WO2015009225A1 - Food composition product - Google Patents

Food composition product Download PDF

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Publication number
WO2015009225A1
WO2015009225A1 PCT/SE2014/050831 SE2014050831W WO2015009225A1 WO 2015009225 A1 WO2015009225 A1 WO 2015009225A1 SE 2014050831 W SE2014050831 W SE 2014050831W WO 2015009225 A1 WO2015009225 A1 WO 2015009225A1
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WO
WIPO (PCT)
Prior art keywords
food composition
composition product
product according
fatty acids
food
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PCT/SE2014/050831
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French (fr)
Inventor
Thomas BUCHAR
Christer FRANZÉN
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Indevex Ab (Publ)
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Publication of WO2015009225A1 publication Critical patent/WO2015009225A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/20Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115Fatty acids or derivatives thereof; Fats or oils
    • A23L33/12Fatty acids or derivatives thereof
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17Amino acids, peptides or proteins
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/20Reducing nutritive value; Dietetic products with reduced nutritive value
    • A23L33/21Addition of substantially indigestible substances, e.g. dietary fibres
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/30Dietetic or nutritional methods, e.g. for losing weight
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/736Glucomannans or galactomannans, e.g. locust bean gum, guar gum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents

Definitions

  • the present invention relates to a novel food composition product designed for the initial weight loss phase during sustainable (long term) weight management.
  • the composition reduces weight without concomitant reduction of intake of essential nutrients, the food composition product comprising of at least two different proteins deriving from both animal and vegetable sources, furthermore Omega 3 and 6 fatty acids and slowly digested carbohydrates including dietary fibers, giving said composition a low glycemic index (Gl ⁇ 55) and equally low glycemic load (GL ⁇ 10).
  • the objective of the present invention is to provide a novel food composition product designed for the initial weight loss phase during sustainable (long term) weight management and a method for weight loss and weight control in overweight and obese subjects in which the food composition product is used.
  • the object is achieved by the subject matter set forth in the independent claims.
  • the invention relates to a food composition product for weight loss management, the food composition product comprising at least two different proteins deriving from both animal and vegetable sources, furthermore Omega 3 and 6 fatty acids and slowly digested carbohydrates including dietary fibers, giving the food composition product a low glycemic load (GL ⁇ 10).
  • the invention is characterized in that the food composition comprises Konjac fiber "Glucomannan".
  • Glucomannan is used in combination with life essential nutrients providing slow and low postprandial blood glucose increase.
  • a food composition product comprising Glucomannan in combination with the nutritional components specified gives rise to increased satiety after administration; hence aids weight control and excessive eating.
  • Glucomannan in combination with proteins in particular give rise to this effect.
  • the food composition product eliminates the risk of nutritional deficiencies as it supplies all essential amino acids and fatty acids.
  • the Konjact fiber is preferably highly condensed.
  • Konjac fiber "Glucomannan” is a fiber product deriving from Konjac flour made from the Konjac plant.
  • Glucomannan hydrocolloid may be provided to the food composition product in the form of konjac flour, or konjac mannan.
  • the effect of Glucomannan includes the ability to increase viscosity of the intestinal fluid, thereby limiting the transport of glucose into the bloodstream and leading to slower gastric emptying.
  • Glucomannan also has a low Gl-value, thereby contributing to the low Gl- value of the food composition product.
  • the present invention uses as nutrient base a dry composition of natural whole food ingredients providing specific life essential nutrition and having the ability of controlling post prandial blood glucose levels, having a preferred effect in weight and diabetes control hereafter referred to as "PWD” combined with the highly condensed fiber "Glucomannan” (Glucomannan is a trading name for a group of Konjac fiber products deriving from the Konjac plant and refined to a high fiber content of not less than 90% and preferably more than 95% pure Konjac fiber ) for a short term weight reduction step, followed by long term weight management using only the PWD.
  • PWD a dry composition of natural whole food ingredients providing specific life essential nutrition and having the ability of controlling post prandial blood glucose levels, having a preferred effect in weight and diabetes control hereafter referred to as "PWD” combined with the highly condensed fiber "Glucomannan” (Glucomannan is a trading name for a group of Konjac fiber products deriving from the Konjac plant and refined to a high fiber content of not less
  • the combination PWD with Glucomannan is unique in it ' s potential to both reduce weight, and in the meantime to secure the basic need of essential nutrients during weight reduction.
  • the method uses the same mechanism of action as novel antidiabetic drugs (often used to overweight patients with manifest or risk for diabetes aiming at reducing weight), to increase the increting response, most important the GLP-1.
  • the pharmacological drugs are so called GLP-1 receptor analogues.
  • the invention has documented the same effect through a pure biological pathway.
  • the inventors biological approach has no side effects, "works with the body” and can be used as long as needed, including life-long use, without any side effects.
  • the incretins are important gut mediators of insulin release and plasma glucose levels.
  • a food product of the composition administrated prior to a major meal stimulates the release of the incretins GIP and GLP-1.
  • the neuroendocrine response reaches the brain through the systemic route and through afferent neurons.
  • Administration of certain nutrients before a meal activates the normal incretin response before the ordinary meal, i.e it has a priming effect on the brain.
  • the GIP/GLP-1 already has stimulated the insulin release, promoted satiety and slowed gastric emptying (the priming effect), which in turn reduce meal size and attenuates plasma glucose response
  • Glucomannan ' s prolongation of gastric emptying increases satiety, decreases the ingestion of foods that increase cholesterol and glucose concentrations, reduces the postprandial rise in plasma glucose, suppresses hepatic cholesterol synthesis, and increases the fecal elimination of cholesterol containing bile acids.
  • the Glucomannan is present in an amount of at least 0,5g and no more than 3g, preferably in l,0g to l,5g in the food composition product.
  • the Glucomannan has a purity of at least 90%, preferably of 95%.
  • the food composition product is preferably taken prior to a main meal as a "Preload", about 15-45 minutes prior to the main meal, and preferably 30 minutes prior to a meal, such that satiety occurs prior to eating thereby leading to smaller meal intakes and weight loss over time (see below).
  • PWD includes at least two and preferably at least four different protein sources. Preferred sources are e.g.; whey which has the fastest onset of effect on the incretins, while pea and casein according to clinical studies have a more significant effect on satiety.
  • the Omega 3 included in the PWD has a proven potentiating effect on the proteins in muscle synthesis.
  • the invention also comprise a method for providing a subject with a food composition product for aiding weight loss, comprising the step of administration of the food composition product to the subject. The administration of the food composition product is performed at least once and preferably 3 times per day over a coherent period of 1 week to 4 weeks.
  • the step of administration of the food composition including the PWD and Glucomannan ingredients may be performed at least 2 times daily as a preload over a coherent period of 1 week to 4 weeks.
  • the food composition product promotes satiety and provided the essential nutrients; thereby the method is part of a weight loss regime.
  • the food composition product when provided to a subject during calorie restriction, contributes to maintaining the muscle mass during weight loss, thereby being beneficial for allowing activities (such as physical exercise) under the weight loss regime.
  • the method of providing a subject with the food composition product over time reduces the risk of nutritional deficiencies that would occur if Glucomannan were to be taken on its own in order to increase satiety.
  • the inventor has initiated a study on weight loss in obese women with Polycystic Ovarian Syndrome, PCOS, where the initial results show that PWD as a preload shift fat body mass to lean body mass (relative more muscle mass.) This is important to achieve also during Glucomannan administration, where PWD add this effect.
  • proteins nutritional role as a source of "building blocks” to the tissues dietary proteins affect many vital functions such as glucose and lipid metabolism, blood pressure, bone metabolism and the immune system. Proteins can also function as a "fuel”, with approximately the same energy content as carbohydrates. Proteins affect metabolism throughout the entire nutrient uptake, from the oral cavity to the colon.
  • the proteins have several regulatory functions in the gastrointestinal system, including the regulation of food intake.
  • the interaction with signal receptors release hormones that influence gastric emptying and transport of food through the Gl system and absorption of nutrients.
  • the proteins also induce nerve signals to the brain (eg, the degree of satiation) through gut receptors and by affecting the intestinal microflora.
  • the interaction between proteins ' degradation products (peptides, amino acids) and the endocrine systems also affects digestion.
  • a dose i.e. a food product, with a minimum of 5 grams of protein when administrated prior to the administration of a meal is sufficient to affect insulin and glycemic response after the meal.
  • At least two protein sources and of which one shall be of animal and the other vegetable origin shall be included in the food composition and preferably these chosen from either; yellow pea, chicken egg, whey and casein, having different kinetics and effects on the plasma glucose levels, incretins and satiety system.
  • the Omega 3 fatty acid content can potentiate the effect of the proteins regarding the above effects.
  • Proteins have multiple points of action in weight management; slows the emptying of the stomach contents (takes longer for carbohydrates to be absorbed), stimulate faster release of insulin (rapid uptake of glucose into tissues), stimulates the synthesis of muscle tissue and impact the degree of saturation, etc. through neurotransmitters and neuropeptides.
  • the food composition product preferably has a low glycemic index (Gl ⁇ 55).
  • Pea protein is among the lowest glycemic index (Gl) foods and have been recommended in national diabetes mellitus (DM) guidelines. Incorporation of legumes as part of a low-GI diet improves both glycemic control and reduced calculated CHD risk score in type 2 DM in a recent study (Arch Intern Med. 2012 Nov 26;172(21):1653-60). It also has been demonstrated that intact pea proteins stimulates CCK and GLP-1 release from human duodenal tissue to a greater extent than egg and codfish protein (PLoS One. 2011; 6(9)).
  • pea protein Unlike other common protein sources such as milk, soy, or wheat proteins, pea protein has a very low allergenic potential, which makes this protein suitable for dietary interventions (PLoS One. 2011;6(9)). In another study of preload, food intake was significantly lower only after casein and pea protein compared to water control (Nutrition Journal 2011, 10:139)
  • omega fatty acids in the food product strengthen the mechanisms that may increase satiety and improve weight control.
  • omega fatty acids it was concluded that there is a considerable body of evidence from animal studies indicating that supplementing the diet with Omega-3 can attenuate weight gain and reduce body fat, in particular visceral fat.
  • human studies there is a growing body of evidence indicating that increasing the intake of Omega-3 by 0.3-3.0 g/day can reduce body weight and body fat in overweight and obese individuals (Nutrients 2010, 2, 1212-1230). It also has been shown that long-term enteral provision of Omega-3 confers a higher sensitivity to insulin-regulated amino acid and glucose disposal and that these responses probably occur, in part, in skeletal muscle.
  • Preload of proteins/nutrients 15-45 minutes before a meal to the subject is beneficial because the maximum insulin response occurs 30 minutes after ingestion of proteins together with carbohydrates.
  • initiation of administration of a food product of the composition is preferably made 15-45 minutes prior to the administration of a meal, more preferably 25-35 minutes prior, most preferably 30 minutes..
  • the food composition product administered as a preload 15-45 minutes before major meals during a longer period (> 3 months) significantly reduced body weight, BMI and fat%.
  • the food composition product also has positive effects on blood lipids, liver enzymes, insulin levels and HbAlC, and improved life quality parameters on VAS-scales.
  • the food composition product may be prepared as a meal by mixing the dry food composition product with a drinkable liquid. Due to the Glucomannan ingredient the food composition product must originally be prepared in dry powder form such that a food product may be prepared as a drinkable shake for serving.
  • a serving of the food composition product should be preferably 70 kcal and not less than 50 kcal and not more than 110 kcal. Therefore, the weight of the powder to be mixed in the drinkable shake is determined based on calories.
  • the benefit of mixing the dry food composition product with a drinkable liquid before serving, such as water, is that this minimizes the risk of choking as the Glucomannan fibers swell upon intake and which may happen if the Glucomannan is taken as a separate supplement, e.g. tablet, which is the common way for other products including the Glucomannan fiber.
  • Glucomannan fibers swell about 80 times their own weight and as the suggested food composition product must be prepared by mixing with liquid/water to be taken, this offers a safety measure decreasing the risk of Glucomannan swelling in a subjects mouth due to lack of accompanying water.
  • a food product of the composition for mixing with a drinkable liquid according to the invention is distinguished primarily by the fact that the composition comprises all the essential food components readily accessible, wherein the relative amounts of the components fat, carbohydrates, proteins, vitamins and minerals of said composition are chosen such that an intake of said composition provides the consumer with a stable blood glucose level.
  • Said fat, carbohydrates, proteins, vitamins and minerals are derived from a diversity of food groups including fruit, vegetable, plant, dairy, egg and other protein sources, and colloidal water sources, resulting in a physiologically balanced composition.
  • the "glycemic index” (Gl) is a measure of the degree to which the concentration of glucose in the blood rises after consumption of certain foodstuffs.
  • a low glycemic index (Gl) here refers to foodstuffs with a Gl-value between 0-55.
  • the glycemic index (Gl) may be calculated using two different references, that is to say either the reference white bread or the reference glucose. In the measurements made on the food composition product according to the invention, the reference glucose was utilised.
  • GL glycemic load
  • the GL-value provides the glycemic effect of realistic portion sizes of different foods.
  • the GL-value is similar to the Gl- value, a measure of the rise of the blood glucose and the subsequent secretion of insulin in the blood stream, but including the aspect of the amount of carbohydrates available in a portion of food (see Foster-Powell K., Holt SH., Brand- Miller JC, Am. J. Clin. Nutr. 76:5-56, 2002).
  • the food composition product contains a protein, fat and complex carbohydrate combination, based on pure natural sources. It also contains slow carbohydrates and dietary fibers that together with the proteins and fats add up to a low glycemic index of below 40 and more preferably below 30%. With the comparing low carbohydrate content this adds up into a low glycemic load (GL) for the food composition product of not more than 10 and preferably below 5 which provides a low and stable post prandial blood sugar and equally insulin levels, and in combination with the protein and fat load also a high satiety.
  • GL low glycemic load
  • the carbohydrates are derived from leguminous plants, preferably yellow peas, and rosaceous plants, preferably apples and rose hips, wherein said leguminous plants and rosaceous plants contribute in giving the food composition product its advantageously low Gl value.
  • carbohydrates may, of course within the scope of the invention, be chosen from other plants having a low glycemic index. Apples and rose hips may furthermore be substituted with pears, peaches, plums, or the like, all of which being rosaceous plants with a low glycemic index.
  • At least 15% of the overall content of the food composition product is derived from yellow peas, at least 10% from apples or other rosaceous plants.
  • the content of the mentioned ingredients preferably does not exceed 30% for yellow peas and 25% for apples or other rosaceous plants so as to maintain the important balance between carbohydrates, proteins and fat.
  • the Gl-value of each of the carbohydrates put together does not determine the Gl of the foodstuffs.
  • the Gl is influenced by a number of factors, for example, the biochemical structure of the carbohydrate, a high amylose/amylopectin ratio, a high degree of native starch, presence of anti- nutritional substances with the ability of inhibiting amylose, and the co-ingestion of fat, fibre and protein.
  • a problem thus occurs when trying to compose a meal which is to provide the consumer with a low glycemic index for the overall food composition product. Due to the contribution of a number of factors to the glycemic index, a meal properly balanced so as to avoid fluctuations in the blood glucose level may be difficult to compose.
  • carbohydrate source is, as also mentioned, another important factor in obtaining a low GL food composition product. Accordingly, carbohydrates having low Gl-values are chosen.
  • the food composition product has a content comprising yellow peas, apples, and rose hips as described above, all of which comprise carbohydrates with low Gl-values.
  • the present inventors have found that when foodstuffs with an average Gl-value, that is between 60-90, are included, the overall food composition product obtains a significantly higher GL-value when compared to a food composition product comprising only carbohydrates with a low Gl-value.
  • the fat of the Food composition product comprises the essential fatty acids with an omega-3 to omega- 6 fatty acid ratio of 1:1 to 1:4.0, more preferably 1:1,2 to 1:3.0, and most preferably 1:1.5 to 1:2.5.
  • a correct balance is significant in order to maintain normal cellular and other functions.
  • a typical western diet consists of far more omega-6 fatty acids than omega-3 fatty acids, many meals are lacking the essential amount of the desired fatty acids and have moreover an inadequate balance of said fatty acids.
  • the fat of the composition is further composed to meet the needs for saturated, and mono-, di-, tri- and polyunsaturated fatty acids.
  • the fat preferably comprises preferably 20-40% saturated fatty acids, preferably 20-40% monounsaturated fatty acids, and preferably 20-40% di- and tri-unsaturated fatty acids.
  • the balance between the three main groups of fatty acids is thus optimised.
  • the content of fat in a properly balanced meal is essential; fats contain important fat soluble vitamins and essential fatty acids which cannot be produced by the human body.
  • the fatty acids are preferably chosen from the group consisting of myristic acid, palmitic acid, palmitoleic acid, heptadecanoic acid, stearic acid, oleic acid, linoleic acid, alfa- linolenic acid, arachidic acid, eicosadienoic acid, behenic acid, docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA).
  • DHA docosahexaenoic acid
  • EPA eicosapentaenoic acid
  • the invention is not restricted to the fatty acids mentioned herein. Other fatty acids which are within the scope of the invention may also be chosen.
  • DHA docosahexaenoic acid
  • EPA eicosapentaenoic acid
  • DHA docosahexaenoic acid
  • Cholesterol is also present in amounts which meet the body's needs.
  • composition is furthermore an excellent source of protein, thus containing all 20 amino acids including the 8 for adult by WHO recognized essential amino acids in physiological doses.
  • the composition further comprises vitamins in comparing high amounts of vitamin B12 and C.
  • the food composition product mixed with drinkable liquid preferably has a pH- range of 5.5 to 6.5 and acts like a buffer.
  • the food composition product is preferably gluten free.
  • the nutritive substances of the food composition product according to the invention are derived from both animal and vegetable sources, thereby providing all the amino acids, including the essential amino acids, fatty acids, and slow-working carbohydrates in a proper balance, all of which contribute to a low glycemic index. No artificial preservatives or thickening agents are added to the food composition product.
  • All ingredients are mechanically treated (heat, air, steam, pressure) to form a powder and are free from chemicals and are GMO free.
  • Said food composition product has also proved to provide a stable blood glucose level, to prevent insulin spikes.
  • basal insulin levels are lowered in all people, and long acting (basal insulin level) and short acting (insulin spike) insulin requirements are significantly reduced with insulin dependent diabetics.
  • the food composition product the components includes a protein content of more than 20% calculated from the food composition products energy content; and thus according to European/EFSA regulations classified as a "protein rich" food composition.

Abstract

The invention concerns a food composition product for weight loss and diabetes management, the food composition product comprising at least two different proteins deriving from both animal and vegetable sources, furthermore Omega 3 and 6 fatty acids and slowly digested carbohydrates including dietary fibers, giving said composition a low glycemic index (GI<55) and equally glycemic load (GL <10), wherein said food composition also comprises Konjac fiber "Glucomannan".

Description

TITLE
Food composition product
TECHNICAL FIELD
The present invention relates to a novel food composition product designed for the initial weight loss phase during sustainable (long term) weight management. The composition reduces weight without concomitant reduction of intake of essential nutrients, the food composition product comprising of at least two different proteins deriving from both animal and vegetable sources, furthermore Omega 3 and 6 fatty acids and slowly digested carbohydrates including dietary fibers, giving said composition a low glycemic index (Gl<55) and equally low glycemic load (GL <10).
BACKGROUND
65 % of the world's populations live in countries where overweight and obesity kills more people than underweight. Worldwide obesity has nearly doubled during the last three decades, now approx. 1.5 billion adults (20 years and older), were overweight defined as BMI > 25. Of these over 200 million men and 300 million women are obese, defined as BMI > 30. An even more alarming fact is the growing obesity among children; more than 40 million children under the age of five were overweight in 2011. Once considered a high-income country problem, overweight and obesity are now on the rise in low- and middle-income countries, particularly in urban settings. Obesity is regarded as major risk factor for several serious diseases such as cardiovascular disorders, hypertension, diabetes typ-2, cancer and osteoarthritis. One consequence is the alarming increase of diabetes typ 2 worldwide.
Conditions as described above can be prevented through lifestyle modification, where diet control is essential, and control of overweight and obesity. Education of the populace is still key to the control of this emerging epidemic. Novel drugs are being developed, yet no definite cure is in sight for obesity and its alarming consequences like CVD and diabetes type 2. On the other hand life style and diet interventions have scientifically strong support in preventing the onset of e.g. type 2 diabetes as well as to prevent deterioration of the manifest disease.
A common way of dealing with obesity is weight loss through low energy diets. However, such diets may lead to poor nutritional intake or even nutritiona l deficiencies. Diet pills are available which provides satiety, and also the use of certain condensed fibers as stomach filler, having the same effect are commonly used but they all risk an incomplete nutritional intake if used over several weeks or periods of weeks, as commonly done when used in long term control of obesity. Therefore the risk of nutritional deficiencies significantly increases with all these methods.
There is thus a need for an improved approach towards controlling weight loss while still providing essential nutrition in order to fight overweight, obesity and the increased medical risks related to unhealthy diets, diabetes type 2, cardiovascular diseases and cancers. The majority of the popular low calorie diets have failed to show sustainably weight loss. Recently the Diogenes study, supported by the EL) Commission, has shown that the only long term sustainable nutrient combination to keep weight stable after weight reduction is combination of high protein content with low Gl (N Engl J Med 363;22, 2010). Yet no available approach in weight management covers the two necessary steps in one product family; (1) reduction of overweight, often as a cure including calorie restriction, followed by (2) long term controlled diet regimen which keeps the reduced weight at a low and stable level, weight control. SUMMARY
The objective of the present invention is to provide a novel food composition product designed for the initial weight loss phase during sustainable (long term) weight management and a method for weight loss and weight control in overweight and obese subjects in which the food composition product is used. The object is achieved by the subject matter set forth in the independent claims.
The invention relates to a food composition product for weight loss management, the food composition product comprising at least two different proteins deriving from both animal and vegetable sources, furthermore Omega 3 and 6 fatty acids and slowly digested carbohydrates including dietary fibers, giving the food composition product a low glycemic load (GL <10).
The invention is characterized in that the food composition comprises Konjac fiber "Glucomannan". Glucomannan is used in combination with life essential nutrients providing slow and low postprandial blood glucose increase. A food composition product comprising Glucomannan in combination with the nutritional components specified gives rise to increased satiety after administration; hence aids weight control and excessive eating. Glucomannan in combination with proteins in particular give rise to this effect. In addition, the food composition product eliminates the risk of nutritional deficiencies as it supplies all essential amino acids and fatty acids. The Konjact fiber is preferably highly condensed.
Konjac fiber "Glucomannan" is a fiber product deriving from Konjac flour made from the Konjac plant. Glucomannan hydrocolloid may be provided to the food composition product in the form of konjac flour, or konjac mannan. The effect of Glucomannan includes the ability to increase viscosity of the intestinal fluid, thereby limiting the transport of glucose into the bloodstream and leading to slower gastric emptying. Glucomannan also has a low Gl-value, thereby contributing to the low Gl- value of the food composition product. The present invention uses as nutrient base a dry composition of natural whole food ingredients providing specific life essential nutrition and having the ability of controlling post prandial blood glucose levels, having a preferred effect in weight and diabetes control hereafter referred to as "PWD" combined with the highly condensed fiber "Glucomannan" (Glucomannan is a trading name for a group of Konjac fiber products deriving from the Konjac plant and refined to a high fiber content of not less than 90% and preferably more than 95% pure Konjac fiber ) for a short term weight reduction step, followed by long term weight management using only the PWD. Both food compositions are designed for use within the same "Preload" concept, where ingestion of the combination of essential amino acids (from proteins in PWD) and fibers (from Glucomannan and PWD) preferably 30 minutes before major meals (preload) stimulates the release of incretin hormones GIP and GLP-1, see below. This release increases the satiety, slows gastric emptying and speeds up the release of insulin, all of which may reduce the following meal size, sugar cravings until next meal (second meal effect), etc (Diabetes Care 2010;33:2552-2554). In a recent study initiated by the inventor, preliminary results support the above effects, with strong support for the effect on postprandial plasma glucose (prof Yu De-Mins, Tianjin, personal communication).
The combination PWD with Glucomannan is unique in it's potential to both reduce weight, and in the meantime to secure the basic need of essential nutrients during weight reduction. The method uses the same mechanism of action as novel antidiabetic drugs (often used to overweight patients with manifest or risk for diabetes aiming at reducing weight), to increase the increting response, most important the GLP-1. The pharmacological drugs are so called GLP-1 receptor analogues. The invention has documented the same effect through a pure biological pathway. The inventors biological approach has no side effects, "works with the body" and can be used as long as needed, including life-long use, without any side effects. The incretins are important gut mediators of insulin release and plasma glucose levels. A food product of the composition administrated prior to a major meal stimulates the release of the incretins GIP and GLP-1. The neuroendocrine response reaches the brain through the systemic route and through afferent neurons. Administration of certain nutrients before a meal activates the normal incretin response before the ordinary meal, i.e it has a priming effect on the brain. When the meal is ingested the GIP/GLP-1 already has stimulated the insulin release, promoted satiety and slowed gastric emptying (the priming effect), which in turn reduce meal size and attenuates plasma glucose response
Glucomannan's prolongation of gastric emptying increases satiety, decreases the ingestion of foods that increase cholesterol and glucose concentrations, reduces the postprandial rise in plasma glucose, suppresses hepatic cholesterol synthesis, and increases the fecal elimination of cholesterol containing bile acids. (Am J Clin Nutr 2008;88:1167-75.)
The Glucomannan is present in an amount of at least 0,5g and no more than 3g, preferably in l,0g to l,5g in the food composition product. The Glucomannan has a purity of at least 90%, preferably of 95%.
The food composition product is preferably taken prior to a main meal as a "Preload", about 15-45 minutes prior to the main meal, and preferably 30 minutes prior to a meal, such that satiety occurs prior to eating thereby leading to smaller meal intakes and weight loss over time (see below).
Glucomannan with it's content of potent fibers, with effects on weight parameters as described above, will potentiate the effect of PWD's proteins. PWD includes at least two and preferably at least four different protein sources. Preferred sources are e.g.; whey which has the fastest onset of effect on the incretins, while pea and casein according to clinical studies have a more significant effect on satiety. The Omega 3 included in the PWD has a proven potentiating effect on the proteins in muscle synthesis. The invention also comprise a method for providing a subject with a food composition product for aiding weight loss, comprising the step of administration of the food composition product to the subject. The administration of the food composition product is performed at least once and preferably 3 times per day over a coherent period of 1 week to 4 weeks.
The step of administration of the food composition including the PWD and Glucomannan ingredients may be performed at least 2 times daily as a preload over a coherent period of 1 week to 4 weeks. The food composition product promotes satiety and provided the essential nutrients; thereby the method is part of a weight loss regime. The food composition product, when provided to a subject during calorie restriction, contributes to maintaining the muscle mass during weight loss, thereby being beneficial for allowing activities (such as physical exercise) under the weight loss regime. The method of providing a subject with the food composition product over time reduces the risk of nutritional deficiencies that would occur if Glucomannan were to be taken on its own in order to increase satiety.
The inventor has initiated a study on weight loss in obese women with Polycystic Ovarian Syndrome, PCOS, where the initial results show that PWD as a preload shift fat body mass to lean body mass (relative more muscle mass.) This is important to achieve also during Glucomannan administration, where PWD add this effect.
Besides proteins nutritional role as a source of "building blocks" to the tissues, dietary proteins affect many vital functions such as glucose and lipid metabolism, blood pressure, bone metabolism and the immune system. Proteins can also function as a "fuel", with approximately the same energy content as carbohydrates. Proteins affect metabolism throughout the entire nutrient uptake, from the oral cavity to the colon.
The proteins have several regulatory functions in the gastrointestinal system, including the regulation of food intake. The interaction with signal receptors release hormones that influence gastric emptying and transport of food through the Gl system and absorption of nutrients. The proteins also induce nerve signals to the brain (eg, the degree of satiation) through gut receptors and by affecting the intestinal microflora. The interaction between proteins' degradation products (peptides, amino acids) and the endocrine systems also affects digestion.
A dose, i.e. a food product, with a minimum of 5 grams of protein when administrated prior to the administration of a meal is sufficient to affect insulin and glycemic response after the meal.
At least two protein sources and of which one shall be of animal and the other vegetable origin shall be included in the food composition and preferably these chosen from either; yellow pea, chicken egg, whey and casein, having different kinetics and effects on the plasma glucose levels, incretins and satiety system. The Omega 3 fatty acid content can potentiate the effect of the proteins regarding the above effects.
Proteins have multiple points of action in weight management; slows the emptying of the stomach contents (takes longer for carbohydrates to be absorbed), stimulate faster release of insulin (rapid uptake of glucose into tissues), stimulates the synthesis of muscle tissue and impact the degree of saturation, etc. through neurotransmitters and neuropeptides.
The food composition product preferably has a low glycemic index (Gl<55). Pea protein is among the lowest glycemic index (Gl) foods and have been recommended in national diabetes mellitus (DM) guidelines. Incorporation of legumes as part of a low-GI diet improves both glycemic control and reduced calculated CHD risk score in type 2 DM in a recent study (Arch Intern Med. 2012 Nov 26;172(21):1653-60). It also has been demonstrated that intact pea proteins stimulates CCK and GLP-1 release from human duodenal tissue to a greater extent than egg and codfish protein (PLoS One. 2011; 6(9)). Unlike other common protein sources such as milk, soy, or wheat proteins, pea protein has a very low allergenic potential, which makes this protein suitable for dietary interventions (PLoS One. 2011;6(9)). In another study of preload, food intake was significantly lower only after casein and pea protein compared to water control (Nutrition Journal 2011, 10:139)
The combination of proteins and omega fatty acids in the food product strengthen the mechanisms that may increase satiety and improve weight control. In a recent review of omega fatty acids it was concluded that there is a considerable body of evidence from animal studies indicating that supplementing the diet with Omega-3 can attenuate weight gain and reduce body fat, in particular visceral fat. Similarly, in human studies there is a growing body of evidence indicating that increasing the intake of Omega-3 by 0.3-3.0 g/day can reduce body weight and body fat in overweight and obese individuals (Nutrients 2010, 2, 1212-1230). It also has been shown that long-term enteral provision of Omega-3 confers a higher sensitivity to insulin-regulated amino acid and glucose disposal and that these responses probably occur, in part, in skeletal muscle. In a fed steady-state, a more sensitive insulin signalling promotes initiation of protein synthesis with concurrent reduction in whole-body amino acid oxidation, increasing the net availability of amino acids to support anabolism, of paramount importance during weight control (shift from fat body mass to lean body mass). The inclusion of fibers in the food composition product further promotes satiety at following meals. In a controlled study the fiber supplement significantly reduced hunger feelings and promoted satiety during a period of caloric reduction (Nutr Diabetes. (2011;l:e22). Most clinicians in the field of obesity medicine agree that dietary intervention for long-term weight management should include volumetric, low-calorie-density, low Gl diets supplemented with moderate amounts of protein. Increasing the intake of fiber should play a central role in this regard. Supplementation of the diet with functional fibers may significantly promote satiety and reduce cardiometabolic risk factors according to a recent review (Curr Obes Rep 2012, 1:59-67).
Preload of proteins/nutrients 15-45 minutes before a meal to the subject is beneficial because the maximum insulin response occurs 30 minutes after ingestion of proteins together with carbohydrates. Thus, initiation of administration of a food product of the composition is preferably made 15-45 minutes prior to the administration of a meal, more preferably 25-35 minutes prior, most preferably 30 minutes..
The food composition product administered as a preload 15-45 minutes before major meals during a longer period (> 3 months) significantly reduced body weight, BMI and fat%. The food composition product also has positive effects on blood lipids, liver enzymes, insulin levels and HbAlC, and improved life quality parameters on VAS-scales. The food composition product may be prepared as a meal by mixing the dry food composition product with a drinkable liquid. Due to the Glucomannan ingredient the food composition product must originally be prepared in dry powder form such that a food product may be prepared as a drinkable shake for serving. A serving of the food composition product should be preferably 70 kcal and not less than 50 kcal and not more than 110 kcal. Therefore, the weight of the powder to be mixed in the drinkable shake is determined based on calories.
The benefit of mixing the dry food composition product with a drinkable liquid before serving, such as water, is that this minimizes the risk of choking as the Glucomannan fibers swell upon intake and which may happen if the Glucomannan is taken as a separate supplement, e.g. tablet, which is the common way for other products including the Glucomannan fiber. Glucomannan fibers swell about 80 times their own weight and as the suggested food composition product must be prepared by mixing with liquid/water to be taken, this offers a safety measure decreasing the risk of Glucomannan swelling in a subjects mouth due to lack of accompanying water.
A food product of the composition for mixing with a drinkable liquid according to the invention is distinguished primarily by the fact that the composition comprises all the essential food components readily accessible, wherein the relative amounts of the components fat, carbohydrates, proteins, vitamins and minerals of said composition are chosen such that an intake of said composition provides the consumer with a stable blood glucose level.
Said fat, carbohydrates, proteins, vitamins and minerals are derived from a diversity of food groups including fruit, vegetable, plant, dairy, egg and other protein sources, and colloidal water sources, resulting in a physiologically balanced composition.
The "glycemic index" (Gl) is a measure of the degree to which the concentration of glucose in the blood rises after consumption of certain foodstuffs. A low glycemic index (Gl) here refers to foodstuffs with a Gl-value between 0-55. The glycemic index (Gl) may be calculated using two different references, that is to say either the reference white bread or the reference glucose. In the measurements made on the food composition product according to the invention, the reference glucose was utilised. In order to estimate the overall glycemic effect of a meal, the concept of "glycemic load" (GL) (Gl x dietary carbohydrate content) has been introduced. As the Gl compares corresponding amounts of carbohydrates, providing a measure of equal carbohydrate quantity, but not quality, the GL-value provides the glycemic effect of realistic portion sizes of different foods. The GL-value is similar to the Gl- value, a measure of the rise of the blood glucose and the subsequent secretion of insulin in the blood stream, but including the aspect of the amount of carbohydrates available in a portion of food (see Foster-Powell K., Holt SH., Brand- Miller JC, Am. J. Clin. Nutr. 76:5-56, 2002).
Such a food composition product formulation is carefully chosen to support the body with essential nutrition. Evidence based medicine support the rationale behind the formula. The food composition product contains a protein, fat and complex carbohydrate combination, based on pure natural sources. It also contains slow carbohydrates and dietary fibers that together with the proteins and fats add up to a low glycemic index of below 40 and more preferably below 30%. With the comparing low carbohydrate content this adds up into a low glycemic load (GL) for the food composition product of not more than 10 and preferably below 5 which provides a low and stable post prandial blood sugar and equally insulin levels, and in combination with the protein and fat load also a high satiety.
According to one preferred embodiment of the invention, the carbohydrates are derived from leguminous plants, preferably yellow peas, and rosaceous plants, preferably apples and rose hips, wherein said leguminous plants and rosaceous plants contribute in giving the food composition product its advantageously low Gl value. However, carbohydrates may, of course within the scope of the invention, be chosen from other plants having a low glycemic index. Apples and rose hips may furthermore be substituted with pears, peaches, plums, or the like, all of which being rosaceous plants with a low glycemic index. In a further preferred embodiment of the invention, at least 15% of the overall content of the food composition product is derived from yellow peas, at least 10% from apples or other rosaceous plants. The content of the mentioned ingredients preferably does not exceed 30% for yellow peas and 25% for apples or other rosaceous plants so as to maintain the important balance between carbohydrates, proteins and fat.
However, even though carbohydrates from different sources may be associated with individual Gl-values, the Gl-value of each of the carbohydrates put together does not determine the Gl of the foodstuffs. The Gl is influenced by a number of factors, for example, the biochemical structure of the carbohydrate, a high amylose/amylopectin ratio, a high degree of native starch, presence of anti- nutritional substances with the ability of inhibiting amylose, and the co-ingestion of fat, fibre and protein. A problem thus occurs when trying to compose a meal which is to provide the consumer with a low glycemic index for the overall food composition product. Due to the contribution of a number of factors to the glycemic index, a meal properly balanced so as to avoid fluctuations in the blood glucose level may be difficult to compose.
Furthermore, the choice of carbohydrate source is, as also mentioned, another important factor in obtaining a low GL food composition product. Accordingly, carbohydrates having low Gl-values are chosen. According to one embodiment of the invention the food composition product has a content comprising yellow peas, apples, and rose hips as described above, all of which comprise carbohydrates with low Gl-values. The present inventors have found that when foodstuffs with an average Gl-value, that is between 60-90, are included, the overall food composition product obtains a significantly higher GL-value when compared to a food composition product comprising only carbohydrates with a low Gl-value.
In a preferred embodiment according to the invention the fat of the Food composition product comprises the essential fatty acids with an omega-3 to omega- 6 fatty acid ratio of 1:1 to 1:4.0, more preferably 1:1,2 to 1:3.0, and most preferably 1:1.5 to 1:2.5. A correct balance is significant in order to maintain normal cellular and other functions. As a typical western diet consists of far more omega-6 fatty acids than omega-3 fatty acids, many meals are lacking the essential amount of the desired fatty acids and have moreover an inadequate balance of said fatty acids. The fat of the composition is further composed to meet the needs for saturated, and mono-, di-, tri- and polyunsaturated fatty acids. The fat preferably comprises preferably 20-40% saturated fatty acids, preferably 20-40% monounsaturated fatty acids, and preferably 20-40% di- and tri-unsaturated fatty acids. The balance between the three main groups of fatty acids is thus optimised. The content of fat in a properly balanced meal is essential; fats contain important fat soluble vitamins and essential fatty acids which cannot be produced by the human body. The fatty acids are preferably chosen from the group consisting of myristic acid, palmitic acid, palmitoleic acid, heptadecanoic acid, stearic acid, oleic acid, linoleic acid, alfa- linolenic acid, arachidic acid, eicosadienoic acid, behenic acid, docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). However, the invention is not restricted to the fatty acids mentioned herein. Other fatty acids which are within the scope of the invention may also be chosen. In addition, the levels of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are optimised and constitute between 1.9- 2.3%, preferably about 2.1% of the total fat. Cholesterol is also present in amounts which meet the body's needs.
The composition is furthermore an excellent source of protein, thus containing all 20 amino acids including the 8 for adult by WHO recognized essential amino acids in physiological doses. The composition further comprises vitamins in comparing high amounts of vitamin B12 and C.
The food composition product mixed with drinkable liquid preferably has a pH- range of 5.5 to 6.5 and acts like a buffer. In order to meet the demands of people with gluten intolerance, the food composition product, is preferably gluten free.
The nutritive substances of the food composition product according to the invention are derived from both animal and vegetable sources, thereby providing all the amino acids, including the essential amino acids, fatty acids, and slow-working carbohydrates in a proper balance, all of which contribute to a low glycemic index. No artificial preservatives or thickening agents are added to the food composition product.
All ingredients are mechanically treated (heat, air, steam, pressure) to form a powder and are free from chemicals and are GMO free.
Said food composition product has also proved to provide a stable blood glucose level, to prevent insulin spikes. In addition, basal insulin levels are lowered in all people, and long acting (basal insulin level) and short acting (insulin spike) insulin requirements are significantly reduced with insulin dependent diabetics.
In an embodiment of the invention the food composition product the components includes a protein content of more than 20% calculated from the food composition products energy content; and thus according to European/EFSA regulations classified as a "protein rich" food composition.

Claims

Food composition product for weight loss management, the food composition product comprising at least two different proteins deriving from both animal and vegetable sources, furthermore Omega 3 and 6 fatty acids and slowly digested carbohydrates including dietary fibers, giving said composition a low glycemic load (GL <10),
characterized in that said food composition comprises Konjac fiber "Glucomannan".
Food composition product according to claim 1 wherein said Konjac fiber "Glucomannan" is a fiber product deriving from Konjac flour made from the Konjac plant.
Food composition product according to claim 1 or 2 wherein the Konjac fiber is present in an amount of not less than 0,5 grams and not more than 3 grams, preferably in an amount of 1,0 gram to 1,
5 grams per serving.
Food composition product according to any of the above claims, wherein Konjac fiber has a fiber purity refined to at least 90%, preferably of 95%.
Food composition product according to any of the above claims wherein the food composition product comprise at least 5 and not more than 20 grams of proteins of which one source shall be deriving from leguminous plants preferably yellow pea, and at least one more deriving from either whey, casein, chicken whole egg, egg albumen or soy sources and the carbohydrates with a low glycemic index "Gl" comprise foodstuffs from at least rosaceous plants and sugar beat fibres.
6. Food composition product according to any of the preceding claims, wherein the food composition product is prepared as a meal by mixing the food composition product with a drinkable liquid.
Food composition product according to any of the preceding claims, wherein at least 15% of the overall content of the food composition product is derived from yellow peas, at least 10% from apples.
Food composition product according to any of the preceding claims, wherein the food composition product comprises dietary fibres providing 3-15g of lOOg respectively 1,5 - 7,5g of lOOkcal of a food composition product, preferably about 5-10g per lOOg resp 2,5-5g per lOOkcal of a food composition product and most preferably 6g per lOOg resp 3g per lOOkcal in a food composition product.
9. Food composition product according to any of the preceding claims, wherein the fat comprises the essential fatty acids with an omega-3 to omega-6 fatty acid ratio of 1:0,8 to 1:4, more preferably 1:1,5 to 1:2.5, and most preferably 1:2.
10. Food composition product according to any of the preceding claims, wherein the fatty acids comprise 20-40%, saturated fatty acids, 20-40%, monounsaturated fatty acids, and 20-40%, di- and tri-unsaturated fatty acids.
11. Food composition product according to any of the preceding claims, wherein the food composition product comprises all 20 amino acids including the 8 essential amino acids.
12. Food composition product according to any of the preceding claims, wherein the food composition product comprises vitamins B12 and C, present in high amounts, and sodium in small amounts.
13. Food composition product according to any of the preceding claims, wherein the food composition product is in the pH-range of 5.5 to 6.5 and acts like a buffer.
14. Food composition product according to any of the preceding claims, wherein the food composition product comprises no, artificial preservatives or thickening agents.
15. Food composition product according to claim 1-14 for use in the treatment of diabetes or obesity.
16. Method for providing a subject with a food composition product according to claim 1-14 for aiding weight loss, comprising the step of administration of the food composition product to said subject.
17. Method according to claim 16, wherein the step of administration of the food composition product is performed at least once and preferably 3 times per day over a coherent period of 1 week to 4 weeks.
PCT/SE2014/050831 2013-07-17 2014-07-01 Food composition product WO2015009225A1 (en)

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BE1022733B1 (en) * 2015-02-27 2016-08-25 Fitr Foods Bvba Low-carbohydrate, protein-rich, wheat, nut and gluten-free flour
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