyclodextrin and fat, wherein the ratio of α-cyclodextrin to fat is approximately 1:20 wt / wt. - 1: 3 wt./wt. Preferably, the ratio of α-cyclodextrin to fat is about 1:13 w / w. - 1: 5 wt./wt., Most preferably, the ratio of α-cyclodextrin to fat is approximately 1: 9 wt./wt. The total cyclodextrin content in the food products of this invention is less than about 9-10 wt.%, Preferably less than about 6% and more preferably below 3 wt.%, And especially in the case of containing the fat of consumed mealy foods of the present invention, the amount of total cyclodextrin is approximately below 3% w / w. Preferably, the fat-containing foods of the present invention include about 7 to about 80% fat, preferably about 20% to about 70% fat, more preferably about 40% to about 70% fat, or about 5 by weight % to about 50% w / w% fat, preferably about 5-30% w / w% fat, and more preferably about 7-25% w / w fat. “Fats,” as defined herein, are triglycerides. Cyclodextrins are often sold as a mixture of α-, β- and γ-cyclodextrin and n-dextrin. The α-cyclodextrin composition that can be used in the products and methods of the present invention is preferably substantially pure α-cyclodextrin containing at least about 95% α-cyclodextrin, preferably at least 98% α-cyclodextrin . α-Cyclodextrin in foods here, in addition to providing other beneficial effects, can be a source of fiber. Consumable products may be a powdery food product or a non-floury food product, for example, a dairy food product, a cooked vegetable product, or a cooked meat product, for example, cooked beef, young lamb, pork, poultry, or food seafood. Consumable food products of the present invention are suitable for consumption by mammals, for example, mice, rats, cats, dogs and humans, but preferably humans.

Cyclodextrins have previously been used in methods to lower levels of free fatty acids, cholesterol or triglycerides in foods, but unlike the foods of the present invention, these methods gave products that were substantially free of cyclodextrin and had lower levels of free acids and cholesterol compared to similar ones. a product that has not been processed. When analyzed in a calorimetric bomb, products obtained by these methods should have a lower calorie content due to lower cholesterol and triglycerides. Consumable food products of this invention contain α-cyclodextrin and do not have reduced levels of fatty acids, cholesterol or triglycerides compared to similar food products without added α-cyclodextrin. As such, the consumable products of the present invention do not have a substantially reduced calorie content analyzed by the calorimetric bomb compared to a similar product that does not contain α-cyclodextrin, and yet the food products of the present invention inhibit the rate of weight gain, stimulate weight loss and provide other health-friendly actions. Thus, the esophagus consumed by the product of this invention is a dietary food product that inhibits weight gain, stimulates weight loss, and provides other health benefits.

Shimada et al. (Shimada et al. "Structure of inclusion comlexes of cyclodextrins with triglyceride at vegetable oil / water interface" J. Food Sci. 1992; 57 (3): 655-656) described that two α-cyclodextrin molecules form a complex with one group fatty acid (FFA), while Szejtli (Szejtli J. "Utilization of cyclodextrins in industrial products and processes" J. Mater. Chem. 1997; 578-587) suggests that this phenomenon depends on the chain length of fatty acids and that, possibly that 3-4 molecules of α-cyclodextrin form a complex with each of the three fatty acids of a triglyceride molecule, he suggests that 9-12 molecules of α-cyclodextrin may be required for complete complexation of bottom molecule of triglyceride. If this were the case, it would be difficult to imagine how to feed the animal a sufficient amount of α-cyclodextrin to form a complex with sufficient amounts of triglycerides to achieve a significant change in body weight.

Suzuki et al infra and Kaewprasert et al. infra have described that a composition of only one cyclodextrin mixed with a food product does not stimulate significant weight loss, even at concentrations of 20% w / w of the total absorbed food product. In particular, Suzuki et al., Denpun Kagaku 30 (2): 240-246 (1983) analyzed the effect of feed containing 20% cyclodextrin on the weight gain of rats and reported that there was no difference in the weight gain of rats fed with food from 20 % cyclodextrin, and rats fed with 20% starch. Similarly, Kaewprasert et al. J. Nutri. Sci. Vitaminol. 47: 335-339 (2001) reported that the weight gain of rats fed with 5% α-cyclodextrin did not differ significantly from rats given control feed. Kaewprasert described a feed containing cyclodextrin and fat in a ratio of approximately 1: 1.4. Suzuki did not discuss the fat content of the experimental feed and did not describe the ratio of cyclodextrin to fat in feed. This effect of relatively large quantities of cyclodextrin has also been noted in Japanese Patent Application S60-094912. S60-094912 suggests that cyclodextrins can inhibit the rate of weight gain and reduce the content of neutral fat (triacylglycerides) in the liver and plasma, but only if cyclodextrin is administered at a level of 20% w / w or higher. S60-094912 describes that if α-cyclodextrin is less than 20% of the total feed consumed, then there is no significant difference in weight loss compared to the control feed. Similarly, Suzuki and Sato, J. Nutri. Sci. Vitaminol. 31: 209-223 (1985) described that rats fed food containing a mixture of n-dextrin and α-, β- and γ-cyclodextrins (50: 30: 15: 5 wt./wt.) Showed weight loss significantly different from the control group only when at least 58.5% w / w of the feed consisted of a mixture of cyclodextrins. In contrast, the inventors of the present invention have found that a significant weight reduction can be obtained in subjects with significantly lower levels of α-cyclodextrin if the subjects consume fat-containing food and the ratio of α-cyclodextrin consumed to consumed fat in food is sufficient to form fat complexes and cyclodextrin. In nature, a thin emulsion of fat in water forms in the body, which is necessary for lipase to catalyze the hydrolysis of fat. Without claiming to be a theory, the invention described here destroys this process by forming large complexes of α-cyclodextrin and fat, so that lipase cannot act on fat. Thus, fat in the fat-containing foods of the present invention is not biologically valuable since it is in the form of α-cyclodextrin / fat complexes that are resistant to lipase activity.

The levels of cyclodextrin in food of the present invention are significantly lower than the indicated levels of cyclodextrin S60-94912 and Zusuki and Sato (J. Nutri Sci Vitaminol 1985 supra) necessary for weight loss. The total cyclodextrin content of the food of the present invention is less than about 9% w / w, preferably less than about 6% w / w, and more preferably less than about 3% w / w especially in the case of consumed powdery foods of the present invention. Subjects who have consumed a diet containing α-cyclodextrin-containing food products of the present invention, preferably foods that contain the amounts of α-cyclodextrin described herein, and in which the ratio of α-cyclodextrin to fat are in the ratios described herein, caused inter alia weight loss, increased HDL levels and lower blood triglycerides.

Without claiming to be related to theory, the results presented here suggest that α-cyclodextrin is particularly suitable for complexing with fat in a food composition, thereby reducing the biological value of fat. When a suitable amount of α-cyclodextrin is eaten with a meal containing fat, or shortly before or slightly after consumption of a meal containing fat, the subject can complex with the eaten fat and inhibit its absorption in the body. The amount of α-cyclodextrin should be sufficient to form complexes with fat in order to thereby reduce the biological value of fat, the amount of α-cyclodextrin is preferably sufficient to achieve an α-cyclodextrin to fat ratio of 1: 20-1: 3, preferably 1: 13-1: 5 and, more preferably, approximately 1: 9, so that complexes of fat and cyclodextrin are formed. Without claiming to be related to theory, it has been shown that a decrease in the biological value of the eaten fat (the amount of eaten fat, which is absorbed and thus becomes acceptable for use by the body), leads, for example, to observed weight loss, lower HLD cholesterol, leptin levels and a decrease in serum triglycerides.

The present invention also relates to methods of complexing with fat contained in an eaten food product, especially a high fat food product, which thus allows to reduce the biological value of the eaten fat. The method comprises swallowing such an amount of α-cyclodextrin with a food product so that the ratio of α-cyclodextrin to fat is from about 1:20 to about 1: 3 wt / wt, preferably from about 1:13 to about 1: 5 wt./wt., most preferably, about 1: 9 wt./wt. α-Cyclodextrin can be swallowed before, together with or after consumption of a food product. In such relationships, fat forms a complex with α-cyclodextrin, and the biological value of the eaten fat is reduced. Alternatively, α-cyclodextrin may be mixed with the food product before consumption in such an amount that the ratio of α-cyclodextrin to fat in the eaten food product is from about 1:20 to about 1: 3 w / w, preferably about from 1:13 to about 1: 5 w / w, most preferably about 1: 9 w / w, so that the food product containing α-cyclodextrin and fat is eaten.

The present invention also relates to methods for producing a fat-containing food product having reduced biological value fat by forming complexes of α-cyclodextrin and fat in a food product, especially in a high fat food product. The method includes mixing α-cyclodextrin with a food product under conditions that are favorable for the formation of fat and α-cyclodextrin complexes, the conditions excluding the formation of a thin emulsion of fat with the food product. The amount of α-cyclodextrin is such that the food product has an α-cyclodextrin to fat ratio of from about 1:20 to about 1: 3 wt./wt., Preferably from about 1:13 to about 1: 5 wt./wt. most preferably about 1: 9 wt./wt. Under such relationships and such conditions, fat forms a complex with α-cyclodextrin, and the biological value of the eaten fat is reduced. The food product may be a mealy food product, for example, light snack slices, breakfast cereal dishes, pancakes, waffles, muffins, fruit-stuffed pastry, tortillas, corn chips, tortilla chips, light crackers, bread, cakes , biscuits or pies, or a non-floury food product, such as a vegetable, dairy or meat food product, such as French fries, tempura (fish and vegetables baked in pastry), veggie burgers (vegetarian burgers), etc. fried beans, hummus, tahini, margarine and peanut butter (e.g. peanut, cashew, almond, hazelnut), marzipan, potato chips, milk, cream, pudding, butter, ice cream and cheese and cooked cheese products, cooked beef, young lamb, pork, poultry or seafood, for example, sausages, slices of delicatessen products, sausages, fish sticks, chicken products with elongated shape and minced meat, for example, meat bread, meatballs and hamburgers, yogurt m and yogurt products and egg products.

Thus, the present invention also relates to a method for stimulating weight loss or inhibiting weight gain in a subject, comprising administering to a subject in need thereof, α-cyclodextrin in an amount and for a time sufficient to achieve weight loss or inhibit weight gain. α-Cyclodextrin is preferably administered to a subject consuming foods with an average fat content (approximately 100 g fat / day, approximately 33 g fat / meal), wherein the amount administered to the subject is such that the ratio of α-cyclodextrin to fat eaten by the subject at one meal or per day is from about 1:20 to about 1: 3 w / w, preferably from about 1:13 to about 1: 5 w / w, more preferably about 1: 9 w / w After the desired weight loss has occurred, α-cyclodextrin can be included in the food product in an amount that inhibits or, preferably, prevents weight gain. For a loss of about 1-1.5 pounds per week for a subject whose fat consumption in the food product is 100 g / day (approximately 33 g fat / meal), the amount of α-cyclodextrin administered is preferably about 2 g / meal , which reduces the biological value of approximately 54 g of fat per day.

In the blood, serum cholesterol is found in combination with proteins. Of particular interest are high density lipoprotein (“good” HDL cholesterol) and low density lipoprotein (“bad” LDL lipoprotein). This invention relates to a method for increasing a lipoprotein (HDL) level in a subject, comprising administering α-cyclodextrin to a subject in need thereof, in an amount and for a time sufficient to increase HDL levels. The amount of α-cyclodextrin administered to the subject is preferably from about four to about eleven grams per day. Preferably, α-cyclodextrin is administered in such an amount that the ratio of α-cyclodextrin to fat, eaten at one meal or daily, is preferably about 1: 20-1: 3 wt./wt., More preferably, about 1: 13-1 : 5% w / w, most preferably about 1: 9% w / w α-Cyclodextrin can be introduced in various forms, for example, in the form of a tablet, capsule, pill, elixir, cachet, drink, or in a food product, for example, bakery products, for example, buns, rolls, biscuits and cereal dishes to breakfast, for example, oatmeal porridge, wheat cream soup, bran with raisins, corn flakes or other cooked cereals, meat products and dairy products, and especially the consumed food products of the present invention. A tablet, capsule, pill, elixir, cachet, drink or food consumed preferably contains cyclodextrin, which is predominantly α-cyclodextrin, for example, cyclodextrin contains at least about 90-98% α-cyclodextrin.

It is possible that total cholesterol levels in the blood will remain constant, even though HDL levels increase if there is a decrease in LDL levels. By the methods of this invention, the levels of total cholesterol are substantially reduced or remain unchanged. Thus, the present invention relates to a method for reducing a cholesterol / HDL ratio in a subject, comprising administering to a subject in need thereof α-cyclodextrin in an amount and for a time sufficient to lower the cholesterol / HDL ratio. α-Cyclodextrin can be introduced in various forms, for example, in the form of a tablet, capsule, pill, elixir, cachet, drink, or in a food product, for example, bakery products, for example, buns, rolls, biscuits and cereal dishes to breakfast, for example, oatmeal porridge, cream of wheat soup, bran with raisins, corn flakes or other ready-to-eat cereals and, especially, consumed food products of the present invention. A tablet, capsule, pill, elixir, cachet, beverage or food product may contain α-cyclodextrin in combination with other cyclodextrins, for example, β- and / or γ-cyclodextrin or n-dextrin. In a tablet, pill, capsule, elixir, cachet, drink or food, cyclodextrin is predominantly α-cyclodextrin, for example, cyclodextrin contains at least about 90-98% α-cyclodextrin.

The invention also relates to a method for lowering triglyceride levels in a subject, comprising administering to a subject in need thereof an amount of α-cyclodextrin sufficient to lower triglyceride levels. The amount of α-cyclodextrin administered to the subject is such that the ratio of α-cyclodextrin to fat eaten by the subject at one time or per day is from about 1:20 to about 1: 3 w / w, preferably, the ratio is from about 1:13 to about 1: 5 wt./wt. and, most preferably, the ratio is approximately 1: 9 wt./wt. α-Cyclodextrin can be introduced in various forms, for example, in the form of a tablet, capsule, pill, elixir, cachet, drink, or in a food product, for example, bakery products, for example, buns, rolls, biscuits and cereal dishes to breakfast, for example, oatmeal porridge, wheat cream soup, bran with raisins, corn flakes or other cooked cereals, and especially the consumed food products of the present invention. A tablet, capsule, pill, elixir, cachet, drink or food consumed may contain α-cyclodextrin in combination with other cyclodextrins, for example, β- and / or γ-cyclodextrins or n-dextrin. In a tablet, pill, capsule, elixir, cachet, drink or food, cyclodextrin is predominantly α-cyclodextrin, for example, cyclodextrin contains at least about 90-98% α-cyclodextrin.

The invention also relates to a method for reducing leptin levels in a subject, comprising administering α-cyclodextrin to a subject in need thereof, in an amount and for a time sufficient to lower leptin levels in the subject. α-Cyclodextrin can be introduced in various forms, for example, in the form of a tablet, capsule, pill, elixir, cachet, drink, or in food products, for example, bakery products, for example, buns, rolls, biscuits and cereals for breakfast for example, oatmeal, wheat soup, bran with raisins, corn flakes or other ready-to-eat cereals and, especially, consumed food products of the present invention. A tablet, capsule, pill, elixir, cachet, drink, or food consumed may contain α-cyclodextrin in combination with other cyclodextrins, for example, β- and / or γ-cyclodextrin or n-dextrin. In a tablet, pill, capsule, elixir, cachet, drink or food, cyclodextrin is predominantly α-cyclodextrin, for example, cyclodextrin contains at least about 90-98% α-cyclodextrin.

This invention also relates to a method for suppressing appetite in a subject by administering α-cyclodextrin to a subject in need thereof, in an amount and for a time sufficient to suppress the appetite of the subject. α-Cyclodextrin is administered in such an amount that the ratio of α-cyclodextrin to fat, eaten by the subject at one time or per day, is approximately 1:20 to about 1: 3 wt./wt., preferably, the ratio is approximately 1: 13 to 1: 5 w / w and, more preferably, the ratio is approximately 1: 9 wt./wt. α-Cyclodextrin can be introduced in various forms, for example, in the form of a tablet, capsule, pill, elixir, cachet, drink, or in food products, for example, bakery products, for example, buns, rolls, biscuits and cereal dishes to breakfast, for example, oatmeal porridge, wheat cream soup, bran with raisins, corn flakes or other cooked cereals, and especially the consumed food products of the present invention. A tablet, capsule, pill, elixir, cachet, drink or food consumed may contain α-cyclodextrin in combination with other cyclodextrins, for example, β- and / or γ-cyclodextrin or with n-dextrin, preferably cyclodextrin in a tablet, pill, the capsule, elixir, cachet, beverage or food product is predominantly α-cyclodextrin, for example, cyclodextrin contains at least about 90-98% α-cyclodextrin.

The present invention further relates to a method for reducing insulin levels and insulin resistance in a subject, comprising administering α-cyclodextrin to a subject in need thereof, in an amount and over time sufficient to reduce insulin levels and insulin resistance in the subject. The amount of α-cyclodextrin administered to a subject is preferably such that the ratio of α-cyclodextrin to fat eaten at one time or daily by the subject is a ratio of from about 1:20 to about 1: 3 wt / wt, preferably which is from about 1:13 to about 1: 5 wt./wt., most preferably, is from about 1: 9 wt./wt. α-Cyclodextrin can be introduced in various forms, for example, in the form of a tablet, capsule, pill, elixir, cachet, drink, or in a food product, for example, bakery products, for example, buns, rolls, biscuits and cereal dishes to breakfast, for example, oatmeal porridge, cream of wheat soup, bran with raisins, corn flakes or other ready-to-eat cereals and, especially, consumed food products of the present invention. The tablet, capsule, pill, elixir, cachet, drink or food consumed preferably contains predominantly cyclodextrin in the form of α-cyclodextrin, for example, cyclodextrin contains at least about 90-98% α-cyclodextrin.

The present invention also relates to a method for alleviating diarrhea in a subject in need thereof, comprising administering to the subject in need thereof α-cyclodextrin in an amount and over time sufficient to alleviate diarrhea in the subject. The amount of α-cyclodextrin administered to the subject is preferably such that the ratio of α-cyclodextrin to fat eaten at one time or per day by the subject is a ratio of from about 1:20 to about 1: 3 w / w, preferably was a ratio of from about 1:13 to about 1: 5 w / w, most preferably, a ratio of about 1: 9 w / w. α-Cyclodextrin can be introduced in various forms, for example, in the form of a tablet, capsule, pill, elixir, cachet, drink or in food products, for example, bakery products, butter buns, rolls, biscuits and cereals for breakfast, for example , oatmeal, wheat soup cream, bran with raisins, corn flakes or other cooked cereals, and especially the consumed food products of the present invention. The tablet, pill, capsule, elixir, cachet, drink or food consumed preferably contains cyclodextrin predominantly in the form of α-cyclodextrin, for example, cyclodextrin contains at least about 90-98% α-cyclodextrin.

The present invention also relates to methods for improving the organoleptic properties of fat-containing foods without reducing the percentage of fat in the food or caloric content due to the presence of fat, the content of which is determined by calorimetry in the bomb. The method comprises adding α-cyclodextrin to the fat-containing food product so that it is present during processing and in the final consumed food product. The amount of α-cyclodextrin that is added to the food product may be based on the amount of fat in the finished consumed product.

Brief Description of the Drawings

Figure 1 depicts the cumulative total mass of feed eaten by four groups of rats, and demonstrates that there is no significant difference in the mass of feed eaten by different groups.

Figure 2 depicts the cumulative caloric intake of four groups of rats and demonstrates that there is no significant difference in the calories of the food eaten by two pairs of rats (low fat and high fat).

Figure 3 illustrates the change in body weight of four groups of adult rats during the entire study period.

Figure 4 shows the faecal fat content of four rat groups. The groups distributed according to the general inscription do not differ significantly.

Figure 5 depicts the plasma parameters of the four groups of rats at killing. Plasma glucose, cholesterol and triglyceride concentrations were measured in all animals.

Figure 6 compares the values of the plasma leptin content obtained in four groups of rats.

Figure 7 depicts plasma triglyceride levels in volunteers eating a high fat breakfast after fasting overnight.

Figure 8 depicts changes in the body weight of human volunteers over a period of approximately 6 months.

Figures 9A-9C depict the results of an in vitro study of vegetable oil (4 g), water (6 g) (with added food colored for contrast) and varying amounts of (A) α-cyclodextrin (100-2000 mg, from right to left), ( B) β-cyclodextrin or (C) γ-cyclodextrin. The strip of “wax-like” material located between the oil and water phases in the test tubes is transparent. The size of this band increases with increasing α-cyclodextrin content to a maximum in a test tube marked with 10% (400 mg of α-cyclodextrin / 4 g of oil). An increase in size (from right to left) of the white layer of unreacted α-cyclodextrin at the bottom of the tubes was noted. This material is displaced from the solution either with oil or with the α-cyclodextrin-oil complex. These tubes were centrifuged to increase the clarity of the separation of the layers. The “Voskopodobny” complex has such a consistency that all tubes, with the exception of the two farthest to the right, can be inverted without leakage of the aqueous phase around the complex.

Description of the invention

This invention relates to a fat-containing consumed food product containing α-cyclodextrin and methods for using it. Consumable food products are suitable for consumption by mammals, for example, mouse, rat, cat, dog, cow, horse, monkey, apes or humans, and thus include, for example, a food product for pet animals, for example, a cat, dogs or horses, or human food. Consumable food products of the present invention contain α-cyclodextrin and fat, preferably the ratio of α-cyclodextrin to fat is about 1: 20-1: 3 w / w, more preferably, the ratio of α-cyclodextrin to fat is about 1:13 -1: 5 wt./wt., Most preferably, the ratio of α-cyclodextrin to fat is approximately 1: 9 wt./wt. The total amount of cyclodextrin in the food consumed is preferably less than about 9 wt.%, More preferably the total amount of cyclodextrin in the consumed food is less than about 6 wt.% And most preferably the total amount of cyclodextrin in food consumed is less than about 3% w / w. The cyclodextrin and fat complexes are preferably evenly distributed throughout the food product. Consumable food products of the present invention are preferably high fat foods having a caloric content of from about 7% to about 80% fat, preferably from about 20% to about 70% fat, more preferably from about 40% to about 70% fat, or by weight, from about 5% w / w% fat to about 50% w / w fat, preferably about 5-30% w / w fat, and more preferably about 7% w / w / wt .% fat to about 25 wt. / wt.% fat. Methods for determining or calculating the amount of fat in a food product are well known. See, for example, Food Processor software by ESHA Research, Salem, OR, incorporated herein by reference. The food products of this invention are preferably prepared with less than 2% linolenic acid, more preferably less than 0.2% linolenic acid. More preferably, the food products of this invention are prepared without detectable levels of linolenic acid. Linolenic acid has been shown to stimulate weight loss, but at levels necessary to stimulate weight loss of approximately 2%, the shelf life of products containing linolenic acid is reduced due to its tendency to become rancid. In addition, high purity linolenic acid is very expensive. Thus, linolenic acid is preferably not added to the food products of this invention before, during or after their preparation.

Various forms of cyclodextrins are commercially available. For example, Wacker-Chemie GmbH manufactures various natural and modified cyclodextrins. Cyclodextrins are often sold as mixtures of α-, β- and γ-cyclodextrins; they can be prepared in various ways. Typically, cyclodextrins are obtained by treating starch, for example, potato or corn, with cyclodextrin transferase, which is produced by various organisms, for example, Bacillus macerans. Cyclodextrins can be isolated from treated starch using various methods that combine concentration, fractionation, filtration, drying, spraying, granulation, etc. For a more complete discussion of the methods for producing and isolating cyclodextrins, see, for example, Schmid publication "Preparation and industrial production of cyclodextrins", Comprehensive Supramolecular Chemistry (1996), 3: 41-56. Eds Szaytli, Jozsef; Osa, Tetsuo. Elsevier, Oxford, UK, incorporated herein by reference.

The fat-containing consumed food products of the present invention can be mealy food products, for example, light snack slices, cereal breakfast dishes, pancakes, waffles, pancakes stuffed with fruit mealy confectionery, tortilla, corn chips, tortilla chips, crackers for light snacks, bread, cakes, cookies or pies, or a non-floury food product, for example, a cooked vegetable product (vegetable products, as described here, include vegetables, fruits s and nuts), especially a product obtained with a fatty ingredient, such as French fries, tempura (fish and vegetables baked in pastry), veggie burgers (vegetarian burgers), pre-fried beans, hummus, tahini, margarine and peanut butter (for example , oils of peanuts, cashews, almonds, hazelnuts), marzipan, potato chips; a dairy food product, for example, milk, cream, pudding, butter, ice cream and cheese and cooked cheese products; yogurt and yogurt products, egg products and meat products, for example, cooked beef, young lamb, pork, poultry or seafood, for example, sausages, slices of delicatessen products, sausages, fish sticks, chicken products with elongated shape and minced meat, for example meat bread, meatballs and hamburgers. The dairy product is preferably a product in which α-cyclodextrin / fat complexes are distributed throughout the entire product, preferably a solid or semi-solid dairy product, for example, pudding, butter, ice cream and cheese and cooked cheese products and yogurt, and whose organoleptic properties preferably not changed in an unfavorable manner. The food products of the present invention may also include, among other products, pre-packaged mealy foods, e.g. pre-packaged cooked pasta, e.g. lasagna (wide noodles), manicotti, spaghetti with sauce, ravioli, tortellini or pasta and cheese, or packaged a dairy product, a packaged cooked vegetable product, or a pre-packaged cooked meat product, wherein the food product contains α-cyclodextrin and fat in the ratios specified herein. A portion of the pre-packaged product preferably provides about 160 mg-11 g of α-cyclodextrin / serving, preferably about 1 g to about 7 g / serving, more preferably about 2-4 g per serving, and most preferably about 2 -3 g / serving. The pre-packaged food product may be enclosed in plastic, paper, cardboard or metal, such as tin or soft foil. A pre-packaged food product may be packaged in bulk packaging, multi-portion packaging, or individual packaging.

The present invention also relates to confectionery products, for example caramels, such as lollipops and respiratory mint candies or afternoon mint candies, and seasonings, for example gravy, sauces, salad dressings, mayonnaise, etc., containing α-cyclodextrin. The confectionery product is preferably a fat-containing product, such as, for example, chocolates.

α-Cyclodextrin can be added to a consumable food product that has been cooked, for example, cooked, baked or fried, or to an un-cooked consumable food product, such as milk, cream, whipped cream, non-dairy whipped dressing on the surface of powdery confectionery or filling a confectionery, yogurt or a drink, such as a milkshake, e-leg, or smoothie (fruit or yogurt drink). α-cyclodextrin can be added to the food product at any stage of its preparation, for example, α-cyclodextrin can be mixed with the ingredients so that it is distributed throughout the food product and the product can be cooked. However, in some cases, α-cyclodextrin may be applied to the surface of the food product, for example, in the form of a glaze or coating, in order to achieve the desired levels of α-cyclodextrin for fat.

The invention also relates to a method for stimulating weight loss or reducing body weight gain, comprising administering to a subject in need thereof an amount of α-cyclodextrin sufficient to reduce weight gain or stimulating body weight loss. A preferred method comprises swallowing amounts of α-cyclodextrin sufficient to complex with the right amount of fat in the fat-containing food product or the right amount of fat per day to stimulate weight loss, reduce weight gain, or maintain constant body weight. Weight loss for a person is preferably about 1-1.5 pounds / week.

An aspect of the invention is method 6 comprising ingesting an amount of α-cyclodextrin sufficient to form a complex with an excess of the required amount of fat per meal or day that the subject wants to absorb. The method comprises determining the amount of fat that the subject wants to absorb for a meal or per day, determining the amount of fat eaten that is in excess relative to the amount that the subject wants to absorb, and then swallowing sufficient amounts of α-cyclodextrin to complex with the excess fat, so so that only excess fat is absorbed. For example, based on the description here, that approximately 1 g of α-cyclodextrin can form a complex with 9 g of fat, an amount sufficient to stimulate a weight loss of 1-1.5 pounds per week in a subject consuming 2500 g / day daily food where such food contains approximately 100 g fat / day, a preferred amount of swallowed α-cyclodextrin is approximately 2 g / meal with three meals per day. The total amount of α-cyclodextrin swallowed daily is preferably from about 500 mg to about 33 mg per day, more preferably from about 5 mg to about 20 g per day, most preferably about 6-11 g / day. α-Cyclodextrin is preferably administered with food in such an amount that the ratio of α-cyclodextrin to the eaten fat, which you want to protect from absorption by the body, is from about 1:20 wt./wt. to about 1: 3 wt./wt., preferably, the ratio is from about 1:13 wt./wt. to about 1: 5 w / w, more preferably, the ratio is about 1: 9 w / w. A subject in need of it is a subject who needs it or who wants to reduce weight or inhibit weight gain, for example, a subject who has a tendency to gain weight, or a subject who already has excess weight or obesity. A subject may also be a subject that consumes daily food containing about 30% or more fat in calories. α-Cyclodextrin can be administered to a subject in the form of a powder, tablet, capsule, drink, or other delivery medium suitable for consumption, preferably a medium that does not contain linolenic acid. α-Cyclodextrin may be administered before, simultaneously with or after consumption of a fat-containing food product. Preferably, α-cyclodextrin is administered immediately before or at the same time as consuming a fat-containing food product. More preferably, α-cyclodextrin is administered to a human subject by consuming a fat-containing food product. α-Cyclodextrin can be introduced in the form of a food product, for example, baked goods, for example, buns, roll or biscuit, or breakfast cereals, for example, oatmeal, wheat soup, bran with raisins, corn flakes or other cooked cereals or, preferably, in the form of food products of the present invention. The subject may be a mammal, for example, a mouse, rat, cat, dog, cow, horse, monkey, anthropoid ape or human, but preferably a human, and within the knowledge of a person skilled in the art it is understandable to regulate the total amounts of α-cyclodextrin administered to the mammal to form a complex with fat sufficient to achieve the desired weight loss. For example, 2 g of α-cyclodextrin per food product reduces the biological value of approximately 18 g fat per food product or approximately 54 g fat per day. This corresponds to a loss of 1-1.5 pounds of body weight per week. This amount of fat represents approximately half the fat intake of normal daily foods for average North Americans.

The present invention also relates to methods for reducing the biological value of fat in a fat-containing food product comprising combining the amount of α-cyclodextrin with a food product so that the food product has an α-cyclodextrin to fat ratio of from about 1:20 to about 1: 3 wt / wt., preferably, from about 1:13 to about 1: 5 wt./wt., most preferably, about 1: 9 wt./wt. The total cyclodextrin content of the food products of the present invention is preferably less than about 9% w / w, more preferably less than about 6% w / w and most preferably less than about 3% w / w wt.%. This method may be suitable for various fat-containing foods, for example, powdery food product, cooked vegetable product, dairy product, cooked meat product or seafood, gravy, sauces and salad dressings. A floury food product may be, for example, light snacks, breakfast cereals, pancakes, waffles, pancakes, tortilla, corn chips, tortilla chips, light crackers, bread, cake, cookies, donuts, zeppolies and pies . The dairy product of the present invention can be, for example, milk, cream, condensed sterilized milk without sugar or sugar, pudding, butter, ice cream, milkshake, yogurt or drinks made with yogurt, for example, fruit or yogurt drink "cmoothie", and cheese or cooked cheese products or egg products, such as scrambled eggs or egg noodles. A vegetable product may be a product that is prepared with fat as one of the ingredients, for example, cream-based vegetable soup, meat broth soups or a vegetable burger, or a vegetable product may be a product that is fried in a fat-containing material, for example French fries potato chips or falafel, where the amount of α-cyclodextrin in the product is based on an estimate of the amount of fat-containing material to be absorbed in the final product. The meat product may be a cooked product of beef, lamb, pork, poultry or seafood, such as sausages, slices of delicatessen products, sausages, fish sticks, chicken products of elongated shape and minced meat, from which hamburgers or meat bread are made, for example. . The method is also suitable for buttered or coated products, such as French fries, fish sticks, chicken products or tempura (fish and vegetables baked in dough), which are fried, and for liquid breading, which is used to cover products that fried in a fat-containing material. The amount of cyclodextrin in the liquid breading of a product is based on determining the amount of fat in its material that will be absorbed by the coated breading product. The method is also suitable for sweets and seasonings, for example chocolates, sauces, mayonnaise and salad dressings.

α-Cyclodextrin can be added to the consumed food product at any stage of its preparation and can be added under conditions that favor the formation of α-cyclodextrin and fat complexes so that the complexes are distributed throughout the consumed food product. Alternatively, α-cyclodextrin can be mixed with the fat-containing food product when it is consumed, determining the approximate amount of fat in the food product and then swallowing α-cyclodextrin in an amount sufficient to achieve a ratio of swallowed α-cyclodextrin to eaten fat from 1:20 to about 1: 3, preferably from 1:13 to about 1: 5, and more preferably, about 1: 9 w / w. A consumed, fat-containing food product preferably contains 7-80% fat, more preferably 20-70% fat, and most preferably 7-27% fat, in calories.

The present invention also relates to methods for alleviating a pathological condition often associated with obesity and overweight, for example, high cholesterol / HDL ratio, high triglycerides, high leptin levels, high insulin levels and insulin resistance, administration of α-cyclodextrin to a subject in need thereof, in an amount and over time sufficient to attenuate the pathological condition associated with obesity and overweight.

In the blood, serum cholesterol is found in combination with proteins. Of particular interest are high density lipoprotein (HDL) and low density lipoprotein (LDL). The invention also relates to a method for increasing a high density lipoprotein (HDL) cholesterol level in a subject, comprising administering α-cyclodextrin to a subject in need thereof, in an amount and for a time sufficient to increase HDL levels. The amount of α-cyclodextrin administered to the subject is preferably from about 500 mg to about 33 g per day, preferably from about 3-21 g per day, and more preferably from about 6-11 g per day. α-Cyclodextrin can be administered before, together with or after eating a fat-containing food product. A subject may be a subject that consumes approximately 100 g of fat / day. α-Cyclodextrin is administered to a subject, preferably with a fat-containing food product. A sufficient amount of α-cyclodextrin is about 165 mg-11 g / food, preferably about 1-7 g / food or, more preferably, about 2-3.3 g / food. α-Cyclodextrin can be administered in any suitable form, for example, in the form of a tablet, pill, capsule, liquid or other delivery medium suitable for human consumption, or in the form of food products, for example, bakery products, buns, rolls, biscuits and cereal breakfast dishes, for example, oatmeal, wheat soup, bran with raisins, corn flakes or other cooked cereals, and especially the food products of the present invention. A serving of food product for use in this method preferably contains 165 mg-11 g of α-cyclodextrin / food product, preferably about 1-7 g of α-cyclodextrin / food product, or more preferably about 2-4 g of α-cyclodextrin . α-Cyclodextrin is preferably administered to the subject in such an amount that the ratio of α-cyclodextrin to fat is from about 1:20 to about 1: 5 wt./wt., preferably from about 1:13 to about 1: wt./ wt., most preferably, about 1-9 wt./wt. on food or per day.

It is possible that total blood cholesterol levels will remain constant, even though HDL levels increase if there is a decrease in LDL levels. Thus, another aspect of the present invention is a method for increasing HDL levels and lowering LDL levels, lowering the cholesterol / HLD ratio or lowering cholesterol levels in a subject in need thereof by administering α-cyclodextrin in an amount and for a time sufficient to increase HDL levels and / or lower LDL levels, lower total cholesterol / HDL, and / or lower cholesterol. A decrease in LDL and an increase in HDL reduces the overall ratio of cholesterol to HDL. Total cholesterol levels are preferably not substantially reduced or increased.

α-Cyclodextrin may be administered to the subject in the form of a powder, tablet, capsule, drink or other delivery medium suitable for consumption, preferably a medium that does not contain linolenic acid. A sufficient amount of α-cyclodextrin is about 165 mg-11 g / food product, preferably about 1-7 g / food product, or more preferably, about 2-3.3 g / food product. The total amount of α-cyclodextrin swallowed daily is preferably from about 500 mg to about 33 g per day, more preferably from about 5 g to about 20 g per day, most preferably from about 6-11 g / day. α-Cyclodextrin is administered with food, preferably so that the ratio of α-cyclodextrin to fat is from about 1:20 wt./wt. to about 1: 3 wt./wt., preferably, the ratio is from about 1:13 wt./wt. to about 1: 5 wt./wt., more preferably, the ratio was 1: 9 wt./wt. on a food product.

A subject in need of increasing HDL and / or lowering LDL levels, lowering cholesterol / HDL ratios or lowering cholesterol levels is a subject who has a high ratio of total cholesterol to HDL or has a predisposition to it. Methods for determining blood cholesterol, HDL and LDL levels are well known in the art and there is no need to develop them here. However, a discussion of cholesterol levels and methods for determining cholesterol, HDL, and LDL levels can be found, for example, in Expert Program on detection, evaluation and treatment of high blood Cholesterol in adults. Executive Summary of the Third Report of the National Cholesterol Education Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III), JAMA 285 (19); 2486-97: 2001, and Handbook of Lipoprotein Testing, Rifai N. Warnick GR and Dominiczak MH, eds. Chapters 9, 11 and 12, AACC Press, Washington DC 200, both of which are incorporated herein by reference.

The present invention also relates to a method for reducing triglycerides in a subject, comprising administering to a subject in need thereof an amount of α-cyclodextrin sufficient to lower triglyceride levels. A subject in need of this is a subject that has high triglyceride levels, has a predisposition to high triglycerides, or has a family history of high triglycerides. High triglyceride levels are involved in various pathological conditions. Thus, this invention also relates to the treatment of a pathological condition, for example, cardiovascular disease, acute pancreatitis, insulin resistance and unregulated diabetes and various dyslipidemia associated with high triglycerides, administration of α-cyclodextrin to a subject in need in an amount sufficient to reduce triglyceride levels in a subject. Those skilled in the art are knowledgeable in methods for determining triglyceride levels in a subject. For an overview of methods for determining blood triglyceride levels, see, for example, Handbook of Lipoprotein Testing, Rifai N. Warnick GR and Dominiczak MH, eds. Chapter 10, AACC Press, Washington DC 200, incorporated herein by reference. α-Cyclodextrin may be administered before, simultaneously with or after ingestion of a meal containing fat. More preferably, α-cyclodextrin is administered to a subject with food containing fat. A sufficient amount of α-cyclodextrin is about 165 mg-11 g / food product, preferably about 1-7 g / food product, and more preferably about 2-4 g / food product. The total amount of α-cyclodextrin swallowed per day is preferably from about 500 mg to about 33 g per day, more preferably from about 5 g to about 20 g per day, most preferably from about 6-11 g / day. Preferably, the consumed ratio of α-cyclodextrin: fat per food product or per day is from about 1:20 to about 1: 3 wt / wt., Preferably, the ratio is from about 1:13 to about 1: 5 wt / wt. . and more preferably, the ratio is about 1: 9 wt./wt. α-Cyclodextrin may be administered to a subject in the form of a powder, tablet, capsule, drink, or other medium suitable for consumption, preferably a medium that does not contain linolenic acid. α-Cyclodextrin may be administered to a subject in the form of a food product, especially a food product of the present invention.

The present invention further relates to a method for reducing leptin levels in a subject, comprising administering α-cyclodextrin to a subject in need thereof in an amount sufficient to reduce leptin levels in the subject, α-Cyclodextrin can be administered before, simultaneously with or after ingestion of a fat-containing food . Preferably, α-cyclodextrin is administered immediately before or at the same time as taking fat-containing foods. More preferably, α-cyclodextrin is administered to a subject with a fat-containing food. The amount of α-cyclodextrin introduced into the food product is preferably about 165 mg-11 g / food product, more preferably about 1-7 g / food product, and most preferably about 2-3.2 g / food product. The total amount of α-cyclodextrin swallowed per day is preferably from about 500 mg to about 33 g per day, more preferably from about 5 g to about 20 g per day, most preferably about 6-11 g / day. Preferably, the amount of α-cyclodextrin administered daily to the subject and the fat consumed daily by the subject is in a ratio of from about 1:20 to about 1: 3 w / w, preferably, the ratio is from about 1:13 to about 1: 5 wt./wt. and more preferably, the ratio is about 1: 9 wt./wt. A subject in need of a decrease in leptin level is a subject that has high levels of leptin, has a predisposition to leptin resistance. Leptin levels can be determined using any method known in the art for determining leptin levels. For a review of various assays for determining leptin resistance, see Maffei et al., Nature Med 1: 1155-1161 (1995), incorporated herein by reference. α-Cyclodextrin can be administered to a subject in the form of a powder, tablet, capsule, drink, confectionery or other delivery medium suitable for human consumption, preferably a medium that contains less than 2% linolenic acid, more preferably a medium that contains less than 0.2% linolenic acid and, most preferably, a medium that does not contain linolenic acid. α-Cyclodextrin may be administered to a subject in the form of a food product, preferably a food product of the present invention.

The present invention further relates to a method for lowering blood insulin levels and insulin resistance in a subject, comprising administering α-cyclodextrin to a subject in need thereof in an amount sufficient to lower insulin levels in the blood of the subject. Insulin resistance usually causes type II diabetes. Insulin resistance can be assessed by the triglyceride / HDL-cholesterol glucose / insulin ratios. A subject in need of this is a subject that exhibits high levels of insulin, has type II diabetes, or is predisposed to develop type II diabetes, or who has a family history of high levels of insulin or type II diabetes. Any method commonly used to determine insulin levels can be used here to analyze and monitor insulin levels and resistance. See, for example, Berson et al. (Eds) Methods in Investigative and Diagnostic Endocrinology, ch 3, Part III, Vol. 28. American Elsevier Publishing Co., New York, 1973, incorporated herein by reference and provided to describe assays for determining insulin levels. α-Cyclodextrin may be administered before, simultaneously with or after ingestion of a meal containing fat. Preferably, α-cyclodextrin is administered immediately before or simultaneously with the intake of fat-containing foods. More preferably, α-cyclodextrin is administered to a subject with a fat-containing food. The amount of α-cyclodextrin introduced into the food product is preferably about 165 mg-11 g / food product, more preferably about 1-7 g / food product, and most preferably about 2-3.3 g / food product. The total amount of α-cyclodextrin swallowed per day is from about 500 mg to about 33 g per day, preferably from about 5 g to about 20 g per day, and most preferably from about 6-11 g / day. Preferably, the amount of α-cyclodextrin administered daily to the subject, based on the fat consumed daily by the subject, is in a ratio of from about 1:20 to about 1: 3 w / w, preferably, the ratio is from about 1:13 to about 1 : 5 wt./wt. and more preferably, the ratio is about 1: 9 wt./wt. α-Cyclodextrin can be administered to a subject in the form of a powder, tablet, gel, capsule, liquid, or other delivery medium suitable for human consumption, preferably a medium that does not contain linolenic acid. α-Cyclodextrin may be administered to a subject in the form of a food product, preferably a food product of the present invention.

The invention also relates to a method for alleviating diarrhea in a subject in need thereof, comprising administering to a subject in need thereof α-cyclodextrin in an amount and for a time sufficient to alleviate diarrhea in the subject. The subject may be a mammal, for example, a mouse, rat, cat, dog, cow, horse, monkey, anthropoid ape or human. Such a subject may be a subject who is prone to diarrhea or currently suffering from diarrhea, for example, the subject may be a patient with cholecystectomy, prone to diarrhea or having diarrhea, a patient suffering from fat-aggravated diarrhea, or a patient having acute or subacute diverticulitis, acute phases of some acute intestinal conditions, for example, ulcerative colitis or Crohn's disease, and such phases after certain types of bowel surgery, for example, colostomy or ileostomy. α-Cyclodextrin may be administered in the form of a food product, preferably a food product of the present invention, for example, a powdery or non-powdery food product of the present invention. α-Cyclodextrin may also be administered to a subject in the form of a powder, tablet, capsule, gel, liquid, or other delivery medium suitable for absorption. α-Cyclodextrin can be administered with the food product in an amount of, for example, about 165 mg-11 g / food product, preferably about 1-7 g / food product, and more preferably about 2-3.3 g / food product. The total amount of α-cyclodextrin swallowed per day is preferably from about 500 mg to about 33 g per day, more preferably from about 5 g to about 20 g per day, most preferably 6-11 g / day. The ratio of the introduced α-cyclodextrin to the eaten fat per food product or per day, preferably a food product, is about 1: 20-1: 3 wt / wt., Preferably, the ratio is about 1: 13-1: 5 wt. / wt., more preferably, the ratio is approximately 1: 9 wt./wt. α-Cyclodextrin may be administered prior to, at the same time as or after ingestion of food containing fat. Preferably, α-cyclodextrin is administered immediately before or simultaneously with the intake of fat-containing foods.

The addition of α-cyclodextrin to the feed product of a beloved animal maintains good qualities or promotes good feces of the beloved animal and / or improves the feces of the beloved animal. Good feces quality of the beloved animal is a very desirable sign, as it is perceived by the owner of the animal so that this sign is usually not only more aesthetically pleasing, but also a sign of good health of the beloved animal. As such, the present invention also relates to a feed product of a beloved animal that contains α-cyclodextrin in an amount sufficient to maintain good quality or to promote good feces of the beloved animal and / or to improve the feces of the beloved animal. Feces of good quality are solid and well formed, retaining their shape. Feces with such a moisture content that the form does not persist (frequent loose stools or diarrhea) or with such a moisture content that the feces are hard and dry, are not feces with good quality. The food of the beloved animal is preferably a packaged food. The packaging may be plastic, paper, cardboard or metal, for example, tin or soft foil. The pet food can be a wet pet food, such as food packaged in cans or soft foil, or a dry pet food, such as food packaged in paper or paperboard, such as wholemeal flour or biscuit. The food for the beloved animal is preferably food designed for a cat, dog, cow or horse. The present invention also relates to a method for maintaining a good animal feces or promoting good feces of a beloved animal and / or improving feces of a beloved animal by administering α-cyclodextrin to a beloved animal, preferably an animal in need thereof, in an amount and for a time sufficient to maintain good quality or promoting good quality animal feces and / or improving the quality of animal feces. α-Cyclodextrin can be administered with food in an amount of, for example, about 165 mg-11 g / feed, preferably about 1-7 g / feed and, more preferably, about 2-3.3 g / feed. The total amount of α-cyclodextrin swallowed daily is preferably from about 500 mg to about 33 g per day, more preferably from about 5 g to about 20 g per day, most preferably 6-11 g / day. The ratio of eaten α-cyclodextrin to eaten fat per feed or per day, preferably per feed, is approximately 1: 20-1: 3 wt. / Wt., Preferably, the ratio is approximately 1: 13-1: 5 wt / wt. ., more preferably, the ratio is approximately 1: 9 wt./wt. α-Cyclodextrin may be administered prior to, at the same time as, or after ingestion of a fat-containing feed. Preferably, α-cyclodextrin is administered immediately before or at the same time as receiving a fat-containing feed. α-Cyclodextrin can be administered to a beloved animal in the form of pills, cachets, tablets, capsules, etc. or in the form of a food product for a beloved animal, especially a food product for a beloved animal product of the present invention, including wet food for a beloved animal, such as food, packaged in cans or soft foil, or dry food for a beloved animal, such as food, packaged in paper or cardboard, such as wholemeal flour or biscuit. A favorite animal in need of this is an animal that has poorly formed feces or is predisposed to have such poorly formed feces, for example, a beloved animal with diarrhea or having a predisposition to diarrhea.

In the methods of this invention, α-cyclodextrin can be administered in the form of a single dosage unit consisting essentially of α-cyclodextrin. A single dosage unit may be in the form of a powder, tablet, capsule, gel, pellet, liquid, etc., α-cyclodextrin may be introduced into a powder, tablet, capsule, gel, ball, liquid, etc. in any way that is commonly used in this field. α-Cyclodextrin can be introduced into a powder, tablet, gel, capsule, bead, liquid, etc. with other commonly used additives, for example, colorants, antioxidants, fillers, starches, sugars, antibacterial or antifungal agents, preservatives, stabilizers or emulsifiers. α-Cyclodextrin can be mixed with any pharmaceutical carrier suitable for oral administration, for example, it can be enclosed in a hard or soft gelatin capsule, compressed into tablets, or included directly in a food product for an individual. In particular, α-cyclodextrin can be included in excipients and used in the form of swallowable tablets, capsules, elixirs, suspensions, syrups, cachets and the like. α-Cyclodextrin may be mixed with other food forms and pharmaceutically acceptable odor enhancers. Suitable pharmaceutical carriers and formulations are described, for example, in Remington's Pharmaceutical Sciences (19 ^th ed.) (Gennaro, ed. (1995) Mack Publishing Co., Easton, Pa), incorporated herein by reference. Preferably, the preparation is such that α-cyclodextrin is released in the stomach for mixing with food eaten so as to form complexes of α-cyclodextrin with fat, so that α-cyclodextrin: fat complexes are already formed when the chyme is pushed into the jejunum and mixed with bicarbonate and lipase.

Since only a relatively small amount of total cyclodextrin (for example, less than about 9 wt.%, Preferably less than about 6 wt.%, More preferably less than about 3 wt.% ) are added to food products to achieve the desired ratio of α-cyclodextrin to fat, α-cyclodextrin can be added to the food composition, while using α-cyclodextrin as a filler to replace an equal amount of dry ingredients in the food product. Thus, the caloric content of the food products of the present invention, determined by the calorimetry in the bomb, does not essentially change with the addition of total cyclodextrin. Even if dry ingredients are removed from the food product to compensate for them with a relatively small amount of cyclodextrin added to the food product (less than about 9%, preferably less than about 6 wt.%, More preferably less than about 3 wt./wt.%), the caloric content of the food product essentially should not be reduced.

The present invention also relates to methods for enhancing the organoleptic properties of a fat-containing consumed food product without reducing the calorie content (analysis was carried out with a calorimetric bomb) or significantly reducing the percentage of fat in the food product. The method comprises adding α-cyclodextrin to a fat-containing food product during product preparation. The amount of α-cyclodextrin added to food is based on the amount of fat in the final product. The food products of the present invention typically have an α-cyclodextrin to fat ratio of about 1: 20-1: 3 w / w, preferably about 1: 13-1: 5 w / w. and more preferably about 1: 9 wt./wt. The total amount of cyclodextrins added to the product is usually less than 9% w / w, preferably less than 6% w / w and more preferably less than 3% w / w. Products made with only 0.7% w / w α-cyclodextrin have enhanced organoleptic properties, such as a fresh taste, and a smoother structure. A consumed, fat-containing food product may contain 7-80% fat, preferably 20-70% or more preferably 40-70% fat, or 5-50% w / w% fat or, preferably, 7-25 wt./wt.% Fat. This method can be used for various fat-containing foods, for example, powdery food product, cooked vegetable product, dairy product, cooked poultry meat product or seafood, soups and seasonings, for example, gravy, sauces, mayonnaise, salad dressing, etc. d. A floury food product may be, for example, light snack slices, breakfast cereal dishes, pancakes, waffles, pancakes, tortilla, corn chips, tortilla chips, light crackers, bread, cake, cookies, donut, zeppoli and pie or another baked product stuffed with fruits or nuts. The dairy product of the present invention can be, for example, milk, cream, condensed sterilized milk without sugar or sugar, pudding, butter, ice cream, milkshake and cream-based sauces or soups, yogurt and drinks made with yogurt, for example fruit and yogurt a smoothie, and cheese or processed cheese products, or egg products, such as scrambled eggs or egg noodles. A plant product can be a product that is made with fat as one of the ingredients, for example, hummus, tahini, margarine and peanut butter, or it can be a vegetable product that is fried in a material containing fat, such as French fries, vegetable tempura (fish and vegetables baked in dough) or falafel, where the amount of α-cyclodextrin in the fried product is based on the amount of fat-containing material, which is measured by the fat contained in the fried food after frying. The meat product may be a cooked product of beef, lamb, pork, poultry or seafood, such as sausages, slices of delicatessen products, sausages, fish fingers, chicken products and elongated meat from which, for example, hamburgers, meatballs or meat bread. The method is also suitable for liquid breading, which is used to coat products, for example, French fries or tempura, for frying in a fat-containing material, for example lard or oil. In addition, the method is suitable for soups and seasonings, for example, gravy, sauces, salad dressings, where the ratio of α-cyclodextrin to fat described by supra can improve the structure and / or flavor of the product. The products of this invention often have a taste comparable to that of the same product, but made without α-cyclodextrin, and / or they have a smoother structure and a fresher taste. In addition, the inclusion of α-cyclodextrin in condensed sterilized milk with or without sugar gives a whiter product compared to the same product, but without α-cyclodextrin.

The present invention also relates to a method for reducing the amount of time required to produce whipped cream, comprising adding α-cyclodextrin to the cream before or during whipping. α-Cyclodextrin is added in an amount sufficient to reduce the amount of time required for the formation of whipped cream. Preferably, the amount of α-cyclodextrin is sufficient to achieve an α-cyclodextrin to fat ratio in cream of about 1: 20-1: 3 wt / wt, preferably about 1: 13-1: 5 wt / wt. and more preferably about 1: 9 wt./wt. Reducing the amount of time required to produce whipped cream reduces the amount of energy needed to operate the mixer, which when calculated on a commercial scale leads to large monetary savings in both electricity and human effort. Whipped cream remains soft and retains the ability to be superimposed with a spatula, whey does not separate from the rest of the components.

It is contemplated herein that whipped cream containing α-cyclodextrin can be used as a decoration on the upper surface of another fat-containing material, which may or may not contain α-cyclodextrin, and that the amount of α-cyclodextrin in whipped cream should be sufficient to form when consumed complex with fat in another fat-containing material, which thus also reduces its biological value.

Example 1

Figures 9A-9C depict the results of an in vitro study of vegetable oil (4 g), water (6 g) (with added food colored for contrast) and varying amounts of (A) α-cyclodextrin (100-2000 mg, from right to left), ( B) β-cyclodextrin or (C) γ-cyclodextrin. The strip of “wax-like” material located between the oil and water phases in the test tubes is transparent. The size of this band increases with increasing α-cyclodextrin content to a maximum in a test tube marked with 10% (400 mg of α-cyclodextrin / 4 g of oil). An increase in size (from right to left) of the white layer of unreacted α-cyclodextrin at the bottom of the tubes was noted. This material is displaced from the solution either with oil or with the α-cyclodextrin-oil complex. These tubes were centrifuged to increase the clarity of the separation of the layers. The “Voskopodobny” complex has such a consistency that all tubes in 9A, with the exception of the ones farthest to the right, can be inverted without seeping the aqueous phase around the complex.

The pore size of α-cyclodextrin is much smaller than the pore size of β-cyclodextrin and γ-cyclodextrin. Thus, one could not expect that α-cyclodextrin forms complexes with triglyceride molecules, since its molecules cannot correspond to the pores of α-cyclodextrin. However, the amount of fat in the form of a complex in test tubes containing an oil / β-cyclodextrin mixture (Figure 9B) and oil / γ-cyclodextrin (Figure 9C) is significantly less than that seen in tubes containing an oil / α-cyclodextrin mixture (figure 9A). This difference is even sharper in Figure 9C, where a strip of wax-like material is clearly visible. The white matter at the bottom of the tubes is precipitated cyclodextrin.

Example 2: Animal Research

To study the effect of α-cyclodextrin on body weight gain and plasma lipid levels in animals fed high-fat and low-fat food, the authors conducted a short-term study using Wistar rats. Forty-two male 10-week-old Wistar rats were obtained from Harlan-Sprague Dawley. After a one-week adaptation while feeding them with a low fat (LF) control feed, they were divided into two equal groups, one had a low fat (LF) feed and the other had a high fat (HF) feed. These two groups were further divided into two subgroups. Two groups received LF food or HF food and served as a control for two other test groups that received LF or HF food containing α-cyclodextrin, where the amount of α-cyclodextrin was such that the ratio of α-cyclodextrin to fat in the feed was 1 : 10 wt./wt. LF was prepared in accordance with AIN-93M and contained 4% (w / w) soybean oil as a source of fat. HF feed was a modification of LF feed with 40% soybean oil. Thus, the LF group receiving α-cyclodextrin (LF-cyclodextrin) ate 0.4 g of α-cyclodextrin / 100 g of feed and the HF group receiving α-cyclodextrin (HF-cyclodextrin) ate 4 g of α-cyclodextrin / 100 g feed. The caloric content of 4 feeds was as follows: LF: 3.96 kcal / g; LF-cyclodextrin: 3.66 kcal / g; HF: 5.70 kcal / g; HF-cyclodextrin: 5.59 kcal / g.

Rats were kept in pairs for five weeks before being placed in individual metabolic cells for six weeks of study. During the last three days of the study, feces of all rats were collected. At the end of a six-week study period, rats were sacrificed by decapitation after brief exposure to carbon dioxide. Torso blood and liver were collected from each animal. The rest of the body was eviscured and all visible fat in the internal cavity of the body was collected and weighed. The carcass was frozen to analyze body composition at a later time.

Eating feed and absorbing energy.

During the first five weeks of the study, the amount of feed eaten by the animals was monitored, and calorie absorption was calculated from these data. These data are presented in table 1 and figures 1 and 2 as the average for each group ± SD (standard deviation).

Table 1: Total feed intake and caloric intake by 4 groups of rats during the first 5 weeks of the study (mean ± SD) Group Total food eaten (g) Calorie Absorption (kcal) Lf 779 ± 40 2970 ± 154 LF-cyclodextrin 786 ± 87 2978 ± 332 Hf 753 ± 70 4072 ± 921 HF-cyclodextrin 769 ± 107 3986 ± 560

There is no statistical difference among any of the groups regarding the amount (g) of food eaten. Due to the higher caloric content of the HF feed, rats in the 2 HF groups absorbed significantly more calories compared to rats in the 2 LF groups. It should be noted that on the absorption of calories between the two groups of HF. or two LF groups were not affected by ingestion of α-cyclodextrin. These data show that (1) all rats were saturated with the amount of food eaten and (2) that if α-cyclodextrin was complexed with part of the fat and thus prevented rats from absorbing fat, the rats did not consume more food to compensate for it. There was no statistical difference among the groups with respect to their water consumption.

Change in body weight:

Figure 1 illustrates the change in body weight of four groups of growing rats throughout the study period. As the authors of the present invention have previously demonstrated (publications Jen Physiol Behav 42: 551-556 (1988) and Jen et al. Int J Obesity 19: 699-708 (1995), incorporated herein by reference), animals receiving HF food gave greater weight gain than animals fed LF. Figure 3 interestingly demonstrates that animals receiving food containing α-cyclodextrin and fat in a ratio of 1:10 wt./wt., Gave a weight gain at a slower speed relative to their respective control groups. Although it turned out that the control group with HF food nevertheless gave a mass gain at a considerable speed, it turned out that the mass growth rate of the other three groups reached a flat portion of the curve. It turned out that in this example, animals receiving α-cyclodextrin / high fat food have a weight gain at almost the same rate as animals receiving low-fat food (4% w / w fat) without α-cyclodextrin. Thus, by adding α-cyclodextrin to animal feed, in which the amount of α-cyclodextrin is based on the amount of fat in the feed, in this example 4% w / w% α-cyclodextrin and 40% w / w fat, weight gain significantly inhibited. This contrasts sharply with previous studies in which the cyclodextrin composition added to rat food does not affect the rate of weight gain until the percentage of cyclodextrin composition in the feed is at least 58.5% w / w. .

Body composition:

Analysis of body composition shows that the addition of α-cyclodextrin to LF food did not affect body fat content. However, when α-cyclodextrin was added to the HF feed, it significantly reduced body fat mass (LF: 48.3 ± 2.4 g; LF-cyclodextrin: 51 ± 6.5 g; HF: 71.3 ± 5.8 g ; HF-cyclodextrin: 55.6 ± 2.4 g, mean ± SE). This means that α-cyclodextrin is most effective in reducing body fat when the fat content of the feed is high.

Stoichiometry:

Shimada et al. (Shimada et al. "Structure of inclusion complexes of cyclodextrins with triglyceride at vegetable oil / water interface" J. Food Sci. 1992; 57 (3): 655-656) described that two α-cyclodextrin molecules form a complex with one free fatty acid (FFA), while Szejtli (Szejtli J. "Utilization of cyclodextrins in industrial products and processes" J. Mater. Chem. 1997; 7: 575-587) suggests that this phenomenon depends on the length of the fatty acid and that, it is possible that 3-4 molecules of α-cyclodextrin form a complex with each of the three free fatty acids of the triglyceride molecule. These results suggest that 9-12 α-cyclodextrin molecules may be required for the complete complexation of one triglyceride molecule. If this were the case, it would be difficult to imagine the possibility of feeding the animal a sufficient amount of α-cyclodextrin to form complexes of a sufficient amount of triglycerides to obtain a significant difference in body weight when the triglycerides and α-cyclodextrin have the same molecular weights. However, from the data described here, in which, for example, a feed containing 4% α-cyclodextrin and 40% fat inhibits mass gain and reduces body fat mass when the molecular weights are very similar, the inventors calculated that one molecule α β-cyclodextrin can complex with approximately nine triglyceride molecules; it is equivalent to 27 free fatty acids. Thus, the authors can present this directly as the possibility of 1 g of α-cyclodextrin to form complexes with approximately 9 g of griglyceride. Without claiming to be a theory, the difference in the number of α-cyclodextrin molecules needed for complexation with triglyceride based on the description of Shimada or Szejtli and the ratio of α-cyclodextrin to fat, described here as forming complexes with fat, suggests that α- cyclodextrin catalyzes the formation of large particles of triglyceride coated with α-cyclodextrin in the form of a very stable micelle, which thus reduces the biological value of fats in these particles. The authors were also able to demonstrate that when purified olive oil is pre-mixed with α-cyclodextrin, the lipolytic activity of pork pancreatic lipase is significantly reduced. When these particles form in the middle of the chyme, a very complex “soup”, the particles may be similar to the particles of lipoprotein in the bloodstream. This may also explain why the bacterial flora, as it turned out, is not able to metabolize complexes of α-cyclodextrin and fat from the small intestine. Feces fat content.

Total lipid determinations were performed on collected feces using standard publication methods of Folch et al. J Biol. Chem. 226: 497-509 (1957), incorporated herein by reference. The results (Figure 4) show a significant increase in fecal fat in rats fed HF-cyclodextrin (p <0.05), but not LF-cyclodextrin. On average, this increase was approximately 25%. These data show that α-cyclodextrin reduced the biological value of fat by preventing the absorption of fat when fat intake was high, and, in addition, prevented the metabolism of the intestinal flora of the colon of animals. The last observation was confirmed by visual inspection of feces. It turned out that all the material collected has a normal shape and consistency; there was no indication for diarrhea.

Plasma glucose, cholesterol and triglyceride levels.

Plasma glucose, cholesterol and triglyceride concentrations were measured in all euthanized animals using standard clinical laboratory methods, which can be found in Tietz Textbook of Clinical Chemistry, second edition. Burtis CA and Ashwood ER eds., W.B. Saunders Company A Division of Harcourt Brace and Company, 1994, Philadelphia, incorporated herein by reference (Figure 5). It turned out that, on average, α-cyclodextrin lowers total cholesterol levels by about 10%. This decrease was not statistically significant over a short study period; the authors expect that with a longer period of feeding, cholesterol levels will continue to decline. HDL cholesterol also decreased, but to a lesser extent, approximately 6-8%. LDL cholesterol levels in all animals were too low to really measure, since in rats, most of the cholesterol is in the HDL-cholesterol fraction, and very little is in the LDL-cholesterol fraction. Triglyceride levels were significantly reduced (p <0.05), by approximately 30%, in animals that received α-cyclodextrin. Glucose levels were not significantly affected by feeding HF or α-cyclodextrin, in contrast to the results described in Japanese Patent Application S60-94912, in which high levels of cyclodextrins (19.5%, 39%, 58.5% or 78 wt./ wt.% CD: total food) significantly reduced blood glucose.

Insulin resistance:

Increased insulin resistance, elevated blood triglyceride levels, and lowered HDL cholesterol are all risk factors for Syndrome X. The insulin / glucose ratios, as well as the triglyceride / HDL ratios, have been calculated to provide insulin resistance and the risk of Syndrome X. (Publication Szejtli J. Mater. Chem. 1997; 575-587, incorporated herein by reference). Although due to the short study period, feeding HF did not significantly induce insulin resistance, there seems to be a tendency in this direction. Similarly, HF-cyclodextrin-eating animals showed a tendency toward reduced insulin resistance. Based on the human study data presented below, the authors expected that when the period of administration of this food is extended, the decrease in insulin resistance will become significant and that α-cyclodextrin can significantly reduce the insulin resistance observed in rats administered with HF. Decreased triglyceride / HDL cholesterol α-cyclodextrin indicates a significant reduction in the risk of X syndrome.

Leptin:

Leptin is a protein hormone with important importance in the regulation of body weight, metabolism and reproductive function. Leptin is secreted mainly by adipocytes, confirming the idea that body weight is perceived as the total mass of fat in the body. Therefore, the authors analyzed plasma leptin levels in animals fed with LF and HF ± α-cyclodextrin using standard methods.

Figure 6 compares the plasma leptin levels obtained from four groups of rats in which leptin levels were determined using the RIA rat leptin determination kit (Linco Research, St. Charles, MO) according to the manufacturer's instructions, incorporated herein by reference. The amount of leptin present in the plasma of rats given HF (18.1 ± 3.2 ng / ml) is statistically higher (p <0.001) than rats given LF (7.5 ± 1.9 ng / ml). The plasma leptin concentration in rats given HF-cyclodextrin (9.6 ± 1.8 ng / ml) was not statistically different from rats with LF. Since adipose tissue is the source tissue for leptin, the data suggest that there is more body fat in rats given HF relative to the other three groups. Since leptin decreases feed intake and body weight, higher leptin levels indicate a state of leptin resistance in these rats given HF. However, when α-cyclodextrin is added to HF food, rats consuming this food have significantly lower leptin levels. This fact shows that body fat mass decreases in rats fed with HF-cyclodextrin and suggests that leptin resistance in these rats is reduced. These results suggest that these rats are more sensitive to leptin and, therefore, future weight gain may be more difficult. When the leptin content per gram of adipose tissue was calculated, it was shown that both feed fat and α-cyclodextrin independently affect blood leptin levels (LF: 0.11 ± 0.02 ng / ml / g adipose tissue; LF-CD: 0.075 ± 0.01; HF: 0.24 ± 0.03; HF-CD: 0.17 ± 0.03; effect of feed p <0.001; effect of CD p <0.001). In rats fed HF supplemented with α-cyclodextrin, the decrease in blood leptin level was higher than the decrease that can be calculated from the reduction in body fat mass. Therefore, α-cyclodextrin reduces blood leptin levels and decreases leptin resistance in addition to the decrease induced by a lower body weight / fat ratio. Similar results were obtained in studies in humans (see example 4).

Example 3: Initial Clinical Data

Effect of α-cyclodextrin on serum triglyceride levels.

To determine the effect of α-cyclodextrin on triglyceride levels, eight volunteers were fed for two consecutive days with an omelet from two eggs with cheese (54 g) and a milkshake containing only 47 g of fat after fasting overnight. On the first day, the food product also contained approximately 5 g of α-cyclodextrin. Blood samples (10 ml) from each volunteer were taken via a permanent venous catheter immediately before meals (zero time) and 1, 2 and 3 hours after meals and samples were analyzed to determine serum triglyceride levels. Zero sample time was used as a baseline to calculate the change in percent serum triglyceride levels in volunteers after one, two, and three hours. Figure 7 illustrates data collected from volunteers. It should be noted that the expected increase in serum triglyceride levels is less when α-cyclodextrin was mixed with food than when it was not present, although the difference did not reach a significant value (p <0.08) due to the large variation among individuals and a small number of individuals included into this study).

Figure 7 also contains data obtained from three volunteers who took part in an earlier two-hour study with a smaller food product (marked with *). An earlier two-hour study also showed that the change in triglyceride levels is less when α-cyclodextrin is included in a food product.

Mass loss effects

To determine whether the addition of α-cyclodextrin to a high fat food product leads to weight loss, α-cyclodextrin was added to the high fat food product of the test subject, i.e. A 50-year-old male volunteer is five feet and seven inches tall with an initial height of 267 pounds. α-Cyclodextrin was added to the subject's food product in an amount of one gram of α-cyclodextrin for every nine grams of fat that was calculated to be consumed by the subject. Figure 8 shows the change in body weight of a subject over a period of 200 days, approximately 6 months. For 6 months, the subject's body weight decreased by 32 pounds. In addition to weight loss, in the first two weeks of the study, the subject's high blood pressure decreased to the point at which he was forced to reduce the dose of the beta-blocker prescribed to him by one third. His blood triglyceride content was also analyzed during this time, and his serum triglyceride levels decreased by 23% in the first month and by 46% at the end of six months. The effect of α-cyclodextrin on various parameters is shown in table 2.

table 2 Parameter Baseline 1 month 6 months Cholesterol (mmol / L) 4.76 4.76 4.0 HDL Cholesterol (mmol / L) 0.97 1.00 1,11 Cholesterol / LDL 4.91 4.76 4.41 Triglycerides (mmol / L) 2.76 2.13 1,50 Insulin resistance 2.85 2.13 1.35 Body mass index 39.17 37.27 Body Fat (%) 33.5 30,0 Waist (cm) 124 117 Thigh (cm) 127 117 Energy of food, kcal / d 1,656 1,795 Total fat (g / a) 112 103 Fat content (%) 60.9 51.7 Total carbohydrate (g / d) 56 84 Carbohydrate Content (%) 13.5 18.7 Total protein (g / d) 106 133 Protein Content (%) 25.6 29.6

α-Cyclodextrin was also added to the food product of two additional volunteers. α-Cyclodextrin was added in such an amount that each food product contained approximately 2 g of α-cyclodextrin. Table 3 shows the effect of α-cyclodextrin on lowering cholesterol, LDL, cholesterol / HDL and serum triglycerides. It should be noted that both of these volunteers, as well as the first volunteer indicated, had to take and still took one of the statin pharmaceuticals to lower their serum cholesterol. All three volunteers took various statins. In addition, the FK volunteer took 3 g / d niacin, which he reduced by 50% in the first two weeks of the study due to unpleasant side effects of this drug.

Table 3 Volunteer Number of months Cholesterol Cholesterol / HD L LDL Tg Fk 2,5 -18.5% -16.1% -25.6% -22.2% Ja 6 -10.2 -8.8 -15.0 -37.5%

Example 4: Levels of Insulin and Leptin

Blood samples were taken from two additional patients in Example 3 at different time points and analyzed for insulin and leptin levels by the Linco Research method (St. Charles, MO) using radioimmune analyzes of human insulin and leptin.

The results of this analysis, presented in Table 4, demonstrate that the decrease in insulin and leptin levels is greater than the decrease that can be calculated from the reduced body weight.

Table 4

Days on a diet Body weight (lbs / kg) Insulin (μE / ml) Leptin (ng / ml) Subject 1 0 196 / 89.09 fourteen 3.6 55 188 / 85.45 13 2.9 112 180 / 81.82 8 1,6 % decrease 5.0% 42.9% 55.6% Subject 2 0 232 / 105.45 26 6.1 28 230 / 104.55 28 6.0 62 220.5 / 100.23 16 3.9 % decrease 5.0% 38.5% 36%

Example 5

A castrated male dog of unknown origin, eighteen months of age, with chronic diarrhea, was subjected to deworming twice and “planted” on hypoallergenic food in an attempt to combat diarrhea. However, chronic diarrhea did not alleviate and the dog stopped eating for a day or two in two or three separate cases.

The dog was then treated with α-cyclodextrin as follows. The dog was fed a diet food containing a teaspoon (2.5 g) of α-cyclodextrin mixed with two cups of dry food, twice a day for two and a half weeks. Based on the fat content in the feed, the ratio of α-cyclodextrin to fat was approximately 1: 9. During this period, the dog’s chronic diarrhea was eliminated, with the exception of the acute episode of clear liquid stool after a day of bathing the dog in the river, but there has not been such a stool since.

The dog was then fed an identical diet that did not contain α-cyclodextrin for 4 days. The dog very quickly lost her appetite, she herself limited her feed intake by about half and began to eat grass, the grass helps to bind his stool. Diarrhea has returned.

α-Cyclodextrin (5 g) was then reintroduced into the dog food and the diarrhea was again eliminated.

Example 6: Food Products

The amount of α-cyclodextrin included in the food products of the present invention is based on the amount of fat contained in the food product. The following describes various common fat-containing foods in which α-cyclodextrin is added in accordance with this invention. Table 5 shows the total mass of food products and the amount of α-cyclodextrin, fat and carbohydrates in the products described in this example, compared with products described in other references.

A. Chocolate Chip Cookies and Espresso

260 g of confectionery flour

75 g cocoa powder

3.8 g baking powder

2.8 g of salt

226 g margarine

150 g sugar

180 ml (165 g) molasses or brown sugar

28 g of α-cyclodextrin

5 g vanilla extract

22 g espresso coffee (at room temperature)

2 eggs

115 g chocolate chips

Flour, cocoa, baking powder and salt are mixed together and then margarine, sugar, molasses (or brown sugar), α-cyclodextrin, vanilla and espresso are added to the mixture. Lightly beaten eggs are rubbed into the dough and chocolate chips are wrapped in it. Large pieces of dough the size of a teaspoon were placed on a slightly greased cookie sheet and then baked for about 15 minutes in a conventional oven or 10-12 minutes in a convection oven previously heated at 375F. Baked cookies were cooled on a wire frame.

Most blind tasters found that sintered biscuits were indistinguishable from biscuits made using the same recipe without the addition of α-cyclodextrin. Those who found the difference preferred liver, which included α-cyclodextrin, as they described that it was more rich, tender, tasty and moist with a more pleasant texture in the mouth than cookies baked without α-cyclodextrin.

B. Honey oatmeal cookies

42 g butter

110 g brown sugar

85 g honey

1 egg

15 g of water

58 g flour

2.5 g salt

0.75 g sodium bicarbonate

81 g flattened oatmeal

4 g of α-cyclodextrin

In a mixer, preferably with paddle devices, wet ingredients, oil, brown sugar, honey, an egg and water are mixed together. The remaining dry ingredients, with the exception of flattened oatmeal, were sieved into the tank. Flattened oatmeal was then added to the dry ingredients. Wet and dry ingredients were then mixed together and aliquots of the dough were applied to a greased cookie sheet and baked for 12-15 minutes in a conventional oven preheated to 350F, or 8-10 minutes in a convection oven. Baked cookies were cooled on a wire frame.

Most blind tasters found that sintered biscuits were indistinguishable from biscuits made using the same recipe without the addition of α-cyclodextrin. Those who found the difference preferred liver, which included α-cyclodextrin, as they described that it was more rich, tender, tasty and moist with a more pleasant texture in the mouth than cookies baked without α-cyclodextrin.

C. Five-layer bars

69 g corn flakes

100 g sugar

113 g butter or margarine

115 g chocolate chips

115 g caramel chips

124 g coconut flakes

63 g chopped nuts

1 can (14 ounces, 400 g) of condensed milk with sugar

36 g of α-cyclodextrin

Corn flakes, molten butter and 18 g of α-cyclodextrin were mixed together in a baking dish measuring 13 × 9 × 2 inches and mixed together. The mixture was evenly and tightly pressed at the bottom of the mold to form a crust.

Chocolate chips, caramel chips, coconut and chopped nuts were evenly distributed over the crust and 14 ounces (400 g) of condensed milk with sugar mixed with 18 g of α-cyclodextrin were poured evenly over 5 layers and then baked at 350F for 23 minutes or until light brown edges appear. The product was completely cooled and cut into 24 pieces.

Most blind tasters found that sintered bars were indistinguishable from bars made using the same recipe without the addition of α-cyclodextrin. Those who found the difference preferred bars that included α-cyclodextrin, as they described that the bars were more rich, delicate, tasty and moist with a more pleasant texture in the mouth than bars without α-cyclodextrin. It should be noted that condensed milk with sugar undergoes a significant change when mixed with α-cyclodextrin. Usually condensed milk with sugar is very thick, which makes it difficult to pour out, and has an unattractive, not quite white color. When mixed with α-cyclodextrin, it becomes much more tender and more liquid in nature, and its appearance changes to a very bright white color.

D. Macaroni and cheese

98 g butter

29 g flour

484 g bold drinking cream

4 g of salt

0.53 g ground white pepper

6 g hot chili pepper sauce

106 g grated Parmesan cheese

57 g grated cheddar cheese

50 g grated fontina cheese

50 g grated Gruyere cheese

450 g pasta

3 g chopped garlic

25 g of fresh crumbs

3 g of spices

33 g of α-cyclodextrin

1/2 teaspoon of spices

33 g of α-cyclodextrin

29 g of flour and 33 g of α-cyclodextrin are added to 56 g of oil, the mixture is melted and cooked for 3 minutes. Bold drinking cream is slowly added to the mixture of molten butter and flour and then boiled with frequent stirring until thick, about 4-5 minutes. The mixture is removed from the heat and salt, pepper, hot sauce and half of the grated Parmesan are added to the mixture and mixed until the cheese melts.

Boil the pasta in boiling water and cooked pasta mixed with butter and chopped garlic. A mixture of cheeses is added to the pasta. The remaining cheeses are mixed and added to the pasta mixture, crumbs are applied in a layer on pasta and cheese and baked for 40-45 minutes.

Blind-working tasters found that this food product obtained with α-cyclodextrin was more delicate and soft and moisturized than the same product obtained without α-cyclodextrin.

Table 5 Total weight g Total CHO, g Total fat, g Added α-CD, g α-CD as% of total weight α-CD as% CHO α-CD as% fat Kcal fat (%) Fat mass / total weight (%) Kcal CHO (%) Weight CHO / total weight (%) Cheese omelette 162 5 thirty 3.5 2.2% 70% 11.7% 68% 18.5% 5% 3.1% Peanut butter 34 (2 tsp) 8 16 2.0 5.9% 25% 12.5% 70% 47% fifteen% 23.5% Meat bread 1659 146 317 36 2.2% 24.7% 11.4% 69% 19.1% fourteen% 8.8% Macaroni w / 4 with cheese 1586 395 293 33 2.1% 8.4% 11.3% 51% 18.5% 31% 24.9% Five Layer Bars 1241 702 292 35 2.8% 5.0% 12% 46% 23.5% 49% 56.6% French bread pudding with apples 1365 295 112 10.5 0.8% 3.6% 9.4% 42.4% 8.2% 49.6% 21.6% Honey Oatmeal Cookies 492 308 48 3.5 0.7% 1.1% 7.3% 24% 9.8% 69% 62.6% Chocolate Chip Cookies with Express Cookies 1020 556 231 28 2.8% 5.0% 12.2% 46% 22.7% 49% 54.5% Biscuit 1323 870 108 12 0.9% 1.4% 11.1% twenty% 8.2% 71% 65.8% Oil Cakes, Japan Patent Application S60-94912 470 170 141 50 (CD comp) ² 10.6% (CD comp) ² , 3.2% α-CD 29.4% (CD comp) ² , 8.8% α-CD 35.5% (CD comp) ² , 10.6% α-CD 64% thirty% 31% 36.2% Chinese Noodles, Japan Patent Application S60-94912 1336 535 22.15 300 (CD comp) ² 22.5% (comp) ² , 7.5% α-CD 56.1% (CD comp) ² , 18.7% α-CD 1364% (CD comp) ² , 454% α-CD 7% 1.7% (18.8% when frying) 72% 74.9% Biscuit, Japan Patent Application S60-94912 2015 1400 400 500 (CD comp) 2 24.8% (CD comp) ² , 7.4% α-CD 35.7% (CD comp) ² , 10.7% α-CD 125% (CD comp) ² , 37.5% α-CD 45% 19.9% 49% 69.5% ¹ CD comp. = Cyclodextrin Blend ² From Best Recipes This Side of Heaven Holy Trinity Anglican Church Cookbook Committee, Yorkton, Saskatchewan p. 172, Perksen Printers Ltd. Steinbach, Manitoba ROA 2AO CA

There is a clear association between weight gain, obesity, and various pathological disorders, such as diabetes, insulin resistance, cardiovascular disease, elevated blood lipid levels, sleep apnea, arthritis, certain types of cancer, and increased mortality rates (Solomon and Manson, "Obesity and mortality: a review of epidemiological data ". Am J Clin Nutr 1997; 66: 1044S-1050S). Health care and the cost of mass loss for obesity-related disorders reached $ 117 billion in 2000 (Overweight and obesity: At a glance. Office of the surgeon General, 2001). It is indicated that changes in body mass index (BMI) precede the onset of diabetes (Resnick et al., "Relation of weight gain and weight loss on subsequent diabetes risk in overweight adults" J Epidemiol Community Health 2000; 54: 596-602) and for each one kg increase in body weight increases the prevalence of diabetes by 9% (Mokdad et al. "Diabetes trends in US: 1990-1998." Diabetes Care 2000; 23: 1278-1283). Although type II diabetes is associated with overweight, other metabolic disorders observed in obesity may contribute to the onset of type II diabetes. Obese individuals tend to hyperlipidemia, hyperinsulinemia, and insulin resistance, all of which have been found to increase the risk of developing type II diabetes (Kisseban et al. Health risks of obesity. Med Clin North Am 1989; 73: 111-138; Kreisberg et al., Insulin secretion in obesity. N. Engl J Med 1967; 276: 314-319, and Olefsky J. Insulin resistance and insulin action: an in vitro and in vivo perspective. Diabetes 1981; 30: 148-162). Therefore, reducing the severity of any of these disorders can also reduce the risk of developing type II diabetes. The products of this invention have organoleptic properties desirable for consumers and also stimulate weight loss and other health benefits.

Claims (58)

1. Consumed food product containing α-cyclodextrin and fat, where the specified food product has a ratio of α-cyclodextrin to fat from 1:20 wt./wt. to about 1: 3 wt./wt. in said food product and where said food product contains less than about 9% w / w of total cyclodextrin. 2. Consumed food product according to claim 1, where the specified food product is a powdery food product. 3. Consumed food product according to claim 2, containing at least about 7 to about 80% fat by calorie content. 4. Consumed food product according to claim 2, containing less than about 6 wt./wt.% Of total cyclodextrin. 5. Consumed food product according to claim 2, where the food product is cooked. 6. Consumed food product according to claim 1, where the specified food product is a non-floury food product. 7. Consumed food product according to claim 6, where the specified non-floury food product is a dairy, meat or vegetable food product. 8. The consumed food product according to claim 6, containing from 5 wt. / Wt.% Up to 50 wt. / Wt.% Fat. 9. A method of enhancing the organoleptic properties of a fat-containing consumed food product, comprising adding α-cyclodextrin to said fat-containing food product so that the food product has an α-cyclodextrin to fat ratio of about 1: 20-1: 3 wt./wt. and that said food product contains less than about 9% w / w of total cyclodextrin. 10. The method according to claim 9, where α-cyclodextrin is essentially pure α-cyclodextrin. 11. The method according to claim 9, where the specified consumed food product contains from about 7 to about 80% fat by caloric content. 12. The method according to claim 9, where the fat-containing consumed food product is a consumed mealy food product. 13. A method of reducing the biological value of fat in a consumed, fat-containing food product, comprising determining the amount of fat in a consumed, fat-containing food product and mixing α-cyclodextrin with a consumed, fat-containing food product so that the consumed, fat-containing food product has a ratio α-cyclodextrin to fat is from about 1:20 to about 1: 3 wt / wt, wherein said food product contains less than about 9 wt / wt% of total cyclodextrin, wherein said α β-cyclodextrin is not removed from the specified food product before consumption. 14. The method according to item 13, where the consumed food product is a consumed mealy food product. 15. The method according to item 13, where the consumed food product is a consumed non-floury food product. 16. The method according to clause 15, where the consumed non-powdery food product is a consumed dairy, meat or vegetable product. 17. The method according to 14, where the consumed powdery food product contains from about 7 wt. / Wt.% Up to 80 wt. / Wt.% Fat by caloric content. 18. The method according to item 13, where α-cyclodextrin is combined with the consumed fat contained in the food product in the form of a pill, tablet, powder, capsule, liquid or confectionery. 19. A method of increasing high density lipoprotein (HDL) cholesterol in a subject in need thereof, comprising administering α-cyclodextrin to the subject in an amount sufficient to achieve a ratio of from 1:20 to about 1: 3% w / w cyclodextrin to fat in a food consumed by a subject. 20. The method according to claim 19, where approximately 165 mg-11 g of α-cyclodextrin is administered to the specified subject with a consumed food product. 21. The method according to claim 19, where the specified subject consumes approximately 100 g of fat per day. 22. The method according to claim 19, where the total cholesterol levels in the specified subject does not increase. 23. The method according to claim 19, where α-cyclodextrin is administered in a form selected from the group consisting of tablets, powder, capsules, liquids and confectionery. 24. The method according to claim 19, where α-cyclodextrin is administered to the subject in the form of a consumed powdery food product according to claim 2. 25. The method according to claim 19, where approximately 500 mg-33 g of α-cyclodextrin is administered to a subject in need of it daily to increase high density lipoprotein (HDL). 26. The method according to claim 19, where α-cyclodextrin is administered to the subject in the form of a consumed non-powdery food product according to claim 6. 27. A method of reducing a cholesterol / HDL ratio in a subject, comprising administering to a subject in need thereof an amount of α-cyclodextrin such that the amount of α-cyclodextrin administered to the subject and the fat in the food consumed by the subject are approximately from 1:20 to about 1: 3, w / w. 28. The method according to item 27, where α-cyclodextrin is administered in a form selected from the group consisting of tablets, powder, capsules, liquid and confectionery. 29. The method according to item 27, where α-cyclodextrin is administered to the subject in the form of a powdery food product according to claim 2. 30. The method according to item 27, where approximately 500 mg-33 g of α-cyclodextrin is administered to a subject in need of it daily to reduce the cholesterol / HDL ratio. 31. The method according to item 27, where α-cyclodextrin is administered to the subject in the form of a consumed non-powdery food product according to claim 6. 32. A method of stimulating weight loss in a subject in need thereof, comprising administering to the subject such an amount of α-cyclodextrin such that the amount of α-cyclodextrin administered to the specified subject and the amount of fat in the food consumed by the indicated subject, which the subject wishes to prevent absorption, was in a ratio of from about 1:20 to about 1: 3, wt./wt. 33. The method according to p, where the specified subject has a daily diet containing at least 30% fat by caloric content. 34. The method according to p, where α-cyclodextrin is administered in the form of a tablet, powder, capsule, liquid or confectionery. 35. The method according to p, where α-cyclodextrin is administered to the subject in the form of a consumed powdery food product according to claim 2. 36. The method of claim 32, wherein approximately 500 mg-33 g of α-cyclodextrin is administered to a subject in need thereof daily to stimulate weight loss. 37. The method according to p, where α-cyclodextrin is administered to the subject in the form of a consumed non-powdery food product according to claim 6. 38. A method of reducing triglyceride levels in a subject, comprising administering to a subject in need thereof an amount of α-cyclodextrin such that the amount of α-cyclodextrin administered to the subject and the fat in the food consumed by the subject is in a ratio of from about 1 : 20 to about 1: 3, w / w. 39. The method according to § 38, where α-cyclodextrin is administered in the form of a tablet, powder, capsule, liquid or confectionery. 40. The method according to § 38, where α-cyclodextrin is administered to the subject in the form of a consumed, mealy food product according to claim 2. 41. The method of claim 38, wherein approximately 500 mg-33 g of α-cyclodextrin is administered to a subject in need thereof daily. 42. The method according to § 38, where α-cyclodextrin is administered to the subject in the form of a consumed non-floury food product according to claim 6. 43. A method of reducing leptin levels, insulin levels, or insulin resistance in a subject, comprising administering α-cyclodextrin to a subject in need thereof in an amount sufficient to achieve a ratio of from about 1:20 to about 1: 3% w / w cyclodextrin to fat in the consumed food product adopted by the subject to reduce leptin levels, insulin levels or insulin resistance in the specified subject. 44. The method according to item 43, where α-cyclodextrin is administered in the form of a tablet, powder, capsule, liquid or confectionery. 45. The method according to item 43, where α-cyclodextrin is administered to the subject in the form of a consumed powdery food product according to claim 2. 46. The method according to item 43, where approximately 500 mg-33 g of α-cyclodextrin is administered to a subject in need of it daily. 47. The method according to item 43, where α-cyclodextrin is administered to the subject in the form of a consumed non-powdery food product according to claim 6. 48. The method according to clause 47, where the consumed food product contains approximately 40-70% fat wt./wt. or in calories. 49. A method of alleviating diarrhea in a subject, comprising administering to a subject in need thereof, α-cyclodextrin in an amount sufficient to achieve a ratio of from 1:20 to about 1: 3 wt / wt% cyclodextrin to fat in a consumed food product subject. 50. The method according to 49, where the specified subject is a subject with cholecystectomy or a patient suffering from exacerbation of diarrhea due to fat intake. 51. The method according to § 49, where α-cyclodextrin is administered in the form of a consumed powdery food product according to claim 2. 52. The method of claim 49, wherein the α-cyclodextrin is administered to a subject in the form of a pill, capsule, cachet, tablet, powder, liquid, or confectionery. 53. The method of claim 49, wherein approximately 500 mg-33 g of α-cyclodextrin is administered daily to a subject in need thereof. 54. The method according to § 49, where α-cyclodextrin is administered in the form of a consumed non-powdery food product according to claim 6. 55. The method according to § 49, where the consumed food product contains approximately 20-70% fat wt./wt. or in calories. 56. The method according to 49, where the subject is a mammal. 57. The method according to p, where the mammal is selected from the group consisting of man, horse, cattle, dog and cat. 58. The method according to clause 57, where α-cyclodextrin is administered in the form of animal feed.

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