WO2011001283A2 - Composition and method for reducing food intake - Google Patents
Composition and method for reducing food intake Download PDFInfo
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- WO2011001283A2 WO2011001283A2 PCT/IB2010/001722 IB2010001722W WO2011001283A2 WO 2011001283 A2 WO2011001283 A2 WO 2011001283A2 IB 2010001722 W IB2010001722 W IB 2010001722W WO 2011001283 A2 WO2011001283 A2 WO 2011001283A2
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- guarana
- fiber
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/77—Sapindaceae (Soapberry family), e.g. lychee or soapberry
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/04—Anorexiants; Antiobesity agents
Definitions
- FIBRESURE is a 100% natural fiber supplement that can be taken daily.
- the term fiber covers a wide variety of substances belonging to the family of carbohydrates that resist hydrolysis by human alimentary enzymes but are fermented by colonic micro flora (Bianchi & Capurso (2002) Dig. Liver Dis. 34 (Suppl 2):S129-33). Fiber is normally connected with increases in satiety due to its high viscosity and bulking effect (Burton-Freeman (2000) J " . Nutr. 130:272S-275S) . However, FIBRESURE is a fiber product with little effect on viscosity.
- FIBRESURE contains the soluble fiber inulin, which is a prebiotic carbohydrate derived from chicory root. Inulin and inulin-type fructans are mostly oligosaccharides or oligofructoses and stimulate colonic production of Short Chain Fatty Acids (SCFAs) , (Guarner (2005) Brit. J. Nutr. 93:S61-5). Fiber fermentability which produces SCFA has been linked with increasing satiety (Bosch (2008) Br. J. Nutr. 102:318-325).
- inulin and inulin-type fructans exert a satiating effect have not been identified.
- gastrointestinal peptides that affect food intake such as ghrelin, cholecystokinin (CCK) , glucagon- like peptide-1 (7-36) amide (GLP-I) , oxyntomodulin, peptide YY (PYY) and pancreatic polypeptide (PP) .
- Fructans modulate gastrointestinal peptides involved in the control of food intake, particularly GLP-I and ghrelin (Orskov, et al . (1989) J. Biol. Chem. 264 (22) : 12826-12829) .
- GLP-I is an anorectic peptide secreted by the L-cells which suppresses meal-induced gastric acid and pancreatic juice secretion and slows gastric emptying (Schjoldager, et al . (1989) Dig. Dis. Sci . 34:703-708).
- peripheral injection of GLP-I decreases food intake and consequently body weight in rats and human subjects, (Meier, et al . (2002) Eur. J. Pharmacol. 440 :269-279 ; Zander, et al . (2002) Lancet 359:824-830).
- Ghrelin is associated with the mesolimbic cholinergic dopaminergic reward system.
- This reward link is composed of cholinergic input from the laterodorsal tegmental area to the mesolimbic dopamine system that originates in the ventral - A - tegmental area and projects to the nucleus accumbens (Jerlhag, et al . (2007) Addict. Biol. 12(1): 6-16).
- treatment of human volunteers with approximately 2Og of oligofructose per day for 7 days increased serum GLP-I levels (Piche, et al . (2003) Gastroenterology 124 (4) : 894-902) .
- the present invention features a composition for suppressing appetite, said composition being composed of a dietary fiber and a combination of selected herbal extracts wherein said combination includes at least one herbal extract capable of inhibiting gastric emptying and one herbal extract which increases metabolic rate.
- the herbal extract which increases metabolic rate contains caffeine.
- the at least one herbal extract capable of modifying metabolic rate achieves said effect through the presence of significant concentrations of caffeine.
- the herbal extract which contains caffeine is Guarana, Paraguay or Kola.
- the herbal extracts are selected from Buchu, Vervain, Damiana, Guarana, Paraguay, Kola and Ginseng.
- the present invention features a composition containing the combination of selected herbal extracts including Guarana, Damiana and Paraguay, e.g., at a ratio of 2.6:1:3.1, or when based on weight, the proportion is Guarana 95: Damiana 36: Paraguay 112.
- the dietary fiber is fermentable and is selected from the group of inulin, a beta-glucan (e.g., isolated from oat bran, whole oats, oatrim or rolled oats), a pectin, a natural gum (e.g., xanthan gum, acacia gum or guar gum) , an oligosaccharide
- fructooligosaccharide e.g., fructooligosaccharide
- psyllium seed husk e.g., psyllium seed husk
- a resistant dextrin e.g., psyllium seed husk
- the present invention also features a method for reducing food intake by administering to a subject in need thereof an effective amount of a dietary fiber and a combination of selected herbal extracts wherein said combination comprises at least one herbal extract capable of inhibiting gastric emptying and one herbal extract which increases metabolic rate, thereby suppressing the subject's food intake.
- the combination of selected herbal extracts includes Guarana, Damiana and Paraguay and the dietary fiber is fermentable.
- the periodic discharge of food from the stomach into the small intestine is caused by contraction of the muscles in the wall of the stomach. These muscles are innervated by the cranial vagus nerves, which stimulate contraction of the gastric muscles and allow sphincter between the stomach and the duodenum to open.
- the present invention relates to a composition comprising a combination of selected herbal extracts wherein at least one of the herbal extracts inhibits gastric emptying. Because nutritional uptake through the mucosal lining of the stomach is extremely low, the extended retention period in the stomach of food resulting from these compositions does not have any discernable effect on the eventual uptake of nutrients. However, inhibition of gastric emptying results in a decreased appetite thereby decreasing food intake.
- compositions of the present invention further include at least one herbal extract capable of modifying metabolic rate through the presence of significant concentrations of caffeine.
- at least one herbal extract capable of modifying metabolic rate through the presence of significant concentrations of caffeine.
- Active ingredients extracted from plants are used as a natural nutritional supplement in such a way to control the uptake of nutrients by delaying gastric emptying.
- plant extracts are incorporated which are known to promote weight loss by increasing metabolism.
- the composition of the present invention thus provides a combination of selected herbal extracts which has been shown to be effective in producing weight loss in clinical studies.
- Herbal plant extracts that have been assessed and found to be suitable for selection and incorporation into a composition of the present invention for achieving a controlled and durable weight loss include Buchu (Barosma betulina, B. crenulata, B. serratifolia) , Vervain ⁇ Verbena officinales, V. jamaicensis, V. lappulacae, V. hesitate, V. urticifolia, V. Sinuata) , Damiana (Tumera diffusa var . aphrodisiaca, T. opifera, T. ulmifoliei) , Guarana ⁇ Paullinia cupana, P.
- each herbal extract is desirably as follows: extracts from the leaves of Buchu containing diosphenol (buchu camphor) ; extracts from the leaves or flowers of Vervain containing glycosides ⁇ e.g., verbanaline) , adenosine, essential oils, tannin, livertin and/or emulin; Damiana extract containing ethers, terpenes (a-pinene, cineol, p-cymol, sesquiterpenes), resin, bitter pineapple, tannin, caoutchouc, albuminoids, starch, arbutin,- extracts of Kola nut containing caffeine; Guarana extract containing caffeine and other xanthines (tetramethylxanthine, theobromine, theophylline, tannin); Paraguay extract containing caffeine; or extracts from the leaves or flowers of Ginseng containing triterpenoid saponins .
- an herbal extract which increases metabolic rate is specifically selected to contain caffeine.
- the herbal extract which increases metabolic rate does so through the presence of significant concentrations of caffeine.
- herbal extracts containing caffeine include, but are not limited to, Guarana, Paraguay (also referred to herein as yerbe mate) and Kola.
- Herbal extracts for combination into a composition of the present invention are obtained in accordance with methods described herein and those well-known and routine to those of skill in the art.
- a combination of selected herbal extracts e.g., yerbe mate extract, guarana extract, damiana extract
- dietary fiber can significantly decrease food intake compared to use of the herbal extracts alone or dietary fiber alone.
- the combination of herbal extract and dietary fiber described herein provided a significant reduction in gram (91.4g, 24.3%) and kcal intake (2O2.kcal, 26.7%) as compared to placebo-water.
- the combined administration of herbal extract and dietary fiber produced a significant reduction in gram intake compared to placebo in all food groups except low fat sweet items; intake of high fat savory items was reduced by 18.5g (27.6%), low fat savory intake reduced by 19.
- the present invention features a composition composed of a dietary fiber and a combination of selected herbal extracts which inhibit gastric emptying and increase metabolic rate for use in reducing food consumption and/or calorie intake.
- an appetite suppressant is a composition that decreases the desire for food, as evidenced by a decrease in food consumption and/or calorie intake .
- the composition of the present invention is composed of soluble extracts of yerbe mate (leaves of Ilex paraguayensis, I. vomitora, or I. dahoon) , guarana (seeds of Paullinia cupana or P. sorbalis) and damiana (leaves of Turnera diffusa var. aphrodisiaca, T. opifera, or T. ulmifoliei) .
- Soluble extracts of the invention can be prepared by conventional methods of drying and/or grinding plant biomass and subjecting the same to one or more suitable solvents, thereby providing an extract, which may be either used as a crude extract or further fractionated.
- Suitable methods for drying plant biomass include: sun drying followed by a heated air-drying or freeze- drying; lyophilization or chopping the biomass into small pieces, e.g., 2-10 cm, followed by heated air-drying or freeze-drying. Once sufficient moisture has been removed, e.g., more than 90%, the material can be ground to a coarse particle size, e.g., 0.01-1 mm, using a commercial grinder. For laboratory scale extraction, a coffee grinder or equivalent can be used.
- a suitable method for preparing an extract of plant biomass includes the steps of treating collected plant biomass with a solvent to extract a fraction having appetite suppressant or curbing activity, separating the extraction solution from the rest of the plant biomass, removing the solvent from the extraction solution and recovering the extract.
- the extract so recovered may be further purified by way of suitable extraction or purification procedures.
- plant biomass can be ground to a coarse powder as described above.
- a suitable solvent e.g., a food grade solvent
- a good grade solvent is any solvent which is suitable and approved for use in conjunction with foods intended for human consumption.
- suitable solvents are alcohol -based solvents, ethyl acetate, liquid carbon dioxide, hexane, and one or more components of fusel oil, e.g., ethyl acetate.
- Alcohol -based solvents i.e., pure alcohol solvents and mixtures thereof with water or other organic solvents, are most desirable.
- the extraction solution can then be separated from the residual plant biomass by an appropriate separation procedure such as filtration and/or centrifugation.
- the solvent can be removed, e.g., by means of a rotary evaporator.
- the separated crude extract can then be tested to confirm appetite suppressant or appetite curbing activity in a suitable in vivo bioassay.
- a suitable and accepted in vivo model for measuring appetite suppression or appetite curbing activity in an animal model is described in Example 2.
- a clinically effective and medically approved anti-obesity drug, e.g., sibutramine can be used as a positive control for reduction in food intake in this model . Positive results from this test model are an indicator of clinical efficacy in the human context.
- suppression, reduction or curbing of appetite can be assessed by any of the methods referred to in WO 98/46243.
- Plant extracts of the invention can be dried to remove moisture, e.g., by spray-drying, freeze-drying or vacuum-drying, to yield a free-flowing powder.
- the extracts can be dried on a pharmaceutically acceptable carrier, such as maltodextrin or starch.
- plant biomass can be extracted and concentrated without drying to give a liquid extract, which is effective in curbing or suppressing appetite.
- composition of the invention can further include extracts from one or more of Buchu, Vervain, Kola nut , and Ginseng .
- the instant composition also features a dietary fiber.
- dietary fiber is the indigestible portion of plant foods that pushes food through the digestive system and absorbs water. Dietary fiber can be soluble (able to dissolve in water) or insoluble (not able to dissolve in water) . Soluble fiber, like all fiber, cannot be digested. But it does change as it passes through the digestive tract, being transformed or fermented by bacteria therein. In contrast, insoluble fiber passes through the body largely unchanged. Accordingly, in particular embodiments of the present invention, the dietary fiber is fermentable or soluble.
- Fermentable dietary fiber can be obtained from a variety of plant foods, including, but not limited to legumes (e.g., peas, soybeans, and other beans); grains such as oats, rye, chia, and barley; some fruits and fruit juices including prune juice, plums, berries, bananas, and the insides of apples and pears; certain vegetables such as broccoli, carrots and Jerusalem artichokes; root vegetables such as potatoes, sweet potatoes, and onions; and psyllium seed husk.
- the dietary fiber is isolated and/or substantially purified to homogeneity, e.g., at least to 75%, 80%, 85%, or 90%, homogeneity or up to 99% homogeneity.
- the isolated, fermentable dietary fiber is inulin, a beta- glucan, a pectin, a natural gum, an oligosaccharide, psyllium seed husk, a resistant dextrin, an alginate or a combination thereof.
- Inulin belonging to the class of fibers known as fructans, is typically extracted from enriched plant sources such as chicory roots or Jerusalem artichokes.
- Beta-glucans polysaccharides of D-glucose monomers linked by glycosidic bonds, are typically isolated from oat bran, whole oats, oatrim or rolled oats.
- Pectins a complex set of polysaccharides that are present in most primary cell walls and particularly abundant in the non- woody parts of terrestrial plants, are composed of a linear chain of ⁇ - (1-4) -linked D-galacturonic acid that forms the pectin-backbone.
- Natural gums which are polysaccharides of natural origin that are capable of causing a large viscosity increase in solution, include, but are not limited to xanthan gum, acacia gum or guar gum.
- Alginate is a soluble fiber extracted from seaweed.
- oligosaccharides saccharide polymers containing a small number (typically three to ten) of component sugars (also known as simple sugars) , particularly include fructooligosaccharides .
- a resistant dextrin is a water- soluble dietary fiber obtained by, e.g., subjecting starch to high-temperature heating and enzymatic hydrolysis with ⁇ -amylase and glucoamylase .
- the selection of the dietary fiber to be used in the composition of the present invention can be dependent upon the form of the composition and the manner in which the formulation is administered, e.g., as multiple different formulations or as one formulation containing yerbe mate extract, guarana extract, damiana extract and dietary fiber.
- the dietary fiber of the instant composition is inulin.
- the herbal extracts and dietary fiber can be provided as a composition prepared as individual formulations ⁇ e.g., the composition includes or comprises a formulation containing yerbe mate extract, a formulation containing guarana extract, a formulation containing damiana extract, and a formulation containing a dietary fiber) , or the composition can be prepared as a combination of formulations ⁇ e.g., the composition includes or comprises a formulation containing yerbe mate extract, guarana extract, and damiana extract; and a formulation containing a dietary fiber) , or the composition can be prepared as a single unitary formulation ⁇ e.g., the composition includes or comprises a formulation containing yerbe mate extract, guarana extract, damiana extract, and dietary fiber) .
- compositions when the composition is prepared as individual or a combination of formulations, said formulations can be the same, e.g., all tablets; or different, e.g., a capsule formulation and a liquid formulation.
- said formulations when taken as individual formulations, said formulations can be taken simultaneously or consecutively, e.g., within minutes of each other.
- Soluble plant extracts, dietary fiber or a combination thereof can be admixed by conventional compounding procedures with any conventional pharmaceutical or nutritionally acceptable excipient, diluent or carrier in the preparation of pharmaceuticals, nutraceuticals, nutritional compositions, such as dietary supplements, slimming compositions, medical nutrition or functional foods.
- fillers such as cellulose, lactose, sucrose, mannitol, sorbitol, and calcium phosphates
- binders such as starch, gelatin, tragacanth, methylcellulose and/or polyvinylpyrrolidone (PVP) .
- PVP polyvinylpyrrolidone
- Optional additives include lubricants and flow conditioners, e.g., silicic acid, silicon dioxide, talc, stearic acid, magnesium/calcium stearates and polyethylene glycol (PEG) diluents; disintegrating agents, e.g., starch, carboxymethyl starch, cross- linked PVP, agar, alginic acid and alginates, coloring agents, flavoring agents and melting agents. Dyes or pigments may be added to tablets or dragee coatings, for example, for identification purposes or to indicate different doses of active ingredient .
- flow conditioners e.g., silicic acid, silicon dioxide, talc, stearic acid, magnesium/calcium stearates and polyethylene glycol (PEG) diluents
- disintegrating agents e.g., starch, carboxymethyl starch, cross- linked PVP, agar, alginic acid and alginates, coloring agents, flavoring agents and melting agents.
- composition of the invention can optionally include conventional food additives, such as any of emulsifiers, stabilizers, sweeteners, flavorings, coloring agents, preservatives, chelating agents, osmotic agents, buffers or agents for pH adjustment, acidulants, thickeners, texturizers and the like.
- conventional food additives such as any of emulsifiers, stabilizers, sweeteners, flavorings, coloring agents, preservatives, chelating agents, osmotic agents, buffers or agents for pH adjustment, acidulants, thickeners, texturizers and the like.
- Suitable product formulations according to the present invention include sachets, soft gel, powders, syrups, pills, capsules, tablets, liquid drops, sublinguals, patches, suppositories, and liquids.
- food and beverage products containing the composition of the present invention such as solid food products, like bars (e.g., nutritional bars or cereal bars), powdered drinks, dairy products, breakfast cereals, muesli, candies, confectioneries, cookies, biscuits, crackers, chocolate, chewing-gum, desserts and the like; liquid comestibles, like soft drinks, juice, sports drinks, milk drinks, milk-shakes, yogurt drinks or soups, as well as pet treats, pet foods, etc.
- composition of the invention can be provided as a component of a normal meal, e.g., a nutritional or slimming composition, or dietary supplement, in the form of a health drink, a snack or a nutritionally fortified beverage, as well as a pill, a tablet or a softgel, for example.
- a normal meal e.g., a nutritional or slimming composition, or dietary supplement
- a health drink e.g., a snack or a nutritionally fortified beverage
- a snack or a nutritionally fortified beverage e.g., a nutritionally fortified beverage
- a pill e.g., a tablet or a softgel
- the composition according to the invention can be nutritionally complete, i.e., may include vitamins, minerals, trace elements as well as nitrogen, carbohydrate and fatty acid sources so that it may be used as the sole source of nutrition supplying essentially all the required daily amounts of vitamins, minerals, carbohydrates, fatty acids, proteins and the like.
- the composition of the invention may be provided in the form of a nutritionally balanced complete meal, e.g., suited for oral or tube feeding.
- the composition of the invention may also include one or more further active ingredients, e.g., capsaicin (red pepper); fatty acids, especially linoleic acid (LA) and conjugated linoleic acid (CLA) ; glycomacropeptide (GMP) ; Long Chain Triglyceride (LCT) ; enterostatin,- galactose; glucuronic acid; hydroxycitrate (HCA); citrus; ⁇ -hydroxy butyrate; medium chain tryglycerides (MCTs) ; D- tagatose; caffeine; potato extract; green tea extract; epigallocatechin gallate, or other catechins; peptide D4 ; vitamins B, C and/or E; and chromium picolinate.
- capsaicin red pepper
- fatty acids especially linoleic acid (LA) and conjugated linoleic acid (CLA)
- GMP glycomacropeptide
- LCT Long Chain Triglyceride
- composition of the invention may be combined with an anti-obesity drug, such as sibutramine.
- an anti-obesity drug such as sibutramine.
- the composition of the invention may be provided in the form of a kit for separate, sequential or simultaneous administration in conjunction with an anti- obesity drug such as orlistat (XENICALTM) , Hoodia extract, and the like.
- compositions of the present invention would usually be single or multiple servings per day, e.g., once or twice daily, for acute or chronic use.
- benefit may be derived from dosing regimens that can include consumption on a daily, weekly or monthly basis or any combination thereof.
- Administration of compositions of the invention, e.g., treatment could continue over a period of days, weeks, months or years, in order, for example, to constantly control the weight, or until a healthy or cosmetically beneficial loss of body weight has occurred.
- the composition of the invention is consumed at least once a day on a regular basis, prior to (i.e., pre-prandial administration) , or during a meal.
- the composition of the invention is consumed prior to a meal .
- the amount and dosage regimen of the composition of the invention to be administered is determined in the light of various relevant factors including the purpose of administration, the age, sex and body weight of an individual subject, i.e., inter alia on the severity of the subject's obesity or overweight.
- the compositions of the invention can be administered under the supervision of a medical specialist, or may be self- administered.
- Preferred delivery formats for the appetite suppressing or appetite curbing composition of the invention would be as a dietary supplement containing about 50 mg to about 150 mg, or preferably about 100 mg to about 120 mg, dry weight of yerbe mate extract; about 50 mg to about 120 mg, or preferably about 90 mg to 100 mg, of gaurana extract; about 20 mg to about 50 mg, or preferably about 30 mg to about 40 mg, of damiana extract; and about 2 grams to about 10 grams, or preferably about 5 grams to 7 grams, of dietary fiber.
- the herbal extracts are, by weight, used at a ratio of Guarana 95:Damiana 36: Paraguay 112. Alternatively, the ratio of Guarana : Damiana : Paraguay is 2.6:1:3.1.
- An illustrative example of a formulation of herbal extracts is 27.5% weight yerbe mate extract, 23.2% weight Guarana, 9% weight Damiana extract, and 40.3% weight of dicalcium phosphate, talc, sodium carboxymethylcellulose, magnesium stearate and hydroxypropylmethylcellulose as additional ingredients.
- the present invention also features a method for decrease food intake and/or suppressing appetite by administering to a subject in need thereof an effective amount of yerbe mate extract, guarana extract, and damiana extract in combination with a dietary fiber.
- Administration of the composition of the present invention results in a 10% to 40% decrease in food consumption (gram weight) or a 10% to 35% decrease in calorie intake (Kcal) as compared to a subject not receiving the composition.
- the composition of the present invention achieves a 20 to 30% reduction in food consumption or calorie intake, levels which unexpectedly surpass other nutritional weight loss compositions.
- HCA-SX hydroxycitric acid
- NBC niacin-bound chromium
- GSE Gymnema sylvestre extract
- the levels of reduction in food/calorie intake of the instant composition are more comparable to pharmacological options including sibutramine (12-26% reduction; Rolls, et al . (1998) Obes . Res. 6:1-11; Chapelot, et al . (2000) Physiol. Behav. 68:299-308), diethylpropion (11-15% reduction; Porikos, et al .- (1980) Clin. Pharmacol. Ther. 27:815-822), fluoxetin (13-16% reduction; McGuirk & Silverstone (1990) Int. J. Obes.
- Subjects benefiting from the method of the invention include those in need of weight loss, e.g. overweight or obese subjects, as well as subjects controlling food intake so as not to gain weight.
- subjects receiving the composition of this invention are average or slightly overweight, i.e., having a BMI of 18.5-29.9 kg/m 2 .
- subjects receiving the composition of this invention are overweight, i.e., having a BMI of greater than 29.9 kg/m 2 .
- subjects benefiting from the method of the invention are those that consume high fat food, e.g., food containing greater than 8g of fat per 10Og.
- the invention further provides a composition according to the invention for use in suppressing appetite.
- the invention additionally provides the use of yerba mate extract, guarana extract, daminiana extract and a dietary fiber in the manufacture of a composition for suppressing appetite.
- Example 1 Effect of Selected Herbal Extracts on Gastric Emptying and Metabolic Weight
- a composition of the present invention containing a combination of selected herbal extracts was administered to patients in a double blind controlled clinical trial.
- the combination tested included Guarana, Damiana, and Paraguay. These extracts were obtained as powders.
- the components were mixed and prepared as capsules. Each capsule contained 95 mg Guarana, 112 mg Paraguay, and 36 mg Damiana extract.
- the subjects for the study were 20 otherwise healthy subjects, complaining of light-moderate overweight with a body mass index between 25 and 30 kg/m 2 . None of the subjects were taking any drug or dietary supplement at the time of the study. All were briefed on the protocol and gave consent to the trial .
- the rate of gastric emptying was assessed by scintigraphy.
- Three volunteer male subjects with no gastrointestinal illness or intake of medicinal drugs took part in the study. They were given a meal composed of 18 g peas, 100 g dried potatoes, and 200 ml of water containing 16-20 Mbc 113 Indium-DPTA. The subjects were fasting before the test and the meal was consumed in five minutes.
- the test was conducted with the subjects in a semi -upright position with a gamma camera placed in front.
- the time course of radioactivity in the stomach was determined by measuring the radioactivity in an appropriate region of interest every minute over 90 minutes.
- the test as repeated after each subject had taken three capsules of the drug combination three times daily and three capsules having been mixed with the food. Results showed that the rate of gastric emptying was significantly decreased in the three subjects after taking the herbal extract combination product. Halving times of gastric emptying were 49, 31, and 32 minutes after taking the test product and 61, 50, and 49 minutes, respectively, after taking the placebo.
- Study Design This was a double-blind, placebo- controlled study using a randomized within-subject design to evaluate the effects of ZOTRIM and inulin fiber given together, separately and against placebo control in terms of food intake in grams and kilocalories and subsequent food ratings measured using visual analogue scales (VAS) of hunger, fullness, prospective consumption, desire to eat and satisfaction pre dosing, pre and post meals and at hourly intervals across the day.
- VAS visual analogue scales
- the independent variables were the four conditions - ZOTRIM (tablet form) and inulin fiber (powder mixed with water), ZOTRIM and control, inulin fiber and placebo and control and placebo.
- the dependant variables were food intake measured in grams, kilocalories and macronutrients and the VAS ratings. All food and water was recorded by weight scales (Sartorius Model CPA 4202S, Sartorius Ltd, Epsom, UK; 0.1 gram accuracy) before and after meals to ascertain intake in grams, kilocalories and macronutrients, and food choice. There were two VAS' s: the first was given nine times throughout the study day and measured hunger, fullness, prospective consumption, desire to eat, satisfaction, nausea and thirst. The second VAS measured pleasantness, palatability, tastiness, saltiness and sweetness and was given after breakfast and lunch. The product/placebo was administered 15 minutes before breakfast and lunch which were four hours apart . Participants were randomized to the study by means of a block plan created on an internet-based randomization program.
- Exclusion Criteria Following screening, participants were excluded from the study if they reported any of the following: significant health problems; not having dieted in the last 12 months to lose or control weight; currently adhering to a specific food avoidance diet; gastrointestinal symptoms requiring treatment; bariatric surgery; systemic or local treatment likely to interfere with evaluation of the study parameters; taking medication known to affect appetite or weight within the past month and/or during the study; pregnant or planning to become pregnant or breastfeeding; history of anaphylaxis to food; general or specific food allergies, including caffeine and any of the study foods; dislike of more than 25% of the ad-libitum study foods; extreme dietary restraint; non breakfast eaters; working in nutrition, dietetics, food research, food manufacturing or supplements industry.
- the ZOTRIM formulation contained 112 mg Yerbe Mate, 95 mg Guarana and 36 mg Damiana.
- Guarana a dough made from the seeds of Paullinia cupana, which grows in Brazil and Venezuela, contains 3-6% caffeine, 5-8.5% tannins, 7.8% resins, 2-3% lipid, 0.06% saponin, 5-6% starch and 1.5% coloring agents (Schery (1954) Plants for Man. London: George Allen and Unwin, pp. 518-519) .
- Yerbe Mate is an extract- of Ilex paraguayensis from Brazil, Argentina and Paraguay containing 1-1.5% caffeine, 4-10% tannins and 3% resins and lipids (Hill (1952) Economic Botany.
- Damiana is obtained from the leaves of the plant Turnera diffusa var. aphrodisiaca from California, Mexico, Brazil and Peru and contains ethereal oils, resins and tannins (Bradley (1992) British Medical Compendium, Vol. 1. London: British Herbal Medical Association, pp. 71-72.).
- the placebo contained lactose and other ingredients minus the active ingredients.
- ZOTRIM and placebo were supplied as individual tablets and packaged in coded containers labeled A or B to ensure the double-blind status of the study. All capsule components (active and inert ingredients) were those approved and commonly used for commercial supplements and health ingredients and produced by a commercial capsule manufacturer.
- the inulin fiber (FIBRESURE) was derived from chicory root and packaged in powder form in 5.8g individual stick packs, containing 5 g fiber per pack. Each dose of 5 grams of fiber was mixed into 100 grams of water.
- VAS were used to rate degree of hunger, fullness, satisfaction, desire to eat, perception of how much participants could eat (prospective consumption), thirst and nausea.
- VAS was composed of 100 mm horizontal lines anchored by "not at all” and “extremely” at opposite ends, upon which participants record with a vertical line their subjective ratings. For example, hunger was rated along a 100mm line that was preceded by the question “how hungry do you feel at this moment?" and anchored on the left by “not at all hungry” and on the right by “extremely hungry” , or "how pleasant was the breakfast?" being anchored on the left by “not at all pleasant” and on the right by “extremely pleasant” .
- TITS nine times during each test day. The exact times were: pre dose pre breakfast (Tl), pre breakfast (T2), post breakfast (T3) , Interval 1(T4), Interval 2 (T5) , Interval 3 (T6) , pre dose pre lunch (T) , pre lunch (T8) , and post lunch (T9)
- TITS nine times
- Procedure At the screening visit, participants were asked if they had read and understood the information sheet concerning the study (which they were sent a minimum of two days before the screening visit) . Participants were then asked to sign two copies of the consent form. Participants' height and weight were measured. BMIs were calculated ensuring they were in a suitable range for the study. Participant's medical history and weight control history were taken. A DEBQ and list of study foods were shown to the participants to ensure that they did not have any objections or intolerances to the study foods. Following the screening, participants were contacted to determine whether or not they were able to continue in the study. Successful participants then received an information pack which contained details of their agreed times to visit the lab. Participants were asked to fill in an evening food and activity diary prior to attending the visits.
- Visit two took place at a minimum of two days after screening. Subsequent visits took place as soon as possible leaving two days between visits (giving a total of four visits) .
- Breakfast was served between 8:30 AM and 9:45 AM (time depending on when researcher and participant had arranged to meet at lab) . If participants failed to attend their visit within these time limits, their session was rescheduled for another day.
- Test Meals A standard fixed-load breakfast (496 kcal) was dispensed to participants in all conditions (Table 2) . In addition to the fixed-load breakfast, at the first visit, participants were offered a hot drink of tea or coffee with additional milk (35 g) and sugar if desired. If requested, this drink had to be consumed on each subsequent visit. The amount and energy composition of the ad-libitum cold test lunch items is listed in Table 3. The protein, carbohydrate and fat content of each test lung item are respectively listed in Tables 4-6. This meal was designed to offer a selection of high and low fat savory and sweet food items. Water (500 ml) was offered at the test meal. Participants were instructed to eat as much as they wished and to signal via a booth-based buzzer when they had finished.
- Intake at the test meal was initially analyzed for amount consumed (in grams and kcal) using a two-way ANOVA with condition (inulin fiber and ZOTRIM) as within-subject factors. Because breakfast was fixed, this was not included in the statistical analysis. Paired t-tests were used to investigate any significant differences. This analysis was then re-run incorporating the kcal content of breakfast and the kcal content in the inulin fiber conditions. A two-way ANOVA with inulin and ZOTRIM as within subject factors was performed to analyze food choice at the test meal . Kcal intake of high and low fat savory and high and low fat sweet items were compared between conditions.
- Subjective parameters e.g., hunger, gastric fullness
- Subjective parameters e.g., hunger, gastric fullness
- time pre-dose pre-breakfast , pre-breakfast , post-breakfast, 10 AM, 11 AM, 12 PM, pre-dose pre-lunch, pre-lunch, post-lunch, 2 PM, 3 PM, 4 PM, and 5 PM; T1-T13
- paired t-tests were conducted at each rating time between conditions.
- the dose was composed of three tablets, either ZOTRIM or a placebo, and a hundred grams of water into which inulin fiber was or was not mixed according to condition. Participants were then offered an ad-libitum buffet lunch and the intake of each item of lunch was measured. Appetite was assessed using VAS.
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EP10743229.6A EP2448591B1 (en) | 2009-07-01 | 2010-06-28 | Composition and method for reducing food intake |
US13/380,099 US8470377B2 (en) | 2009-07-01 | 2010-06-28 | Composition and method for reducing food intake |
CA2766095A CA2766095A1 (en) | 2009-07-01 | 2010-06-28 | Composition and method for reducing food intake |
AU2010267652A AU2010267652B2 (en) | 2009-07-01 | 2010-06-28 | Composition and method for reducing food intake |
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US22214109P | 2009-07-01 | 2009-07-01 | |
US61/222,141 | 2009-07-01 |
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EP (1) | EP2448591B1 (en) |
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US9789151B2 (en) | 2009-07-01 | 2017-10-17 | Natures Remedies Ltd. | Composition and method for reducing food intake |
US10314326B2 (en) | 2009-07-01 | 2019-06-11 | Natures Remedies Ltd | Composition for reducing food intake |
WO2015155177A1 (en) * | 2014-04-08 | 2015-10-15 | Specialites Pet Food | Method for selecting petfoods having a palatability effect and a calorie intake reducing effect for pets |
EP3149686A2 (en) * | 2014-05-26 | 2017-04-05 | Spécialités Pet Food | Methods for selecting a petfood providing a satisfying feeding experience upon consumption by pets |
US10765863B2 (en) | 2015-02-24 | 2020-09-08 | Elira, Inc. | Systems and methods for using a transcutaneous electrical stimulation device to deliver titrated therapy |
US10463854B2 (en) | 2015-02-24 | 2019-11-05 | Elira, Inc. | Systems and methods for managing symptoms associated with dysmenorrhea using an electro-dermal patch |
US10376145B2 (en) | 2015-02-24 | 2019-08-13 | Elira, Inc. | Systems and methods for enabling a patient to achieve a weight loss objective using an electrical dermal patch |
CA3227448A1 (en) * | 2015-02-24 | 2016-09-01 | Elira, Inc. | Systems and methods for enabling appetite modulation and/or improving dietary compliance using an electro-dermal patch |
US10864367B2 (en) | 2015-02-24 | 2020-12-15 | Elira, Inc. | Methods for using an electrical dermal patch in a manner that reduces adverse patient reactions |
US10335302B2 (en) | 2015-02-24 | 2019-07-02 | Elira, Inc. | Systems and methods for using transcutaneous electrical stimulation to enable dietary interventions |
US10154922B1 (en) | 2015-02-24 | 2018-12-18 | Elira, Inc. | Systems and methods for enabling appetite modulation and/or improving dietary compliance using percutaneous electrical neurostimulation |
US20220062621A1 (en) | 2015-02-24 | 2022-03-03 | Elira, Inc. | Electrical Stimulation-Based Weight Management System |
US9956393B2 (en) | 2015-02-24 | 2018-05-01 | Elira, Inc. | Systems for increasing a delay in the gastric emptying time for a patient using a transcutaneous electro-dermal patch |
US10609945B2 (en) * | 2016-01-26 | 2020-04-07 | Societe Des Produits Nestle S.A. | Compositions comprising 2FL and LNnT to control food intake and growth in infants or young children |
CN111096416A (en) * | 2019-12-26 | 2020-05-05 | 宁波御坊堂生物科技有限公司 | Diet-depriving composition for weight-losing meal replacement and preparation method thereof |
US20240000875A1 (en) * | 2022-07-01 | 2024-01-04 | Unicity Properties, Inc. | Compositions, systems, & methods for improving health |
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WO1998046243A2 (en) | 1997-04-15 | 1998-10-22 | Csir | Pharmaceutical compositions having appetite suppressant activity |
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US5945107A (en) | 1997-12-08 | 1999-08-31 | Natural Medio Tech A/S | Compositions and methods for weight reduction |
US20040265398A1 (en) * | 2002-04-25 | 2004-12-30 | Fleischner Albert M. | Herbal composition for weight control |
US20040087514A1 (en) * | 2002-09-06 | 2004-05-06 | Hughes Thomas E | Nutritional compositions |
CA2518658A1 (en) * | 2003-03-14 | 2004-09-30 | Pro-Health, Inc. | Composition and method for appetite and craving suppression and mood enhancement |
WO2005030195A1 (en) * | 2003-09-20 | 2005-04-07 | Glykon Technologies Group, Llc | (-)-hydroxycitric acid for delaying gastric emptying |
WO2005034650A1 (en) * | 2003-10-17 | 2005-04-21 | Diet Formulations Ltd. | Weight-loss supplement |
US20050238654A1 (en) * | 2004-04-26 | 2005-10-27 | Yoshinori Takeda | Compositions and methods for weight loss |
US20060083795A1 (en) * | 2004-10-19 | 2006-04-20 | Lima Shatkina | Meal replacement products having appetite suppressing qualities |
AU2006100120A4 (en) * | 2005-02-18 | 2006-04-06 | Biovital Pty Ltd | Dietary slimming beverage |
US20080081826A1 (en) * | 2006-04-28 | 2008-04-03 | Springuel Damien P | System for effecting weight loss |
US20080305096A1 (en) * | 2007-06-07 | 2008-12-11 | Unicity International, Inc. | Method and composition for providing controlled delivery of biologically active substances |
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- 2010-06-28 AU AU2010267652A patent/AU2010267652B2/en not_active Ceased
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US20110003021A1 (en) | 2011-01-06 |
US20120121735A1 (en) | 2012-05-17 |
AU2010267652B2 (en) | 2014-04-17 |
EP2448591A2 (en) | 2012-05-09 |
EP2448591B1 (en) | 2017-10-25 |
WO2011001283A3 (en) | 2011-05-26 |
US8470377B2 (en) | 2013-06-25 |
CA2766095A1 (en) | 2011-01-06 |
AU2010267652A1 (en) | 2012-01-19 |
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