Methods and compositions for producing health benefits in animals

Abstract

The present disclosure provides compositions and methods for providing a health benefit to an animal comprising administering to the animal a food composition comprising about 25% to about 60% protein, about 15% to about 45% fat, and about 5% to about 25% carbohydrate, wherein the protein to carbohydrate caloric contribution ratio is in the range of 3.5:1 to 2.5:1, the fat to carbohydrate caloric contribution ratio is in the range of 2.5:1 to 1.5:1, and the protein to fat caloric contribution ratio is in the range of 3:1 to 1:1.

Description

Cross - reference to related applications 【0001】 【0001】This application claims the benefit and priority of U.S. Provisional Patent Application No. 63 / 283,751, filed on November 29, 2021, the entire disclosure of which is incorporated herein by reference. 【Background Art】 【0002】 【0002】In obese and overweight animals, the risk of many chronic diseases, including heart disease, diabetes, hypertension, stroke, dyslipidemia, certain types of cancer, apnea, and osteoarthritis, is increased. Therefore, in overweight and obese animals, including humans and pets, it is important to reduce excess body fat to maintain health and quality of life. Unfortunately, it is difficult to reduce excess body fat or maintain a healthy weight after weight loss, and various solutions can have adverse effects such as loss of fat - free mass or weight rebound after weight loss. 【0003】 【0003】Obesity is one of the most serious health problems in humans and pets and is considered to be one of the preventable causes of death. Maintaining a healthy weight is important for optimal metabolism, normal physical activity, and good health. Therefore, there is a need for methods and compositions for increasing satiety, promoting weight loss, and / or maintaining a healthy weight to improve animal health and well - being. 【Summary of the Invention】 【0004】

[0004] In one embodiment, a method for producing a health effect in an animal may include the step of administering a food composition to the animal, the food composition comprising about 25% to about 60% protein, about 15% to about 45% fat, and about 5% to about 25% carbohydrates, the caloric contribution ratio of protein to carbohydrates being in the range of 3.5:1 to 2.5:1, the caloric contribution ratio of fat to carbohydrates being in the range of 2.5:1 to 1.5:1, and the caloric contribution ratio of protein to fat being in the range of 3:1 to 1:1. 【0005】

[0005] In another embodiment, the pet food composition may contain about 25% to about 60% protein, about 15% to about 45% fat, and about 5% to about 25% carbohydrates, with a protein-to-carbohydrate calorie contribution ratio in the range of 3.5:1 to 2.5:1, a fat-to-carbohydrate calorie contribution ratio in the range of 2.5:1 to 1.5:1, and a protein-to-fat calorie contribution ratio in the range of 3:1 to 1:1. 【0006】

[0006] Other and further objects, features, and advantages of the present invention will be readily apparent to those skilled in the art. [Modes for carrying out the invention] 【0007】 [Definition]

[0007] The term “animal” means any animal that is subject to the health effects described herein, and includes humans, birds (avian), bovines, canines, equines, felines, hircines, lupines, murines, ovines, or porcines. In one embodiment, the animal may be a mammal. 【0008】

[0008] The term “companion animal” means domesticated animals such as cats, dogs, rabbits, guinea pigs, ferrets, hamsters, mice, gerbils, horses, cows, goats, sheep, donkeys, and pigs. In one embodiment, a companion animal may be a canid. In another embodiment, a companion animal may be a feline. 【0009】

[0009] The term "calorie contribution ratio" refers to the ratio of major nutrients measured as the percentage of calorie contribution from each food composition. For example, the calorie contribution ratio of protein to fat is measured by dividing the calorie percentage of protein derived from the food composition by the calorie percentage of fat derived from the food composition. 【0010】

[0010] The term “therapeutic dose” means an amount of a compound disclosed herein that (i) treats or prevents a particular disease, condition, or disorder; (ii) alleviates, improves, or eliminates one or more symptoms of a particular disease, condition, or disorder; or (iii) prevents or delays the onset of one or more symptoms of a particular disease, condition, or disorder as described herein. 【0011】

[0011] The terms “to treat,” “to treat,” and “treatment” encompass both preventive treatment and palliative treatment. 【0012】

[0012] The term “animal health and / or wellness” means not merely the absence of disease or infirmity, but a state in which the animal is fully satisfied physically, mentally and socially. 【0013】

[0013] The term “together” means that the food compositions, their components, or other compositions disclosed herein are administered to an animal (1) together as a single food composition, or (2) separately at the same or different frequencies using the same or different routes of administration, either nearly simultaneously or periodically. “Periodic” means that the food compositions, their components, or other compositions are administered on a schedule permissible for a particular compound or composition. “Nearly simultaneously” generally means that the food compositions, their components, or other compositions are administered at the same time or within about 72 hours of each other. 【0014】

[0014] The terms “food,” “food product,” or “food composition” mean a product or composition intended for consumption by animals, including humans, and that provides nutrition to animals. 【0015】

[0015] The term "carbohydrate" refers to digestible carbohydrates, such as sugars and starches, and does not include fibers, such as cellulose fibers or fermentable fibers. 【0016】

[0016] The term “regularly” means administration at least once a month, and in one embodiment, administration at least once a week. In certain embodiments, more frequent administration or intake, such as twice or three times a week, may be implemented. In one embodiment, the administration plan may include intake at least once a day. 【0017】

[0017] The term “single package” means that the components of a kit are in or physically associated with one or more containers and are considered as a single unit for the purpose of manufacture, distribution, sale, or use. Containers include, but are not limited to, bags, boxes, cartons, bottles, shrink-wrapped packages, stapled or otherwise attached components, or combinations thereof. A single package may be a container of a food composition or its components that is physically associated so as to be considered as a single unit for manufacture, distribution, sale, or use. 【0018】

[0018] The term “virtual package” means that the components of the kit are associated with instructions relating to one or more physical or virtual kit components that instruct the user on how to obtain other components (for example, including, in a bag or other container, one component and instructions that instruct the user to view a website, contact a recorded message or fax reply service, view a visual message, or contact a caregiver or instructor to obtain instructions on how to use the kit or safety or technical information relating to one or more components of the kit). 【0019】

[0019] The term "approximately" means ±20% of a number, which in one aspect means ±10%, in another aspect means ±5%, and in a further specific aspect means ±2%. For example, in one aspect where "approximately" means ±20% of a number, the phrase "approximately 10% to approximately 20%" can include the range of 8% to 24% or 12% to 16%, and any sub-range thereof. 【0020】

[0020] Embodiments, aspects and examples using the word “comprising” or other non-limiting words as used herein may be replaced with embodiments “consisting essentially of” and “consisting of.” 【0021】

[0021] The term “complete and balanced” when referring to a food composition means a food composition that contains all known necessary nutrients in appropriate amounts and proportions, based on the recommendations of recognized authorities in the field of animal nutrition, and that can therefore serve as the sole source of dietary intake to sustain life or promote production without the need for additional nutritional supplements. Nutritionally balanced pet foods and animal diet compositions, such as complete and balanced food compositions formulated according to standards set forth by the Association of American Feed Control Officials (AAFCO), are widely known and used in the art. In one embodiment, “complete and balanced” may be in accordance with the current standards published by AAFCO on January 1, 2021. 【0022】

[0022] All percentages expressed herein are weight-based on a dry matter basis unless otherwise stated. Those skilled in the art will understand that the term "dry matter basis" means that the concentration or percentage of the raw materials in the composition is measured or specified after all free water in the composition has been removed. 【0023】

[0023] Where used herein, the term "range" is used herein as an abbreviation to avoid the need to enumerate and list every single value within that range. Any suitable value within such range can be selected as the upper limit, lower limit, or boundary value of that range as appropriate. 【0024】 As used herein, unless the context clearly dictates otherwise, the singular forms of words include the plural forms thereof, and vice versa. Thus, references to "a," "an," and "the" generally include the plural forms of the respective terms. For example, reference to a singular "supplement," "method," or "food" includes the plural "supplements," "methods," or "foods" thereof. Similarly, the terms "comprise," "comprises," and "comprising" are to be construed as non-exclusive terms that may include other elements. Similarly, the terms "include," "including," and "or" are all to be construed as inclusive of other elements unless such construction is clearly precluded by the context. Similarly, the term "examples" is merely illustrative and explanatory, particularly when followed by a listing of terms, and should not be construed as exclusive or comprehensive. 【0025】 【0025】The methods and compositions and other developments disclosed herein are not limited to the specific methodologies, procedures, and reagents described herein, because, as will be understood by those skilled in the art, they are variable. Further, the terms used herein are for the purpose of describing only particular embodiments and are not intended, nor are they to be construed, to limit the disclosure or claims. 【0026】 【0026】Unless otherwise defined, all technical, scientific, and specialized terms and acronyms used herein have the meanings commonly understood by those skilled in the art in the field(s) of the present invention, or in the field(s) in which the terms are used. Any compositions, methods, products, or other means or materials similar to or equivalent to those described herein can be used in the practice of the present invention, but the specific compositions, methods, products, or other means or materials are described herein. 【0027】 【0027】All patents, patent applications, publications, technologies and / or academic papers, and other references cited or referred to in this specification are incorporated herein in their entirety to the extent permitted by law. The discussion of these references is only intended to summarize the claims made in those references. None of such patents, patent applications, publications, or references, or any portion thereof, is admitted to be related art, essential art, or prior art. The present disclosure expressly reserves the right to challenge the accuracy and validity of any assertion that such patents, patent applications, publications, and other references are related art, essential art, or prior art. 【0028】 [Mode for Carrying Out the Invention] 【0028】The present method and composition are based on the discovery that certain food compositions have been confirmed to increase satiety in animals. Specifically, the food composition utilizes a protein-to-carbohydrate ratio that increases satiety and provides a health benefit as compared to known treatment regimens such as low-calorie food compositions, dietary therapies, or the use of expensive additives or supplements. However, these conventional treatments can be used in combination with the present method and composition. 【0029】 【0029】In one embodiment, a method for providing a health benefit in an animal can include administering a food composition to the animal, the food composition including from about 25% to about 60% protein, from about 15% to about 45% fat, and from about 5% to about 25% carbohydrate, wherein the calorie contribution ratio of protein to carbohydrate is in the range of 3.5:1 to 2.5:1, the calorie contribution ratio of fat to carbohydrate is in the range of 2.5:1 to 1.5:1, and the calorie contribution ratio of protein to fat is in the range of 3:1 to 1:1. 【0030】

[0030] In another embodiment, the pet food composition may contain about 25% to about 60% protein, about 15% to about 45% fat, and about 5% to about 25% carbohydrates, with a protein-to-carbohydrate calorie contribution ratio in the range of 3.5:1 to 2.5:1, a fat-to-carbohydrate calorie contribution ratio in the range of 2.5:1 to 1.5:1, and a protein-to-fat calorie contribution ratio in the range of 3:1 to 1:1. 【0031】

[0031] The diet of the present invention is generally high in protein and low in carbohydrates, but the macronutrient profile of the present invention is unique and has a specific ratio that produces an unexpected satiety effect. Notably, the diet of the present invention is not a ketogenic diet (traditional or modified); that is, it is not a diet that relies on high fat or a diet in which fat is the main component of the diet. Furthermore, the diet of the present invention is distinct from a typical high-protein diet, as shown in the following examples. The methods and compositions of the present invention rely not on a single macronutrient component, but on a unique macronutrient ratio that has not been understood in the art to date. 【0032】

[0032] Generally speaking, the compositions of the present invention contain protein. The protein may be crude protein material and may include plant proteins such as soybean meal, soybean protein concentrate, corn gluten meal, wheat gluten, cottonseed, pea protein, canola meal and peanut meal, or animal proteins such as casein, albumin and meat protein. Examples of meat proteins useful herein include beef, pork, lamb, horse, poultry, fish and mixtures thereof. The compositions may also optionally contain other materials such as dried whey and other dairy by-products. In one embodiment, the food composition may contain protein in amounts ranging from about 25% by weight, 30% by weight, 35% by weight, 40% by weight, 45% by weight, 50% by weight or even 55% by weight, to about 35% by weight, 40% by weight, 45% by weight, 50% by weight, 55% by weight or even 60% by weight, including various sub-ranges within these ranges. In one embodiment, the protein may constitute about 40% to about 60% by weight of the food composition. In another embodiment, the protein may constitute about 45% to about 55% by weight of the food composition. 【0033】

[0033] Generally, any type of carbohydrate can be used in the food composition. Suitable examples of carbohydrates include grains or cereals such as rice, corn, millet, sorghum, alfalfa, barley, soybeans, canola, oats, wheat, rye, rye wheat, and mixtures thereof. In one embodiment, the carbohydrate constitutes about 15% to about 25% by weight of the food composition. In another embodiment, the carbohydrate constitutes about 10% to about 20% by weight of the food composition. In other embodiments, the carbohydrate may be present in amounts ranging from about 5%, 10%, 15% or even 20% by weight to about 10%, 15% or even 25% by weight. 【0034】

[0034] Generally, food compositions contain fats. Examples of suitable fats include animal fats and vegetable fats. In one embodiment, the fat source may be an animal fat source such as animal fat, lard, or poultry fat. Vegetable oils such as corn oil, sunflower oil, safflower oil, grape seed oil, soybean oil, olive oil, fish oil, and other oils rich in monounsaturated fatty acids and n-6 ​​and n-3 polyunsaturated fatty acids may also be used. In one embodiment, the food composition may contain fat in amounts ranging from about 15% by weight, 20% by weight, 25% by weight, 30% by weight, 35% by weight, or even 40% by weight, to about 20% by weight, 25% by weight, 30% by weight, 35% by weight, 40% by weight, or even 45% by weight, including various sub-ranges within these ranges. In one embodiment, fat constitutes about 20% to about 40% by weight of the food composition. In one embodiment, fat constitutes about 25% to about 35% by weight of the food composition. 【0035】

[0035] Generally, the ratios of protein, carbohydrates, and fats are such that they provide health benefits to animals. Typically, the calorie contribution ratio of protein to carbohydrates is in the range of 3.5:1 to 2.5:1, the calorie contribution ratio of fat to carbohydrates is in the range of 2.5:1 to 1.5:1, and the calorie contribution ratio of protein to fat is in the range of 3:1 to 1:1. In some embodiments, the calorie contribution ratio of protein to carbohydrates may be in the range of 3.25:1 to 2.75:1, or even 3.15:1 to 3:1. In other embodiments, the calorie contribution ratio of fat to carbohydrates may be in the range of 2.25:1 to 1.75:1, or even 2:1 to 1.75:1. In yet another embodiment, the calorie contribution ratio of protein to fat may be in the range of 2:1 to 1.6:1, or even 1.9:1 to 1.65:1. 【0036】

[0036] Administration may be carried out periodically or intermittently as needed and desired. In one embodiment, the food composition may be administered to animals periodically. In one embodiment, administration may be carried out at least once a week. In certain embodiments, more frequent administration or intake may be carried out, such as twice or three times a week. In one embodiment, the administration schedule may include intake at least once a day. 【0037】

[0037] The methods of the present disclosure may include administration as part of a dietary therapy, and may extend throughout the period from birth to adulthood of the animal. In various embodiments, the animal may be a human or a companion animal such as a dog or cat. In certain embodiments, the animal may be a juvenile or growing animal. In other embodiments, administration may begin, for example, when the animal has reached about 10%, 20%, 30%, 40%, or 50% of its estimated or expected lifespan, and may be administered regularly or on an extended regular basis. In some embodiments, the animal may have reached 40%, 45%, or 50% of its predicted lifespan. In yet another embodiment, the animal may be older, having reached 60%, 66%, 70%, 75%, or 80% of its expected lifespan. The calculation of lifespan may be based on health statistics tables, calculations, or estimates, and may take into account past, present, and future influences or factors known to have a positive or negative effect on lifespan. Species, sex, size, genetic factors, environmental factors and stressors, current and past health status, past and present nutritional status, and other factors such as stressors may also have an influence and should be considered when calculating lifespan. 【0038】

[0038] Such administrations may be carried out over a period of time necessary to achieve one or more of the purposes described herein, for example, increasing satiety in animals. Other dosages may be appropriate and may be determined based on the animal's initial body weight, as well as other variable factors such as species, sex, breed, age, and desired health effect. 【0039】

[0039] The moisture content of such food compositions varies depending on the properties of the food composition. The food composition may be a dry composition (e.g., kibble), a semi-moist composition, a moist composition, or any mixture thereof. In one embodiment, the composition may be a pet food composition, which in one embodiment may be a complete and nutritionally balanced pet food. In this embodiment, the pet food may be a “wet food,” “dry food,” or “intermediate moisture content” food. “Wet food” typically refers to pet food that is sold in cans or foil bags and has a moisture content typically in the range of about 70% to about 90%. “Dry food” refers to pet food that has a similar composition to wet food but has a limited moisture content typically in the range of about 5% to about 15% or 20% (typically in the form of kibble, such as small biscuits). In one embodiment, the composition may have a moisture content of about 5% to about 20%. Dry food products include a variety of foods with a variety of moisture contents that are relatively shelf-stable and resistant to deterioration or contamination by microorganisms or fungi. In one embodiment, the dry food composition may be an extruded food product for either humans or companion animals. In one embodiment, the pet food composition may be formulated for dogs. In another embodiment, the pet food composition may be formulated for cats. 【0040】

[0040] The food composition may also contain one or more fiber sources. Such fiber sources include soluble, insoluble, fermentable, and non-fermentable fibers. Such fibers may be plant-derived, such as marine plants, but microbial fiber sources can also be used. As is known to those skilled in the art, a variety of soluble or insoluble fibers can be used. Fiber sources may include beet pulp (derived from sugar beets), gum arabic, gum talha, psyllium, rice bran, corn bran, wheat bran, oat bran, carob gum, citrus pulp, pectin, fructooligosaccharides, short-chain oligofructose, mannan-oligofructose, soy fiber, arabinogalactan, galactooligosaccharides, arabinoxylan, cellulose, or mixtures thereof. 【0041】

[0041] Alternatively, the fiber source may be fermentable fiber. Fermentable fiber has been previously reported to be beneficial to the immune system of companion animals. Fermentable fiber or other compositions known to those skilled in the art that provide prebiotics and promote the growth of probiotics in the intestines may also be incorporated into the composition to help enhance the effects described herein or to enhance the effects on the immune system of animals. 【0042】

[0042] In some embodiments, the ash content of the food composition is in the range of less than 1% to about 15%. In one embodiment, the ash content may be about 5% to about 10%. 【0043】

[0043] Generally, food compositions may be suitable for consumption by humans and animals, including companion animals such as dogs and cats, as meals, meal components, snacks, or treats. Such compositions may include complete foods intended to provide animals with the necessary dietary requirements. Examples of such food compositions include, but are not limited to, dry food, wet food, beverages, bars, cooked frozen foods, cooked preserved foods, and cooked refrigerated foods. 【0044】

[0044] The food composition may further contain one or more substances such as vitamins, minerals, antioxidants, probiotics, prebiotics, salts, and functional additives such as palatants, colorants, emulsifiers, and antimicrobial agents or other preservatives. Examples of minerals that may be useful in such a composition include calcium, phosphorus, potassium, sodium, iron, chloride, boron, copper, zinc, magnesium, manganese, iodine, and selenium. Examples of additional vitamins that may be useful herein include fat-soluble vitamins such as vitamin A, vitamin D, vitamin E, and vitamin K, and water-soluble vitamins including vitamin B and vitamin C. Inulin, amino acids, enzymes, coenzymes, etc., may be useful when included in various embodiments. 【0045】

[0045] The present method for increasing satiety can bring health benefits to animals. In one embodiment, health benefits may include: reduction of body fat, weight loss, reduction of weight gain, reduction of insulin resistance, reduction of diabetes risk, reduction of prediabetes risk, low cholesterol, low glucose, low triglycerides, low insulin, improved insulin sensitivity, low leptin, prevention of prediabetes, delay of the onset of prediabetes, treatment of prediabetes, prevention of diabetes, delay of the onset of diabetes, treatment of diabetes, prevention of insulin resistance, delay of the onset of insulin resistance, treatment of insulin resistance, prevention of overweight or obesity, delay of the onset of overweight or obesity, treatment of overweight or obesity, promotion of metabolic health, promotion of better blood glucose control, reduction of chronic inflammation and inflammatory cytokines, improvement of spontaneous activity, improvement of daytime activity, increased satiety, and combinations thereof. 【0046】

[0046] In various embodiments, the food composition comprises at least one of the following: (1) one or more probiotics; (2) one or more inactivated probiotics; (3) one or more components of an inactivated probiotic that promote similar or identical health effects to those of probiotics, e.g., proteins, lipids, glycoproteins; (4) one or more prebiotics; and (5) a combination thereof. The probiotics or components thereof can be incorporated into the food composition (e.g., distributed uniformly or non-uniformly in the composition) or applied to the food composition (e.g., applied topically with or without a carrier). Such methods are known to those skilled in the art and are described, for example, in U.S. Patent No. 5,968,569 and related patents. 【0047】

[0047] Typical probiotics include Lactobacillus, Bifidobacteria, or Enterococcus species, such as Lactobacillus reuteii, Lactobacillus acidophilus, Lactobacillus animalis, Lactobacillus ruminis, Lactobacillus johnsonii, Lactobacillus casei, Lactobacillus paracasei, Lactobacillus rhamnosus, and Lactobacillus fermentum. Examples of probiotic strains include, but are not limited to, species of the genus Bifidobacterium (fermentum), Enterococcus faecium, and species of the genus Enterococcus. In some embodiments, the probiotic strains include Lactobacillus reuteri (NCC2581; CNCM I-2448), Lactobacillus reuteri (NCC2592; CNCM I-2450), Lactobacillus rhamnosus (NCC2583; CNCM I-2449), Lactobacillus reuteri (NCC2603; CNCM I-2451), Lactobacillus reuteri (NCC2613; CNCM I-2452), Lactobacillus acidophilus (NCC2628; CNCM I-2453), Bifidobacterium adolescentis (e.g., NCC2627), Bifidobacterium species NCC2657, or Enterococcus faecium SF68 (NCIMB It can be selected from the group consisting of 10415). Generally, food compositions are about 10 4 ~about 10 12 cfu / individual / day, in one aspect, 10 5 ~about 1011 cfu / individual / day, and in a particular embodiment, 10 7 ~10 10 The probiotics may be contained in an amount sufficient to supply cfu / individual / day. Even if the probiotics are sterilized or inactivated, the aforementioned amount of sterilized or inactivated probiotics or their components should produce the same beneficial effects as live microorganisms. Many such probiotics and their effects are known to those skilled in the art, for example, in European Patent No. 1213970(B1), European Patent No. 1143806(B1), U.S. Patent No. 7189390, European Patent No. 1482811(B1), European Patent No. 1296565(B1), and U.S. Patent No. 6929793. In one embodiment, the probiotics may be Enterococcus faecium SF68 (NCIMB 10415). In another embodiment, the probiotics may be encapsulated in a carrier using methods and materials known to those skilled in the art. 【0048】

[0048] As described above, the food composition may contain one or more prebiotics, such as fructooligosaccharides, glucooligosaccharides, galactooligosaccharides, isomaltoligosaccharides, xylooligosaccharides, soybean oligosaccharides, lactosucrose, lactulose, and isomaltulose. In one embodiment, the prebiotics may be chicory root, chicory root extract, inulin, or a combination thereof. Generally, prebiotics can be administered in amounts sufficient to actively stimulate the healthy gut microbiota and promote the growth of these "good" bacteria. Typical amounts range from about 1 g to about 10 g per serving, or about 5% to about 40% of the recommended daily intake of dietary fiber for animals. Probiotics and prebiotics can be incorporated into the composition by any preferred means. Generally, these active ingredients can be mixed with the composition or applied to the surface of the composition, for example, by spraying or misting. If the active ingredient is part of a kit, it may be mixed with other materials or contained within a package for the active ingredient. Typically, the food composition contains about 0.1% to about 10% prebiotics on a dry matter basis, about 0.3% to about 7% in one embodiment, and about 0.5% to 5% in a particular embodiment. Prebiotics can be incorporated into the composition by methods known to those skilled in the art, for example, using U.S. Patent No. 5952033. 【0049】

[0049] A person skilled in the art can determine the appropriate amounts of food ingredients, vitamins, minerals, probiotics, prebiotics, antioxidants, or other ingredients to be used in the manufacture of a particular composition to be administered to a particular animal. A person skilled in the art can consider the animal's species, age, size, weight, health condition, etc., when determining the optimal formulation of a particular composition containing such ingredients. Other factors that may be considered include the desired dose of each ingredient, the average intake of a particular type of composition by various animals (e.g., based on species, weight, activity / energy requirements, etc.), and the manufacturing requirements of the composition. 【0050】

[0050] In a further embodiment, the Disclosure provides a kit suitable for administering a food composition to an animal. Depending on the components of the kit, the kit includes, in separate containers in a single package or in separate containers in a virtual package, one or more of the following: (1) one or more raw materials suitable for ingestion by animals; (2) instructions on how to combine the raw materials with other kit components to produce a composition useful for producing the health effects described herein; (3) instructions on how to use the food composition to obtain such effects; (4) one or more probiotics; (5) one or more inactivated probiotics; (6) one or more components of inactivated probiotics that promote similar or identical health effects to probiotics, e.g., proteins, lipids, glycoproteins; (7) one or more prebiotics; (8) a device for preparing or combining the components of the kit to produce a composition suitable for administration to an animal; and (9) a device for administering the combined or prepared kit components to an animal. In one embodiment, the kit includes one or more raw materials suitable for ingestion by animals. In another embodiment, the kit includes instructions on how to combine raw materials for producing compositions useful for obtaining the health effects described herein. 【0051】

[0051] If the kit includes a virtual package, the kit is limited to instructions in a virtual environment combined with one or more physical kit components. The kit contains components in amounts sufficient to obtain the health effects described herein. Typically, the components of the kit can be mixed immediately before ingestion by an animal. The kit may contain the components of the kit in any of various combinations and / or mixtures. In one embodiment, the kit includes a food container for ingestion by an animal. The kit may include additional articles such as a device for mixing raw materials or a device for holding mixtures (e.g., a food bowl). In another embodiment, the food composition may be mixed with additional nutritional supplements such as vitamins and minerals that promote good health in animals. The components may be provided in separate containers contained in a single package, or as a mixture of various components contained in different packages. In some embodiments, the kit includes one or more other raw materials suitable for ingestion by animals. In one embodiment, such a kit may include instructions describing a method of combining raw materials to form a food composition for animal consumption, the method generally involving mixing the raw materials or applying optional additives to other raw materials, for example, by sprinkling a nutritional supplement onto the food composition. 【0052】

[0052] In further embodiments, means may be provided for conveying information or instructions relating to one or more of the following: (1) the use of a food composition to obtain one of the health effects described herein; (2) contact information for consumers to use if they have questions regarding the methods and compositions described herein; and (3) nutritional information relating to the food composition. The means of conveyance may be useful for explaining the effects of using the methods or compositions and for conveying approved methods for administering the food composition to animals. Such means include one or more physical or electronic documents, digital storage media, optical storage media, audio presentations, audiovisual displays, or visual displays containing such information or instructions. In one embodiment, the means may be selected from the group consisting of displayed websites, display kiosks, brochures, product labels, accompanying documents, advertisements, leaflets, notices, audio tapes, video tapes, DVDs, CD-ROMs, computer-readable chips, computer-readable cards, computer-readable disks, USB devices, FireWire devices, computer memory, and any combination thereof. 【0053】

[0053] In another embodiment, a method for producing a food composition comprising one or more other raw materials suitable for consumption by animals (for example, one or more of proteins, fats, carbohydrates, fibers, vitamins, minerals, probiotics, prebiotics, etc.) may include a step of mixing one or more raw materials suitable for consumption by animals. The composition can be produced according to any method appropriate in the art. 【0054】

[0054] In another embodiment, a package useful for containing the compositions described herein may include at least one vessel suitable for containing the food composition and a label affixed to the package containing one or more words, images, designs, acronyms, slogans, phrases, or other designs, or a combination thereof, indicating that the contents of the package contain the food composition. In some embodiments, the label affixed to the package may include one or more words, images, designs, acronyms, slogans, phrases, or other designs, or a combination thereof, indicating that the contents of the package contain a food composition having beneficial properties relating to the health effects described herein. In one embodiment, such a device may include the words “satiety-enhancing,” or equivalent or similar expressions, printed on the package. Any package configuration and package material suitable for containing the composition, such as bags, boxes, bottles, cans, and pouches made from paper, plastic, foil, and metal, can be used in the present invention. In one embodiment, the package contains a food composition tailored to a specific animal, such as a human, a canid, or a feline, as appropriate depending on the label, and in one embodiment, it contains a companion animal food composition for dogs or cats. In one embodiment, the package may be a can or pouch containing the food composition described herein. In various embodiments, the package further includes at least one window that allows the contents of the package to be viewed without opening the package. In some embodiments, the window may be a transparent portion of the package member. In other embodiments, the window may be a portion where no package member exists. [Examples] 【0055】

[0055] The present invention can be further illustrated by the following examples, but these examples are included for illustrative purposes only and should be understood not to limit the scope of the invention unless otherwise stated. 【0056】 Example 1: Test I in cats

[0056] To evaluate the effect of diets on satiety and spontaneous food intake in cats, two panels of cats, each containing 20 cats, were tested. The cats were given either a control diet or a test diet freely for two days, and after a 2-5 day break, they were switched to the opposite diets and given the corresponding diet freely for another two days. The number of meals, the time between meals, the time spent at each meal (mean), and the total calorie intake were recorded. Table 1 shows the breakdown of major nutrients in the diets used. 【0057】 [Table 1] 【0058】

[0057] As shown in Tables 2 to 5, when cats were fed the test food, they ate more of the test food and their feeding rate (g food / minute) increased, but the time between meals increased, the number of meals per day decreased, and a significant reduction in voluntary daily calorie intake was observed. These data support the conclusion that the test food significantly increased satiety and reduced voluntary food intake. Furthermore, the increased feeding rate of the test food proves that the overall difference in intake (and the currently claimed effect) was not due to the inferior palatability of the test food. 【0059】 [Table 2] 【0060】 [Table 3] 【0061】 [Table 4] 【0062】 [Table 5] 【0063】

[0058] As shown in Table 5, the test diet significantly reduced the number of meals per day. This reduction is related to a decrease in voluntary food intake in cats. Furthermore, as shown in Table 6 below, the test diet resulted in an increase in the time between meals, thereby demonstrating that cats fed the test diet experienced a higher level of satiety. 【0064】 [Table 6] 【0065】

[0059] These data support the finding that the test diet significantly increased satiety and resulted in a reduction in voluntary food intake in cats. This reduction in voluntary food intake significantly reduced weight gain and helped cats maintain a healthy weight and healthy metabolism. 【0066】 Example 2: Experiment II in Cats

[0060] Forty-five adult cats were randomly divided into three groups of 15 cats each, based on the cats' baseline maintenance energy requirement (MER), percentage of body, body condition score (BCS), and body weight. These groups were fed three different diets with varying protein-to-fat-to-carbohydrate (CHO) ratios, as shown in Table 7. 【0067】 [Table 7] 【0068】

[0061] The cats were fed 25% more than their baseline MER for 12 months. As shown in Table 8, there was no significant difference in average food intake between the groups, and in fact, the highest protein diet (group 3) had the highest intake. 【0069】 [Table 8] 【0070】

[0062] As shown above, the diets in Table 7 did not produce a satiety effect. The fact that even the high-protein diet did not produce a satiety effect further demonstrates that the satiety effect of the test diet in Example 1 was completely unexpected. 【0071】 Example 3: Experiment III in cats

[0063] Thirty overweight cats were randomly divided into two groups based on their baseline maintenance energy requirement (MER), body weight, body fat percentage, and BSC. Cats in the control group were fed a control diet, and cats in the test group were fed a test diet. The major nutrients for both diets are shown in Table 9. Both the control and test groups were fed 75% of their baseline MER for 4 months, and then 60% of their baseline MER for a further 2 months. Body composition was measured using quantitative magnetic resonance imaging (QMR) at baseline, 1 month, 2 months, 3 months, 4 months, and 6 months during the weight loss study. Cats were removed from the weight loss study when they reached an ideal BCS score of 5. The baseline parameters of the cats are summarized in Table 10. 【0072】 [Table 9] 【0073】 [Table 10] 【0074】

[0064] The results of the percentage reduction in body fat are summarized in Table 11. Cats fed the test diet showed significantly greater reduction in body fat compared to cats fed the control diet. As a result, at the end of the 6-month weight loss trial, 86.7% of the cats in the test group reached an ideal body condition score (BCS) of 5, while only 60% of the cats in the control group reached a BCS of 5. As shown in Table 12, the cats in the test group experienced less reduction in lean body mass compared to the cats in the control group. 【0075】 [Table 11] 【0076】 [Table 12] 【0077】

[0065] Another health benefit of the test diet is improved glucose management, independent of weight loss. As shown in Table 13, cats fed the test diet had lower interstitial glucose levels compared to control cats during a 9-hour period starting from day 2 of the weight loss study (from 6 p.m. on day 2 to 3 a.m. on day 3). 【0078】 [Table 13] 【0079】

[0066] Specific embodiments of the present invention are disclosed herein. Specific terms are used, but these are general and illustrative only and are not intended to limit the scope. The scope of the present invention is defined in the "Claims." It is obvious, in light of the above teachings, that the present invention is capable of many modifications and variations. Therefore, it is understood that the present invention is implementable within the appended claims, even if not specifically described.

Claims

[Claim 1] A method for increasing the provision of health benefits in animals, comprising the step of administering a food composition to the animal, wherein the food composition is 25% to 60% protein, 15% to 45% fat, It contains 5% to 25% carbohydrates, The calorie contribution ratio of protein to carbohydrates is in the range of 3.25:1 to 2.75:1, the calorie contribution ratio of fat to carbohydrates is in the range of 2.25:1 to 1.75:1, and the calorie contribution ratio of protein to fat is in the range of 3:1 to 1.6:

1. method. [Claim 2] The method according to claim 1, wherein the protein constitutes 40% to 60% of the food composition. [Claim 3] The method according to claim 1, wherein the carbohydrate constitutes 15% to 25% of the food composition. [Claim 4] The method according to claim 1, wherein the fat constitutes 20% to 40% of the food composition. [Claim 5] The method according to claim 1, wherein the food composition is administered to the animal on a regular basis. [Claim 6] The method according to claim 1, wherein the food composition is a pet food composition. [Claim 7] The method according to claim 1, wherein the animal is a companion animal. [Claim 8] The method according to claim 1, wherein the health effects are selected from the group consisting of reduction of body fat, reduction of body weight, reduction of weight gain, reduction of insulin resistance, reduction of diabetes risk, reduction of prediabetes risk, reduction of cholesterol levels, reduction of glucose levels, reduction of triglyceride levels, reduction of insulin levels, reduction of leptin levels, improvement of insulin sensitivity, prevention of prediabetes, delay of the onset of prediabetes, treatment of prediabetes, prevention of diabetes, delay of the onset of diabetes, treatment of diabetes, prevention of insulin resistance, delay of the onset of insulin resistance, treatment of insulin resistance, prevention of overweight or obesity, delay of the onset of overweight or obesity, treatment of overweight or obesity, promotion of healthy metabolism, promotion of better blood glucose control, reduction of chronic inflammation and inflammatory cytokines, improvement of spontaneous activity, improvement of daytime activity, increased satiety, and combinations thereof. [Claim 9] 30% to 60% protein, 15% to 45% fat, It contains 5% to 25% carbohydrates, A pet food composition in which the calorie contribution ratio of protein to carbohydrates is in the range of 3.25:1 to 2.75:1, the calorie contribution ratio of fat to carbohydrates is in the range of 2.25:1 to 1.75:1, and the calorie contribution ratio of protein to fat is in the range of 2:1 to 1.6:

1. [Claim 10] The composition according to claim 9, wherein the protein constitutes 40% to 60% of the pet food composition. [Claim 11] The composition according to claim 9, wherein the carbohydrate constitutes 15% to 25% of the pet food composition. [Claim 12] The composition according to claim 9, wherein the fat constitutes 20% to 40% of the pet food composition. [Claim 13] The composition according to claim 9, wherein the pet food composition is formulated for use in felines.

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