Methods of providing and determining effective weight loss diet for dogs

Abstract

The present disclosure provides a method of determining the efficacy of a weight loss diet in a canine, the method comprising analyzing a biomarker of a serum or plasma sample from the canine before and after administration of the weight loss diet wherein the biomarker is selected from the group consisting of 3-methylhistidine, 1-methylhistidine, and combinations thereof, and determining that the weight loss diet is effective if the amount of the biomarker has decreased.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application Serial No. 63 / 406,172, filed on September 13, 2022, the disclosure of which is incorporated herein by reference in its entirety. Background Art

[0003] Obese and overweight animals are at increased risk for many chronic diseases, including heart disease, diabetes, hypertension, stroke, dyslipidemia, certain types of cancer, apnea, and osteoarthritis. Therefore, it is important for overweight and obese animals (including humans and pets) to reduce excess body fat to maintain health and quality of life. Unfortunately, losing excess body fat or maintaining a healthy weight after weight loss is difficult to achieve, and various solutions may have adverse consequences, such as loss of lean body mass during weight loss or weight regain after weight loss.

[0004] Obesity is one of the most serious health problems in humans and pets and is considered the leading preventable cause of death. Maintaining a healthy body weight is essential for optimal metabolism, normal physical activity and good health. Therefore, methods and compositions that increase satiety, promote body fat loss and maintain lean body mass and healthy body weight are needed to better promote the health and well-being of animals, as well as methods for determining the efficacy of weight loss diets. Summary of the invention

[0005] In one embodiment, a method for determining the efficacy of a canine weight loss diet may include analyzing a first serum or plasma sample from the canine for a biomarker selected from the group consisting of 3-methylhistidine, 1-methylhistidine, and combinations thereof; determining the amount of the biomarker in the first serum or plasma sample; analyzing a second serum or plasma sample for the biomarker after the canine has been administered the weight loss diet; determining the amount of the biomarker in the second serum or plasma sample; and determining that the weight loss diet is effective if the amount of the biomarker in the second serum or plasma sample has decreased compared to the amount of the biomarker in the first serum or plasma sample, or determining that the weight loss diet is ineffective if the amount of the biomarker in the second serum or plasma sample has not changed or has increased compared to the amount of the biomarker in the first serum or plasma sample.

[0006] In another embodiment, a method of providing a canine with an effective weight loss diet may include analyzing a first serum or plasma sample from the canine for a biomarker selected from the group consisting of: 3-methylhistidine, 1-methylhistidine, and combinations thereof; determining the amount of the biomarker in the first serum or plasma sample; analyzing a second serum or plasma sample for the biomarker after the canine has been administered the weight loss diet; determining the amount of the biomarker in the second serum or plasma sample; and determining the amount of the biomarker in the second serum or plasma sample if the amount of the biomarker in the second serum or plasma sample is greater than the amount in the first serum or plasma sample. The method of claim 10, wherein the weight loss diet is determined to be effective if the amount of the biomarker in the first serum or plasma sample has decreased, or is determined to be ineffective if the amount of the biomarker in the second serum or plasma sample has not changed or has increased compared to the amount of the biomarker in the first serum or plasma sample; and wherein when the weight loss diet is ineffective, providing the canine with an effective weight loss diet comprising protein, fat, carbohydrates, omega-3 fatty acids and isoflavones; wherein the weight ratio of protein to carbohydrate when fed ranges from 4.5:1 to 2.5:1.

[0007] Other and further objects, features and advantages of the present invention will be apparent to those skilled in the art. DETAILED DESCRIPTION

[0008] definition

[0009] The term "treatment" includes both prophylactic treatment (ie, preventive treatment) and palliative treatment.

[0010] The term "effective" when referring to a weight loss diet refers to a weight loss diet that maximizes the loss of body fat and / or minimizes or prevents the loss of lean body mass during administration of the weight loss diet to a canine.

[0011] The term "food" or "food product" or "food composition" means a product or composition intended for ingestion by a canine and that provides nutrition to a canine.

[0012] The term "carbohydrate" refers to digestible carbohydrates, such as sugars and starches, and does not include fibers, such as cellulose or fermentable fibers.

[0013] The term "crude fiber" refers to the insoluble fiber portion found in the edible part of plant cell walls and is a measure of the amount of indigestible cellulose, lignin, and other components of this type in a food.

[0014] The term "total dietary fiber" refers to the portion of food of plant origin that cannot be completely broken down by canine digestive enzymes and includes soluble fiber and insoluble fiber. Soluble fiber dissolves in water and is fermented in the colon by the intestinal microbiota. Examples of soluble fiber are beta-glucan, guar gum, psyllium, inulin, wheat dextrin, resistant starch. Insoluble fiber does not dissolve in water. Examples of insoluble fiber are cellulose and lignin.

[0015] The term "regularly" refers to at least monthly administration, and in one aspect, refers to at least weekly administration. In certain embodiments, more frequent administration or consumption may be performed, such as twice or three times per week. In one aspect, the administration regimen may include consumption at least once per day.

[0016] The term "single package" means that the multiple components of a kit are physically associated in or with one or more containers and are considered a unit for manufacture, packaging, sale, or use. Containers include, but are not limited to, bags, boxes, cartons, bottles, packaging (such as shrink wrap), binding or otherwise attached components, or combinations thereof. A single package can be a container of a food composition or components thereof that are physically associated so that they are considered a unit for manufacture, packaging, sale, or use.

[0017] The term "virtual packaging" means that the components of the kit are associated by instructions on one or more physical or virtual kit components that instruct a user how to obtain other components (e.g., in a bag or other container that holds one component); and by instructions that have the following functions: instructing the user to visit a website, contact a recording message or callback 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 about one or more components of the kit.

[0018] The term "about" refers to a value of ±20%; in one aspect, ±10%; in another aspect, ±5%; and in a particular aspect, ±2%. For example, in one aspect (where "about" is a value of ±20%), the phrase "about 10% to about 20%" may include a range of 8% to 24% or 12% to 16%, including any subranges therein.

[0019] As used herein, embodiments, aspects, and examples using "comprising" language or other open language may be replaced with "consisting essentially of and "consisting of" embodiments.

[0020] When referring to a food composition, the term "complete and balanced" refers to a food composition that contains all known essential nutrients in appropriate amounts and proportions based on the recommendations of recognized authorities in the field of canine nutrition, and is therefore capable of being used as a sole source of dietary intake to sustain life or promote production without the addition of supplementary sources of nutrition. Nutritionally balanced pet food compositions are well known in the art and have been widely used, for example, complete and balanced food compositions formulated according to standards established by the Association of American Feed Control Officials (AAFCO). In one embodiment, "complete and balanced" may be based on the current standards published by AAFCO on January 1, 2022.

[0021] Unless otherwise specifically stated, all percentages expressed herein are calculated by weight on a dry matter basis of the composition. Those skilled in the art will recognize that the term "dry matter basis" refers to the concentration or percentage of an ingredient in a composition measured or determined after removing any free water in the composition.

[0022] As used herein, the ranges used herein are abbreviated ranges to avoid having to list and describe each value within the range. Any appropriate value within the range can be selected, and when appropriate, the upper limit, lower limit or end value of the range can be selected.

[0023] As used herein, the singular form of a word includes the plural form and vice versa, unless the context clearly dictates otherwise. Thus, references to "a," "an," and "the" generally include the plural form of the corresponding term. For example, reference to a "supplement," "method," or "food" includes a plurality of such "supplements," "methods," or "foods." Similarly, the words "include," "comprise," and "contain" are to be interpreted inclusively rather than exclusively. Similarly, the terms "include," "comprises," and "or" should all be considered inclusive unless the context clearly prohibits such an interpretation. Similarly, the term "example" (especially when followed by a list of terms) is exemplary and illustrative only and should not be considered exclusive or exhaustive.

[0024] The methods, compositions and other advances disclosed herein are not limited to the specific methods, protocols and reagents described herein, as these specific methods, protocols and reagents may vary, as will be appreciated by those skilled in the art. In addition, the terminology used herein is for the purpose of describing specific embodiments only and is not intended to limit and will not limit the scope of the disclosure or protection of the claims.

[0025] Unless otherwise defined, all technical terms, technical terms and acronyms used herein have the meanings commonly understood by those of ordinary skill in the art to which the invention belongs or in which these terms are used. Although any compositions, methods, articles or other means or materials similar or equivalent to those described herein may be used in the practice of the present invention, certain compositions, methods, articles or other means or materials are described herein.

[0026] All patents, patent applications, publications, technical and / or scholarly papers, and other references cited or mentioned herein are incorporated herein by reference in their entirety to the extent permitted by law. The discussion of these references is intended only to summarize the assertions made therein. We do not admit that any of these patents, patent applications, publications, or references, or any portion thereof, is relevant, substantial, or prior art. We specifically reserve the right to challenge the accuracy and relevance of any assertion that these patents, patent applications, publications, and other references are relevant, substantial, or prior art. DETAILED DESCRIPTION

[0028] The methods of the present invention are based on the discovery that specific biomarkers can be used to determine the efficacy of a weight loss diet.

[0029] In one embodiment, a method for determining the efficacy of a canine weight loss diet may include analyzing a first serum or plasma sample from the canine for a biomarker selected from the group consisting of 3-methylhistidine, 1-methylhistidine, and combinations thereof; determining the amount of the biomarker in the first serum or plasma sample; analyzing a second serum or plasma sample for the biomarker after the canine has been administered the weight loss diet; determining the amount of the biomarker in the second serum or plasma sample; and determining that the weight loss diet is effective if the amount of the biomarker in the second serum or plasma sample has decreased compared to the amount of the biomarker in the first serum sample, or determining that the weight loss diet is ineffective if the amount of the biomarker in the second serum or plasma sample has not changed or has increased compared to the amount of the biomarker in the first serum or plasma sample.

[0030] In another embodiment, a method of providing a canine with an effective weight loss diet may include analyzing a first serum or plasma sample from the canine for a biomarker selected from the group consisting of: 3-methylhistidine, 1-methylhistidine, and combinations thereof; determining the amount of the biomarker in the first serum sample; analyzing a second serum or plasma sample for the biomarker after the canine has been administered the weight loss diet; determining the amount of the biomarker in the second serum or plasma sample; and if the amount of the biomarker in the second serum or plasma sample is greater than that in the first serum or plasma sample, determining the amount of the biomarker in the second serum or plasma sample; The method of claim 10, wherein the weight loss diet is determined to be effective if the amount of the biomarker in the plasma sample has decreased, or is determined to be ineffective if the amount of the biomarker in the second serum or plasma sample has not changed or has increased compared to the amount of the biomarker in the first serum or plasma sample; and wherein, when the weight loss diet is ineffective, providing the canine with an effective weight loss diet comprising protein, fat, carbohydrates, omega-3 fatty acids and isoflavones; wherein the weight ratio of protein to carbohydrate when fed ranges from 4.5:1 to 2.5:1.

[0031] Typically, the diet can be administered regularly. In one embodiment, the weight loss diet can be administered to the canine for at least one month. In other aspects, the weight loss diet can be administered for at least 2 months, 3 months, 4 months, 5 months, 6 months, or even one year. The method may also include administering a weight loss diet to the canine.

[0032] In addition, the method of the present invention may also include recommending a different weight loss diet to the canine when it has been determined that the administered weight loss diet is ineffective. Typically, the recommended weight loss diet is an effective weight loss diet. Such an effective weight loss diet is further described herein.

[0033] Such effective weight loss diets are usually high in protein and low in carbohydrates, but also have unique macronutrient metrics, i.e., have specific ratios and components that provide specific health benefits. It is noteworthy that the effective diet of the present invention is not a ketogenic diet (traditional or modified), i.e., a diet that relies on high fat or a diet with fat as the main component of the diet. In addition, the effective diet of the present invention is different from the general high-protein diet known in the art. The methods and compositions of the present invention do not rely on a single macronutrient component or ratio, but rely on a unique combination of macronutrient ratios and food components.

[0034] Typically, the effective composition of the present invention comprises protein. Protein can be a crude protein material, and can include vegetable protein (such as soy flour, soy protein concentrate, corn gluten meal, wheat gluten, cottonseed, pea protein, rapeseed meal and peanut meal) or animal protein (such as casein, albumin and meat protein). Examples of meat protein that can be used for the present invention include beef, pork, lamb, horse meat, poultry, fish and mixtures thereof. The composition can also optionally include other materials, such as dry whey and other dairy by-products. In one embodiment, the food composition can include about 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 of the amount of protein, including various sub-ranges within these amounts. In one aspect, protein can be about 40% by weight to about 60% by weight of a food composition. In another aspect, protein can be about 45% by weight to about 55% by weight of a food composition.

[0035] In spite of the above-mentioned protein, the effective composition of the present invention also comprises isoflavones. In various embodiments, isoflavones include at least one of the following: daidzein, 6-O-malonyl daidzein, 6-O-acetyl daidzein, genistein, 6-O-malonyl genistein, 6-O-acetyl genistein, glycitein, 6-O-malonyl glycitein, 6-O-acetyl glycitein, biochanin A or formononetin. In certain embodiments, isoflavones or its metabolites can be from soybean (soybean / Glycine max). When present, the one or more metabolites preferably include equol. In one embodiment, the food composition can include isoflavones in an amount of about 300 mg, 400 mg, 500 mg, 600 mg, 700 mg, 800 mg, 900 mg or even 1000 mg / kg of the food composition to about 500 mg, 600 mg, 700 mg, 800 mg, 900 mg, 1000 mg, 1100 mg, 1200 mg, 1300 mg, 1400 mg or even 1500 mg / kg of the food composition, including various sub-ranges within these amounts. In one aspect, the isoflavones can be present in an amount of about 100 mg to 1500 mg per kilogram of the pet food composition. In another aspect, the isoflavones can be present in an amount of about 300 mg to 1200 mg per kilogram of the pet food composition.

[0036] Generally, any type of carbohydrate can be used in effective food compositions.The example of suitable carbohydrate includes grain or cereal, such as rice, corn, millet, sorghum, alfalfa, barley, soybean, mustard, oats, wheat, rye, triticale and mixtures thereof.In one embodiment, carbohydrate accounts for about 15 % by weight to about 25 % by weight of food compositions.In another embodiment, carbohydrate accounts for about 10 % by weight to about 20 % by weight of food compositions.In other aspects, carbohydrate can exist with the amount of about 5 % by weight, 10 % by weight, 15 % by weight or even 20 % by weight to about 10 % by weight, 15 % by weight, 20 % by weight or even 25 % by weight.

[0037] Typically, the protein and carbohydrates are in a ratio that provides health benefits to canines. Typically, the weight ratio of protein to carbohydrates ranges from 4.5:1 to 2.5:1. In some aspects, the weight ratio of protein to carbohydrates can range from 4.25:1 to 3.75:1, or even 4.15:1 to 3:1.

[0038] Usually, effective food composition comprises fat.The example of suitable fat comprises animal fat and vegetable fat.In one aspect, fat source can be animal fat source, such as tallow, lard or poultry fat.Also can use vegetable oil, 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.In one embodiment, food composition can comprise the fat of about 10 % by weight, 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, be included in various sub-ranges within these amounts.In one aspect, fat accounts for about 10 % by weight to about 40 % by weight of this food composition.In another aspect, fat accounts for about 10 % by weight to about 30 % by weight of this food composition.In another aspect, fat accounts for about 10 % by weight to about 15 % by weight of this food composition.

[0039] In spite of the above-mentioned fat, effective composition of the present invention comprises ω-3 fatty acid.The non-limiting example of suitable ω-3 fatty acid comprises eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), alpha-linolenic acid (ALA), octadecatetraenoic acid (SDA), eicosatrienoic acid (ETE), eicosatetraenoic acid (ETA), heneicosapentaenoic acid (HPA), docosapentaenoic acid (DPA), tetracosopentaenoic acid, tetracosahexenoic acid (nisinic acid) and their mixture.In one embodiment, ω-3 fatty acid range can account for about 0.1%, 0.2%, 0.5%, 1%, 1.5%, 2%, 2.5% or even 3% to about 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5% or even 5% of composition weight.In some embodiments, ω-3 fatty acid is present in food composition with the amount of about 0.1% by weight to about 5% by weight. In some embodiments, omega-3 fatty acids are present in the food composition in an amount from about 0.5% to about 2.5% by weight.

[0040] In addition to the fat and fatty acid discussed herein, the composition of the present invention may also include ω-6 fatty acids. The non-limiting example of suitable ω-6 fatty acids includes linoleic acid (LA), gamma-linolenic acid (GLA), arachidonic acid (AA, ARA), eicosadienoic acid, octadecatrienoic acid, dihomo-gamma-linolenic acid (DGLA), docosadienoic acid, adrenal acid, docosapentaenoic acid, tetracosatetraenoic acid, tetracospentaenoic acid and their mixture. In one embodiment, the ω-6 fatty acid range can account for about 0.2%, 0.5%, 1%, 2% or even 3% to about 1%, 2%, 3%, 4% or even 5% of the composition weight. In some embodiments, ω-6 fatty acids are present in the food composition with an amount of about 1% by weight to about 5% by weight. In some embodiments, ω-6 fatty acids are present in the food composition with an amount of about 1% by weight to about 2% by weight.

[0041] Administration may be performed as needed, as desired, regularly or intermittently. In one aspect, the food composition may be administered to the canine regularly. In one aspect, administration may be performed at least weekly. In certain embodiments, more frequent administration or consumption may be performed, such as twice or three times per week. In one aspect, the administration regimen may include consumption at least once per day.

[0042] According to the presently described methods, administration (including administration as part of a dietary regimen) can continue from birth to adulthood in the canine. In certain embodiments, the canine can be a young or growing canine. In other embodiments, administration can begin, for example, regularly or on a long-term regular basis, when the canine has reached more than about 10%, 20%, 30%, 40%, or 50% of its estimated or expected lifespan. In some embodiments, the canine may have reached 40%, 45%, or 50% of its expected lifespan. In other embodiments, the canine may be older, reaching 60%, 66%, 70%, 75%, or 80% of its possible lifespan. Determination of lifespan can be based on species, sex, size, genetic factors, environmental factors and stressors, current and past health status, past and present nutritional status, stressors, etc.

[0043] Such administration may be performed for a time required to achieve one or more of the objectives described herein (e.g., maintaining lean body mass in dogs during weight loss). Other administration amounts may be appropriate and may be determined based on the initial weight of the dog and other variables such as species, sex, breed, age, desired health benefits, etc.

[0044] The moisture content of such effective food compositions varies according to the properties of the food compositions. The effective food compositions can be dry compositions (e.g., kibble), semi-wet compositions, wet compositions, or any mixture thereof. In one embodiment, the pet food composition can be a complete and nutritionally balanced pet food. In this embodiment, the pet food can be a "wet food," "dry food," or "medium moisture" content of food. "Wet food" describes pet food that is usually sold in cans or foil bags, and its moisture content is usually in the range of about 70% to about 90%. "Dry food" describes pet food that is similar in composition to wet food, but the moisture content it contains is limited, usually in the range of about 5% to about 15% or 20% (usually in the form of small biscuit-like kibble). In one embodiment, the composition can have a moisture content of about 5% to about 20%. Dry food includes various foods of various moisture contents, making them relatively storage-resistant and anti-microbial or fungal deterioration or contamination. Moreover, in one aspect, the dry food composition can be an extruded food product.

[0045] The effective food composition may also include one or more fiber sources. Such fiber sources include soluble, insoluble, fermentable and non-fermentable fibers. This fiber may be from plant sources (such as marine plants), but microbial fiber sources may also be used. A variety of soluble or insoluble fibers may be used, which will be known to those of ordinary skill in the art. The fiber source may be beet pulp (derived from beets), gum arabic, gum talha, psyllium, rice bran, corn husk, wheat bran, oat bran, carob bean gum, citrus pulp, pectin, oligofructose, short-chain oligofructose, manno-oligofructose, soy fiber, arabinogalactan, galactooligosaccharide, arabinoxylan, cellulose, chicory or a mixture thereof.

[0046] Alternatively, the fiber source may be fermentable fiber. Fermentable fiber has previously been described as beneficial to the canine immune system. Fermentable fiber or other compositions known to the skilled artisan that provide prebiotics to promote the growth of probiotics in the intestine may also be incorporated into the composition to help enhance the beneficial effects described herein or to enhance the canine immune system.

[0047] In one embodiment, effective food composition can comprise the total dietary fiber of about 1 % by weight to about 15 % by weight. In some respects, the content of total dietary fiber can be about 5 % by weight to about 15 % by weight or even about 8 % by weight to about 13 % by weight. In another embodiment, food composition can comprise the crude fiber of about 1 % by weight to about 10 % by weight. In some respects, the content of crude fiber can be about 3 % by weight to about 10 % by weight or even about 3 % by weight to about 7 % by weight.

[0048] In some embodiments, the ash content of the food composition ranges from less than 1% to about 15%. In one aspect, the ash content can be from about 5% to about 10%.

[0049] Generally speaking, effective food compositions may be suitable for canines to consume as a meal, dietary component, snack, or treat. Such compositions may include complete foods intended to provide the necessary dietary requirements for canines. In one embodiment, the diet may include a complete and balanced pet food. Examples of food compositions include, but are not limited to, dry foods, wet foods, beverages, bars, frozen prepared foods, shelf-prepared foods, and refrigerated prepared foods.

[0050] Effective food compositions may also include one or more substances such as vitamins, minerals, antioxidants, probiotics, prebiotics, salts, and functional additives (such as flavor enhancers, colorants, emulsifiers, and antimicrobial or other preservatives). Minerals that can be used in such compositions include, for example, calcium, phosphorus, potassium, sodium, iron, chlorine, boron, copper, zinc, magnesium, manganese, iodine, selenium, and the like. Examples of other vitamins that can be used herein include fat-soluble vitamins such as A, D, E, and K, and water-soluble vitamins including B vitamins and vitamin C. In various embodiments, it may be useful to include inulin, amino acids, enzymes, coenzymes, and the like.

[0051] The methods of the present invention can provide health benefits to canines. In one embodiment, the health benefits can include: maintaining lean body mass, minimizing lean body mass during weight loss, reducing body fat, reducing body weight, reducing weight gain, reducing insulin resistance, reducing the risk of diabetes, reducing the risk of prediabetes, low cholesterol, low glucose, low triglycerides, low insulin, improved insulin sensitivity, low leptin, preventing prediabetes, delaying the onset of prediabetes, treating prediabetes, preventing diabetes, delaying the onset of diabetes, treating diabetes, preventing insulin resistance, delaying the onset of insulin resistance, treating insulin resistance, preventing overweight or obesity, delaying the onset of overweight or obesity, treating overweight or obesity, promoting metabolic health, promoting better glycemic control, reducing chronic inflammation and proinflammatory cytokines, improving voluntary daytime activity, reducing daytime and nighttime restlessness, increasing satiety, and combinations thereof.

[0052] In various embodiments, the effective food composition contains at least one of the following components: (1) one or more probiotics; (2) one or more inactivated probiotics; (3) one or more inactivated probiotic components that promote health benefits similar to or identical to probiotics, such as proteins, lipids, glycoproteins, etc.; (4) one or more prebiotics; and (5) combinations thereof. The probiotics or components thereof can be incorporated into the food composition (e.g., uniformly or non-uniformly distributed in the composition) or applied to the food composition (e.g., topically applied with or without a carrier). Such methods are known to those skilled in the art, such as those described in US5968569 and related patents.

[0053] Typical probiotics include, but are not limited to, probiotic strains selected from Lactobacilli, Bifidobacteria or Enterococci, such as Lactobacillus reuteii, Lactobacillus acidophilus, Lactobacillus animalis, Lactobacillus ruminis, Lactobacillus johnsonii, Lactobacillus casei, Lactobacillus paracasei, Lactobacillus rhamnosus, Lactobacillus fermentum and Bifidobacterium sp., Enterococcus faecium and Enterococcus sp. In some embodiments, the probiotic strain can be selected from the group consisting of: 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 sp. NCC2657, or Enterococcus faecalis SF68 (NCIMB 10415). Generally, the food composition can contain an amount of probiotics sufficient to provide about 10 4 to about 10 12 cfu / canine / day, in one aspect, 10 5 to about 10 11 cfu / canine / day, and in one particular aspect, 10 7 Up to 10 10cfu / canine / day. When the probiotics are killed or inactivated, the amount of the probiotics killed or inactivated or its components should produce a beneficial effect similar to that of live microorganisms. Many such probiotics and their benefits are known to those skilled in the art, such as described in EP1213970B1, EP1143806B1, US7189390, EP1482811B1, EP1296565B1 and US6929793. 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.

[0054] As mentioned above, the effective food composition may contain one or more prebiotics, such as oligofructose, oligoglucose, oligogalactose, oligoisomaltosaccharides, oligoxylose, oligosaccharides, soy oligosaccharides, lactose sucrose, oligolactose, lactulose and isomaltulose. In one embodiment, the prebiotic may be chicory root, chicory root extract, inulin or a combination thereof. Typically, prebiotics may be administered in an amount sufficient to actively stimulate the healthy microbiota in the intestinal tract and to breed these "beneficial" bacteria. Typical amounts are in the range of about 1 gram to about 10 grams per serving, or in the range of about 5% to about 40% of the recommended daily dietary fiber for dogs. Probiotics and prebiotics may be a part of the composition by any suitable means. Typically, the agent may be mixed with the composition, or applied to the surface of the composition, for example, by spraying or spraying. When the agent is a part of the kit, the agent may be mixed with other substances or in its own packaging. Typically, the food composition contains about 0.1% to about 10% prebiotics, in one aspect, about 0.3% to about 7% prebiotics, and in one particular aspect, about 0.5% to 5% prebiotics, based on dry matter. Prebiotics can be incorporated into the composition using methods known to those skilled in the art, such as the methods described in US5952033.

[0055] Those skilled in the art can determine the appropriate amounts of food ingredients, vitamins, minerals, probiotics, prebiotics, antioxidants, or other ingredients for preparing a particular composition to be administered to a particular canine. Such skilled persons can consider the canine's species, age, size, weight, health, etc. when determining how best to formulate a particular composition containing such ingredients. Other factors that may be considered include the desired dosage of each component, the average consumption of a particular type of composition by different canines (e.g., based on species, weight, activity / energy requirements, etc.), and the manufacturing requirements of the composition.

[0056] In another aspect, the present disclosure provides a kit suitable for administering an effective food composition to a canine. Depending on the kit components, the kit includes one or more of the following components in a separate container in a single package or in a separate container in a virtual package: (1) one or more ingredients suitable for canine consumption; (2) instructions on how to combine the ingredients and other kit components to produce a composition that can be used to provide health benefits as described herein; (3) instructions on how to use the food composition to obtain such benefits; (4) one or more probiotics; (5) one or more inactivated probiotics; (6) one or more inactivated probiotic components that promote health benefits similar to or identical to probiotics, such as proteins, lipids, glycoproteins, etc.; (7) one or more prebiotics; (8) a device for preparing or combining kit components to produce a composition suitable for administration to a canine; and (9) a device for applying the combined or prepared kit components to a canine. In one embodiment, the kit contains one or more ingredients suitable for canine consumption. In another embodiment, the kit includes instructions on how to combine the ingredients to produce a composition that can be used to obtain health benefits as described herein.

[0057] When the kit includes a virtual package, the kit is limited to providing instructions in conjunction with one or more physical kit parts in a virtual environment. The kit contains enough components to obtain health benefits as described herein. Typically, the kit components can be mixed before canine consumption. The kit may contain kit components in any form in a variety of combinations and / or mixtures. In one embodiment, the kit includes a container for food for canine consumption. The kit may include additional items, such as equipment for mixing ingredients or equipment for accommodating mixtures, such as food bowls. In another embodiment, the food composition may be mixed with other nutritional supplements (such as vitamins and minerals) that promote canine health. Each component may be provided in a separate container in a single package, or in a mixture of each component in different packages. In some embodiments, the kit includes one or more other ingredients suitable for canine consumption. In one aspect, this type of kit may include instructions describing how to combine ingredients to form a food composition for canine consumption, typically by mixing ingredients or by applying optional additives to other ingredients to form a food composition, such as by spraying a nutritional supplement on the food composition.

[0058] In another aspect, the present invention may provide a device for communicating information or instructions about one or more of the following: (1) using the food composition to obtain one of the health benefits described herein; (2) contact information for consumers to use when they have questions about the methods and compositions described herein; and (3) nutritional information about the food composition. The communication device can be used to provide guidance on the benefits of using the methods and compositions of the present invention and to communicate approved methods for administering the food composition to dogs. The device includes one or more of a physical or electronic document, a digital storage medium, an optical storage medium, an audio presentation, an audiovisual display, or a visual display containing the information or instructions. In one aspect, the device can be selected from a displayed website, a visual display kiosk, a brochure, a product label, a package insert, an advertisement, a flyer, a bulletin, an audio tape, a video tape, a DVD, a CD-ROM, a computer readable chip, a computer readable card, a computer readable disk, a USB device, a FireWire device, a computer memory, and any combination thereof.

[0059] In another aspect, a method for making a food composition may include mixing one or more ingredients suitable for canine consumption, the food composition comprising one or more other ingredients suitable for canine consumption, such as one or more of protein, fat, carbohydrate, fiber, vitamins, minerals, probiotics, prebiotics, etc. The composition may be prepared according to any suitable method in the art.

[0060] In another aspect, the packaging that can be used to hold a composition as described herein may include at least one material suitable for holding a food composition and a label that is adhered to the packaging, the label comprising one or more words, pictures, designs, acronyms, slogans, phrases or other patterns or combinations thereof, for indicating that the contents of the packaging include food compositions. In some embodiments, the label that is adhered to the packaging comprises one or more words, pictures, designs, acronyms, slogans, phrases or other patterns or combinations thereof, for indicating that the contents of the packaging contain food compositions, and the food compositions have the beneficial properties associated with the health benefits as described herein. In one aspect, such devices may include the words "effective weight loss diet" or equivalent or similar expressions printed on the packaging. Any packaging configuration and packaging materials that are suitable for holding the composition can be used herein, such as bags, boxes, bottles, jars, pouches, etc. manufactured by paper, plastics, foil, metal, etc. Typically, the packaging comprises a food composition suitable for dogs, consistent with the label. In one embodiment, the packaging can be a jar or pouch comprising a food composition as described herein. In various embodiments, the packaging also includes at least one window, which allows the contents of the package to be observed without opening the packaging. In some embodiments, the window can be a transparent portion of the packaging material. In other embodiments, the window can be a missing portion of the packaging material.

[0061] Example

[0062] The present invention can be further illustrated by the following examples, but it should be understood that these examples are included herein for illustrative purposes only and are not intended to limit the scope of the present invention unless otherwise specifically stated.

[0063] Example 1 —Dog Research

[0064] In this study, 30 overweight dogs were randomized into two groups of 15 dogs each based on their baseline energy maintenance requirement (MER), body weight, body fat %, and sex. Dogs in the control and test groups were fed 75% of their baseline MER during the first 4 months of the weight loss study, and then 60% of their baseline MER during the last 2 months of the weight loss study. Body composition was determined using a DEXA machine. The diets are shown in Table 1.

[0065] Table 1

[0066] Components Test diet (wt%) Control diet (wt%) Moisture 8.07 8.09 protein 48.70 26.47 starch 15.65 31.60 Fat 10.1 14.73 Crude Fiber 5.00 11.40 Total dietary fiber 12.93 19.70 Ash 5.94 5.19 n-3 PUFA* 1.2166 0.08902 n-6PUFA** 1.53587 1.62164 Total isoflavones (mg / kg) 965.33 138.67

[0067] *ω-3 polyunsaturated fatty acids

[0068] **ω-6 polyunsaturated fatty acids

[0069] In dogs fed the test diet, there was no significant difference in lean body mass between baseline and any of the three time points (2 months, 4 months, and 6 months). In contrast, as shown in Table 2, dogs fed the control diet lost significant amounts of lean body mass at all three time points compared to baseline.

[0070] Table 2

[0071]

[0072]

[0073] Both groups of dogs lost significant amounts of body fat compared to baseline. However, as shown in Table 3, at the end of the 6-month weight loss study, the dogs fed the test diet had lost more body fat than the control dogs (5.93 kg vs. 4.98 kg).

[0074] Table 3

[0075]

[0076] Several markers associated with muscle growth / breakdown were analyzed. Surprisingly, 2 markers were found that distinguished the test diet from a traditional diet, such as a control diet. The results are shown in Table 4.

[0077] Table 4

[0078]

[0079] As shown in Table 4, 3-methylhistidine and 1-methylhistidine showed significant differentiation between the test diet and the control diet. Therefore, 3-methylhistidine and 1-methylhistidine can be used as diagnostic markers to determine the efficacy of a weight loss diet. The use of these markers can help veterinarians determine whether a weight loss diet is a healthy weight loss diet, such as maintaining lean body mass, or an unhealthy weight loss diet, such as reducing significant lean body mass without the need for expensive or unavailable dual energy x-ray absorptiometry (DEXA) or quantitative magnetic resonance (QMR) scanners.

Claims

1. A method for determining the efficacy of a canine weight loss diet, the method comprising: analyzing a first serum or plasma sample from the canine for a biomarker selected from the group consisting of: 3-methylhistidine, 1-methylhistidine, and combinations thereof; determining the amount of the biomarker in the first serum or plasma sample; analyzing a second serum or plasma sample for the biomarker after the canine has been administered the weight reduction diet; determining the amount of the biomarker in the second serum or plasma sample; and If the amount of the biomarker in the second serum sample or plasma sample has decreased compared to the amount of the biomarker in the first serum sample, the weight loss diet is determined to be effective, or if the amount of the biomarker in the second serum sample or plasma sample has not changed or has increased compared to the amount of the biomarker in the first serum or plasma sample, the weight loss diet is determined to be ineffective.

2. The method of claim 1, wherein the weight loss diet has been regularly administered to the canine.

3. The method of claim 1, wherein the weight reduction diet has been administered to the canine for at least 1 month.

4. The method of claim 1, wherein the weight loss comprises a complete and balanced pet food.

5. The method of claim 1, further comprising administering the weight reduction diet to the canine.

6. The method according to claim 1, wherein: When the weight loss diet is effective, the weight loss diet provides a health benefit selected from the group consisting of: maintaining lean body mass, minimizing lean body mass during weight loss, reducing body fat, reducing body weight, reducing weight gain, reducing insulin resistance, reducing the risk of diabetes, reducing the risk of prediabetes, low cholesterol, low glucose, low triglycerides, low insulin, low leptin, improving insulin sensitivity, preventing prediabetes, delaying the onset of prediabetes, treating prediabetes, preventing diabetes, delaying the onset of diabetes, treating diabetes, preventing insulin resistance, delaying the onset of insulin resistance, treating insulin resistance, preventing overweight or obesity, delaying the onset of overweight or obesity, treating overweight or obesity, promoting metabolic health, promoting better glycemic control, reducing chronic inflammation and pro-inflammatory cytokines, improving voluntary daytime activity, reducing daytime and nighttime restlessness, increasing satiety, and combinations thereof.

7. The method according to claim 1, wherein: When the weight loss diet is ineffective, a different weight loss diet is recommended to the canine.

8. A method for providing an effective weight loss diet for a canine, the method comprising: analyzing a first serum or plasma sample from the canine for a biomarker selected from the group consisting of: 3-methylhistidine, 1-methylhistidine, and combinations thereof; determining said amount of said biomarker in said first serum or plasma sample; analyzing a second serum or plasma sample for the biomarker after the canine has been administered the weight reduction diet; determining said amount of said biomarker in said second serum or plasma sample; determining that the weight loss diet is effective if the amount of the biomarker in the second serum or plasma sample has decreased compared to the amount of the biomarker in the first serum or plasma sample, or determining that the weight loss diet is ineffective if the amount of the biomarker in the second serum or plasma sample has not changed or has increased compared to the amount of the biomarker in the first serum or plasma sample; as well as Wherein, when the weight loss diet is ineffective, an effective weight loss diet is provided to the dog, wherein the weight loss diet comprises protein, fat, carbohydrates, ω-3 fatty acids and isoflavones; wherein the weight ratio of the protein to the carbohydrates during feeding ranges from 4.5:1 to 2.5:

1.

9. The method of claim 8, wherein the omega-3 fatty acid is selected from the group consisting of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), alpha-linolenic acid (ALA), and mixtures thereof; and wherein the omega-3 fatty acid is present in an amount of about 0.1% to about 5% by weight of the pet food composition.

10. The method of claim 8, wherein the isoflavones are selected from the group consisting of daidzein, 6-O-malonyl daidzein, 6-O-acetyl daidzein, genistein, 6-O-malonyl genistein, 6-O-acetyl genistein, glycitein, 6-O-malonyl glycitein, 6-O-acetyl glycitein, biochanin A, formononetin, or a mixture thereof.

11. The method of claim 8, wherein the isoflavones are present in an amount of about 300 mg to 1500 mg per kilogram of the pet food composition.

12. The method of claim 8, wherein the protein is present in an amount from about 30% to about 60% by weight of the pet food composition and the carbohydrate is present in an amount from about 5% to about 25% by weight of the pet food composition.

13. The method of claim 8, wherein the ratio of the protein to the carbohydrate ranges from 4.25:1 to 3.75:

1.

14. The method of claim 8, wherein the effective weight loss diet is administered to the canine on a regular basis.

15. The method of claim 8, wherein the effective weight loss diet is administered to the canine for at least 1 month.

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