Use of collagen hydrolysate in the prevention and / or treatment of food cravings - Patent Application 20070229933

Abstract

The present invention relates to the use of collagen hydrolysate in the prevention and / or treatment of food cravings. Collagen hydrolysate may have therapeutic and / or non-therapeutic effects. The prevention and / or treatment of cravings with collagen hydrolysate may be aimed at reducing weight or improving general well-being. Collagen hydrolysate is preferably administered as a daily food supplement formulation.

Description

[Technical field]

[0001] The present invention relates to a method for the prevention and / or treatment of food cravings, in particular to a food supplement for the prevention and / or treatment of food cravings. [Background technology]

[0002] Food craving is a strong desire to eat a particular food or foods. The strength and specificity of food cravings are different from normal hunger. Food cravings may have cognitive (e.g., a strong desire for food), emotional (e.g., mood changes), behavioral (e.g., food seeking), and physiological (e.g., salivation) characteristics (Rodriguez-Martin et al., Front Psychol. 2015;6:21). Women are more likely to develop food cravings than men, which may be related to hormonal differences between women and men. Food cravings may be triggered by certain mood states and may also be triggered by environmental cues such as stress (Cepeda-Benito et al., Behav Res Ther. 2000 Nov;38(11):1125-38). Food cravings are typically seen in the late afternoon and / or early evening.

[0003] Food craving is considered to be a state quite different from hunger. In contrast to hunger, food craving is not necessarily related to food deprivation and hunger (Pelchat ML et al., Physiol Behav. 2000 Jan;68(3):353-9). Food craving is generally not relieved by food intake. Instead, it is a strong desire for high-energy foods, especially foods that are high in sugar, fat, and / or carbohydrates. Food craving is not induced by exposing subjects to appetizing food cues, which also shows that food craving is distinct from hunger (Grubliauskiene et al., Front.Psychol.5:788). Although food craving and hunger can coexist, hunger is not considered to be a necessary condition for food craving to be expressed.

[0004] Excessive food cravings can pose health and psychological risks (Kemps et al., Current Directions in Psychological Science, 19(2), 86-90). Overeating leads to increased body mass index and obesity, insulin resistance, and other health problems. Overeating also leads to psychological consequences such as guilt, shame, and depression. On the other hand, food cravings are not necessarily pathological. Food cravings may resolve naturally or lessen over time, with or without occasional recurrence. In other words, food cravings are not necessarily chronic conditions. Food cravings may also not necessarily cause other health problems, especially in less extreme forms of food cravings. Nevertheless, healthy individuals or those who experience less extreme forms of food cravings may benefit from measures to prevent and / or treat food cravings by maintaining or improving the aesthetic appearance of the body and / or by improving overall function and well-being.

[0005] Food cravings may occur in healthy individuals, but may be more frequent and intense in certain medical conditions, including but not limited to obesity, pregnancy, gastrointestinal disorders, Addison's disease, premenstrual syndrome, hormonal imbalance, hyperthyroidism, stress, hyperphagia, low serotonin, cystic fibrosis, and liver disease.In these medical conditions, food cravings may be considered a symptom of the underlying medical condition, but are generally unrelated to the pathophysiology of the underlying condition.It appears that the biological mechanism of food cravings may be different between healthy individuals and those suffering from one of the above medical conditions.For example, it has been shown that the role of thalamic activity in food cravings is more prominent in obese individuals compared to lean individuals (Jastreboff et al., Diabetes Care (2013) 36:394-402).

[0006] Appropriate measures to prevent and / or treat food cravings are desirable from both pathological (therapeutic) and non-pathological (non-therapeutic) points of view, e.g. cosmetic effects, improved systemic function, enhanced sense of well-being) points of view.

[0007] It has been proposed to reduce food cravings by appetite suppression. Appetite suppression has been achieved mostly by appetite suppressants that act through brain catecholamine or serotonin pathways (Silverstone et al., Drugs, vol. 43, pp. 820-836, 1992). Appetite suppressants include amphetamines, antidepressants, and drugs that enhance serotonin activity. These appetite suppressants have several limitations. First, they are considered to exhibit unacceptable side effects. Second, appetite suppressants are not suitable for use as prescription drugs in healthy individuals (e.g., non-obese individuals). Second, appetite suppressants do not selectively target food cravings, so they reduce general appetite and interfere with normal food intake. Second, food cravings do not always occur at the same time or point in the day, making it difficult to time the appetite suppressant intake appropriately to effectively reduce food cravings. Typically, a subject may take the appetite suppressant after a food craving has already manifested, and thus the appetite suppressant may be taken late, or too late, to effectively prevent and / or treat the food craving.

[0008] There remains an unmet need for methods of preventing and / or treating food cravings. In particular, methods that are considered safe and can be applied as therapeutic or non-therapeutic methods are desired. Furthermore, methods that more specifically target food cravings overeating, for example, without suppressing normal hunger and / or without interfering with normal eating, are desired. On the one hand, for example, normal weight healthy individuals who are not necessarily seeking weight loss may benefit from suppressing cravings without affecting normal appetite. On the other hand, overweight or obese individuals may benefit from reducing normal food intake in addition to reducing cravings. Also, methods of preventing and / or treating food cravings that are less dependent on the timing of application of the methods or not at all are desired. Also, methods for preventing and / or treating food cravings that do not cause the undesirable side effects of commonly applied appetite suppressants are desired. Summary of the Invention [Problem to be solved by the invention]

[0009] The present invention aims to provide such a method. [Means for solving the problem]

[0010] The present inventors have discovered that supplementation with collagen hydrolysate prevents and / or treats food cravings.

[0011] In one aspect, the present invention relates to the use of collagen hydrolysate in the non-therapeutic prevention and / or non-therapeutic treatment of food cravings.

[0012] In one aspect, the present invention relates to the use of collagen hydrolysate in the therapeutic prevention and / or therapeutic treatment of food cravings.

[0013] In one aspect, the invention relates to a method of using collagen hydrolysate to treat a subject experiencing food cravings.

[0014] In one aspect, the present invention relates to the use of a collagen hydrolysate for the manufacture of a medicament for preventing and / or treating food cravings.

[0015] Some findings of the present inventors show that the prevention and / or treatment of food cravings by collagen hydrolysate is not necessarily mediated by reducing hunger and / or increasing satiety.The present inventors first discovered that food cravings are prevented and / or treated, especially after repeated (daily) intake of collagen hydrolysate.The present inventors then discovered that the subject's food cravings are prevented and / or treated without affecting the subject's normal eating habits, such as the subject's normal food intake.The present inventors then discovered that there is no clear correlation between the timing of collagen hydrolysate intake and the prevention and / or treatment of food cravings.

[0016] Without being bound by theory, the inventors have found that the dosing regimen may play a role in managing cravings. This allows (if necessary) to further specifically reduce cravings without affecting normal appetite. For example, the specific reduction of cravings is greatest when the total daily dose of collagen hydrolysate is not too large (e.g., a daily dose of 40g or less) and is divided into two or more unit doses (e.g., each unit dose of 20g or less, preferably about 10g). Furthermore, the specific reduction of cravings is highest when collagen hydrolysate is taken once every other day or every day. A molecular weight of collagen hydrolysate of less than 9000Da appears to be beneficial for the specific reduction of cravings. Without being bound by theory, the inventors believe that a higher molecular weight leads to a stronger feeling of satiety, and therefore a greater suppression of normal appetite without necessarily further reducing cravings. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] In one aspect, the present invention relates to the use of collagen hydrolysate in the non-therapeutic prevention and / or non-therapeutic treatment of food cravings.

[0018] In one aspect, the present invention relates to the use of collagen hydrolysate in the therapeutic prevention and / or therapeutic treatment of food cravings.

[0019] The benefits and advantages of the present invention are as follows: -The use of collagen hydrolysate, for example as a daily supplement, is generally considered safe. The use of collagen hydrolysate in the prevention and / or treatment of food cravings applies both as a therapeutic or non-therapeutic method. - The use of collagen hydrolysate in the prevention and / or treatment of food cravings does not necessarily interfere with normal food intake and does not necessarily suppress normal hunger and appetite (e.g. food cravings are more specifically targeted than with the use of appetite suppressants). This is particularly beneficial for normal weight healthy individuals who are not necessarily seeking weight loss. Overweight or obese individuals may also benefit from reduced normal food intake in addition to reduced cravings, - the use of collagen hydrolysate in preventing and / or treating food cravings is relatively independent of the timing of its application (e.g., compared to the use of appetite suppressants). Typically, collagen hydrolysate is taken before the onset of food cravings, which allows food cravings to be more effectively prevented and / or treated; - Food cravings were reduced after both 4 and 8 weeks of collagen hydrolysate supplementation, suggesting that collagen hydrolysate’s ability to prevent and / or treat food cravings is durable.

[0020] (Prevention and / or Treatment of Food Cravings) As used herein, the term "food craving" refers to a strong desire to eat a particular type of food, typically food with a particular caloric density (e.g., high calorie), texture, and / or flavor. The manifestation of food craving is believed to be multifaceted. Physiologically, food craving may prepare the body for food intake, as indicated by increased salivary flow and activation of reward-related regions of the brain, such as the striatum. Food cravings often also include cognitive (i.e., excessive thinking about food) and emotional (e.g., mood changes) components. Food cravings often also include behavioral components, including excessive desire for food (Meule et al., Current Nutrition Reports, Vol. 9, pp. 251-257, 2020). Food cravings generally increase throughout the day. Food cravings are most typically seen in the late afternoon and / or early evening, e.g., after dinner or at night. Food cravings are generally not relieved by the consumption of regular meals (e.g., breakfast, lunch, dinner). Food cravings are considered to be distinct from hunger. Hunger is typically the result of an empty stomach, whereas food cravings are typically not the result of an empty stomach. Hunger is typically relieved by the ingestion of any type of food, whereas food cravings are typically relieved by high-calorie foods. Hunger typically correlates with the length of time of food deprivation, whereas food cravings typically do not correlate with food deprivation or the length of time of food deprivation. Typically, food cravings (not hunger) are considered to develop when there is a desire for food, preferably a strong desire for food, within 1-1.5 hours of ingesting a meal (e.g., a regular breakfast, lunch, or dinner). Hunger is usually accompanied by certain physical symptoms (e.g., stomach noises and / or dizziness) associated with food deprivation and / or an empty stomach, whereas this is not usually the case with food cravings. Additionally or alternatively, "food craving" is believed to be distinguished from hunger by its intensity, i.e., food craving is a stronger or more extreme form of the desire for food. Although hunger and food craving may coexist, hunger is not believed to be a necessary condition for the expression of food craving.

[0021] As used herein, "hunger" refers to lack of fullness or satiety, and is generally the result of an empty stomach. Hunger is generally relieved by the intake of any type of food, including high-calorie or non-high-calorie foods. Hunger is generally correlated with the length of time of food deprivation, i.e., the longer the time of food deprivation, the hungrier the hungrier. Hunger is usually accompanied by certain physical symptoms associated with food deprivation and / or an empty stomach, such as stomach noises and / or dizziness. These symptoms typically decrease or disappear after eating.

[0022] In one embodiment, a "food craving" as disclosed herein is not the same as or related to hunger (feeling hungry).

[0023] In one embodiment, "food craving" as disclosed herein is not the same as or related to satiety (feelings of satiety).

[0024] In one embodiment, the "food craving" disclosed herein is unrelated to food deprivation.

[0025] In one embodiment, the "food craving" disclosed herein is independent of the length of time of food deprivation.

[0026] In one embodiment, the "food craving" disclosed herein is unrelated to physical symptoms, and preferably is unrelated to physical symptoms associated with food deprivation and / or an empty stomach (e.g., stomach noises and / or dizziness).

[0027] In one embodiment, the "food cravings" disclosed herein are unrelated to stomach fullness.

[0028] In one embodiment, a "food craving" as disclosed herein is an increased desire for food in the late afternoon, evening and / or nighttime.

[0029] In one embodiment, a "food craving" as disclosed herein is a desire for high calorie food.

[0030] In one embodiment, the "food craving" disclosed herein is independent of a desire for food that is not a high-calorie food.

[0031] In one embodiment, the "food cravings" disclosed herein are unrelated to the desire for and / or intake of nutrient dense foods.

[0032] In a preferred embodiment, a "food craving" as disclosed herein is a desire for food within 3 hours, preferably within 1.5 hours, and more preferably within 1 hour after a meal.

[0033] In a preferred embodiment, the uses of the collagen hydrolysates disclosed herein include use in food cravings, which are cravings for high calorie foods.

[0034] The inventors have discovered that food cravings may be prevented and / or treated without interfering with normal food intake, such as normal dietary intake.

[0035] In a preferred embodiment, the use of the collagen hydrolysates disclosed herein includes reducing hunger and / or preventing and / or treating food cravings independent of satiety.

[0036] In a preferred embodiment, the use of the collagen hydrolysates disclosed herein includes preventing and / or treating food cravings independent of normal dietary intake.

[0037] In one embodiment, the food cravings disclosed herein are characterized by a preference for calorie dense foods over nutrient dense foods.

[0038] As used herein, "high calorie food" refers to food that has a large amount of calories relative to its weight. High calorie density is typically due to high levels of saturated fat, added sugars and / or other simple carbohydrates. "High calorie food" herein preferably contains more than 100 kcal per 100 g of food weight, more preferably more than 200 kcal per 100 g of food weight, most preferably more than 300 kcal per 100 g of food weight. Additionally or alternatively, high calorie food may refer to food that contains more than 10 g of sugar, preferably more than 25 g of sugar, more preferably more than 50 g of sugar, per 100 g of food weight. Additionally or alternatively, high calorie food may refer to food that contains more than 10 g of saturated fat, preferably more than 25 g of saturated fat, more preferably more than 50 g of saturated fat, per 100 g of food weight. "High calorie food" herein is preferably not a nutrient-dense food.

[0039] The high calorie foods disclosed herein can be one or more selected from the group including processed foods, fried foods, French fries, pizza, fast food, candy, chips, pastries, cakes, ice cream, chocolate, fast food, nuts, butter, cream, cheese, bacon, sausage, sauces, condiments, dressings, and sugary drinks.

[0040] As used herein, a "nutrient-dense food" refers to a food that is high in nutritional value (e.g., per energy content and / or per weight). Several indices of nutrient density of food are available. For example, the Nutrient-Dense Food (NRF) index score is used to determine nutrient profile and is based on nutrient density. Nutrient density is the ratio of the nutrient components of a food to the nutrient requirements of human consumers. The development of an NRF index score typically involves several methodological issues, including the selection of macronutrients, the selection of recommended daily allowances (RDA) and the calculation basis (per 100g, per 100kcal (418kJ) or per serving size). The median NRF9.3 index score is the NRF index score known to those skilled in the art. The higher the NRF index score, the higher the nutrient density per 100kcal (Drewnowski et al., Am J Clin Nutr. 2010 Apr;91(4):1095S-1101S). A "nutrient-dense food" as disclosed herein preferably means that the food has a median NRF9.3 index score per 100 kcal of greater than 0, preferably greater than 20, more preferably greater than 40.

[0041] As used herein, a "meal" refers to an eating occasion occurring at a particular time and includes prepared foods. Meals occur daily, typically several times per day. Breakfast, lunch, and dinner are considered meals. A meal is typically considered to involve eating a substantial amount of food (e.g., 500-1000 kcal per meal). Consumption of a meal typically reduces hunger, increases satiety, and induces a feeling of fullness.

[0042] (Non-therapeutic and therapeutic prevention and / or treatment of food cravings) The collagen hydrolysates disclosed herein may have both non-therapeutic and therapeutic uses in the prevention and / or treatment of food cravings. Non-therapeutic or therapeutic uses may be differentiated based on the nature of the food craving and / or on the different subject groups in which the food craving is expressed.

[0043] The first group (herein "healthy subjects") includes healthy subjects who will not receive therapeutic benefit from treatment with the collagen hydrolysate disclosed herein. For example, the food cravings may be non-pathological, meaning that the food cravings are generally of a severity that would not be expected to cause health problems and that the food cravings do not cause symptoms such as pain and distress. Additionally or alternatively, the food cravings may be of such a nature or severity that they will naturally disappear over time (i.e., not chronic). Additionally or alternatively, the severity of food cravings in the healthy subjects is such that they generally do not seek help from a specialized medical professional. The healthy subjects may require less or shorter treatment with collagen hydrolysate to prevent and / or treat food cravings compared to subjects whose food cravings are of a pathological nature. The collagen hydrolysate disclosed herein may improve the overall performance of the healthy subjects. In the healthy subjects, the collagen hydrolysate disclosed herein may provide the following effects: -improving the aesthetic appearance of the body (e.g. for cosmetic purposes to promote slimming), -Loss of weight, - Reduction in body mass index, -Reduction in food-seeking events, -Improved productivity in everyday life, -Improved self-esteem, -Reduced feelings of guilt, -Reduction of embarrassment, improvement of general functioning and / or well-being; and - Relief of non-morbid conditions caused by overeating and / or eating high calorie foods, e.g., one or more non-morbid conditions selected from the group including cramps, abdominal pain, bloating, gas, diarrhea, constipation One or more of the following effects may be achieved.

[0044] The second group (herein "pathological subject group") includes subjects whose food cravings are pathological, i.e., whose food cravings can cause symptoms of pain and suffering and / or cause (serious) health and psychological risks. The severity of food cravings is such that professional medical professionals are generally sought for help. Pathological subject group may require more or longer treatment with collagen hydrolysate to prevent and / or treat food cravings compared to cases in which food cravings are non-pathological. In pathological subject group, food cravings can be the primary or only pathological condition. Alternatively, food cravings can be a symptom of an underlying disease, and therefore in this case food cravings are neither the primary nor the only pathological condition. For example, the pathological subject group includes patients with gastrointestinal disorders, obesity, Addison's disease, premenstrual syndrome, hormonal imbalance, hyperthyroidism, stress, binge eating, low serotonin, cystic fibrosis or liver disease, and food craving is one symptom (of one or more possible symptoms). Treating these subjects with collagen hydrolysate can generally treat food craving as one of many symptoms (of many), without further affecting the underlying disease or pathophysiology.

[0045] A professional medical professional can typically determine on a case-by-case basis whether a food craving event requires therapeutic or non-therapeutic intervention (i.e. whether one falls into the healthy or pathological group). A professional medical professional can, for example, determine whether a food craving can lead to (significant) health and psychological risks. Additionally or alternatively, a professional medical professional can determine whether a food craving is a symptom of an underlying medical condition.

[0046] In one embodiment, the use of the collagen hydrolysate disclosed herein is non-therapeutic. In one embodiment, the use of the collagen hydrolysate disclosed herein is for cosmetic purposes. In one embodiment, the use of the collagen hydrolysate disclosed herein is in healthy individuals. In one embodiment, the food cravings disclosed herein are not symptoms of an underlying medical condition. In one embodiment, the use of the collagen hydrolysate disclosed herein is for food cravings that are not chronic and / or that disappear naturally. In one embodiment, the use of the collagen hydrolysate disclosed herein is for food cravings that are not in extreme form and / or are not associated with additional symptoms, diseases and / or health problems. In one embodiment, the use of the collagen hydrolysate disclosed herein is for food cravings that do not exhibit a pathological nature.

[0047] In one embodiment, the use of the collagen hydrolysate disclosed herein is in the healthy population disclosed herein.

[0048] In one embodiment, the use of the collagen hydrolysate disclosed herein includes: - Reduction in body mass index, -Reduction in food-seeking events, -Improved productivity in everyday life, -Improved self-esteem, -Reduced feelings of guilt, -Improved general functioning and / or well-being; and - Relief of non-morbid conditions caused by overeating and / or eating high calorie foods, e.g., one or more non-morbid conditions selected from the group including cramps, abdominal pain, bloating, gas, diarrhea, constipation The present invention is directed to one or more selected from the group including:

[0049] In a preferred embodiment, the collagen hydrolysate disclosed herein is for (therapeutic) use in the prevention and / or treatment of food cravings.

[0050] In a preferred embodiment, the food craving targeted for treatment is a symptom of one or more conditions selected from the group including gastrointestinal disorders, obesity, Addison's disease, premenstrual syndrome, hormonal imbalance, hyperthyroidism, stress, bulimia, low serotonin, cystic fibrosis and liver disease.

[0051] In one embodiment, the use of the collagen hydrolysate disclosed herein is in a pathological subject population disclosed herein.

[0052] In one embodiment, the use of the collagen hydrolysate disclosed herein for preventing and / or treating food cravings is in a patient suffering from one or more conditions selected from the group including gastrointestinal disorders, obesity, Addison's disease, premenstrual syndrome, hormonal imbalance, hyperthyroidism, stress, binge eating, low serotonin, cystic fibrosis and liver disease.

[0053] As used herein, "obesity" refers to a medical condition in which excess body fat accumulates to an extent that may adversely affect health. Obesity is not merely a cosmetic concern. Obesity is a medical problem because it increases the risk of other diseases and health problems, such as heart disease, diabetes, high blood pressure, and certain cancers. A professional medical practitioner may determine whether a person is obese by one or more means. It is generally believed that a body mass index (BMI) of 30.0 or greater indicates the presence of obesity. Reducing the body fat and / or BMI of an obese person is considered to be a therapeutic intervention herein. In the present disclosure, a BMI of 25.0 or greater and less than 30 indicates being overweight. As used herein, "overweight" refers to a non-medical condition characterized by the excess accumulation of body fat. Reducing the body fat and / or BMI of an overweight person is considered to be a non-therapeutic intervention herein.

[0054] The collagen hydrolysate disclosed herein comprises: - Subjects with a healthy weight, - Overweight subjects, and - Subjects who are obese The composition may be suitable for preventing and / or treating cravings in one or more subject groups selected from the group comprising:

[0055] The collagen hydrolysates disclosed herein may be suitable for preventing and / or treating cravings in a variety of subjects with different BMIs.

[0056] In one embodiment, the prevention and / or treatment of food cravings disclosed herein is in a subject with a BMI of less than 25, for example, a subject with a BMI of 15-25 or 20-25.

[0057] In one embodiment, the prevention and / or treatment of food cravings disclosed herein is in a subject with a BMI of 25-30.

[0058] In one embodiment, the prevention and / or treatment of food cravings disclosed herein is in a subject with a BMI of 30 or greater, such as a subject with a BMI of 30-50, or 30-40, or 30-35.

[0059] In one aspect, the present invention relates to a method, preferably a therapeutic method, for the prevention and / or treatment of food cravings. The method disclosed herein may be used in subjects who have already developed food cravings (e.g., as a method for treating a subject) or in subjects who have not yet developed food cravings (e.g., as a method for preventing food cravings). The method of prevention and / or treatment may include one or more features of the embodiments described herein for the use of collagen hydrolysate in the prevention and / or treatment of food cravings, including the type(s) of collagen hydrolysate for use disclosed herein, the formulation(s) of collagen hydrolysate for use disclosed herein, the timing(s) of administration or ingestion of collagen hydrolysate for use disclosed herein, and the dose(s) of administration or ingestion of collagen hydrolysate for use disclosed herein (e.g., dosage regimen, unit dose, daily dose). The method of prevention and / or treatment disclosed herein may be suitable for treating subjects who have one or more less extreme forms of food cravings disclosed herein (e.g., in need of non-therapeutic intervention). The methods of prevention and / or treatment may additionally or alternatively be suitable for treating subjects who have one or more extreme forms of food cravings and / or whose food cravings may pose (significant) health and psychological risks as disclosed herein (e.g. requiring therapeutic intervention).

[0060] In one aspect, the present invention relates to the use of collagen hydrolysate as described herein for the manufacture of a medicament for the prevention and / or treatment of food craving. The use of collagen hydrolysate as described herein for the manufacture of a medicament may include one or more features of the embodiment described herein for the use of collagen hydrolysate in the prevention and / or treatment of food craving, including the type(s) of collagen hydrolysate for use as disclosed herein, the formulation(s) of collagen hydrolysate for use as disclosed herein, the timing(s) of administration or ingestion of collagen hydrolysate for use as disclosed herein, and the dose(s) of administration or ingestion of collagen hydrolysate for use as disclosed herein (e.g., dosage regimen, unit dose, daily dose). The medicament comprising collagen hydrolysate may be suitable for treating a subject having one or more less extreme forms of food craving as disclosed herein (e.g., requiring non-therapeutic intervention). A medicinal product comprising collagen hydrolysate may additionally or alternatively be suitable for treating subjects who have one or more extreme forms of food cravings and / or whose food cravings may pose (e.g., require therapeutic intervention) the (serious) health and psychological risks disclosed herein.

[0061] (collagen hydrolysate) As used herein, "collagen hydrolysate" is a mixture of short chains of amino acids obtained from native collagen, generally through a hydrolysis process including enzymatic hydrolysis (also called enzymatic hydrolysation). The degree of hydrolysis usually affects the average molecular weight of the final product. Collagen hydrolysates typically have a molecular weight of 1-10 kDa (Daltons). The term "collagen hydrolysate" may be used interchangeably and synonymously with the terms "hydrolyzed collagen" or "collagen peptides".

[0062] The collagen hydrolysates disclosed herein may be derived from one or more types of collagen selected from the group including collagen type I, collagen type II, and collagen type III. Additionally or alternatively, the collagen hydrolysates disclosed herein may be a mixture of one or more of collagen types I, II, and III.

[0063] The collagen hydrolysates disclosed herein are preferably derived from type I and / or type II collagen. Additionally or alternatively, the collagen hydrolysates disclosed herein are preferably derived from an animal source that contains primarily type I and / or type II collagen as collagen therein.

[0064] The collagen hydrolysate as part of the present invention may comprise hydrolyzed collagen or partially hydrolyzed collagen, and the collagen may be derived from any species of animal. Animal in this context may refer to any animal from which connective tissue can be obtained and from which the collagen hydrolysate can be prepared.

[0065] In one embodiment, the collagen taught herein is of bovine origin. In one embodiment, the collagen taught herein is of porcine origin. In one embodiment, the collagen taught herein is of fish origin.

[0066] In various embodiments, the collagen disclosed herein is a mixture of collagens from different sources, such as collagens from multiple animal species and / or collagens from different tissues.For example, the collagen disclosed herein can be a mixture of two or more collagens selected from the group including fish collagen, porcine collagen and bovine collagen.In addition, or alternatively, the collagen can be a mixture of collagens selected from skin-derived collagen, cartilage-derived collagen, bone-derived collagen and / or connective tissue-derived collagen.

[0067] "Hide" is generally used to refer to the outer covering of larger animals, such as bovine or any other large animal. "Skin" is generally used to refer to the outer covering of smaller animals, such as deer, goats, sheep, etc. The terms "skin" and "hide" may be used interchangeably herein and may refer to the outer covering of an animal regardless of size.

[0068] The "connective tissue" disclosed herein can be one or more types selected from the group including corpus callosum, skin, antlers, protruding (e.g., knob) horns, head, brain, neck, ears, eyes, nose, tongue, lips, mouth, esophagus, trachea, limbs, feet, toes, palms, nails, bones, cartilage, bone marrow, joints, membranes, hind, ligaments, tendons, ribs, diaphragm, muscles, skeletal muscle, smooth muscle, intestine, venetian, blood vessels, bladder, stomach, aorta, heart, liver, kidneys, breast, lungs, spleen, pancreas, eggs, sperm, testes, ovaries, nerves, gallbladder, and abdominal connective tissue.

[0069] In a preferred embodiment, the collagen taught herein is derived from skin and / or dermal connective tissue. In another preferred embodiment, the collagen taught herein is derived from cartilage. In yet another preferred embodiment, the collagen taught herein is derived from bone.

[0070] The collagen disclosed herein may be a mixture of collagens from two or more tissues and / or two or more animals. In one embodiment, the collagen disclosed herein is a mixture of two or more collagens selected from the group including skin collagen, cartilage collagen and bone collagen.

[0071] In various embodiments of the invention, the collagen hydrolysate may be produced by enzymatic or partial enzymatic hydrolysis of collagen, and the enzymes used for this purpose may be one or more selected from the group comprising serine proteases, alkaline proteases, neutral proteases, flavour proteases, complex proteases, thiol proteases, bromelain, metalloproteases, aspartame, proteases, carboxypeptidases, pepsin, chymotrypsin, trypsin, cathepsin K, chymotrypsin, papain and subtilisin.

[0072] The molecular weights disclosed herein are preferably average (mean) molecular weights, more preferably weight average molecular weights (M W ).

[0073] The collagen hydrolysates disclosed herein may have an average molecular weight of at least 100 Da, at least 200 Da, at least 300 Da, at least 400 Da, at least 500 Da, at least 1000 Da, at least 1500 Da, at least 2000 Da, at least 2500 Da, at least 3000 Da, at least 3500 Da, at least 4000 Da, at least 4500 Da, at least 5000 Da, at least 5500 Da, at least 6000 Da, at least 6500 Da, at least 7000 Da, at least 7500 Da, at least 8000 Da, at least 8500 Da, at least 9000 Da, at least 9500 Da or at least 10000 Da. Additionally or alternatively, the collagen hydrolysates disclosed herein may have an average molecular weight of less than or equal to 10000 Da, 9500 Da, 9000 Da, 8500 Da, 8000 Da, 7500 Da, 7000 Da, 6500 Da, 6000 Da, 5500 Da, 5000 Da, 4500 Da, 4000 Da, 3500 Da, 3000 Da, 2500 Da, 2000 Da, 1500 Da, 1000 Da, 500 Da, 400 Da, 300 Da, 200 Da or 100 Da.

[0074] In a preferred embodiment, the collagen hydrolysate disclosed herein has an average molecular weight of between 1500 Da and 6000 Da.

[0075] In the present invention, it is beneficial if the collagen hydrolysate has an average molecular weight of less than 9000 Da, for example, an average molecular weight of 1500-6000 Da. For example, the inventors have found that collagen hydrolysates with average molecular weights of about 2000 Da (-2000), about 5000 Da (-5000) or about 9000 Da (-9000) reduce cravings, with the greatest reduction in cravings observed when the average molecular weight is 2000 Da or 5000 Da.

[0076] The collagen hydrolysates disclosed herein may have an average molecular weight of from 300 Da to 10,000 Da, for example from 500 Da to 7,500 Da, from 1,000 Da to 6,000 Da, from 1,500 Da to 5,000 Da, or from 1,500 Da to 3,000 Da.

[0077] In one embodiment, the collagen hydrolysate disclosed herein has an average molecular weight of between 1250 Da and 2750 Da, preferably between 1500 Da and 2500 Da, more preferably between 1750 Da and 2250 Da.

[0078] In one embodiment, the collagen hydrolysate disclosed herein has an average molecular weight of between 4250 Da and 5750 Da, preferably between 4500 Da and 5500 Da, more preferably between 4750 Da and 5250 Da.

[0079] In one embodiment, the collagen hydrolysate disclosed herein has an average molecular weight of between 2000 Da and 5000 Da, preferably between 2500 Da and 4500 Da, more preferably between 3000 Da and 4000 Da.

[0080] In one embodiment, the collagen hydrolysate disclosed herein has an average molecular weight of between 1500 Da and 3000 Da, or between 3000 Da and 6000 Da.

[0081] In one embodiment, the collagen hydrolysate disclosed herein has a protein content of 75-99% by weight, preferably 80-99% by weight, more preferably 85-99% by weight, and most preferably 90-99% by weight (e.g., 95-99%).

[0082] In one embodiment, the collagen hydrolysate disclosed herein comprises glycine in an amount of 15-25% by weight, proline in an amount of 9-18% by weight, and hydroxyproline in an amount of 6-15% by weight, based on the total weight of amino acids in the collagen hydrolysate.

[0083] In one embodiment, the collagen hydrolysate disclosed herein comprises glycine in an amount of 5-50% by weight, preferably glycine in an amount of 10-30% by weight, more preferably glycine in an amount of 12.5-27.5% by weight, even more preferably glycine in an amount of 15-25% by weight, and most preferably glycine in an amount of 17.5-22.5% by weight, based on the total weight of amino acids in the collagen hydrolysate.

[0084] In one embodiment, the collagen hydrolysate disclosed herein comprises proline in an amount of 2-25% by weight, preferably proline in an amount of 7-20% by weight, more preferably proline in an amount of 9-18% by weight, and most preferably proline in an amount of 12-15% by weight, based on the total weight of amino acids in the collagen hydrolysate.

[0085] In one embodiment, the collagen hydrolysate disclosed herein comprises hydroxyproline in an amount of 2-20% by weight, preferably hydroxyproline in an amount of 7-18% by weight, more preferably hydroxyproline in an amount of 6-15% by weight, and most preferably hydroxyproline in an amount of 9-12% by weight, based on the total weight of amino acids in the collagen hydrolysate.

[0086] In one embodiment, the collagen hydrolysate disclosed herein has a molecular weight of 1750-2250 Da and comprises glycine in an amount of 15-25% by weight, proline in an amount of 9-18% by weight, and hydroxyproline in an amount of 6-15% by weight, relative to the total weight of amino acids in the collagen hydrolysate.

[0087] In one embodiment, the collagen hydrolysate disclosed herein has a molecular weight of 4750-5250 Da and comprises glycine in an amount of 15-25% by weight, proline in an amount of 9-18% by weight, and hydroxyproline in an amount of 6-15% by weight, relative to the total weight of amino acids in the collagen hydrolysate.

[0088] In one embodiment, the collagen hydrolysate disclosed herein has a molecular weight of 1500-3000 Da and comprises glycine in an amount of 15-25% by weight, proline in an amount of 8-18% by weight, and hydroxyproline in an amount of 6-15% by weight, relative to the total weight of amino acids in the collagen hydrolysate.

[0089] (Collagen hydrolysate blend) The collagen hydrolysate disclosed herein may be provided in a food formulation, a food supplement formulation or a pharmaceutical formulation, preferably a food supplement formulation.

[0090] The collagen hydrolysate disclosed herein may be provided in a solid dosage form such as a capsule, tablet or powder, preferably a powder.

[0091] The collagen hydrolysates disclosed herein may be provided in a formulation, for example, a drinkable solution or suspension, a beverage such as a beer, a syrup, an artificially flavored beverage, a carbonated beverage, a (water soluble) powder mix, a (water soluble) paste, a (water soluble) powder, a (water soluble) tablet, a (water soluble) pill, a (water soluble) dragee, a (water soluble) caplet, a (water soluble) sachet or a (water soluble) capsule, etc. Additionally or alternatively, the collagen hydrolysates disclosed herein may be present in a functional food, for example, in juices, shakes, dairy drinks, yogurt, yogurt drinks, desserts, energy bars, nutrition bars, weight loss bars, or confectioneries such as gummies or centered gummies.

[0092] (Timing of administration or ingestion of collagen hydrolysate) In one embodiment, the disclosed collagen hydrolysate is administered at least 2 hours, preferably at least 4 hours, and more preferably at least 6 hours before a meal.

[0093] In one embodiment, the collagen hydrolysate disclosed herein is administered repeatedly to a subject.

[0094] In one embodiment, the collagen hydrolysate disclosed herein is administered to a subject daily.

[0095] In one embodiment, the disclosed collagen hydrolysate is administered to a subject for at least 2 consecutive weeks, more preferably at least 4 consecutive weeks, even more preferably at least 6 consecutive weeks, and most preferably at least 8 consecutive weeks.

[0096] The collagen hydrolysate disclosed herein may be administered daily, once every other day, three times a week, twice a week, or once a week. Additionally or alternatively, the collagen hydrolysate disclosed herein may be administered once a day, twice a day, or three times a day. Additionally or alternatively, the collagen hydrolysate disclosed herein may be administered for at least 1 day, or at least 2 days, or at least 3 days, or at least 4 days, or at least 5 days, or at least 6 days, or at least 1 week, or at least 2 weeks, or at least 3 weeks, or at least 4 weeks, or at least 5 weeks, or at least 6 weeks, or at least 8 weeks, or at least 12 weeks, or at least 16 weeks.

[0097] The present inventors have discovered that collagen hydrolysate can prevent and / or treat food cravings regardless of the timing of its administration (e.g., compared to the use of appetite suppressants, etc.). Typically, collagen hydrolysate is taken before food cravings appear, thereby more effectively preventing and / or treating food cravings. In accordance with the above, collagen hydrolysate disclosed herein can be administered at various preferred times during the day, thereby less affecting normal food intake. For example, collagen hydrolysate can be administered early in the morning and / or before or during breakfast. Additionally or alternatively, collagen hydrolysate can be administered late at night, such as before going to bed or during or after dinner.

[0098] In a preferred embodiment, the use of the collagen hydrolysate disclosed herein involves administering the collagen hydrolysate at least 2 hours, preferably at least 4 hours, more preferably at least 6 hours before a meal.

[0099] In a preferred embodiment, the use of the collagen hydrolysate disclosed herein involves repeated administration of the collagen hydrolysate to a subject.

[0100] In a preferred embodiment, the repeated administration of the collagen hydrolysate disclosed herein comprises: -Daily and / or - for at least 1 consecutive week, preferably at least 2 consecutive weeks, more preferably at least 4 consecutive weeks It is.

[0101] In certain subjects, food cravings may occur consistently at certain times and / or at certain points in the day.The inventors believe that the prevention and / or treatment of food cravings with collagen hydrolysate is more effective when the collagen hydrolysate is administered well before the time and / or point in the day when food cravings occur consistently in the subject.For example, if the subject typically experiences food cravings between 10:00 pm and 11:00 pm, the collagen hydrolysate is preferably administered between 8:00 pm and 9:00 pm, or between 6:00 pm and 7:00 pm, or between 4:00 pm and 5:00 pm, or in the morning (e.g., before or during breakfast).

[0102] In a preferred embodiment, the collagen hydrolysate disclosed herein is administered 2 or more hours, preferably 4 or more hours, more preferably 6 or more hours, such as 8 or more hours or 12 or more hours, prior to the time of day when food cravings are typically experienced by the subject.

[0103] In a preferred embodiment, the collagen hydrolysate disclosed herein is - In the morning, e.g. before or during breakfast, and / or - In the evening, during or after dinner Administer to.

[0104] The inventors have found that repeated daily intake of collagen hydrolysate leads to the prevention and / or treatment of food cravings.According to the above, collagen hydrolysate is preferably administered for at least 2 days, at least 3 days, at least 4 days, at least 5 days, at least 6 days, at least 7 days, at least 10 days or at least 14 days, which are preferably consecutive days before the prevention and / or treatment of food cravings is performed or is most effective.

[0105] In a preferred embodiment, the prevention and / or treatment of food cravings with the collagen hydrolysate disclosed herein is carried out by repeated daily administration of the collagen hydrolysate, preferably for at least 2 consecutive days, more preferably for at least 4 consecutive days, and most preferably for at least 7 consecutive days.

[0106] (Administration or ingestion of collagen hydrolysate) In various embodiments, the daily dose of the collagen hydrolysate disclosed herein is at least 1 g, at least 5 g, at least 10 g, at least 15 g, at least 20 g, at least 25 g, at least 30 g, at least 35 g, at least 40 g, at least 45 g, at least 50 g, at least 55 g, at least 60 g, at least 65 g, at least 70 g, at least 75 g, at least 80 g, at least 85 g, at least 90 g, at least 95 g, at least 100 g, at least 110 g, at least 120 g, at least 130 g, at least 140 g, at least 150 g, at least 160 g, at least 170 g, at least 180 g, at least 190 g, or at least 200 g, where the daily dose is the total dry weight administered to a subject per day. Additionally or alternatively, in various embodiments, the daily dose of the collagen hydrolysate disclosed herein is 200g or less, 190g or less, 180g or less, 170g or less, 160g or less, 150g or less, 140g or less, 130g or less, 120g or less, 110g or less, 100g or less, 95g or less, 90g or less, 85g or less, 80g or less, 75g or less, 70g or less, 65g or less, 60g or less, 55g or less, 50g or less, 45g or less, 40g or less, 35g or less, 30g or less, 25g or less, 20g or less, 15g or less, 10g or less, 5g or less, or 1g or less, where the daily dose is the total dry weight of the subject per day.

[0107] In preferred embodiments, the use of the collagen hydrolysate disclosed herein includes administering the collagen hydrolysate in an amount of 1 g to 200 g, or 1 g to 100 g, or 2 g to 50 g, or 5 g to 25 g, where the daily dose is the total dry weight administered to a subject per day.

[0108] In the present invention, in order not to reduce normal appetite and / or to reduce craving more specifically, it is beneficial if the daily dose of collagen hydrolysate does not exceed a certain threshold amount.For example, for healthy individuals, a daily dose of 20g of collagen hydrolysate is preferred over a daily dose of 100g of collagen hydrolysate, since ingesting 100g seems to affect normal appetite and normal meal intake (especially lunch, dinner).

[0109] In a preferred embodiment, the use of the collagen hydrolysate disclosed herein comprises administering the collagen hydrolysate in a daily dose in an amount of 2-200 g, preferably 5-100 g, more preferably 10-50 g, wherein the amount is the dry weight of the collagen hydrolysate.

[0110] In various embodiments, the unit dose of the collagen hydrolysate disclosed herein is an amount of at least 1 g, at least 2 g, at least 3 g, at least 4 g, at least 5 g, at least 6 g, at least 7 g, at least 8 g, at least 9 g, at least 10 g, at least 11 g, at least 12 g, at least 13 g, at least 14 g, at least 15 g, at least 20 g, at least 25 g, at least 30 g, at least 35 g, at least 40 g, at least 45 g, at least 50 g, at least 55 g, at least 60 g, at least 65 g, at least 70 g, at least 75 g, at least 80 g, at least 85 g, at least 90 g, at least 95 g, at least 100 g, at least 110 g, at least 120 g, at least 130 g, at least 140 g, at least 150 g, at least 160 g, at least 170 g, at least 180 g, at least 190 g, or at least 200 g, wherein the amount is the dry weight of the collagen hydrolysate. Additionally or alternatively, in various embodiments, the unit dose of the collagen hydrolysate disclosed herein is 200g or less, 190g or less, 180g or less, 170g or less, 160g or less, 150g or less, 140g or less, 130g or less, 120g or less, 110g or less, 100g or less, 95g or less, 90g or less, 85g or less, 80g or less, 75g or less, 70g or less, 65g or less. or less than 60g, 55g or less, 50g or less, 45g or less, 40g or less, 35g or less, 30g or less, 25g or less, 20g or less, 15g or less, 14g or less, 13g or less, 12g or less, 11g or less, 10g or less, 9g or less, 8g or less, 7g or less, 6g or less, 5g or less, 4g or less, 3g or less, 2g or less, or 1g or less, wherein all amounts are by dry weight of collagen hydrolysate.

[0111] In one embodiment, the collagen hydrolysate disclosed herein is administered in a unit dose in an amount of 0.5 g to 200 g, or 1 g to 100 g, or 2 g to 50 g, or 5 g to 25 g, or 5 to 15 g, where the amount is the dry weight of the collagen hydrolysate.

[0112] In a preferred embodiment, the use of the collagen hydrolysate disclosed herein comprises administering the collagen hydrolysate in a unit dose in an amount of 2-50 g, preferably 5-25 g, more preferably 5-15 g, wherein the amount is the dry weight of the collagen hydrolysate.

[0113] In the present invention, in order not to reduce normal appetite and / or to reduce craving more specifically, it is beneficial to divide the daily dose of collagen hydrolysate into multiple unit doses (e.g., 2 unit doses, 3 unit doses or 4 unit doses).For example, taking the daily dose of collagen hydrolysate as a single dose seems to affect appetite and normal meal intake (especially lunch, dinner), which is undesirable for healthy people.

[0114] The daily dose of collagen hydrolysate may be administered as a single unit dose, or as two, three, four or more unit doses. The two or more unit doses may be equal or different in amount. The daily dose of collagen hydrolysate disclosed herein is preferably administered as two unit doses, each corresponding to 30-70% of the daily dose, preferably 40-60% of the daily dose.

[0115] In one embodiment, two or more unit doses disclosed herein are administered at least 1 hour, at least 2 hours, at least 3 hours, at least 4 hours, at least 5 hours, at least 6 hours, at least 7 hours, at least 8 hours, at least 9 hours, at least 10 hours, at least 11 hours, or at least 12 hours apart from each other.

[0116] In a preferred embodiment, the administration regimen of the collagen hydrolysate disclosed herein comprises administering a daily dose of collagen hydrolysate as two unit doses, each unit dose is in an amount of 5-25 g, preferably 5-15 g, where the amount is the dry weight of collagen hydrolysate; and / or - The two unit doses are administered at least 6 hours apart, preferably 8 hours, more preferably 12 hours apart from each other.

[0117] In a preferred embodiment, the daily dose of collagen hydrolysate is administered as two or more unit doses, each unit dose is in an amount of 5-25 g, preferably 5-15 g, where the amount is the dry weight of collagen hydrolysate; and / or - Two or more unit doses are administered at least 6 hours apart, preferably 8 hours, more preferably 12 hours apart from each other.

[0118] In a preferred embodiment, the collagen hydrolysate disclosed herein is administered with a meal.

[0119] In one embodiment, the collagen hydrolysate dosing regimen comprises administering a daily dose of collagen hydrolysate as two unit doses, one unit dose administered in the morning (e.g., before or during breakfast) and one unit dose administered in the evening (e.g., during or after dinner, or before bedtime).

[0120] In a preferred embodiment, the administration regimen of the collagen hydrolysate disclosed herein comprises administering the collagen hydrolysate at least once a week.

[0121] In the present invention, it is beneficial to administer the daily dose of collagen hydrolysate frequently, for example, every day or every other day, etc. In comparison, ingesting collagen hydrolysate only once a week is less / ineffective in reducing cravings.

[0122] In a preferred embodiment, the administration regimen of the collagen hydrolysate disclosed herein comprises administering the collagen hydrolysate daily or every other day.

[0123] In a preferred embodiment, the collagen hydrolysate is administered daily or every other day.

[0124] In a preferred embodiment, the administration regimen of the collagen hydrolysate disclosed herein comprises administering the collagen hydrolysate at least once daily.

[0125] In a preferred embodiment, the collagen hydrolysate is administered at least once daily.

[0126] In the present invention, it is beneficial if the subject is administered a daily dose of collagen hydrolysate for more than one week, as administration over a longer period results in the greatest reduction in cravings.

[0127] In one embodiment, the administration regimen of the collagen hydrolysate disclosed herein comprises administering the collagen hydrolysate for at least 2 consecutive days, preferably for at least 4 consecutive days, and more preferably for at least 7 consecutive days.

[0128] In one embodiment, the administration regimen of the collagen hydrolysate disclosed herein comprises administering the collagen hydrolysate for at least 2 consecutive weeks, preferably at least 4 consecutive weeks, and more preferably at least 8 consecutive weeks.

[0129] In a preferred embodiment, the administration regimen of the collagen hydrolysate disclosed herein comprises administering the collagen hydrolysate for at least 1 week, preferably at least 2 consecutive weeks, more preferably at least 4 consecutive weeks.

[0130] general definition The term "unit dose" as used herein relates to the amount of a compound, substance or composition that a subject takes in a single dose. A unit dose is typically in a pre-prepared form (e.g., a pre-filled dose) that is ready for administration. A unit dose can also be identifiable, for example, on the product packaging or label. A daily dose can be divided into multiple unit doses.

[0131] As used herein, the term "administer" or "administration" includes providing a compound, substance, or composition to a subject who will consume it. A subject who consumes a compound, substance, or composition may administer it to the subject himself / herself. In such cases, the term "administer" may be interpreted as "ingest."

[0132] As used herein, "preventing" or "prevention" means to prevent a condition (e.g., selective hunger) from developing in a subject. An intervention is also considered to be preventative herein if the onset of the condition is delayed, the severity is reduced, and / or the incidence is reduced, even if the onset of the condition is not completely prevented. As used herein, "preventing" or "prevention" by an intervention encompasses a situation where a subject has previously developed a condition, but the intervention has prevented the recurrence of the condition. "Preventing" or "prevention" can have therapeutic and / or non-therapeutic effects. When "preventing" or "prevention" is therapeutic in nature, it can also be directed to a disease or condition and / or to the symptoms of the underlying condition. "Preventing" or "prevention" can be defined by any delay, change in severity and / or change in incidence, such as at least 5%, at least 10%, at least 20%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, at least 100%, or any change in between, as compared to a control or baseline, as measured by any standard technique.

[0133] As used herein, "treating" or "treatment" means that when a condition already exists, an intervention reduces, improves, and / or cures the condition (e.g., food cravings). The terms "lowering", "reducing" and "improving" can be used interchangeably with the term "treating" when describing a change in a condition. "Treatment" or "treating" can have therapeutic and / or non-therapeutic effects. When "treatment" or "treating" is therapeutic in nature, it can be directed to a disease or condition and / or to the symptoms of the underlying pathology. Treatment can be any reduction in the severity, incidence and / or frequency of a condition, such as at least 5%, 10%, 20%, 40%, 50%, 60%, 80%, 90%, 95% or at least 100%, or any value therebetween, as measured by any standard technique. In the present disclosure, "treating" a food craving or "treatment" of a food craving preferably refers to "treating" or "treatment" of the incidence, frequency and / or severity of a food craving. As used herein, "treating" also encompasses "curing."

[0134] As used herein, the term "subject" refers to any animal in which food cravings can develop. Typically, the term "subject" is used in reference to humans.

[0135] The term "symptom" as used herein relates to any physical (e.g., functional decline), psychological (e.g., pain) or biological (e.g., biochemical or histological changes in bodily tissues) characteristic that is considered to be indicative of a disease pathology. A symptom may be experienced by a subject who has the symptom, or may additionally or alternatively be diagnosed or measured as part of a diagnostic process.

[0136] The term "healthy" as used herein refers to a good physical or mental condition. As used herein, a "healthy" subject is a subject that does not suffer from a pathological condition associated with excessive food craving. Furthermore, a "healthy" subject herein does not develop symptoms of pain and suffering associated with food craving that require medical treatment. A "healthy" subject can be any subject in which prevention and / or treatment of food craving is not expected to cause a therapeutic effect.

[0137] As used herein, "satiation" refers to an improvement in appetite following ingestion of food, typically during or after ingestion of a meal. Satiation produces a feeling of fullness, which typically results in a person ceasing to eat.

[0138] As used herein, "satiety" refers to a physical feeling of fullness that allows a subject to stop eating for a period of time. Satiety typically affects the time between two meals, as it can extend the time it takes to feel hungry.

[0139] As used herein, the terms "comprise" or "comprising" and conjugations thereof refer to the context in which these terms are used in an open-ended sense to mean that the items following the word are included, but not excluding items not specifically mentioned. This also encompasses the more restrictive verbs "consisting essentially of" and "consisting of."

[0140] The reference to an element by the indefinite article "a" or "an" does not exclude the possibility that more than one of those elements is present, unless the context clearly dictates that only one of those elements must be present. Thus, the indefinite article "a" or "an" normally means "at least one".

[0141] As used herein, a level is "increased" or "decreased" when it is at least 1% higher or lower than the corresponding level in a control or reference, such as 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45% or 50% higher or lower, respectively. Alternatively, a level in a sample may be considered to be increased or decreased when it is statistically significantly higher or lower, respectively, compared to the level in the control or reference (including at a previous time point). The term "reducing" may be used interchangeably herein with "reducing". The term "reducing" may be used interchangeably herein with "reducing".

[0142] The term "continuous" or "consecutively" as used herein with respect to administration of collagen hydrolysate means that administration is sequential and without any interval during a given period.For example, when "collagen hydrolysate is administered for 4 consecutive days", this means that collagen hydrolysate is administered at least once a day for 4 consecutive days (e.g., on Monday, Tuesday, Wednesday and Thursday of the same week), regardless of the number of administrations per day or the total number of administrations.For example, when "collagen hydrolysate is administered for 4 consecutive weeks", this means that collagen hydrolysate is administered at least once a week for 4 consecutive weeks, regardless of the number of administrations per day, the number of administrations per week or the total number of administrations. [Brief description of the drawings]

[0143] [Figure 1] FIG. 1 shows the mean craving scores reported by individuals at baseline, 4 weeks and 8 weeks after collagen hydrolysate supplementation.

[0144] Experimental Example

[0145] Example 1

[0146] the purpose A study was conducted to determine the effect of daily collagen hydrolysate supplementation on food cravings in healthy women.

[0147] method The study included healthy women (body mass index 25 kg / m or less) who were not receiving any other dietary or lifestyle interventions. 2 Fourteen people (aged 35-65 years or older) participated in the study. None of the participants had any medical conditions or were taking any medications.

[0148] Participants were supplemented with 20 g of dietary collagen hydrolysate (Peptan®, B5000, bovine origin) daily for 8 weeks. The daily dose was divided into two 10 g unit doses. One unit dose was taken in the morning, typically early in the morning before breakfast. One unit dose was taken in the evening or with or after dinner.

[0149] At baseline, 4 weeks after supplementation, and 8 weeks after supplementation, participants were asked to complete the Medical Symptom Questionnaire (MSQ). The MSQ asked participants to indicate whether they had experienced food cravings in the 48 hours prior to completing the MSQ. For this purpose, the MSQ was scored using the following method: 0 - No or almost no symptoms 1 - Symptoms may be present, but effects are not severe 2 - Symptoms may be present and effects are severe 3 - Symptoms occur frequently and the impact is not severe 4 - Symptoms are frequent and the impact is severe was established.

[0150] At the end of the study, participants were interviewed. In addition to the MSQ, the interview included, among other things, the following items: -If there was a reduction in food cravings, when did this first occur after starting daily supplementation with collagen hydrolysate? - if there was a reduction in food cravings, whether the reduction was primarily due to a decrease in the frequency or severity of food cravings; -Have you noticed any changes in your usual eating habits? -Whether there is a correlation between the timing of collagen hydrolysate intake and reduced food cravings, -Whether daily supplementation with collagen hydrolysate caused any potentially adverse events; The purpose was to clarify.

[0151] result The mean craving score decreased from 3.1 at baseline to 2.4 at both 4 and 8 weeks (Figure 1). This reduction in food craving was statistically significant (p < 0.05) by paired t-test. Eleven of 14 participants (79%) experienced a reduction in food craving score of at least 1 point over the course of the study compared to baseline.

[0152] The interview revealed the following: Decreased food cravings were most typically observed during the first week of daily collagen hydrolysate supplementation. It was found that in most individuals, the reduction in food cravings began on the third or fourth day after starting daily supplementation with collagen hydrolysate. - the reduction in food cravings is due to a reduction in the frequency and / or severity of food cravings, most typically due to a reduction in the frequency of food cravings; -Participants generally did not experience any significant changes in their usual eating habits. -There was no clear correlation between the timing of collagen hydrolysate intake and reduced food cravings. For example, reduced food cravings were observed when there was a delay of several hours between collagen hydrolysate intake and the time when food cravings would normally occur. Participants who consumed collagen hydrolysate early in the morning and late in the evening showed reduced food cravings during the day. - Daily supplementation with collagen hydrolysate did not cause any side effects.

[0153] conclusion Collagen hydrolysate reduces food cravings in healthy subjects. The reduction in food cravings by collagen hydrolysate was found to be sustained, based on the observation that the effect was observed both 4 and 8 weeks after the start of supplementation. The reduction in food cravings by collagen hydrolysate was found to be not necessarily a direct effect on increased hunger and satiety. First, repeated daily intake of collagen hydrolysate was found to help reduce food cravings. Second, participants generally did not show any significant changes in their usual eating habits. Second, no clear correlation could be found between the timing of collagen hydrolysate intake and the reduction in food cravings. Daily intake of 20 g of collagen hydrolysate does not cause side effects and appears to be a safe way to reduce food cravings.

[0154] Example 2

[0155] the purpose To examine how collagen hydrolysate doses and administration regimens affect food cravings and normal appetite in healthy individuals.

[0156] method Female participants (inclusion criteria per Example 1) were given supplemental collagen hydrolysate (Peptan®, B5000, bovine origin).

[0157] Comparisons will be performed between participants receiving a total daily dose of 20 g or 100 g of collagen hydrolysate. The daily dose will be split into two unit doses, one to be taken in the morning and one in the afternoon or evening.

[0158] A comparison is made between a daily dose of collagen hydrolysate (20 g) provided as a single unit dose (1 x 20 g) and multiple unit doses (2 x 10 g) divided throughout the day. This is also compared to a daily dose of collagen hydrolysate of 40 g, provided as four unit doses (i.e., 4 x 10 g) divided throughout the day.

[0159] Comparisons are made between collagen hydrolysate ingestion (2 x 10 g unit doses per day) over a 1-week or 8-week period.

[0160] Comparisons will be made between daily, alternate day or weekly collagen hydrolysate ingestion (2 x 10 g unit doses per day).

[0161] To determine the effect of the dosing regimen on craving, the following scoring system was used: 0 - No or almost no cravings 1 - Cravings may occur, but effects are not severe 2 - Cravings may occur and the effects are severe 3 - Cravings are frequent and not severely affected 4 - Cravings are frequent and severe is used.

[0162] To determine the effect of the dosing regimen on changes in normal appetite for food, the following scoring system was used: 0 - No or almost no loss of appetite 1- Decreased appetite may occur, but the effects are not severe 2- Loss of appetite may occur and the effects are severe 3- Loss of appetite is frequent and not severely affected 4- Loss of appetite is frequent and severe is used.

[0163] result

[0164] The results are summarized in Table 1.

[0165] Both the 20 g and 100 g unit doses reduce cravings, but the 100 g unit dose also reduces normal appetite and food intake and is therefore less desirable, for example, in healthy individuals of normal weight who are not necessarily seeking to lose weight.

[0166] Ingestion of two or more unit doses of collagen hydrolysate is more effective at reducing cravings than ingestion of the same daily amount in a single unit dose. Ingestion of a (relatively large) single unit dose has a greater effect on normal appetite and may therefore be less desirable under certain circumstances. Similar results are obtained when collagen hydrolysate is administered as 2 x 10g, 4 x 5g or 4 x 10g. Dividing the total intake into multiple unit doses is particularly beneficial when increasing the total daily dose. The specific reduction in cravings is greatest when each unit dose is 20g or less, e.g., about 10g.

[0167] Daily consumption of collagen hydrolysate for one week reduced cravings without affecting normal appetite, but consumption of collagen hydrolysate for eight weeks produced the greatest specific reduction in cravings.

[0168] The reduction in cravings was especially large when collagen hydrolysate was consumed daily or every other day, but there was some (but not much) reduction in cravings when collagen hydrolysate was consumed once a week.

[0169] Overall, the specific reduction in cravings is highest when the collagen hydrolysate dose does not exceed a certain threshold amount (e.g., about 20g or about 40g daily dose), and is preferably divided into two or more unit doses.Furthermore, the specific reduction in cravings is highest when collagen hydrolysate is taken every other day or every day.These parameters in the dosing regimen allow specific reduction in cravings without affecting normal appetite and normal food intake.

[0170] [Table 1]

[0171] conclusion Overall, the specific reduction in cravings (i.e., no impact on normal appetite) is greatest when the collagen hydrolysate dose is not too high (e.g., 20 g or 40 g daily dose) and is divided into two or more unit doses, e.g., 20 g or less each, e.g., about 10 g, etc. Furthermore, the specific reduction in cravings is greatest when the collagen hydrolysate is consumed once every other day or every day.

[0172] Example 3

[0173] the purpose The reduction in cravings is compared between collagen hydrolysates having average molecular weights of about 2000 Da (~2000), about 5000 Da (~5000), or about 9000 Da (~9000).

[0174] method Female participants (entry criteria according to Example 1) are given a daily dose of 20 g of collagen hydrolysate for a period of 8 weeks. The daily dose is divided into two unit doses, one taken in the morning and one taken in the afternoon or evening.

[0175] The reduction in cravings is measured according to Examples 1 and 2.

[0176] result For collagen hydrolysates, a specific reduction in cravings is observed at all average molecular weights tested, but the greatest reduction in cravings occurs when the average molecular weight of the collagen hydrolysate is about 2000 Da (~2000) or about 5000 Da (~5000).

[0177] conclusion Collagen hydrolysate with average molecular weight less than 9000 Da shows the greatest specific reduction in craving. Without being bound by theory, based on these observations, the inventors believe that the higher molecular weight leads to greater satiety and therefore greater suppression of normal appetite, without necessarily suppressing craving more.

Claims

1. Use of collagen hydrolysate in the non-therapeutic prevention and / or non-therapeutic treatment of food cravings.

2. Use of collagen hydrolysate in the therapeutic prevention and / or therapeutic treatment of food cravings.

3. The collagen hydrolysate is and / or in a daily dose in an amount of 2 to 200 g, preferably 5 to 100 g, more preferably 10 to 50 g; In unit doses in an amount of 2-50 g, preferably 5-25 g, more preferably 5-15 g.

3. Use of the collagen hydrolysate according to claim 1 or claim 2, wherein the amount is the dry weight of the collagen hydrolysate.

4. 4. Use of collagen hydrolysate according to any one of claims 1 to 3, wherein the daily dose of said collagen hydrolysate is administered as two or more unit doses, each unit dose being in an amount of 5 to 25 g, preferably 5 to 15 g, said amount being the dry weight of the collagen hydrolysate.

5. 5. Use of collagen hydrolysate according to any one of claims 1 to 4, wherein the daily dose of said collagen hydrolysate is administered as two or more unit doses, said two or more unit doses being administered at least 6 hours, preferably 8 hours, more preferably 12 hours apart from each other.

6. Use of the collagen hydrolysate according to any one of claims 1 to 5, wherein the administration regimen of the collagen hydrolysate comprises administering the collagen hydrolysate every day or every other day.

7. Use of the collagen hydrolysate according to any one of claims 1 to 6, wherein the administration regimen of the collagen hydrolysate comprises administering the collagen hydrolysate at least once a day.

8. Use of collagen hydrolysate according to any one of claims 1 to 7, wherein the administration regimen of the collagen hydrolysate comprises administering the collagen hydrolysate for at least 2 consecutive days, preferably for at least 4 consecutive days, more preferably for at least 7 consecutive days.

9. 9. Use of collagen hydrolysate according to any one of claims 1 to 8, wherein the administration regimen of the collagen hydrolysate comprises administering the collagen hydrolysate for at least 2 consecutive weeks, preferably at least 4 consecutive weeks, more preferably at least 8 consecutive weeks.

10. Use of the collagen hydrolysate according to any one of claims 1 to 9, wherein the collagen hydrolysate is administered with a meal.

11. Use of the collagen hydrolysate according to any one of claims 1 to 10, wherein said collagen hydrolysate is provided in a food formulation, a food supplement formulation or a pharmaceutical formulation, preferably a food supplement formulation.

12. 12. Use of the collagen hydrolysate according to any one of claims 1 to 11, wherein the collagen hydrolysate is derived from collagen obtained from one or more tissues selected from the group comprising skin, cartilage, bone, tendon, ligament and connective tissue.

13. Use of the collagen hydrolysate according to any one of claims 1 to 12, wherein the collagen hydrolysate is derived from one or more types of collagen selected from the group comprising porcine collagen, bovine collagen and fish collagen.

14. The use according to any one of claims 1 to 13, wherein the collagen hydrolysate has an average molecular weight of from 1500 Da to 6000 Da.

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