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 differ from normal hunger. (ordinary hunger) Food cravings are distinct from food cravings. Food cravings may have cognitive (e.g., 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 experience food cravings than men, which may be related to hormonal differences between women and men. Food cravings can be triggered by specific mood states and can 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 experienced in the late afternoon and / or early evening.

[0003] Food craving is considered to be a state quite distinct from hunger. In contrast to hunger, food craving is not necessarily associated with 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 high in sugar, fat, and / or carbohydrates. Exposure of subjects to appetizing food cues does not induce food craving, which also indicates 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 the development of food craving.

[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 spontaneously or lessen over time, with or without occasional recurrence. In other words, food cravings are not necessarily chronic conditions. Food cravings, especially less extreme forms of food cravings, may also not necessarily cause other health problems. Nevertheless, healthy individuals or those experiencing 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, binge eating, low serotonin, cystic fibrosis, and liver disease.In these medical conditions, food cravings may be considered a symptom of the underlying medical condition, but may be considered to be unrelated to the pathophysiology of the underlying condition as a whole.It appears that the biological mechanism of food craving 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 craving is more pronounced in obese individuals than in 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) perspectives, e.g., cosmetic effects, improved overall function, and enhanced well-being.

[0007] It has been proposed that appetite suppression can reduce food cravings. Appetite suppression has mostly been achieved by appetite suppressants that act via 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 have 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, and therefore reduce general appetite. Normal Food intake (normal food intake)Secondly, food cravings do not always occur at the same time or at the same point in time of the day, so it is difficult to properly time the intake of appetite suppressants to effectively reduce food cravings.Typically, subjects may take appetite suppressants after food cravings have already occurred, so that the intake of appetite suppressants may be delayed or too late to effectively prevent and / or treat food cravings.

[0008] There remains an unmet need for methods to prevent and / or treat food cravings. In particular, methods that are considered safe and can be applied as therapeutic or non-therapeutic methods are desirable. Furthermore, methods that more specifically target overeating of food cravings, e.g., methods that target normal hunger, are also desirable. (normal feeling of hunger) without restraining, and / or Normal meal (normal food diet) On the other hand, for example, for people of normal weight who do not necessarily want to lose weight, (normal weight) In healthy people, there is a normal appetite (normal appetite) On the other hand, in overweight or obese individuals, in addition to reducing cravings, Normal It may also be beneficial to reduce food intake. Also desired are methods for preventing and / or treating food cravings that are less dependent on the timing of application, or not at all. Also desired are methods for preventing and / or treating food cravings that do not cause the undesirable side effects of commonly applied appetite suppressants. 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 present invention relates to a method of treating a subject experiencing food cravings using collagen hydrolysate.

[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] The inventors have found that the prevention and / or treatment of food cravings by collagen hydrolysate is not necessarily mediated by reducing hunger and / or increasing satiety. The inventors first discovered that food cravings are prevented and / or treated, especially after repeated (daily) intake of collagen hydrolysate. The inventors then found that the subject's food cravings are prevented and / or treated by the subject's Normal Food intake (normal intake of meals) etc. Normal eating habits (normal food routine) The 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 discovered that the dosage regimen may play a role in managing cravings. This allows for (if necessary) a more specific reduction in cravings without affecting normal appetite. For example, when the total daily dose of collagen hydrolysate is not too large (e.g., a daily dose of 40 g or less) and is divided into two or more unit doses (e.g., each unit dose of 20 g or less, preferably about 10 g), the specific reduction in cravings is greatest. Furthermore, when collagen hydrolysate is taken every other day or every day, the specific reduction in cravings is greatest. A molecular weight of less than 9000 Da of collagen hydrolysate appears to be beneficial for the specific reduction in cravings. Without being bound by theory, the inventors believe that a higher molecular weight leads to a stronger feeling of fullness, and therefore a greater suppression of normal appetite without necessarily further reducing cravings. DETAILED DESCRIPTION OF THE INVENTION

[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 is applied 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 NormalIt does not interfere with food intake and does not necessarily suppress normal hunger and appetite (e.g., food cravings are more specifically targeted than with appetite suppressants). This is particularly beneficial for healthy individuals of normal weight who are not necessarily seeking weight loss. For overweight or obese individuals, in addition to reducing cravings, Normal Reducing food intake may also be beneficial, 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, thereby more effectively preventing and / or treating food cravings; - Food cravings were reduced after both 4 and 8 weeks of collagen hydrolysate supplementation, demonstrating 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 content), texture, and / or flavor. The manifestation of food craving is believed to be multifaceted. Physiologically, food craving can prepare the body for food intake, as indicated by increased salivary flow and activation of reward-related brain regions such as the striatum. Food cravings often also include cognitive components (i.e., excessive thinking about food) and emotional components (e.g., mood changes). 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 experienced in the late afternoon and / or evening, e.g., after dinner or at night. Food cravings are generally not relieved by consuming regular meals (e.g., breakfast, lunch, dinner). Food cravings are considered to be distinct from hunger. Hunger is typically the result of stomach emptying, whereas food cravings are typically not the result of stomach emptying. Hunger is typically relieved by the ingestion of any type of food, whereas food cravings are typically relieved by high-calorie foods. Hunger is typically correlated with the length of time of food deprivation, whereas food cravings are typically not correlated with either food deprivation or the length of time of food deprivation. Typically, hunger is relieved by a diet (e.g., Normal Food craving (but not hunger) is believed to occur when there is a desire for food, preferably a strong desire for food, within 1 to 1.5 hours after consuming breakfast, lunch, or dinner. Hunger is typically accompanied by certain physical symptoms associated with food deprivation and / or an empty stomach (e.g., stomach noises and / or dizziness), which is typically not the case with food craving. 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. While hunger and food craving can coexist, hunger is not believed to be a necessary condition for the development of food craving.

[0021] As used herein, "hunger" refers to the lack of a feeling 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 greater the hunger. 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 unrelated to hunger (hunger).

[0023] In one embodiment, the "food cravings" disclosed herein are not the same as or related to satiation (feelings of fullness).

[0024] In one embodiment, the "food cravings" disclosed herein are 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 cravings" disclosed herein are unrelated to 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, more preferably within 1 hour after eating.

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

[0034] The inventors have demonstrated that food cravings Normal Food intake, etc. Normal It has been discovered that these conditions can be prevented and / or treated without interfering with food intake.

[0035] In preferred embodiments, uses of the collagen hydrolysates disclosed herein include reducing hunger and / or preventing and / or treating food cravings independent of satiety.

[0036] In a preferred embodiment, the use of the collagen hydrolysate disclosed herein is Normal This includes preventing and / or treating food cravings independent of 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 concentrations of saturated fat, added sugars, and / or other simple carbohydrates. A "high-calorie food" herein preferably contains more than 100 kcal per 100 g of food, more preferably more than 200 kcal per 100 g of food, and most preferably more than 300 kcal per 100 g of food. Additionally or alternatively, a high-calorie food may refer to a food that contains more than 10 g of sugar, preferably more than 25 g of sugar, and more preferably more than 50 g of sugar per 100 g of food. Additionally or alternatively, a high-calorie food may refer to a food that contains more than 10 g of saturated fat, preferably more than 25 g of saturated fat, and more preferably more than 50 g of saturated fat per 100 g of food. Preferably, a "high-calorie food" herein is 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 nutritious (e.g., per energy content and / or per weight). Several indicators of the nutrient density of a food are available. For example, the Nutrient-Dense Food (NRF) Index score is used to determine a nutrient profile and is based on nutrient density. Nutrient density refers to the ratio of a food's nutrient components to the nutrient requirements of a human consumer. The development of an NRF Index score typically involves several methodological issues, including the selection of macronutrients, the selection of the Recommended Daily Allowance (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, "meal" refers to an eating occasion that occurs at a specific time and includes prepared food. 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 causes 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 can be differentiated based on the nature of the food craving and / or the different subject groups in which the food craving is manifested.

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

[0044] The second group (herein referred to as "pathological subject group") includes subjects whose food cravings are pathological, i.e., whose food cravings may cause symptoms of pain and distress and / or pose (serious) health and psychological risks. The severity of food cravings is generally such that professional medical professionals are sought for help. In pathological subject group, the treatment with collagen hydrolysate for preventing and / or treating food cravings may be more frequent or longer than in cases where food cravings are non-pathological. In pathological subject group, food cravings may be the primary or only pathological condition. Alternatively, food cravings may 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, bulimia, low serotonin, cystic fibrosis or liver disease, and food craving is one symptom (among one or more possible symptoms). Treating these subjects with collagen hydrolysate can generally treat food craving as one of (many) symptoms, 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 a person falls into the group of healthy or pathological subjects). A professional medical professional can, for example, determine whether a food craving may lead to (serious) 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 resolve naturally. In one embodiment, the use of the collagen hydrolysate disclosed herein is for food cravings that are not in extreme forms 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 subject population disclosed herein.

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

[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 the pathological subject groups disclosed herein.

[0052] In one embodiment, the use of the collagen hydrolysate disclosed herein to prevent and / or treat 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, bulimia, low serotonin, cystic fibrosis, and liver disease.

[0053] As used herein, "obesity" refers to a medical condition characterized by the accumulation of excess body fat 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 professional may determine whether a person is obese by one or more means. A body mass index (BMI) of 30.0 or greater is generally considered to indicate the presence of obesity. Reducing body fat and / or BMI in an obese person is considered a therapeutic intervention herein. For the purposes of this disclosure, a BMI of 25.0 or greater but less than 30 indicates being overweight. As used herein, "overweight" refers to a non-medical condition characterized by the excessive accumulation of body fat. Reducing body fat and / or BMI in an overweight person is considered 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, for example, 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 preventing and / or treating food cravings. The method disclosed herein may be used in a subject who has already developed a food craving (e.g., as a method for treating a subject), or in a subject who has not yet developed a food craving (e.g., as a method for preventing food cravings). The prevention and / or treatment method may include one or more features of the embodiments described herein for the use of a collagen hydrolysate in preventing and / or treating 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 prevention and / or treatment method disclosed herein may be suitable for treating a subject with one or more less extreme forms of food cravings disclosed herein (e.g., requiring 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 the collagen hydrolysate described herein in the manufacture of a medicament for the prevention and / or treatment of food cravings. The use of the collagen hydrolysate in the manufacture of a medicament disclosed herein may include one or more features of the embodiments described herein for the use of the 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). A medicament comprising collagen hydrolysate may be suitable for treating a subject with one or more less extreme forms of food cravings disclosed herein (e.g., requiring non-therapeutic intervention). Additionally or alternatively, a medicinal product comprising collagen hydrolysate may 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" refers to a mixture of short chains of amino acids obtained from native collagen through a hydrolysis process, generally involving 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 to 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 can be derived from one or more types of collagen selected from the group including type I collagen, type II collagen, and type III collagen. Additionally or alternatively, the collagen hydrolysates disclosed herein can be a mixture of one or more of type I collagen, type II collagen, and type III collagen.

[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 animal sources that primarily contain type I and / or type II collagen as the 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, and animal herein may refer to any animal from which connective tissue can be obtained and from which the connective tissue can be used to prepare the collagen hydrolysate.

[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. Additionally 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 large animals, such as bovine or any other large animal. "Skin" is generally used to refer to the outer covering of small 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, antler, protruding (e.g., knob) horn, head, brain, neck, ear, eye, nose, tongue, lips, mouth, esophagus, trachea, limb, foot, toe, palm, nail, bone, cartilage, bone marrow, joint, membrane, hind, ligament, tendon, rib, diaphragm, muscle, skeletal muscle, smooth muscle, intestine, Venetian, blood vessel, bladder, stomach, aorta, heart, liver, kidney, breast, lung, spleen, pancreas, egg, sperm, testes, ovary, nerve, 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 can be a mixture of collagens derived 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 consisting of skin collagen, cartilage collagen, and bone collagen.

[0071] In various embodiments of the present 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, flavor 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 can have an average molecular weight of less than or equal to 10,000 Da, 9,500 Da, 9,000 Da, 8,500 Da, 8,000 Da, 7,500 Da, 7,000 Da, 6,500 Da, 6,000 Da, 5,500 Da, 5,000 Da, 4,500 Da, 4,000 Da, 3,500 Da, 3,000 Da, 2,500 Da, 2,000 Da, 1,500 Da, 1,000 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 for the collagen hydrolysate to have an average molecular weight of less than 9000 Da, for example, an average molecular weight of 1500 to 6000 Da. For example, the inventors have found that collagen hydrolysates with an average molecular weight of about 2000 Da (about 2000), about 5000 Da (about 5000), or about 9000 Da (about 9000) reduce cravings, with the greatest reduction in craving 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 300 Da to 10,000 Da, for example, 500 Da to 7,500 Da, 1,000 Da to 6,000 Da, 1,500 Da to 5,000 Da, or 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 2000 Da to 5000 Da, preferably 2500 Da to 4500 Da, more preferably 3000 Da to 4000 Da.

[0080] In one embodiment, the collagen hydrolysate disclosed herein has an average molecular weight of 1500 Da to 3000 Da or an average molecular weight of 3000 Da to 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 wt. % relative to the total weight of amino acids in the collagen hydrolysate, preferably glycine in an amount of 10-30 wt. %, more preferably glycine in an amount of 12.5-27.5 wt. %, even more preferably glycine in an amount of 15-25 wt. %, and most preferably glycine in an amount of 17.5-22.5 wt. %.

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

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

[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, based on 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 contains 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.

[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, based on the total weight of amino acids in the collagen hydrolysate.

[0089] (Collagen hydrolysate blend) The collagen hydrolysates 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, a juice, a shake, a dairy drink, a yogurt, a yogurt drink, a dessert, an energy bar, a nutrition bar, a weight loss bar, or a confectionery such as a gummy or centered candy.

[0092] (Timing of administration or intake 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 multiple times to the 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 two consecutive weeks, more preferably at least four consecutive weeks, even more preferably at least six consecutive weeks, and most preferably at least eight consecutive weeks.

[0096] The collagen hydrolysates disclosed herein can be administered daily, once every other day, three times a week, twice a week, or once a week. Additionally or alternatively, the collagen hydrolysates disclosed herein can be administered once a day, twice a day, or three times a day. Additionally or alternatively, the collagen hydrolysates disclosed herein can 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 occur, thereby more effectively preventing and / or treating food cravings. In accordance with the above, the collagen hydrolysate disclosed herein can be administered at various preferred times throughout the day, thereby: Normal The impact on food intake is reduced. For example, the collagen hydrolysate may be administered early in the morning and / or before or during breakfast. Additionally or alternatively, the collagen hydrolysate may be administered before bedtime or later in the evening, such as 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 is.

[0101] In certain subjects, food cravings may occur consistently at certain times and / or at certain times of the day.The present inventors believe that the prevention and / or treatment of food cravings with collagen hydrolysate is more effective when the collagen hydrolysate is administered at a time and / or time that is significantly before the time that food cravings occur consistently in the subject during the day.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 (for example, before or during breakfast).

[0102] In a preferred embodiment, the collagen hydrolysate disclosed herein is administered at least 2 hours, preferably at least 4 hours, more preferably at least 6 hours, such as at least 8 hours or at least 12 hours before the time of day when food cravings typically occur in a 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 present inventors have discovered that repeated daily intake of collagen hydrolysate leads to the prevention and / or treatment of food cravings. According to the above, the 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, and these days are preferably the number of 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 two consecutive days, more preferably for at least four consecutive days, and most preferably for at least seven 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 interest per day.

[0107] In preferred embodiments, the use of the collagen hydrolysate disclosed herein comprises 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 more specifically reduce cravings, it is beneficial if the daily dose of collagen hydrolysate does not exceed a certain threshold amount. For example, ingesting 100 g will reduce normal appetite and Normal meal (normal meals)A daily dose of 20 g of collagen hydrolysate is preferable to a daily dose of 100 g of collagen hydrolysate for healthy individuals, as this appears to affect daily intake (especially at lunch and 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 to 200 g, preferably 5 to 100 g, more preferably 10 to 50 g, where 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 may be 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, 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, 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, wherein 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 to 50 g, preferably 5 to 25 g, more preferably 5 to 15 g, where the amount is the dry weight of the collagen hydrolysate.

[0113] In the present invention, in order to avoid reducing normal appetite and / or to more specifically reduce cravings, it is beneficial to divide the daily dose of collagen hydrolysate into multiple unit doses (e.g., two unit doses, three unit doses, or four unit doses). For example, taking the daily dose of collagen hydrolysate as a single dose can reduce appetite and Normal It appears to affect food intake (especially lunch and dinner), which is undesirable for healthy individuals.

[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 to 25 g, preferably 5 to 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 to 25 g, preferably 5 to 15 g, where the amount is the dry weight of collagen hydrolysate; and / or - The 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 a daily dose of collagen hydrolysate frequently, for example, every other day, etc. In comparison, consuming collagen hydrolysate only once a week is less / ineffective in reducing cravings.

[0122] In preferred embodiments, 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 of time 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 two consecutive days, preferably at least four consecutive days, and more preferably at least seven consecutive days.

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

[0129] In a preferred embodiment, the administration regimen of the collagen hydrolysate disclosed herein comprises administering the collagen hydrolysate for at least one week, preferably at least two consecutive weeks, and more preferably at least four 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 ingests 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 may also be identifiable, for example, on the product packaging or label. A daily dose may be divided into multiple unit doses.

[0131] As used herein, the terms "administer" or "administration" include 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 themselves. In such cases, the term "administer" can be interpreted as "ingest."

[0132] As used herein, "preventing" or "prevention" means preventing a condition (e.g., selective hunger) from developing in a subject. As used herein, an intervention is also considered to be preventative if the onset of the condition is delayed, the severity is reduced, and / or the incidence is reduced, even if the occurrence of the condition is not completely prevented. As used herein, "preventing" or "prevention" by an intervention encompasses situations where a subject has previously developed a condition, but the intervention has prevented the condition from recurring. "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 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 therebetween, as compared to a control or baseline, as measured by any standard technique.

[0133] As used herein, "treating" or "treatment" means that an intervention alleviates, improves, and / or cures a condition (e.g., food cravings) when the condition is already present. The terms "lowering," "reducing," and "improving" can be used interchangeably with the term "treating" when describing a change in a condition. "Treating" or "treating" can have therapeutic and / or non-therapeutic effects. When "treatment" or "treating" is therapeutic in nature, it can be directed at a disease or condition and / or 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% compared to a control or baseline, 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 occur. 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 state. As used herein, a "healthy" subject refers to a subject who is not suffering from a pathological condition associated with excessive food cravings. Furthermore, a "healthy" subject herein does not experience symptoms of pain and suffering associated with food cravings that require medical treatment. A "healthy" subject may be any subject in whom the prevention and / or treatment of food cravings is not expected to produce a therapeutic effect.

[0137] As used herein, "satiety" refers to an improvement in appetite after ingesting food, typically during or after ingesting a meal. Satiety leads to 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 can typically increase the time it takes to feel hungry, thus affecting the time between meals.

[0139] As used herein, the terms "comprise" or "comprising" and their conjugations refer to situations in which these terms are used in an open-ended sense to mean that the items following the word are included, but items not specifically mentioned are not excluded. 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 indicates 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, e.g., 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, or 50% higher or lower, respectively, than the corresponding level in a control or reference. Alternatively, a level in a sample may be considered to be increased or decreased, respectively, when it is statistically significantly higher or lower compared to the level in the control or reference (including at a previous time point). The term "decreasing" may be used interchangeably herein with "reducing." The term "reducing" may be used interchangeably herein with "reducing."

[0142] The term "continuous" or "consecutively" used herein in relation to the administration of collagen hydrolysate herein means that the 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 (for example, 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 explanation of the drawings]

[0143] [Figure 1] FIG. 1 shows the mean craving scores reported by individuals at baseline, after 4 weeks, and after 8 weeks of 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 ) who were not receiving any other dietary or lifestyle intervention. 2 Fourteen people (aged 35-65 years or older) participated. 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 before breakfast early in the morning. 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 the effects are severe 3 - Symptoms are frequent and the impact is not severe 4 - Symptoms are frequent and severe was established.

[0150] At the end of the study, participants were interviewed. In addition to the MSQ, the interview included, among other things: -If a reduction in food cravings was observed, when did this first occur after daily supplementation with collagen hydrolysate begin? - If there is a reduction in food cravings, whether the reduction is primarily due to a decrease in the frequency or severity of food cravings; - Normal Have you noticed any changes in your 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 potential adverse events, The purpose was to clarify the following.

[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 less than 0.05) by paired t-test. Eleven of 14 participants (79%) experienced a reduction of at least one point in their food craving score over the course of the study compared to baseline.

[0152] The interview revealed the following: Decreased food cravings were most commonly observed during the first week of daily collagen hydrolysate supplementation. In most individuals, the reduction in food cravings began on the third or fourth day of daily collagen hydrolysate supplementation. - 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 were generally Normal No significant changes in eating habits were observed -There is no clear correlation between the timing of collagen hydrolysate intake and reduced food cravings. For example, there is no clear correlation between the timing of collagen hydrolysate intake and reduced food cravings. normal to (normally) The reduction in food cravings was observed even when there was a delay of several hours between onset. Participants who consumed collagen hydrolysate early in the morning and late at night experienced a reduction in 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 individuals. The reduction in food cravings by collagen hydrolysate was found to be sustained, based on the observed effects both 4 and 8 weeks after the start of supplementation. The reduction in food cravings by collagen hydrolysate was found not necessarily to be a direct effect on increased hunger and satiety. First, repeated daily intake of collagen hydrolysate was found to be helpful in reducing food cravings. Second, participants were generally Normal No significant changes in eating habits were observed. Second, no clear correlation was found between the timing of collagen hydrolysate intake and reduced food cravings. Daily intake of 20g of collagen hydrolysate does not cause side effects and appears to be a safe method for reducing food cravings.

[0154] Example 2

[0155] the purpose To test 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) receive supplemental collagen hydrolysate (Peptan®, B5000, bovine origin).

[0157] Comparisons will be conducted between participants receiving a total daily dose of 20 g or 100 g of collagen hydrolysate. The daily dose will be divided 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 provided as 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 (two 10 g unit doses per day) over a 1 week or 8 week period.

[0160] Comparisons will be made between daily, every other day, or weekly collagen hydrolysate intake (two 10g 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 severe 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- Poor appetite may occur, but the effect is not severe 2- Loss of appetite may occur and the effects are severe 3- Loss of appetite is frequent and not severe 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, for healthy individuals of normal weight who are not necessarily seeking weight loss.

[0166] Taking two or more unit doses of collagen hydrolysate is more effective at reducing cravings than taking the same daily amount in a single unit dose. Taking a (relatively large) single unit dose has a greater impact on normal appetite and may therefore be less desirable under certain circumstances. Similar results are obtained when collagen hydrolysate is administered as 2 x 10 g, 4 x 5 g, or 4 x 10 g. 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 20 g or less, e.g., about 10 g.

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

[0168] Consuming collagen hydrolysate every day or every other day resulted in a particularly large reduction in cravings, but consuming collagen hydrolysate once a week resulted in a slight (but not significant) reduction in cravings.

[0169] Overall, the specific reduction in cravings is greatest when the collagen hydrolysate dose does not exceed a certain threshold amount (e.g., a daily dose of about 20 g or about 40 g), and is preferably divided into two or more unit doses. Furthermore, the specific reduction in cravings is greatest when the collagen hydrolysate is taken every other day or every day. These parameters in the administration regimen allow for normal appetite and Normal It becomes possible to specifically reduce cravings without affecting 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., a daily dose of 20 g or 40 g) 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 taken once every other day or every day.

[0172] Example 3

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

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

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

[0176] result For collagen hydrolysates, a specific reduction in craving was observed at all average molecular weights tested, but the greatest reduction in craving was observed when the average molecular weight of the collagen hydrolysate was 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 the molecular weight, the greater the satiety, and therefore the greater the suppression of normal appetite, without necessarily suppressing craving more. <Additional Notes> The present invention includes the following aspects. <Section 1> Use of collagen hydrolysate in the non-therapeutic prevention and / or non-therapeutic treatment of food cravings. <Section 2> Use of collagen hydrolysate in the therapeutic prevention and / or therapeutic treatment of food cravings. <Section 3> The collagen hydrolysate in a daily dose of 2 to 200 g, preferably 5 to 100 g, more preferably 10 to 50 g, and / or A unit dose of 2 to 50 g, preferably 5 to 25 g, more preferably 5 to 15 g Use of the collagen hydrolysate according to <Item 1> or <Item 2>, wherein the amount is the dry weight of the collagen hydrolysate. <Section 4> Use of the collagen hydrolysate according to any one of <Item 1> to <Item 3>, wherein the daily dose of the collagen hydrolysate is administered as two or more unit doses, each unit dose being 5 to 25 g, preferably 5 to 15 g, and the amount is the dry weight of the collagen hydrolysate. <Section 5> Use of the collagen hydrolysate according to any one of <Item 1> to <Item 4>, wherein the daily dose of the collagen hydrolysate is administered as two or more unit doses, and the two or more unit doses are administered at least 6 hours, preferably 8 hours, more preferably 12 hours apart from each other. <Section 6> Use of the collagen hydrolysate according to any one of <Item 1> to <Item 5>, wherein the administration regimen of the collagen hydrolysate comprises administering the collagen hydrolysate every day or every other day. <Section 7> Use of the collagen hydrolysate according to any one of <Item 1> to <Item 6>, wherein the administration regimen of the collagen hydrolysate comprises administering the collagen hydrolysate at least once a day. <Section 8> Use of the collagen hydrolysate according to any one of <Item 1> to <Item 7>, wherein the administration regimen of the collagen hydrolysate comprises administering the collagen hydrolysate for at least two consecutive days, preferably at least four consecutive days, more preferably at least seven consecutive days. <Section 9> Use of the collagen hydrolysate according to any one of <Item 1> to <Item 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. <Section 10> Use of the collagen hydrolysate according to any one of <Item 1> to <Item 9>, wherein the collagen hydrolysate is administered together with a meal. <Section 11> Use of the collagen hydrolysate according to any one of <Item 1> to <Item 10>, wherein the collagen hydrolysate is provided in a food formulation, a food supplement formulation or a pharmaceutical formulation, preferably a food supplement formulation. <Section 12> Use of the collagen hydrolysate according to any one of <Item 1> to <Item 11>, wherein the collagen hydrolysate is derived from collagen obtained from one or more tissues selected from the group consisting of skin, cartilage, bone, tendon, ligament, and connective tissue. <Section 13> Use of the collagen hydrolysate according to any one of <Item 1> to <Item 12>, wherein the collagen hydrolysate is derived from one or more types of collagen selected from the group consisting of porcine collagen, bovine collagen, and fish collagen. <Section 14> The use according to any one of <Item 1> to <Item 13>, wherein the collagen hydrolysate has an average molecular weight of 1500 Da to 6000 Da.

Claims

1. 1. A composition for non-therapeutic reduction of food cravings without affecting normal food intake, said composition comprising a collagen hydrolysate; the collagen hydrolysate has an average molecular weight of less than 9000 Da; The administration regimen of the composition comprises: (1) administering the composition daily or every other day; and (2) administering said collagen hydrolysate in one or more unit doses for a total daily dose of 15-60 g / day, wherein each unit dose is 20 g or less, and the dose is the dry weight of the collagen hydrolysate.

2. 10. The composition of claim 1, wherein the food craving is for a high-calorie food, wherein the high-calorie food is defined as a food containing more than 200 kcal per 100 g of weight.

3. 3. The composition of claim 2, wherein said high-calorie food is further defined as a food containing more than 10g of sugar per 100g of the weight of said food.

4. 3. The composition of claim 2, wherein said high calorie food is further defined as a food containing more than 10g of saturated fat per 100g of weight of said food.

5. 10. The composition of claim 1, wherein the food craving is for one or more foods selected from the group consisting of processed foods, fried foods, French fries, pizza, fast food, candy, chips, pastries, cake, ice cream, chocolate, nuts, butter, cream, cheese, bacon, sausage, sauces, condiments, dressings, and sugary drinks.

6. 10. The composition of claim 1, wherein the food craving is evening and / or nighttime.

7. 10. The composition of claim 1, wherein the collagen hydrolysate has an average molecular weight of 1500 Da to 6000 Da.

8. 10. The composition of claim 1, wherein the total daily dose is administered as two or more 5-15 g unit doses, said doses being the dry weight of collagen hydrolysate.

9. 10. The composition of claim 1, wherein the daily dose of collagen hydrolysate is administered as two or more unit doses, and wherein the two or more unit doses are administered at least six hours apart from each other.

10. 10. The composition of claim 1, wherein the administration regimen of the collagen hydrolysate comprises administering the composition for at least two consecutive days.

11. 10. The composition of claim 1, wherein the administration regimen of the collagen hydrolysate comprises administering the composition for at least two consecutive weeks.

12. The composition of claim 1 , wherein the composition is administered with a meal.

13. 2. The composition of claim 1, wherein the collagen hydrolysate is derived from collagen obtained from one or more tissues selected from the group including skin, cartilage, bone, tendon, ligament and connective tissue.

14. 2. The composition of claim 1, wherein the collagen hydrolysate is derived from one or more types of collagen selected from the group consisting of porcine collagen, bovine collagen, and fish collagen.

15. The composition according to any one of claims 1 to 14, wherein the composition is a food composition.

16. The composition of any one of claims 1 to 14, wherein the composition is a food supplement composition.

17. A method for non-therapeutic reduction of food cravings without affecting normal food intake, the method comprising administering to a subject a composition comprising collagen hydrolysate, the collagen hydrolysate has an average molecular weight of less than 9000 Da; The administration regimen of the composition comprises: (1) administering the composition daily or every other day; and (2) administering said collagen hydrolysate in one or more unit doses for a total daily dose of 15-60 g / day, wherein each unit dose is 20 g or less, and the dose is by dry weight of the collagen hydrolysate.

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