Methods for Providing and Determining Effective Weight-Loss Diets for Canines

Abstract

The present disclosure provides a method for determining the effectiveness of a weight loss diet for a canine, comprising analyzing serum or plasma samples from the canine before and after administration of the weight loss diet for a biomarker, 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 is reduced.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 406,172, filed September 13, 2022, the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0002]

[0002] Obese and overweight animals are at increased risk for many chronic diseases, including heart disease, diabetes, hypertension, stroke, dyslipidemia, certain types of cancer, sleep apnea, and osteoarthritis. Therefore, reducing excess body fat is important for overweight and obese animals, including humans and pets, to maintain their health and quality of life. Unfortunately, reducing excess body fat or maintaining a healthy weight after weight loss is difficult to achieve, and various solutions can result in adverse effects, such as a loss of lean body mass during weight loss or weight rebound after weight loss.

[0003]

[0003] Obesity is considered one of the most serious health problems and preventable causes of death in humans and pets. Maintaining a healthy body 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 body fat loss, and maintaining lean body mass and optimal body weight for better health and wellness in animals, as well as methods for determining the effectiveness of weight-loss diets.

[0004] [Summary of the Invention]

[0004] In one embodiment, a method for determining the effectiveness of a weight loss diet for a canine comprises the steps of 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, measuring 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 is administered the weight loss diet and measuring 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 is decreased from 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 is unchanged or increased from the amount of the biomarker in the first serum or plasma sample.

[0005] In another embodiment, a method of providing an effective weight loss diet to a canine includes 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, and measuring the amount of the biomarker in the first serum or plasma sample; after the canine is administered the weight loss diet, analyzing a second serum or plasma sample for the biomarker and measuring the amount of the biomarker in the second serum or plasma sample; and measuring the amount of the biomarker in the 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 is decreased from 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 is unchanged or increased from the amount of the biomarker in the first serum or plasma sample; and if 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 protein to carbohydrate ratio at the time of feeding is in the range of 4.5:1 to 2.5:1 by weight.

[0006] Other and further objects, features, and advantages of the present invention will be readily apparent to those skilled in the art. DETAILED DESCRIPTION OF THE INVENTION

[0007] definition

[0007] The terms "treating", "treat", and "treatment" include both prophylactic, i.e., preventative, and palliative, treatment.

[0008]

[0008] 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.

[0009]

[0009] The term "food" or "food product" or "food composition" means a product or composition that is intended for consumption by a canine and that provides nutrition to a canine.

[0010]

[0010] The term "carbohydrate" refers to digestible carbohydrates, such as sugars and starches, and does not include fiber, such as cellulosic fiber or fermentable fiber.

[0011]

[0011] The term "crude fiber" refers to that portion of the insoluble fiber found in the edible portion of plant cell walls; crude fiber is a measure of the amount of indigestible cellulose, lignin, and other components of this type in a food.

[0012]

[0012] The term "total dietary fiber" refers to the plant-derived food portion that cannot be completely broken down by canine digestive enzymes and includes both soluble and insoluble fiber. Soluble fiber dissolves in water and is fermented in the colon by the intestinal microflora. Examples of soluble fiber are β-glucan, guar gum, psyllium, inulin, wheat dextrin, and resistant starch. Insoluble fiber does not dissolve in water. Examples of insoluble fiber are cellulose and lignin.

[0013] The term "regularly" refers to administration at least once a month, and in one aspect, at least once a week. In certain embodiments, more frequent administration or consumption can be performed, such as two or three times a week. In one aspect, the dosing regimen can include consumption at least once a day.

[0014] The term "single package" means that the components of the kit are in or physically associated with one or more containers and are considered a single unit for manufacture, distribution, sale, or use. Containers include, but are not limited to, bags, boxes, cartons, bottles, packages, stapled or otherwise attached components such as shrink-wrap packages, or combinations thereof. A single package may be containers of a food composition or its components physically associated so as to be considered a single unit for manufacture, distribution, sale, or use.

[0015] The term "virtual package" means that the components of a kit are associated with one or more physical or virtual kit components instructions that instruct the user how to obtain the other components, such as a bag or other container containing one component and instructions instructing the user to visit a website, contact a recorded message or fax return 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 regarding one or more components of the kit.

[0016] The term "about" refers to ±20% of the numerical value, in one embodiment ±10%, in another embodiment ±5%, and in a more specific embodiment ±2%. For example, in one embodiment where about is ±20% of the numerical value, the phrase "about 10% to about 20%" can include ranges of 8% to 24% or 12% to 16%, including any subranges thereof.

[0017]

[0017] As used in this specification, embodiments, aspects, and examples using the word "comprising" or other non-limiting language may be replaced with "consisting essentially of" and "consisting of" embodiments.

[0018] 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 recommendations from recognized authorities in the field of canine nutrition, and thus can serve as the sole source of dietary intake to sustain life or promote production without the need for additional nutritional supplements. Nutritionally balanced pet food compositions are widely known and used in the art, and include, 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 conform to the current standards published by AAFCO on January 1, 2022.

[0019]

[0019] All percentages expressed herein are by weight of the composition 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 an ingredient in a composition is measured or specified after all free moisture in the composition has been removed.

[0020]

[0020] As used herein, ranges are used herein as shorthand to avoid having to list and describe each and every value within that range. Any appropriate value within such a range can be selected as the upper, lower, or boundary value of that range, as appropriate.

[0021] As used herein, the singular form of a word includes the plural, and vice versa, unless the context clearly dictates otherwise. Thus, references to "a," "an," and "the" generally include the plural of the respective term. For example, a reference to the singular "a supplement," "a method," or "a food" includes the plural "supplements," "methods," or "foods." Similarly, the words "comprise," "comprises," and "comprising" should be construed as inclusive rather than exclusive. Similarly, the terms "include," "including," and "or" should all be construed as inclusive unless the context clearly prohibits such a construction. Similarly, the term "examples," particularly when followed by a listing of the term, is merely exemplary and illustrative and should not be considered exclusive or comprehensive.

[0022] The methods and compositions and other developments disclosed herein are not limited to the particular methodology, procedures, and reagents described herein, as these may vary, as will be understood by those skilled in the art. Furthermore, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to, and does not, limit the scope of the disclosure or claims.

[0023]

[0023] Unless otherwise defined, all technical and scientific terms, terminology, and acronyms used herein have the meaning commonly understood by one of ordinary skill in the art of one or more of the fields of the invention or in the field or fields in which the term is used. Although any compositions, methods, products, or other means or materials similar or equivalent to those described herein can be used in the practice of the invention, specific compositions, methods, products, or other means or materials are described herein.

[0024] All patents, patent applications, publications, technical and / or journal articles, and other references cited or referenced herein are hereby incorporated by reference in their entirety to the extent permitted by law. The discussion of these references is intended merely to summarize the assertions made in the references. No admission is made that any such patents, patent applications, publications, or references, or any portion thereof, are related, essential, or prior art. The right to challenge the accuracy and pertinence of any assertion that such patents, patent applications, publications, and other references are related, essential, or prior art is expressly reserved. [Mode for Carrying Out the Invention]

[0025]

[0025] The present method is based on the discovery that certain biomarkers can be used to determine the effectiveness of a weight loss diet.

[0026]

[0026] In one embodiment, a method for determining the effectiveness of a weight loss diet for a canine comprises the steps of 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, and measuring the amount of the biomarker in the first serum or plasma sample; after the canine is administered the weight loss diet, analyzing a second serum or plasma sample for the biomarker and measuring 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 is decreased from 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 is unchanged or increased from the amount of the biomarker in the first serum or plasma sample.

[0027] In another embodiment, a method of providing an effective weight loss diet to a canine includes 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, and measuring the amount of the biomarker in the first serum sample; after the canine is administered the weight loss diet, analyzing a second serum or plasma sample for the biomarker and measuring the amount of the biomarker in the second serum or plasma sample; and measuring the amount of the biomarker in the 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 is decreased from 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 is unchanged or increased from the amount of the biomarker in the first serum or plasma sample; and if the weight loss diet is ineffective, providing the canine with an effective weight loss diet comprising protein, fat, carbohydrate, omega-3 fatty acids, and isoflavones, wherein the protein to carbohydrate as fed weight ratio is in the range of 4.5:1 to 2.5:1.

[0028] Generally, the composition can be administered periodically. 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 two months, three months, four months, five months, six months, or even one year. The method can further include administering the weight-loss diet to the canine.

[0029]

[0029] Additionally, the methods of the present invention can include recommending a different weight loss diet to the canine if the administered weight loss diet is determined to be ineffective. Generally, the recommended weight loss diet is an effective weight loss diet. Such effective weight loss diets are further described herein.

[0030]

[0030] Such effective weight loss diets are generally not only high in protein and low in carbohydrate, but also have a unique macronutrient profile, i.e., specific ratios and ingredients that provide specific health benefits. Notably, the effective diets of the present invention are not ketogenic diets (traditional or modified), i.e., diets that rely on high fat or have fat as the primary dietary component. Furthermore, the effective diets of the present invention are distinct from typical high-protein diets, as known in the art. The methods and compositions of the present invention do not rely on a single macronutrient component or ratio, but rather on a unique combination of macronutrient ratios and food ingredients.

[0031] Generally, the effective compositions of the present invention comprise protein. The protein may be a crude protein material, such as vegetable proteins, such as soybean meal, soy protein concentrate, corn gluten meal, wheat gluten, cottonseed, pea protein, canola meal, and peanut meal, or animal proteins, such as casein, albumin, and meat proteins. Examples of meat proteins useful herein include beef, pork, lamb, horse, poultry, fish, and mixtures thereof. The compositions may also optionally contain other ingredients, such as dried whey and other dairy by-products. In one embodiment, the food composition may comprise protein in an amount from about 30%, 35%, 40%, 45%, 50%, or even 55% by weight to about 35%, 40%, 45%, 50%, 55%, or even 60% by weight, including various subranges within these ranges. In one embodiment, the protein may be about 40% to about 60% by weight of the food composition, hi another embodiment, the protein may be about 45% to about 55% by weight of the food composition.

[0032]

[0032] While proteins have been discussed above, effective compositions of the present invention also include isoflavones. In various embodiments, the isoflavones include at least one of daidzein, 6-O-malonyldaidzein, 6-O-acetyldaidzein, genistein, 6-O-malonylgenistein, 6-O-acetylgenistein, glycitein, 6-O-malonylglycitein, 6-O-acetylglycitein, biochanin A, or formononetin. In certain embodiments, the isoflavones or metabolites thereof may be derived from soybean (Glycine max). If present, the one or more metabolites preferably include equol. In one embodiment, the food composition may include isoflavones in an amount from about 300 mg, 400 mg, 500 mg, 600 mg, 700 mg, 800 mg, 900 mg, or even 1,000 mg per kg of food composition to about 500 mg, 600 mg, 700 mg, 800 mg, 900 mg, 1,000 mg, 1,100 mg, 1,200 mg, 1,300 mg, 1,400 mg, or even 1,500 mg per kg of food composition, including various subranges within these ranges. In one aspect, the isoflavones may be present in an amount from about 100 mg to 1,500 mg per kilogram of pet food composition. In another aspect, the isoflavones may be present in an amount from about 300 mg to 1,200 mg per kilogram of pet food composition.

[0033] Generally, any type of carbohydrate can be used in the effective food composition. Examples of suitable carbohydrates include grains or cereals such as rice, corn, millet, sorghum, alfalfa, barley, soybeans, canola, oats, wheat, rye, triticale, and mixtures thereof. In one embodiment, the carbohydrate comprises from about 15% to about 25% by weight of the food composition. In another embodiment, the carbohydrate comprises from about 10% to about 20% by weight of the food composition. In other aspects, the carbohydrate can be present in an amount from about 5%, 10%, 15%, or even 20% by weight to about 10%, 15%, 20%, or even 25% by weight.

[0034] Generally, the protein to carbohydrate ratio is in a range that provides health benefits to canines. Typically, the protein to carbohydrate weight ratio ranges from 4.5:1 to 2.5:1. In some embodiments, the protein to carbohydrate weight ratio can range from 4.25:1 to 3.75:1, or even from 4.15:1 to 3:1.

[0035]

[0035] Generally, effective food compositions include fat. Examples of suitable fats include animal fats and vegetable fats. In one aspect, the fat source can be an animal fat source, such as tallow, lard, or poultry fat. Vegetable oils, such as corn oil, sunflower oil, safflower oil, grapeseed oil, soybean oil, olive oil, fish oil, and other oils rich in monounsaturated fatty acids, and n-6 ​​and n-3 polyunsaturated fatty acids, can also be used. In one embodiment, the food composition can include fat in an amount from about 10%, 15%, 20%, 25%, 30%, 35%, or even 40% by weight to about 20%, 25%, 30%, 35%, 40%, or even 45% by weight, including various subranges within these ranges. In one embodiment, the fat comprises from about 10% to about 40% by weight of the food composition. In another embodiment, the fat comprises from about 10% to about 30% by weight of the food composition. In yet another embodiment, the fat comprises from about 10% to about 15% by weight of the food composition.

[0036]

[0036] While fats have been mentioned above, the effective compositions of the present invention also include omega-3 fatty acids. Non-limiting examples of suitable omega-3 fatty acids include eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), alpha-linolenic acid (ALA), stearidonic acid (SDA), eicosatrienoic acid (ETE), eicosatetraenoic acid (ETA), heneicosapentaenoic acid (HPA), docosapentaenoic acid (DPA), tetracosapentaenoic acid, tetracosahexaenoic acid (nisinic acid), and mixtures thereof. In one embodiment, the omega-3 fatty acids may range from about 0.1%, 0.2%, 0.5%, 1%, 1.5%, 2%, 2.5%, or even 3% by weight of the composition to about 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, or even 5% by weight. In some embodiments, the omega-3 fatty acids are present in the food composition in an amount of about 0.1% to about 5% by weight. In some embodiments, the omega-3 fatty acids are present in the food composition in an amount of about 0.5% to about 2.5% by weight.

[0037]

[0037] Effective compositions of the present invention can include omega-6 fatty acids in addition to the fats and fatty acids discussed herein. Non-limiting examples of suitable omega-6 fatty acids include linoleic acid (LA), gamma-linolenic acid (GLA), arachidonic acid (AA, ARA), eicosadienoic acid, calendic acid, dihomo-gamma-linolenic acid (DGLA), docosadienoic acid, adrenic acid, osbondoic acid, tetracosatetraenoic acid, tetracosapentaenoic acid, and mixtures thereof. In one embodiment, the omega-6 fatty acids can range from about 0.2%, 0.5%, 1%, 2%, or even 3% by weight of the composition to about 1%, 2%, 3%, 4%, or even 5% by weight. In some embodiments, the omega-6 fatty acids are present in the food composition in an amount of about 1% to about 5% by weight. In some embodiments, the omega-6 fatty acids are present in the food composition in an amount of about 1% to about 2% by weight.

[0038] Administration can be regular or intermittent, as needed and desired. In one aspect, the food composition can be administered to a canine on a regular basis. In one aspect, administration can be at least once a week. In certain embodiments, more frequent administration or consumption can be performed, such as two or three times a week. In one aspect, the administration regimen can include at least one daily consumption.

[0039] In accordance with the methods described herein, administration can extend from birth through adulthood of the canine, including administration as part of a dietary regimen. In certain embodiments, the canine can be a juvenile or growing canine. In other embodiments, administration can be on a regular or extended regular basis, beginning, for example, when the canine has reached greater 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 predicted lifespan. In yet other embodiments, the canine may be older, having reached 60%, 66%, 70%, 75%, or 80% of its expected lifespan. Lifespan calculations 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.

[0040] Such administration can be carried out for a period of time necessary to achieve one or more of the objectives described herein, for example, to preserve lean body mass in a canine during weight loss. Other dosage amounts may be appropriate and can be determined based on the canine's initial body weight, as well as other variables, such as species, sex, breed, age, and the desired health effect.

[0041] The moisture content of such useful food compositions varies depending on the nature of the food composition. Useful food compositions may be dry compositions (e.g., kibble), semi-moist compositions, wet compositions, or any mixture thereof. In one embodiment, the pet food composition may be a complete and nutritionally balanced pet food. In this embodiment, the pet food may be a "wet food," a "dry food," or a "medium moisture" food. "Wet food" refers to pet food typically sold in cans or foil bags and having a moisture content typically ranging from about 70% to about 90%. "Dry food" refers to pet food (typically in the form of small biscuit-like kibble) that is similar in composition to wet food but has a limited moisture content, typically ranging from about 5% to about 15% or 20%. 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 varying moisture contents that are relatively shelf-stable and resistant to microbial or fungal deterioration or contamination. Also, in one aspect, the dry food composition may be an extruded food product.

[0042]

[0042] Effective food compositions may also contain one or more fiber sources. Such fiber sources include soluble, insoluble, fermentable, and non-fermentable fibers. Such fibers may be derived from plant sources, such as marine plants, although microbial fiber sources may also be used. A variety of soluble or insoluble fibers may be used, as known to those skilled in the art. The fiber source may be beet pulp (derived from sugar beet), 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, chicory, or mixtures thereof.

[0043] Alternatively, the fiber source may be a fermentable fiber. Fermentable fiber has previously been reported to be beneficial to the immune system of canines. Fermentable fiber or other compositions known to those skilled in the art that provide prebiotics and promote the growth of probiotics in the intestine may also be incorporated into the composition to help enhance the effects described herein or to help enhance the effect on the canine immune system.

[0044] In one embodiment, the effective food composition can comprise from about 1% to about 15% by weight of total dietary fiber. In some aspects, the total dietary fiber can be present in an amount of from about 5% to about 15% by weight, or even from about 8% to about 13% by weight. In another embodiment, the food composition can comprise from about 1% to about 10% by weight of crude fiber. In some aspects, the crude fiber can be present in an amount of from about 3% to about 10% by weight, or even from about 3% to about 7% by weight.

[0045] In some embodiments, the ash content of the food composition ranges from less than 1% to about 15%. In one aspect, the ash content may be from about 5% to about 10%.

[0046] Generally, effective food compositions may be suitable for consumption by canines as a meal, a component of a meal, a snack, or a treat. Such compositions may include complete foods intended to provide the necessary dietary requirements of canines. In one embodiment, the diet may comprise a complete and balanced pet food. Examples of food compositions include, but are not limited to, dry foods, wet foods, drinks, bars, pre-prepared frozen meals, pre-prepared preserved meals, pre-prepared refrigerated meals, etc.

[0047] Useful food compositions may further comprise one or more substances, such as vitamins, minerals, antioxidants, probiotics, prebiotics, salts, and functional additives, such as palatants, colorants, emulsifiers, and antimicrobials or other preservatives. Minerals that may be useful in such compositions include, for example, calcium, phosphorus, potassium, sodium, iron, chloride, boron, copper, zinc, magnesium, manganese, iodine, and selenium. Examples of additional vitamins useful herein include fat-soluble vitamins, such as vitamin A, vitamin D, vitamin E, and vitamin K, and water-soluble vitamins, such as vitamin B and vitamin C. In various embodiments, it may be useful to include inulin, amino acids, enzymes, and coenzymes.

[0048] The methods of the invention can provide health benefits to canines. In one embodiment, the health benefits can include preserving lean body mass, minimizing lean body mass during weight loss, reducing body fat, reducing body weight, reducing weight gain, reducing insulin resistance, reducing risk of diabetes, reducing risk of prediabetes, lowering cholesterol levels, lowering glucose levels, lowering triglyceride levels, lowering insulin levels, improving insulin sensitivity, lowering leptin levels, 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 a healthy metabolism, promoting better glycemic control, reducing chronic inflammation and inflammatory cytokines, improving spontaneous daytime activity, reducing daytime and nighttime restlessness, increasing satiety, and combinations thereof.

[0049]

[0049] In various embodiments, an effective food composition comprises at least one of: (1) one or more probiotics; (2) one or more inactivated probiotics; (3) one or more components of the inactivated probiotics, such as proteins, lipids, glycoproteins, etc., that promote similar or identical health benefits to the probiotics; (4) one or more prebiotics; and (5) combinations thereof. The probiotics or components thereof can be incorporated into the food composition (e.g., distributed uniformly or non-uniformly throughout 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. Pat. No. 5,968,569 and related patents.

[0050]

[0050] Typical probiotics include bacteria of the genus 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 the like. fermentum, and probiotic strains selected from Bifidobacterium species, Enterococcus faecium, and Enterococcus species. In some embodiments, the probiotic strain is 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 faecium SF68 (NCIMB 10415). Generally, the food composition may be selected from the group consisting of about 10 4 ~about 10 12 cfu / individual / day, in one embodiment, 10 5 ~about 1011 cfu / individual / day, and in one particular embodiment, 10 7 ~10 10 The probiotic may be contained in an amount sufficient to provide a sufficient amount of cfu / individual / day. Even if the probiotic is killed or inactivated, the amount of the killed or inactivated probiotic or its components should produce the same beneficial effects as live bacteria of the microorganism. Many such probiotics and their effects are known to those skilled in the art, for example, EP 1213970 (B1), EP 1143806 (B1), U.S. Patent No. 7189390, EP 1482811 (B1), EP 1296565 (B1), and U.S. Patent No. 6929793. In one embodiment, the probiotic may be Enterococcus faecium SF68 (NCIMB 10415). In another embodiment, the probiotic may be encapsulated in a carrier using methods and materials known to those skilled in the art.

[0051] As discussed above, effective food compositions may contain one or more prebiotics, such as fructooligosaccharides, glucooligosaccharides, galactooligosaccharides, isomaltooligosaccharides, xylooligosaccharides, soybean oligosaccharides, lactosucrose, lactulose, and isomaltulose. In one embodiment, the prebiotic may be chicory root, chicory root extract, inulin, or a combination thereof. Generally, prebiotics can be administered in an amount sufficient to actively stimulate healthy gut flora 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 dietary fiber intake for canines. Probiotics and prebiotics can be incorporated into the composition by any suitable means. Generally, these agents can be mixed with the composition or applied to the surface of the composition, for example, by dusting or spraying. When the agent is part of a kit, the agent may be mixed with other ingredients or may be in its own packaging. Typically, the food composition contains about 0.1% to about 10% prebiotics on a dry matter basis, in one embodiment about 0.3% to about 7%, and in one particular embodiment about 0.5% to 5% prebiotics. Prebiotics can be incorporated into the composition using methods known to those skilled in the art, such as those described in U.S. Patent No. 5,952,033.

[0052] One of ordinary skill in the art can determine the appropriate amounts of food ingredients, vitamins, minerals, probiotics, prebiotics, antioxidants, or other ingredients to use in making a particular composition for administration to a particular canid. One of ordinary skill in the art can consider the species, age, size, weight, health, etc. of the canid when determining the optimal formulation for a particular composition containing such ingredients. Other factors that may be considered include the desired dosage of each ingredient, the average intake of a particular type of composition by various canids (e.g., based on species, weight, activity / energy requirements, etc.), and manufacturing requirements for the composition.

[0053] In a further aspect, the present disclosure provides kits suitable for administering effective food compositions to canines. The kits may include, depending on the kit components, in separate containers within a single package or in separate containers within a virtual package, one or more of the following: (1) one or more ingredients suitable for consumption by canines; (2) instructions on how to combine the ingredients with the other kit components to produce a composition useful for providing the health benefits described herein; (3) instructions on how to use the food composition to achieve such benefits; (4) one or more probiotics; (5) one or more inactivated probiotics; (6) one or more components of the inactivated probiotics, such as proteins, lipids, glycoproteins, etc., that promote similar or identical health benefits as the probiotics; (7) one or more prebiotics; (8) a device for preparing or combining the kit components to produce a composition suitable for administration to canines; and (9) a device for administering the combined or prepared kit components to canines. In one embodiment, the kit includes one or more ingredients suitable for consumption by a canine, hi another embodiment, the kit includes instructions on how to combine the ingredients to produce a composition useful for achieving the health benefits described herein.

[0054]

[0054] When 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 the components in amounts sufficient to achieve the health benefits described herein. Typically, the kit components can be mixed immediately prior to ingestion by the canine. The kit may include the kit components in any of various combinations and / or mixtures. In one embodiment, the kit includes a food container for ingestion by the canine. The kit may include additional items, such as a device for mixing ingredients or a device for containing the mixture (e.g., a food bowl). In another embodiment, the food composition can be mixed with additional nutritional supplements, such as vitamins and minerals, that promote good health in canines. The components can each be provided in separate containers in a single package or as a mixture of various components in different packages. In some embodiments, the kit includes one or more other ingredients suitable for ingestion by a canine. In one aspect, such kits can include instructions describing how to combine the ingredients to form a food composition for consumption by a canine, generally by mixing the ingredients or applying optional additives to other ingredients, e.g., sprinkling a dietary supplement onto the food composition.

[0055] In a further aspect, a means for communicating information or instructions regarding one or more of: (1) use of the food composition to obtain one of the health benefits described herein; (2) contact information for the consumer to use if they have questions regarding the methods and compositions described herein; and (3) nutritional information regarding the food composition may be provided. The communication means may be useful for explaining the benefits of using the methods or compositions of the present invention and for communicating approved methods for administering the food composition to canines. Such means may include 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 such information or instructions. In one aspect, the means may be selected from the group consisting of a displayed website, a display kiosk, a brochure, a product label, a package insert, an advertisement, a flyer, a notice, an audiotape, a videotape, a DVD, a CD-ROM, a computer-readable chip, a computer-readable card, a computer-readable disk, a USB device, a FireWire device, computer memory, and any combination thereof.

[0056] In another aspect, a method for producing a food composition that includes one or more additional ingredients suitable for consumption by a canine, such as one or more of protein, fat, carbohydrate, fiber, vitamins, minerals, probiotics, and prebiotics, can include mixing the one or more ingredients suitable for consumption by a canine. The composition can be produced according to any method suitable in the art.

[0057] In another aspect, a package useful for containing the compositions described herein can include at least one device suitable for containing a food composition and a label affixed to the package, the label including one or more words, images, designs, acronyms, slogans, phrases, or other graphics, or a combination thereof, indicating that the contents of the package include a food composition. In some embodiments, the label affixed to the package includes one or more words, images, designs, acronyms, slogans, phrases, or other graphics, or a combination thereof, indicating that the contents of the package include a food composition having the beneficial health properties described herein. In one aspect, such a device can include the words "effective weight loss diet" or equivalent or similar wording printed on the package. Any package configuration and material suitable for containing a composition, such as bags, boxes, bottles, cans, and pouches made from paper, plastic, foil, metal, and the like, can be used in the present invention. Generally, the package contains a food composition tailored for canines according to the label. In one embodiment, the package can be a can or pouch containing the food composition described herein. In various embodiments, the package further comprises at least one window that allows the contents of the package to be viewed without opening the package. In some embodiments, the window can be a transparent portion of a packaging member. In other embodiments, the window can be a portion where no packaging member is present. [Example]

[0058]

[0058] The present invention can be further illustrated by the following examples, which are included for illustrative purposes only and are not intended to limit the scope of the invention unless otherwise specified.

[0059] Example 1: Dog studies In this study, 30 overweight dogs were randomized into two groups, with 15 dogs per group, based on the dogs' baseline maintenance energy requirement (MER), body weight, % body fat, and sex. Dogs in both the control and test groups were fed 75% of their baseline MER for the first 4 months of the weight loss trial, and then 60% of their baseline MER for the last 2 months of the weight loss trial. Body composition was measured using a DEXA device. The diets are shown in Table 1.

[0060] [Table 1]

[0061] In dogs fed the test diet, there were no significant differences in lean body mass between baseline and any of the three time points (2 months, 4 months, and 6 months). In contrast, dogs fed the control diet lost significant amounts of lean body mass compared to baseline at all three time points, as shown in Table 2.

[0062] [Table 2]

[0063] Dogs in both groups lost significant amounts of body fat compared to baseline. However, as shown in Table 3, dogs fed the test diet lost more body fat than control dogs at the end of the 6-month weight loss study (5.93 kg vs. 4.98 kg).

[0064] [Table 3]

[0065]

[0062] Several markers related to muscle growth / muscle breakdown were analyzed. Surprisingly, two markers were found that distinguished the test diet from traditional diets, such as the control diet. The results are shown in Table 4.

[0066] [Table 4]

[0067] As shown in Table 4, 3-methylhistidine and 1-methylhistidine were shown to significantly distinguish the test diet from the control diet. Therefore, 3-methylhistidine and 1-methylhistidine can be used as diagnostic markers to determine the effectiveness of weight-loss diets. The use of these markers can help veterinarians determine whether a weight-loss diet is healthy, e.g., one that maintains lean body mass, or unhealthy, e.g., one that significantly reduces lean body mass, without the need for expensive or unavailable DEXA (dual-energy X-ray absorptiometry) or QMR (quantitative magnetic resonance) scanners.

Claims

1. 1. A method for determining the effectiveness of a weight loss diet for a canine, 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; measuring the amount of said biomarker in said first serum or plasma sample; analyzing a second serum or plasma sample for the biomarkers after the canine has been administered the weight loss diet; measuring the 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 is decreased from 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 is unchanged or increased from the amount of the biomarker in the first serum or plasma sample; A method comprising:

2. 10. The method of claim 1, wherein the weight loss diet is administered to the canine on a regular basis.

3. 10. The method of claim 1, wherein the weight-reducing diet is administered to the canine for at least one month.

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

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

6. 10. The method of claim 1, wherein the weight loss diet, when effective, provides a health benefit selected from the group consisting of preserving lean body mass, minimizing lean body mass during weight loss, reducing body fat, reducing body weight, reducing weight gain, reducing insulin resistance, reducing risk of diabetes, reducing risk of prediabetes, lowering cholesterol levels, lowering glucose levels, lowering triglyceride levels, lowering insulin levels, lowering leptin levels, 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 a healthy metabolism, promoting better glycemic control, reducing chronic inflammation and inflammatory cytokines, improving spontaneous daytime activity, reducing daytime and nighttime restlessness, increasing satiety, and combinations thereof.

7. 10. The method of claim 1, wherein if the weight loss diet is ineffective, a different weight loss diet is recommended for the canine.

8. 1. A method of providing an effective weight loss diet to a canine, 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; measuring the amount of said biomarker in said first serum or plasma sample; analyzing a second serum or plasma sample for the biomarkers after the canine has been administered the weight loss diet; measuring the 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 is decreased from 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 is unchanged or increased from the amount of the biomarker in the first serum or plasma sample; Including, If 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 protein to carbohydrate ratio at feeding is in the range of 4.5:1 to 2.5:1 by weight.

9. 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 the omega-3 fatty acid is present in an amount from about 0.1% to about 5% by weight of the pet food composition.

10. 9. The method of claim 8, wherein the isoflavone is selected from the group consisting of daidzein, 6-O-malonyldaidzein, 6-O-acetyldaidzein, genistein, 6-O-malonylgenistein, 6-O-acetylgenistein, glycitein, 6-O-malonylglycitein, 6-O-acetylglycitein, biochanin A, formononetin, or a mixture thereof.

11. 9. The method of claim 8, wherein the isoflavones are present in an amount of about 300 mg to 1,500 mg per kilogram of the pet food composition.

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

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

1.

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

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

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