WO2013052433A2

WO2013052433A2 - Methods and compositions for reducing food intake and body weight gain in animals

Info

Publication number: WO2013052433A2
Application number: PCT/US2012/058386
Authority: WO
Inventors: Yuanlong Pan; Wei Wang; Scott Sherrill
Original assignee: Nestec SA
Current assignee: Nestec SA
Priority date: 2011-10-06
Filing date: 2012-10-02
Publication date: 2013-04-11
Anticipated expiration: 2014-04-06
Also published as: WO2013052433A3; WO2013052433A8

Abstract

Methods and compositions for reducing food intake and body weight gain and particularly to the use of carotenoids and unsaturated fatty acids (UFA) for reducing food intake and body weight gain in animals. The methods comprise administering in conjunction to the animal one or more carotenoids and one or more UFA in an amount effective for reducing food intake and body weight gain in the animal.

Description

METHODS AND COMPOSITIONS FOR REDUCING FOOD INTAKE AND BODY

WEIGHT GAIN IN ANIMALS

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application Serial No. 61/626999 filed October 6, 2011, the disclosure of which is incorporated herein by this reference.

Field of the Invention

[0002] The invention relates generally to methods for reducing food intake and body weight gain in animals and particularly to methods and compositions using unsaturated fatty acids (UFA) and carotenoids for reducing food intake and body weight gain in animals.

Description of Related Art

[0003] Companion animals considered overweight or obese are increasing in numbers. It is now estimated that 54% of companion animals in the U.S. are overweight or obese. This estimate translates roughly to 43 million dogs and 50 million cats. An animal is classified as obese when their body weight is 30% higher than their ideal body weight and overweight when their body weight is 15 to 29% higher than their ideal body weight. A companion animal has an ideal body weight if the animal's ribs can be felt, but not seen. Obesity in companion animals is implicated in increased risk of diabetes mellitus, arthritis, pancreatitis, hepatic lipidosis, orthopedic disorders, cardiovascular disease, respiratory ailments, hip dysplasia, liver disease, gastrointestinal disorders, and skin problems. Owners indulge their pets with treats, foods high in calories and fat, and table scraps, resulting in overweight pets, often with shortened lives. Pets along with their owners spend more time on the couch than exercising, exacerbating the problem. Some breeds of dogs and cats have particular propensities for rapid weight gain in spite of a diligent owner's attempts to curb the pet's increasing weight.

[0004] Pets, like humans, have been barraged with dieting schemes and exercise regimens to aid in controlling body weight. Advances have been made in development of reduced calorie pet foods, low-fat pet foods, increased non-soluble fiber pet foods, low carbohydrate/high protein pet foods and other pet foods marketed for weight control. Still, the statistics indicate that as a whole, opportunities for improvement remain and further advances in the art are needed.

[0005] Obesity is among the most serious health problems in humans and pets and considered to be the leading preventable cause of death. There is, therefore, a need for new methods and compositions useful for promoting the health and wellness and improving the quality of life for animals by reducing food intake and body weight gain.

SUMMARY OF THE INVENTION

[0006] It is, therefore, an object of the invention to provide methods for reducing food intake in an animal. [0007] It is another object of the invention to provide methods for reducing body weight gain in an animal.

[0008] It is a further object of the invention to provide methods for promoting satiety in an animal.

[0009] It is another object of the invention to provide methods for promoting lean body mass growth in an animal.

[0010] It is another object of the invention to provide methods for preventing obesity in an animal.

[0011] It is another object of the invention to provide methods for promoting the health and wellness of animals.

[0012] It is yet another object of the present invention to provide methods for extending the prime years of an animal's life.

[0013] One or more of these or other objects are achieved by administering in conjunction to the animal one or more carotenoids and one or more UFA in an amount effective for reducing food intake, reducing body weight gain, promoting satiety, promoting lean body mass growth, or preventing obesity in the animal.

[0014] Other and further objects, features, and advantages of the invention will be readily apparent to those skilled in the art.

DETAILED DESCRIPTION OF THE INVENTION

Definitions

[0015] The term "animal" means any animal that can benefit from reducing food intake or body weight gain, including at least human, avian, bovine, canine, equine, feline, hicrine, lupine, murine, ovine, or porcine animals, and preferably a domesticated animal, and more preferably a companion animal.

[0016] The term "companion animals" means domesticated animals such as dogs, cats, birds, rabbits, guinea pigs, ferrets, hamsters, mice, gerbils, pleasure horses, cows, goats, sheep, donkeys, pigs, and more exotic species kept by humans for company, amusement, psychological support, education, physical assistance, extrovert display, and all of the other functions that humans desire or need to share with animals of other species.

[0017] The term "food" means compositions suitable for consumptions by an animal, including, but not limited to, dry food compositions, wet food compositions, and liquid food compositions.

[0018] The term "dietary supplement" means a product that is intended to be ingested in addition to a normal animal diet. Dietary supplements may be in any form, e.g., solid, liquid, gel, tablet, capsule, powder, and the like. Preferably they are provided in convenient dosage forms, e.g., in sachets. Dietary supplements can be provided in bulk consumer packages such as bulk powders, liquids, gels, or oils. Similarly such supplements can be provided in bulk quantities to be included in other food items such as snacks, treats, supplement bars, beverages, and the like. [0019] The term "unsaturated fatty acid" or "UFA" means one or more polyunsaturated fatty acids and/or monounsaturated fatty acids, including monocarboxylic acids having at least one double bond. UFA include (n-6) fatty acids such as linoleic acid (LA) and arachidonic acid (AA) and (n-3) fatty acids such as eicosapentaenoic acid (EPA), alpha-linolenic acid (ALA), docosapentaenoic acid (DPA) and docosahexaenoic acid (DHA). UFA also include gamma-linolenic acid (GLA), eicosadienoic acid, dihomo-gamma-linolenic acid (DGLA), docosadienoic acid, adrenic acid, docosapentaenoic acid, tetracosatetraenoic acid, tetracosapentaenoic acid, calendic acid, myristoleic acid, palmitoleic acid, oleic acid, linoleic acid, cis-vaccenic acid, and erucic acid.

[0020] The term "fish oil" means a fatty or oily extract, relatively rich in UFA, whether crude or purified, obtained from a sea animal, preferably a cold-water fish such as, but not limited to, salmon, tuna, mackerel, menhaden, herring, sea bass, striped bass, pollock, flounder, halibut, catfish, lake trout, anchovies, and sardines, as well as shark, swordfish, tilefish, shrimp, and clams, or any combination thereof. "Fish oil" is also a term of art used by ingredient suppliers and encompasses a range of products of varying UFA content and purity.

[0021] The term "carotenoid" means one or more naturally occurring organic pigment typically found in plants, algae and various microorganisms. Examples of carotenoids include zeaxanthin, astaxanthin, beta- carotene, lutein, alpha-carotene, gamma-carotene, beta-cryptoxanthin, and lycopene. Additional examples of carotenoids include lycopersene, phytofluene, hexahydrolycopene, torulene, a-zeacarotene, alloxanthin, cynthiaxanthin, pectenoxanthin, cryptomonaxanthin, crustaxanthin, gazaniaxanthin, OH-chlorobactene, loroxanthin, lycoxanthin, rhodopin, rhodopinol, saproxanthin, oscillaxanthin, phleixanthophyll, rhodovibrin, spheroidene, diadinoxanthin, luteoxanthin, mutatoxanthin, citroxanthin, furanoxide, neochrome, foliachrome, trollichrome, vaucheriaxanthin, rhodopinal, wamingone, torularhodinaldehyde, torularhodin, canthaxanthin, capsanthin, capsorubin, cryptocapsin, 2,2'-diketospirilloxanthin, flexixanthin, phoenicoxanthin, hydroxyspheriodenone, okenone, pectenolone, phoeniconone, phoenicopterone, rubixanthone, siphonaxanthin, astacein, fucoxanthin, isofucoxanthin, physalien, dipalmitate, siphonein, P-apo-2'-carotenal, apo-2-lycopenal, apo-6'-lycopenal, azafrinaldehyde, bixin, citranaxanthin, crocetin, crocetinsemialdehyde, crocin, digentiobiosyl, hopkinsiaxanthin, methyl apo-6'-lycopenoate, paracentrone, sintaxanthin, actinioerythrin, peridinin, pyrrhoxanthininol, semi-a-carotenone, semi-P-carotenone 5, triphasiaxanthin, eschscholtzxanthin, eschscholtzxanthone, rhodoxanthin, tangeraxanthin, nonaprenoxanthin, decaprenoxanthin, c.p. 450, c.p. 473, and bacterioruberin.

[0022] The term "effective amount" or "amount effective for" means an amount of a compound, material, composition, dietary supplement, medicament, or other material that is effective to achieve a particular biological result, such as reducing, preventing, treating, or promoting a particular condition. [0023] As used herein, the "prime years" of an animal's life can extend from young adulthood ("young," as described above) into the older or "aged" population. Indeed, the prime years of an animal's life can extend essentially until the animal's death, assuming the animal is healthy and active through the animal's older years.

[0024] The term "extending the prime" means extending the number of years an animal lives a healthy life and not just extending the number of years an animal lives, e.g., an animal receiving a treatment that extends the prime would be healthy in the prime of its life for a longer time, relative to another animal not receiving the treatment.

[0025] The term "health and/or wellness of an animal" means the complete physical, mental, and social well being of the animal, not merely the absence of disease or infirmity.

[0026] The term "quality of life" means the ability to enjoy normal life activities.

[0027] The term "regular basis" means at least monthly dosing with compounds or compositions of the present invention and more preferably weekly dosing. More frequent dosing or consumption, such as twice or three times weekly, is preferred in certain embodiments. Still more preferred are regimens that comprise at least once daily consumption, e.g., when compounds or compositions of the present invention are a component of a food composition that is consumed at least once daily. The term "extended regular basis" as used herein refers to long term administration of a substance on a regular basis.

[0028] The term "in conjunction" means that the carotenoids and UFA, or other compounds or compositions of the present invention are administered to an animal (1) together in a food, dietary supplement, or other composition or (2) separately at the same or different frequency using the same or different administration routes at about the same time or periodically. "Periodically" means that the compound or composition is administered on a dosage schedule acceptable for a specific compound or composition and that the food is fed to an animal routinely as appropriate for the particular animal. "About the same time" generally means that the food and/or compound or composition is administered at the same time or within about 72 hours of each other.

[0029] The term "single package" means that the components of a kit are physically associated in or with one or more containers and considered a unit for manufacture, distribution, sale, or use. Containers include, but are not limited to, bags, boxes, bottles, shrink wrap packages, stapled or otherwise affixed components, or combinations thereof. A single package may be containers of individual food compositions physically associated such that they are considered a unit for manufacture, distribution, sale, or use.

[0030] The term "virtual package" means that the components of a kit are associated by directions on one or more physical or virtual kit components instructing the user how to obtain the other components, e.g., in a bag containing one component and directions instructing the user to go to a website, contact a recorded message, view a visual message, or contact a caregiver or instructor to obtain instructions on how to use the kit.

[0031] The term "mg/kg/day" means milligrams per kilogram of body weight of an animal per day.

[0032] The term "mg/day" means milligrams per day.

[0033] As used herein, ranges are used in shorthand, so as to avoid having to list and describe each and every value within the range. Any appropriate value within the range can be selected, where appropriate, as the upper value, lower value, or the terminus of the range.

[0034] As used herein, the singular form of a word includes the plural, and vice versa, unless the context clearly dictates otherwise. Thus, the references "a", "an", and "the" are generally inclusive of the plurals of the respective terms. For example, reference to "a compound" or "a method" includes a plurality of such "compounds" or "methods." Similarly, the words "comprise", "comprises", and "comprising" are to be interpreted inclusively rather than exclusively. Likewise the terms "include", "including" and "or" should all be construed to be inclusive, unless such a construction is clearly prohibited from the context.

[0035] The terms "comprising" or "including" are intended to include embodiments encompassed by the terms "consisting essentially of and "consisting of. Similarly, the term "consisting essentially of is intended to include embodiments encompassed by the term "consisting of.

[0036] All percentages expressed herein are by weight of the total weight of the composition unless expressed otherwise.

[0037] The methods and compositions and other advances disclosed here are not limited to particular methodology, protocols, and reagents described herein because, as the skilled artisan will appreciate, they may vary. Further, 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 that which is disclosed or claimed.

[0038] Unless defined otherwise, all technical and scientific terms, terms of art, and acronyms used herein have the meanings commonly understood by one of ordinary skill in the art in the field(s) of the invention, or in the field(s) where the term is used. Although any compositions, methods, articles of manufacture, or other means or materials similar or equivalent to those described herein can be used in the practice of the present invention, the preferred compositions, methods, articles of manufacture, or other means or materials are described herein.

[0039] All patents, patent applications, publications, technical and/or scholarly articles, and other references cited or referred to herein are in their entirety incorporated herein by reference to the extent allowed by law. The discussion of those references is intended merely to summarize the assertions made therein. No admission is made that any such patents, patent applications, publications or references, or any portion thereof, are relevant, material, or prior art. The right to challenge the accuracy and pertinence of any assertion of such patents, patent applications, publications, and other references as relevant, material, or prior art is specifically reserved.

The Invention

[0040] In one aspect, the invention provides methods for reducing food intake in an animal. The methods comprise administering in conjunction to the animal one or more carotenoids and one or more UFA in an amount effective for reducing food intake in the animal.

[0041] In another aspect, the invention provides methods for reducing body weight gain in an animal. The methods comprise administering in conjunction to the animal one or more carotenoids and one or more UFA in an amount effective for reducing body weight gain in the animal.

[0042] In another aspect, the invention provides methods for promoting satiety in an animal. The methods comprise administering in conjunction to the animal one or more carotenoids and one or more UFA in an amount effective for promoting satiety in the animal.

[0043] In another aspect, the invention provides methods for preventing obesity in an animal. The methods comprise administering in conjunction to the animal one or more carotenoids and one or UFA in an amount effective for preventing obesity in the animal.

[0044] In another aspect, the invention provides methods for promoting lean body mass growth in an animal. The methods comprise administering in conjunction to the animal one or more carotenoids and one or more UFA in an amount effective for promoting lean body mass growth in the animal.

[0045] In another aspect, the invention provides methods for extending the prime for an animal. The methods comprise administering in conjunction to the animal one or more carotenoids and one or more UFA in an amount effective for reducing food intake in the animal, thereby extending the prime of the animal.

[0046] In another aspect, the invention provides methods for promoting the health and wellness of an animal. The methods comprise administering in conjunction to the animal one or more carotenoids and one or more UFA in an amount effective for reducing food intake in the animal, thereby promoting the health and wellness of the animal.

[0047] In one aspect, the invention provides compositions suitable for one or more of reducing food intake, reducing body weight gain, promoting satiety, promoting lean body mass growth, or preventing obesity in an animal. The compositions comprise one or more carotenoids and one or more UFA in an amount effective for reducing food intake, reducing body weight gain, promoting satiety, promoting lean body mass growth, or preventing obesity in the animal.

[0048] The inventions are based upon the discovery that animals who were administered the compounds of the present invention demonstrated a reduction in voluntary food intake and body weight gain in comparison to animals that were not administered the compounds. [0049] In various embodiments, the animal is any animal that has a need for reducing food intake, reducing body weight gain, promoting satiety, promoting lean body mass growth, or preventing obesity. In one embodiment, the animal is a human or companion animal, preferably a canine or a feline. The methods in various embodiments are directed to humans or companion animals, such as dogs and cats. The animal can be of any age, but the methods are also well-suited to use with aged {i.e., aging) animals.

[0050] The carotenoids can be any carotenoid suitable for administration to an animal. Preferably the carotenoids are zeaxanthin, astaxanthin, beta-carotene, lutein, alpha-carotene, gamma-carotene, beta- cryptoxanthin, and lycopene, more preferably zeaxanthin, astaxanthin, beta-carotene, and lutein.

[0051] The carotenoids are administered to the animal in amounts of from about 0.001 to about 5000 mg/kg/day, although greater or lesser amounts can be administered. In various embodiments, the carotenoids are administered in amounts of from about 0.01 to about 500 mg/kg/day, preferably from about 0.1 to about 100 mg/kg/day. When administered in a composition, the composition comprises from about 0.0001 to about 50% carotenoids. More preferably, the carotenoid content is from about 0.0002 to about 20%, from about 0.0003 to about 10%, or from about 0.0005 to about 5%.

[0052] In some embodiments, lutein is administered in amounts of from about 0.001 to about 5000 mg/kg/day, preferably from about 0.01 to about 500 mg/kg/day, more preferably from about 0.1 to about 100 mg/kg/day. In some embodiments, zeaxanthin is administered in amounts of from about 0.001 to about 5000 mg/kg/day, preferably from about 0.01 to about 500 mg/kg/day, more preferably from about 0.1 to about 100 mg/kg/day. In some embodiments, beta-carotene is administered in amounts of from about 0.001 to about 5000 mg/kg/day, preferably from about 0.01 to about 500 mg/kg/day, more preferably from about 0.1 to about 100 mg/kg/day. In some embodiments, astaxanthin is administered in amounts of from about 0.001 to about 5000 mg/kg/day, preferably from about 0.01 to about 500 mg/kg/day, more preferably from about 0.1 to about 100 mg/kg/day.

[0053] The UFA can be any UFA suitable for administration to an animal. UFA can be obtained from any suitable source, synthetic or natural. Preferred sources of UFA are natural sources of such fatty acids and include, without limitation, primrose; dark green vegetables such as spinach; algae and blue-green algae such as spirulina; plant seeds and oils from plants such as flax, canola, soybean, walnut, pumpkin, safflower, sesame, wheat germ, sunflower, corn, and hemp; and fish such as salmon, tuna, mackerel, herring, sea bass, striped bass, halibut, catfish, sardines, shark, shrimp, and clams; and the extracted oils of any one or more of the foregoing. The UFA may also be synthetic, and as such may be produced according to any means suitable in the art, from any suitable starting material. The UFA may comprise a blend of any one or more UFA from any one or more sources, such as those exemplified above, whether natural or synthetic. In preferred embodiment the UFA comprises one or more of a natural fish oil, ALA, EPA, DP A, DHA, or another n-3 fatty acid from any source, more preferably DHA, EPA, or combination thereof. [0054] The UFA are administered to the animal in amounts of from about 0.01 to about 5000 mg/kg/day, although greater or lesser amounts can be administered. In various embodiments, the UFA are administered in amounts of from about 0.05 to about 2500 mg/kg/day, preferably from about 0.1 to about 500 mg/kg/day. When administered in a composition, the composition comprises from about 0.01 to about 50% UFA. More preferably, the UFA content is from about 0.1 to about 20%, from about 0.25 to about 10%, or from about 0.5 to about 5%.

[0055] In some embodiments, DHA is administered in amounts of from about 0.01 to about 5000 mg/kg/day, preferably from about 0.05 to about 2500 mg/kg/day, more preferably from about 0.1 to about 500 mg/kg/day.

[0056] In some embodiments, EPA is administered in amounts of from about 0.01 to about 5000 mg/kg/day, preferably from about 0.05 to about 2500 mg/kg/day, more preferably from about 0.1 to about 500 mg/kg/day.

[0057] In some embodiments, a combination of DHA and EPA is administered in amounts of from about 0.1 to about 5000 mg/kg/day, preferably from about 0.05 to about 2500 mg/kg/day, more preferably from about 0.5 to about 500 mg/kg/day.

[0058] In various embodiments, the methods comprise administering in conjunction to the animal one or more carotenoids and one or more UFA in an effective amount wherein the carotenoids are lutein, zeaxanthin, beta carotene, astaxanthin, or combinations thereof and the UFA are DHA, EPA, or combination thereof.

[0059] In some embodiments the carotenoids are administered to the animal in amounts of from about 0.001 to about 5000 mg/kg/day, preferably from about 0.01 to about 500 mg/kg/day, more preferably from about 0.1 to about 100 mg/kg day; and the UFA are administered to the animal in amounts of from about 0.01 to about 5000 mg/kg/day, preferably from about 0.05 to about 2500 mg/kg/day, more preferably from about 0.1 to about 500 mg/kg/day.

[0060] In one embodiment, lutein is administered in amounts of from about 0.001 to about 5000 mg/kg/day, zeaxanthin is administered in amounts of from about 0.001 to about 5000 mg/kg/day, beta- carotene is administered in amounts of from about 0.001 to about 5000 mg/kg/day, astaxanthin is administered in amounts of from about 0.00 1 to about 5000 mg/kg/day, DHA is administered in amounts of from about 0.01 to about 5000 mg/kg/day, and EPA is administered in amounts of from about 0.01 to about 5000 mg/kg/day.

[0061] In another embodiment, lutein is administered in amounts of from about 0.01 to about 500 mg/kg/day, zeaxanthin is administered in amounts of from about 0.01 to about 500 mg/kg/day, beta-carotene is administered in amounts of from about 0.01 to about 500 mg/kg/day, astaxanthin is administered in amounts of from about 0.01 to about 500 mg/kg/day, DHA is administered in is administered in amounts of from about 0.05 to about 2500 mg/kg/day, and EPA is administered in amounts of from about 0.05 to about 2500 mg/kg/day. In still another embodiment, lutein is administered in amounts of from about 0.1 to about 100 mg/kg/day, zeaxanthin is administered in amounts of from about 0.1 to about 100 mg/kg/day, beta- carotene is administered in amounts of from about 0.1 to about 100 mg/kg/day, astaxanthin is administered in amounts of from about 0.1 to about 100 mg/kg/day, DHA is administered in is administered in amounts of from about 0.1 to about 500 mg/kg/day, and EPA is administered in amounts of from about 0.1 to about 500 mg/kg/day.

[0062] Compounds of the present invention can be administered in conjunction to the animal in any suitable form using any suitable administration route. In one embodiment, the compounds are administered to an animal in a composition. In various embodiments, the compounds can be administered in a food composition, in a dietary supplement, in a pharmaceutical composition, in a nutraceutical composition, or as a medicament. Similarly, the compounds and compositions can be administered in conjunction using a variety of administration routes, including oral, intranasal, intravenous, intramuscular, intragastric, transpyloric, subcutaneous, rectal, and the like. Preferably, the compounds and compositions are administered to an animal orally. More preferably, the compounds and compositions are administered in conjunction orally to an animal as a dietary supplement or as an ingredient in a food composition.

[0063] In a preferred embodiment, the compounds of the present invention are administered to an animal as an ingredient in a food composition suitable for consumption by an animal, including humans and companion animals such as dogs and cats. Such food compositions include complete foods intended to supply the necessary dietary requirements for an animal or food supplements such as animal treats.

[0064] In various embodiments, food compositions such as pet food compositions or pet treat compositions comprise from about 5% to about 50% crude protein. The crude protein material may comprise vegetable proteins such as soybean meal, soy protein concentrate, corn gluten meal, wheat gluten, cottonseed, and peanut meal, or animal proteins such as casein, albumin, and meat protein. Examples of meat protein useful herein include beef, pork, lamb, equine, poultry, fish, and mixtures thereof.

[0065] The food compositions may further comprise from about 5% ,to about 40% fat. Examples of suitable fats include animal fats and vegetable fats. Preferably the fat source is an animal fat source such as tallow or grease. Vegetable oils such as corn oil, sunflower oil, safflower oil, rape seed oil, soy bean oil, olive oil and other oils rich in monounsaturated and polyunsaturated fatty acids, may also be used.

[0066] The food compositions may further comprise from about 10% to about 60% carbohydrate. 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. The compositions may also optionally comprise other materials such as dried whey and other dairy by-products. [0067] The moisture content for such food compositions varies depending on the nature of the food composition. The food compositions may be dry compositions (e.g., kibble), semi-moist compositions, wet compositions, or any mixture thereof. In a preferred embodiment, the composition is a complete and nutritionally balanced pet food. In this embodiment, the pet food may be a "wet food", "dry food", or food of "intermediate moisture" content. "Wet food" describes pet food that is typically sold in cans or foil bags and has a moisture content typically in the range of about 70% to about 90%. "Dry food" describes pet food that is of a similar composition to wet food but contains a limited moisture content typically in the range of about 5% to about 15% or 20% (typically in the form or small biscuit-like kibbles). In one preferred embodiment, the compositions have moisture content from about 5% to about 20%. Dry food products include a variety of foods of various moisture contents, such that they are relatively shelf-stable and resistant to microbial or fungal deterioration or contamination. Also preferred are dry food compositions that are extruded food products such as pet foods or snack foods for either humans or companion animals.

[0068] The food compositions may also comprise one or more fiber sources. The term "fiber" includes all sources of "bulk" in the food whether digestible or indigestible, soluble or insoluble, fermentable or nonfermentable. Preferred fibers are from plant sources such as marine plants but microbial sources of fiber may also be used. A variety of soluble or insoluble fibers may be utilized, as will be known to those of ordinary skill in the art. The fiber source can be beet pulp (from sugar beet), gum arabic, gum talha, psyllium, rice bran, carob bean gum, citrus pulp, pectin, fructooligosaccharide, short chain oligofructose, mannanoligofructose, soy fiber, arabinogalactan, galactooligosaccharide, arabinoxylan, or mixtures thereof.

[0069] Alternatively, the fiber source can be a fermentable fiber. Fermentable fiber has previously been described to provide a benefit to the immune system of a companion animal. Fermentable fiber or other compositions known to skilled artisans that provide a prebiotic to enhance the growth of probiotics within the intestine may also be incorporated into the composition to aid in the enhancement of the benefit provided by the present invention to the immune system of an animal.

[0070] In some embodiments, the ash content of the food composition ranges from less than 1% to about 15%, preferably from about 5% to about 10%.

[0071] In a preferred embodiment, the composition is a food composition comprising from about 15% to about 50% protein, from about 5% to about 40% fat, and from about 5% to about 10%) ash content, and having a moisture content of about 5% to about 20%. In other embodiments, the food composition further comprises prebiotics or probiotics as described herein.

[0072] When administered in a food composition, the amount of lutein as a percentage of the composition is from about 0.0001 to about 50% of the food composition, preferably from about 0.0002 to about 20%, more preferably from about 0.0003 to about 10%, even more preferably from about 0.0005 to about 5%. In various embodiments, food compositions comprise about 1%, 2%, 4%, 6%, 8%, 10%, 12%, 14%, 16%, 18%, 20%, 22%, 24%, 26%, 28%, 30%, 32%, 34%, 36%, 38%, 40%, 42%, 44%, 46%, 48% or 50% lutein.

[0073] When administered in a food composition, the amount of zeaxanthin as a percentage of the composition is from about 0.0001 to about 50% of the food composition, preferably from about 0.0002 to about 20%, more preferably from about 0.0003 to about 10%, even more preferably from about 0.0005 to about 5%. In various embodiments, food compositions comprise about 1%, 2%, 4%, 6%, 8%, 10%, 12%, 14%, 16%, 18%, 20%, 22%, 24%, 26%, 28%, 30%, 32%, 34%, 36%, 38%, 40%, 42%, 44%, 46%, 48% or 50% zeaxanthin.

[0074] When administered in a food composition, the amount of beta-carotene as a percentage of the composition is from about 0.0001 to about 50% of the food composition, preferably from about 0.0002 to about 20%, more preferably from about 0.0003 to about 10%, even more preferably from about 0.0005 to about 5%. In various embodiments, food compositions comprise about 1%, 2%, 4%, 6%, 8%, 10%, 12%), 14%, 16%, 18%, 20%, 22%, 24%, 26%, 28%, 30%, 32%, 34%, 36%, 38%, 40%, 42%, 44%, 46%, 48% or 50% beta-carotene.

[0075] When administered in a food composition, the amount of astaxanthin as a percentage of the composition is from about 0.0001 to about 50%) of the food composition, preferably from about 0.0002 to about 20%, more preferably from about 0.0003 to about 10%, even more preferably from about 0.0005 to about 5%. In various embodiments, food compositions comprise about 1 %, 2%, 4%, 6%, 8%, 10%, 12%, 14%, 16%, 18%, 20%, 22%, 24%, 26%, 28%, 30%, 32%, 34%, 36%, 38%, 40%, 42%, 44%, 46%, 48% or 50% astaxanthin.

[0076] When administered in a food composition, the amount of vitamin DHA as a percentage of the composition is from about 0.01 to about 40%) of the food composition, preferably from about 0.3 to about 30%, more preferably from about 0.5 to about 20%. In various embodiments, food compositions comprise about 1%, 2%, 4%, 6%, 8%, 10%, 12%, 14%, 16%, 18%, 20%, 22%, 24%, 26%, 28%, 30%, 32%, 34%, 36%, 38%, or 40% DHA.

[0077] When administered in a food composition, the amount of EPA as a percentage of the composition is from about 0.01 to about 40%) of the food composition, preferably from about 0.3 to about 30%, more preferably from about 0.5 to about 20%. In various embodiments, food compositions comprise about 1%, 2%, 4%, 6%, 8%, 10%, 12%, 14%, 16%, 18%, 20%, 22%, 24%, 26%, 28%, 30%, 32%, 34%, 36%, 38%, or 40% EPA.

[0078] In another embodiment, the compounds and compositions are administered to an animal in a dietary supplement. The dietary supplement can have any suitable form such as a gravy, drinking water, beverage, yogurt, powder, granule, paste, suspension, chew, morsel, treat, snack, pellet, pill, capsule, tablet, sachet, or any other suitable delivery form. The dietary supplement can comprise the compounds or compositions and optional compounds such as vitamins, preservatives, probiotics, prebiotics, and antioxidants. This permits the supplement to be administered to the animal in small amounts, or in the alternative, can be diluted before administration to an animal. The dietary supplement may require admixing with a food composition or with water or other diluent prior to administration to the animal. When administered in a dietary supplement, the compounds or compositions comprise from about 0.01 to about 90% of the supplement, preferably from about 0.3 to about 70%, more preferably from about 0.5 to about 60%.

[0079] In another embodiment, the compounds and compositions are administered to an animal in a pharmaceutical or nutraceutical composition. The pharmaceutical or nutraceutical composition comprises the compounds of the present invention and one or more pharmaceutically or nutraceutically acceptable carriers, diluents, or excipients. Generally, pharmaceutical compositions are prepared by admixing one or more compounds with excipients, buffers, binders, plasticizers, colorants, diluents, compressing agents, lubricants, flavorants, moistening agents, and the like, including other ingredients known to skilled artisans to be useful for producing pharmaceuticals and formulating compositions that are suitable for administration to an animal as pharmaceuticals. When administered in a pharmaceutical or nutraceutical composition, the compositions comprise from about 0.1 to about 90% of the compounds of the present invention, preferably from about 0.3 to about 70%, more preferably from about 0.5 to about 60%.

[0080] The compounds and compositions of the present invention can be administered to the animal on an as-needed, on an as-desired basis, or on a regular basis. A goal of administration on a regular basis is to provide the animal with a regular and consistent dose of the compounds or compositions or the direct or indirect metabolites that result from such ingestion. Such regular and consistent dosing will tend to create constant blood levels of the compounds and their direct or indirect metabolites. Thus, administration on a regular basis can be once monthly, once weekly, once daily, or more than once daily. Similarly, administration can be every other day, week, or month, every third day, week, or month, every fourth day, week, or month, and the like. Administration can be multiple times per day. When utilized as a supplement to ordinary dietetic requirements, the compounds or compositions may be administered directly to the animal, e.g., orally or otherwise. The compounds and compositions can alternatively be contacted with, or admixed with, daily feed or food, including a fluid, such as drinking water, or an intravenous connection for an animal that is receiving such treatment. Administration can also be carried out as part of a dietary regimen for an animal. For example, a dietary regimen may comprise causing the regular ingestion in the animal of the compounds or compositions in an amount effective to accomplish the methods of the present invention.

[0081] In one embodiment, the compounds are administered on an extended regular basis. In another embodiment, the compounds are administered to the animal on a daily basis. In some embodiments, the carotenoids are administered to the animal in amounts of from about 0.001 to about 5000 mg/day, preferably from about 0.01 to about 500 mg/day, more preferably from about 0.1 to about 250 mg/day. In another embodiment, the UFA are administered to the animal in amount of from about 0.01 to about 3000 mg/day, preferably from about 0.05 to about 20000 mg/day, more preferably from about 0.1 to about 15000 mg/day. In some embodiment, lutein is administered in amounts of from about 0.001 to about 5000 mg/day, preferably from about 0.01 to about 500 mg/day, more preferably from about 0.1 to about 250 mg/day.; zeaxanthin is administered in amounts of from about 0.001 to about 5000 mg/day, preferably from about 0.01 to about 500 mg/day, more preferably from about 0.1 to about 250 mg/day; beta-carotene is administered in amounts of from about 0.001 to about 5000 mg/day, preferably from about 0.01 to about 500 mg/day, more preferably from about 0.1 to about 250 mg/day; astaxanthin is administered in amounts of from about 0.001 to about 5000 mg/day, preferably from about 0.01 to about 500 mg/day, more preferably from about 0.1 to about 250 mg/day; DHA is administered in amounts of from about 0.01 to about 30000 mg/day, preferably from about 0.05 to about 20000 mg/day, more preferably from about 0.1 to about 15000 mg/day; and EPA is administered in amounts of from about 0.01 to about 30000 mg/day, preferably from about 0.05 to about 20000 mg/day, more preferably from about 0.1 to about 15000 mg/day.

[0082] According to the methods of the invention, administration of the compounds and compositions, including administration as part of a dietary regimen, can span a period ranging from parturition through the adult life of the animal. In various embodiments, the animal is a human or companion animal such as a dog or cat. In certain embodiments, the animal is a young or growing animal. In more preferred embodiments, the animal is an aging animal. In other embodiments administration begins, for example, on a regular or extended regular basis, when the animal has reached more than about 30%, 40%, or 50% of its projected or anticipated lifespan. In some embodiments, the animal has attained 40, 45, or 50% of its anticipated lifespan. In yet other embodiments, the animal is older having reached 60, 66, 70, 75, or 80% of its likely lifespan. A determination of lifespan may be based on actuarial tables, calculations, estimates, or the like, and may consider past, present, and future influences or factors that are known to positively or negatively affect lifespan. Consideration of species, gender, size, genetic factors, environmental factors and stressors, present and past health status, past and present nutritional status, stressors, and the like may also influence or be taken into consideration when determining lifespan.

[0083] The compounds and compositions of the present invention are administered to an animal for a time required to accomplish one or more objectives of the invention, e.g., reducing food intake; reducing body weight gain; promoting satiety; preventing obesity; promoting lean body mass growth; improving the quality of life; extending the prime; and promoting the health and wellness in an animal. Preferably, the compounds or compositions are administered to an animal on a regular basis.

[0084] In another aspect, the invention provides compositions comprising the compounds of the present invention in an amount effective for reducing food intake, reducing body weight gain, promoting satiety, preventing obesity, or promoting lean body mass growth. The compositions contain the compounds of the present invention in amounts sufficient to administer to the carotenoids in amounts of from about 0.001 to about 5000 mg/kg/day, preferably from about 0.01 to about 500 mg/kg/day, more preferably from about 0.1 to about 100 mg/kg/day; and UFA in amounts of from about 0.01 to about 5000 mg/kg/day, preferably from about 0.05 to about 2500 mg/kg/day, more preferably from about 0.1 to about 500 mg/kg/day, when the compounds are administered as anticipated or recommended for a particular composition. Typically, the compounds of the present invention comprise from about 0.1 to about 90% of a composition, preferably from about 0.3 to about 70%, more preferably from about 0.5 to about 60%. In certain embodiments, the compounds of the present invention comprise over 90% of a composition.

[0085] In various embodiments, the compositions further comprise one or more substances such as vitamins, minerals, probiotics, prebiotics, salts, and functional additives such as palatants, colorants, emulsifiers, and antimicrobial or other preservatives. Minerals that may be useful in such compositions include, for example, calcium, phosphorous, potassium, sodium, iron, chloride, boron, copper, zinc, magnesium, manganese, iodine, selenium, and the like. Examples of additional vitamins useful herein include such fat soluble vitamins as A, D, E, and K. Inulin, amino acids, enzymes, coenzymes, and the like may be useful to include in various embodiments.

[0086] In various embodiments, the compositions contain at least one of (1) one or more probiotics; (2) one or more inactivated probiotics; (3) one or more components of inactivated probiotics that promote health benefits similar to or the same as the probiotics, e.g., proteins, lipids, glycoproteins, and the like; (4) one or more prebiotics; and (5) combinations thereof. The probiotics or their components can be integrated into the compositions comprising the compositions (e.g., uniformly or non-uniformly distributed in the compositions) or applied to the compositions comprising the compositions (e.g., topically applied with or without a carrier). Such methods are known to skilled artisans, e.g., US5968569 and related patents.

[0087] Typical probiotics include, but are not limited to, probiotic strains selected from Lactobacilli, Bifidobacteria, or Enterococci, e.g., 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 is selected from the group consisting of Lactobacillus reuteri (NCC2581; CNCM 1-2448), Lactobacillus reuteri (NCC2592; CNCM 1-2450), Lactobacillus rhamnosus (NCC2583; CNCM 1-2449), Lactobacillus reuteri (NCC2603; CNCM 1-2451), Lactobacillus reuteri (NCC2613; CNCM 1-2452), Lactobacillus acidophilus (NCC2628; CNCM 1-2453), Bifidobacterium adolescentis (e.g., NCC2627), Bifidobacterium sp. NCC2657 or Enterococcus faecium SF68 (NCDVIB 10415). The compositions comprising the compositions of the present invention contain probiotics in amounts sufficient to supply from about 10⁴ to about 10¹² cfu/animal/day, preferably from 10^s to about 10¹¹ cfu/aninial day, most preferably from 10⁷ to 10¹⁰ cfu/animal/day. When the probiotics are killed or inactivated, the amount of killed or inactivated probiotics or their components should produce a similar beneficial effect as the live microorganisms. Many such probiotics and their benefits are known to skilled artisans, e.g., EP1213970B1, EP1143806B1, US7189390, EP1482811B1, EP1296565B1, and US6929793. In a preferred embodiment, the probiotic is Enterococcus faecium SF68 (NCTMB 10415). In one embodiment, the probiotics are encapsulated in a carrier using methods and materials known to skilled artisans.

[0088] As stated, the compositions may contain one or more prebiotics, e.g., fructo-oligosaccharides, gluco-oligosaccharides, galacto-oligosaccharides, isomalto-oligosaccharides, xylo-oligosaccharides, soybean oligosaccharides, lactosucrose, lactulose, and isomaltulose. In one embodiment, the prebiotic is chicory root, chicory root extract, inulin, or combinations thereof. Generally, prebiotics are administered in amounts sufficient to positively stimulate the healthy microflora in the gut and cause these "good" bacteria to reproduce. Typical amounts are from about one to about 10 grams per serving or from about 5% to about 40% of the recommended daily dietary fiber for an animal. The probiotics and prebiotics can be made part of the composition by any suitable means. Generally, the agents are mixed with the composition or applied to the surface of the composition, e.g., by sprinkling or spraying. When the agents are part of a kit, the agents can be admixed with other materials or in their own package. Typically, the food composition contains from about 0.1 to about 10% prebiotic, preferably from about 0.3 to about 7%, most preferably from about 0.5 to 5%, on a dry matter basis. The prebiotics can be integrated into the compositions using methods known to skilled artisans, e.g., US5952033.

[0089] A skilled artisan can determine the appropriate amount of the compounds, compositions, food ingredients, vitamins, minerals, probiotics, prebiotics, antioxidants, or other ingredients to be use to make a particular composition to be administered to a particular animal. Such artisan can consider the animal's species, age, size, weight, health, and the like in determining how best to formulate a particular composition and other ingredients. Other factors that may be considered include the type of composition {e.g., pet food composition versus dietary supplement), the desired dosage of each component, the average consumption of specific types of compositions by different animals {e.g., based on species, body weight, activity/energy demands, and the like), and the manufacturing requirements for the composition.

[0090] In another aspect, the invention provides kits suitable for administering in conjunction compounds or compositions to an animal comprising in separate containers in a single package or in separate containers in a virtual package, as appropriate for the kit component, one or more carotenoid and one or more UFA; and one or more of (1) one or more ingredients suitable for consumption by an animal; (2) instructions for how to combine the compounds and other kit components to produce a composition useful for reducing food intake, reducing body weight gain, promoting satiety, promoting lean body mass growth, preventing obesity, improving the quality of life, extending the prime, or promoting the health and wellness in an animal; (3) instructions for how to use the composition for reducing food intake, reducing body weight gain, promoting satiety, promoting lean body mass growth, preventing obesity, improving the quality of life, extending the prime, or promoting the health and wellness in an animal; (4) one or more probiotics; (5) one or more inactivated probiotics; (6) one or more components of inactivated probiotics that promote health benefits similar to or the same as the probiotics, e.g., proteins, lipids, glycoproteins, and the like; (7) one or more prebiotics; (8) a device for preparing or combining the kit components to produce a composition suitable for administration to an animal; and (9) a device for administering the combined or prepared kit components to an animal. In one embodiment, the composition is in a sachet.

[0091] When the kit comprises a virtual package, the kit is limited to instructions in a virtual environment in combination with one or more physical kit components. The kit contains the compounds or compositions and other components in amounts sufficient for reducing food intake, body weight gain, promoting satiety, promoting lean body mass growth, preventing obesity, improving the quality of life, extending the prime, or promoting the health and wellness in an animal. Typically, the compounds or compositions and the other suitable kit components are admixed just prior to consumption by an animal. The kits may contain the kit components in any of various combinations and/or mixtures. In one embodiment, the kit contains a packet containing the compounds or compositions and a container of food for consumption by an animal. The kit may contain additional items such as a device for mixing the compounds or compositions and ingredients or a device for containing the admixture, e.g., a food bowl. In another embodiment, the compounds or compositions are mixed with additional nutritional supplements such as vitamins and minerals that promote good health in an animal. The components are each provided in separate containers in a single package or in mixtures of various components in different packages. In preferred embodiments, the kits comprise the compounds or compositions and one or more other ingredients suitable for consumption by an animal. Preferably such kits comprise instructions describing how to combine the compounds or compositions with the other ingredients to form a food composition for consumption by the animal, generally by mixing the compounds or compositions with the other ingredients or by applying the compounds or compositions to the other ingredients, e.g., by sprinkling the compounds or compositions on a food composition.

[0092] In another aspect, the invention provides means for communicating information about or instructions for one or more of (1) using methods, compounds or compositions for reducing food intake, reducing body weight gain, promoting satiety, promoting lean body mass growth, preventing obesity, improving the quality of life, extending the prime, or promoting the health and wellness in an animal; (2) admixing one or more carotenoid and one or more UFA or other components to produce a composition suitable for reducing food intake, reducing body weight gain, promoting satiety, promoting lean body mass growth, preventing obesity, improving the quality of life, extending the prime, or promoting the health and wellness in an animal; (3) using kits for reducing food intake, reducing body weight gain, promoting satiety, promoting lean body mass growth, preventing obesity, improving the quality of life, extending the prime, or promoting the health and wellness in an animal; (4) contact information for consumers to use if they have a question regarding the methods and compositions; and (5) nutritional information about the composition; the means comprising one or more of a physical or electronic document, digital storage media, optical storage media, audio presentation, audiovisual display, or visual display containing the information or instructions. The means is preferably a displayed website, a visual display kiosk, a brochure, a product label, a package insert, an advertisement, a handout, a public announcement, 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 Fire Wire device, a computer memory, or any combination thereof.

[0093] In another aspect, the invention provides methods of manufacturing a composition comprising one or more carotenoid and one or more UFA, and one or more ingredients suitable for consumption by an animal comprising admixing one or more ingredients suitable for consumption by an animal with one or more carotenoid and one or more UFA, or applying one or more carotenoid and one or more UFA separately or in combination onto the composition. The compositions can be made according to any method suitable in the art.

[0094] In another aspect, the invention provides packages. The packages comprise at least one material suitable for containing one or more carotenoid and one or more UFA; a label affixed to the material containing a word or words, picture, design, acronym, slogan, phrase, or other device, or combination thereof, that indicates that the package contains compounds or compositions with beneficial properties relating to reducing food intake, reducing body weight gain, promoting satiety, promoting lean body mass growth, preventing obesity, improving the quality of life, extending the prime, or promoting the health and wellness in an animal. Typically, such device comprises the words "reducing food intake," "reducing body weight gain," "promoting satiety," "preventing obesity," "promoting lean body mass growth," "promoting healthy weight" or an equivalent expression printed on the material. Any package configuration and packaging material suitable for containing the compositions are useful in the invention, e.g., a bag, box, bottle, can, pouch, and the like manufactured from paper, plastic, foil, metal, and the like. In preferred embodiments, the package further comprises the compounds or compositions of the invention. In various embodiments, the package further comprises at least one window that permit the package contents to be viewed without opening the package. In some embodiments, the window is a transparent portion of the packaging material. In others, the window is a missing portion of the packaging material. In a preferred embodiment, the package contains a food composition adapted for a particular animal such as a human, canine, or feline, as appropriate for the label, preferably a companion animal food composition for dogs or cats. In a preferred embodiment, the package is a can or pouch comprising a food composition of the invention.

[0095] In another aspect, the invention provides for the use of a composition comprising one or more carotenoids and one or more UFA to prepare a medicament for reducing food intake; reducing body weight gain; promoting satiety; promoting lean body mass growth; preventing obesity; improving the quality of life; extending the prime; or promoting the health and wellness in an animal.

EXAMPLES

[0096] The invention can be further illustrated by the following examples, although it will be understood that the examples are included merely for purposes of illustration and are not intended to limit the scope of the invention unless otherwise specifically indicated.

Example 1

Effects of Nutrient Blend on Food Intake and Body Weight Gain

[0097] Experimental Design: Sixteen rats at the age of 21 days were randomized into two groups with 8 rats per group, housed separately, and fed ad libitum for 8 weeks. Rats in the control group were fed a control food composition; rats in the test group were fed a test food composition, which was formulated based on the control food composition ingredients supplemented with fish oil (20 g/kg), lutein (5 mg/kg), zeaxanthin (1 mg/kg), beta-carotene (1 mg kg) and astaxanthin (1 mg/kg). The compositions are shown in Table 1. The food intake was monitored daily and body weight was recorded weekly. The results are shown in Table 2.

[0098] Referring to Table 2, the data show that administration of carotenoids in combination with UFA reduces food intake and lowers body weight gain.

Table 1

Control and Test Food Composition

Control (g/kg) Test (g/kg)

Fish oil 0 20

Lutein 0 5 nig/kg

Zeaxanthin 0 1 mg/kg

Beta-carotene 0 1 mg/kg

Astaxanthin 0 1 mg/kg

Table 2

Effect of the Food Compositions on Body Weight and Food Intake

[0099] In the specification, there have been disclosed typical preferred embodiments of the invention. Although specific terms are employed, they are used in a generic and descriptive sense only and not for purposes of limitation. The scope of the invention is set forth in the claims. Obviously many modifications and variations of the invention are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described.

Claims

CLAIMS What is Claimed is:

1. A method for reducing food intake in an animal comprising administering in conjunction to the animal one or more carotenoids and one or more unsaturated fatty acids (UFA) in an amount effective for reducing food intake in the animal.

2. The method of claim 1 wherein the carotenoids are lutein, zeaxanthin, beta carotene, astaxanthin, alpha-carotene, gamma-carotene, beta-cryptoxanthin, lycopene, or combinations thereof.

3. The method of claim 1 wherein the carotenoids are lutein, zeaxanthin, beta carotene, astaxanthin, or combinations thereof.

4. The method of claim 1 wherein the carotenoids are administered to the animal in amounts of from about 0.001 to about 5000 mg/kg/day.

5. The method of claim 1 wherein the carotenoids are administered to the animal in amounts of from about 0.01 to about 500 mg/kg/day.

6. The method of claim 1 wherein the carotenoids are administered to the animal in amounts of from about 0.1 to about 100 mg/kg/day.

7. The method of claim 1 wherein the UFA are ALA, EPA, DP A, DHA, another n-3 fatty acid from any source, or combinations thereof.

8. The method of claim 1 wherein the UFA are from a fish oil source.

9. The method of claim 1 wherein the UFA are EPA, DELA, or combination thereof.

10. The method of claim 1 wherein the UFA are administered to the animal in amounts of from about 0.01 to about 5000 mg kg/day.

11. The method of claim 1 wherein the UFA are administered to the animal in amounts of from about 0.05 to about 2500 mg/kg/day.

12. The method of claim 1 wherein the UFA are administered to the animal in amounts of from about 0.1 to about 500 mg/kg/day.

13. The method of claim 1 wherein the carotenoids are lutein, zeaxanthin, beta carotene, astaxanthin, or combinations thereof and the UFA are DHA, EPA, or combination thereof.

14. The method of claim 1 wherein the carotenoids are administered to the animal in amounts of from about 0.001 to about 5000 mg kg/day and the UFA are administered to the animal in amounts of from about 0.01 to about 5000 mg/kg/day.

15. The method of claim 1 wherein the carotenoids are administered to the animal in amounts of from about 0.01 to about 500 mg/kg/day and the UFA are administered to the animal in amounts of from about 0.05 to about 2500 mg/kg/day.

16. The method of claim 1 wherein the carotenoids are administered to the animal in amounts of from about 0.1 to about 100 mg/kg/day and the UFA are administered to the animal in amounts of from about 0.1 to about 500 mg/kg/day.

17. The method of claim 1 wherein the animal is a human or companion animal.

18. The method of claim 17 wherein the companion animal is a canine or a feline.

19. The method of claim 1 wherein the UFA and the carotenoids are administered to the animal in a composition.

20. The method of claim 19 wherein the UFA and the carotenoids are administered to the animal in a food composition.

21. The method of claim 20 wherein the food composition further comprises from about 15 to about 50% protein, from about 5 to about 40% fat, from about 5 to about 10% ash content, and having a moisture content of from about 5 to about 20%.

22. The method of claim 19 wherein the UFA and the carotenoids are administered to the animal in a nutraceutical or pharmaceutical composition.

23. The method of claim 22 further comprising one or more pharmaceutically or nutraceutically acceptable-carriers, diluents, or excipients.

24. The method of claim 19 wherein the carotenoids and UFA are administered in a human food composition, a pet food composition, or a dietary supplement.

25. The method of claim 1 wherein the UFA and the carotenoids are administered to the animal on an extended regular basis.

26. The method of claim 25 wherein the UFA and the carotenoids are administered to the animal on a daily basis.

27. The method of claim 26 wherein the carotenoids are administered to the animal in amounts of from about 0.001 to about 5000 mg/day and the UFA are administered to the animal in amounts of from about 0.01 to about 30000 mg/day.

28. The method of claim 1 further comprising administering in conjunction to the animal one or more prebiotics, probiotics, or a combination thereof.

29. A method for reducing body weight gain in an animal comprising administering in conjunction to the animal one or more carotenoids and one or more UFA in an amount effective for reducing body weight gain in the animal.

30. The method of claim 29 wherein the carotenoids are lutein, zeaxanthin, beta carotene, astaxanthin, alpha-carotene, gamma-carotene, beta-cryptoxanthin, lycopene, or combinations thereof.

31. The method of claim 29 wherein the carotenoids are lutein, zeaxanthin, beta carotene, astaxanthin, or combinations thereof.

32. The method of claim 29 wherein the carotenoids are administered to the animal in amounts of from about 0.001 to about 5000 mg/kg day.

33. The method of claim 29 wherein the carotenoid s are administered to the animal in amounts of from about 0.01 to about 500 mg/kg/day.

34. The method of claim 29 wherein the carotenoids are administered to the animal in amounts of from about 0.1 to about 100 mg/kg/day.

35. The method of claim 29 wherein the UFA are ALA, EPA, DPA, DHA, another n-3 fatty acid from any source, or combinations thereof.

36. The method of claim 29 wherein the UFA are from a fish oil source.

37. The method of claim 29 wherein the UFA are EPA, DHA, or combination thereof.

38. The method of claim 29 wherein the UFA are administered to the animal in amounts of from about 0.01 to about 5000 mg/kg/day.

39. The method of claim 29 wherein the UFA are administered to the animal in amounts of from about 0.05 to about 2500 mg kg/day.

40. The method of claim 29 wherein the UFA are administered to the animal in amounts of from about 0.1 to about 500 mg/kg/day.

41. The method of claim 29 wherein the carotenoids are lutein, zeaxanthin, beta carotene, astaxanthin, or combinations thereof and the UFA are DHA, EPA, or combination thereof.

42. The method of claim 29 wherein the carotenoids are administered to the animal in amounts of from about 0.001 to about 5000 mg/kg/day and the UFA are administered to the animal in amounts of from about 0.01 to about 5000 mg/kg/day.

43. The method of claim 29 wherein the carotenoids are administered to the animal in amounts of from about 0.01 to about 500 mg/kg/day and the UFA are administered to the animal in amounts of from about 0.05 to about 2500 mg/kg/day.

44. The method of claim 29 wherein the carotenoids are administered to the animal in amounts of from about 0.1 to about 100 mg/kg/day and the UFA are administered to the animal in amounts of from about 0.1 to about 500 mg/kg/day.

45. The method of claim 29 wherein the animal is a human or companion animal.

46. The method of claim 45 wherein the companion animal is a canine or a feline.

47. The method of claim 29 wherein the UFA and the carotenoids are administered to the animal in a composition.

48. The method of claim 47 wherein the UFA and the carotenoids are administered to the animal in a food composition.

49. The method of claim 48 wherein the food composition further comprises from about 15 to about 50% protein, from about 5 to about 40% fat, from about 5 to about 10% ash content, and having a moisture content of from about 5 to about 20%.

50. The method of claim 47 wherein the UFA and the carotenoids are administered to the animal in a nutraceutical or pharmaceutical composition.

51. The method of claim 50 further comprising one or more pharmaceutically or nutraceutically acceptable-carriers, diluents, or excipients.

52. The method of claim 47 wherein the carotenoids and UFA are administered in a human food composition, a pet food composition, or a dietary supplement.

53. The method of claim 29 wherein the UFA and the carotenoids are administered to the animal on an extended regular basis.

54. The method of claim 53 wherein the UFA and the carotenoids are administered to the animal on a daily basis.

55. The method of claim 54 wherein the carotenoids are administered to the animal in amounts of from about 0.001 to about 5000 mg/day and the UFA are administered to the animal in amounts of from about 0.01 to about 30000 mg/day.

56. The method of claim 29 further comprising administering in conjunction to the animal one or more prebiotics, probiotics, or a combination thereof.

57. A composition useful for reducing food intake or reducing body weight gain in an animal comprising one or more carotenoids and one or more unsaturated fatty acids (UFA) in an amount effective for reducing food intake or reducing body weight gain in the animal.

58. The composition of claim 57 wherein the carotenoids are lutein, zeaxanthin, beta carotene, astaxanthin, alpha-carotene, gamma-carotene, beta-cryptoxanthin, lycopene, or combinations thereof.

59. The composition of claim 57 wherein the carotenoids are lutein, zeaxanthin, beta carotene, astaxanthin, or combinations thereof.

60. The composition of claim 57 wherein the UFA are ALA, EPA, DPA, DHA, another n-3 fatty acid from any source, or combinations thereof.

61. The composition of claim 57 wherein the UFA are from a fish oil source.

62. The composition of claim 57 wherein the UFA are EPA, DHA, or combination thereof.

63. The composition of claim 57 wherein the carotenoids are lutein, zeaxanthin, beta carotene, astaxanthin, or combinations thereof and the UFA are DHA, EPA, or combination thereof.

64. The composition of claim 57 formulated as a human food composition, pet food composition, or a dietary supplement.

65. The composition of claim 57 wherein the composition is a food composition further comprising about 15% to about 50% protein, about 5% to about 40% fat, about 5% to about 10% ash content, and having a moisture content of about 5% to about 20%.

66. The composition of claim 57 further comprising one or more prebiotics, probiotics, or a combination thereof.

67. A pharmaceutical or nutraceutical composition comprising the composition of claim 51 and one or more pharmaceutically or nutraceutically acceptable-carriers, diluents, or excipients.

68. A kit suitable for administering in conjunction a composition to an animal comprising in separate containers in a single package or in separate containers in a virtual package, as appropriate for the kit component, one or more carotenoid and one or more UFA; and one or more of (1) one or more ingredients suitable for consumption by an animal; (2) instructions for how to combine the compounds and other kit components to produce a composition useful for reducing food intake or reducing body weight gain in an animal; (3) instructions for how to use the composition for reducing food intake or reducing body weight gain in an animal; (4) one or more probiotics; (5) one or more inactivated probiotics; (6) one or more components of inactivated probiotics that promote health benefits similar to or the same as the probiotics, e.g., proteins, lipids, glycoproteins, and the like; (7) one or more prebiotics; (8) a device for preparing or combining the kit components to produce a composition suitable for administration to an animal; and (9) a device for administering the combined or prepared kit components to an animal.

69. The kit of claim 68 wherein the carotenoids and UFA are in a sachet.

70. A means for communicating information about or instructions for one or more of (1) using methods or compositions for reducing food intake or reducing body weight gain in an animal; (2) admixing one or more carotenoid and one or more UFA or other components to produce a composition suitable for reducing food intake or reducing body weight gain in an animal; (3) using kits for reducing food intake or reducing body weight gain in an animal; (4) contact information for consumers to use if they have a question regarding the methods and compositions; and (5) nutritional information about the composition; the means comprising one or more of a physical or electronic document, digital storage media, optical storage media, audio presentation, audiovisual display, or visual display containing the information or instructions.

71. The means of claim 70 selected from the group consisting of a displayed website, a visual display kiosk, a brochure, a product label, a package insert, an advertisement, a handout, a public announcement, 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 Fire Wire device, a computer memory, and any combination thereof.

72. A package comprising at least one material suitable for containing one or more carotenoid and one or more UFA; a label affixed to the material containing a word or words, picture, design, acronym, slogan, phrase, or other device, or combination thereof, that indicates that the package contains a composition with beneficial properties relating to reducing food intake or reducing body weight gain in an animal.

73. The package of claim 72 further comprising the compounds.

74. The package of claim 72 further comprising at least one window.

75. A use of a composition comprising one or more carotenoid and one or more UFA; to prepare a medicament for reducing food intake or reducing body weight gain in an animal.

76. A method for manufacturing a composition comprising one or more carotenoid and one or more UFA, and one or more ingredients suitable for consumption by an animal comprising admixing one or more ingredients suitable for consumption by an animal with one or more carotenoid and one or more UFA, or applying one or more carotenoid and one or more UFA separately or in combination onto the composition.

77. A method for promoting satiety, preventing obesity, or promoting lean body mass growth in an animal comprising administering in conjunction to the animal one or more carotenoids and one or more UFA in an amount effective for promoting satiety, preventing obesity, or promoting lean body mass growth in the animal.

78. The method of claim 77 wherein the carotenoids are lutein, zeaxanthin, beta carotene, astaxanthin, alpha-carotene, gamma-carotene, beta-cryptoxanthin, lycopene, or combinations thereof.

79. The method of claim 77 wherein the carotenoids are lutein, zeaxanthin, beta carotene, astaxanthin, or combinations thereof.

80. The method of claim 77 wherein the carotenoids are administered to the animal in amounts of from about 0.001 to about 5000 mg/kg/day.

81. The method of claim 77 wherein the carotenoids are administered to the animal in amounts of from about 0.01 to about 500 mg/kg/day.

82. The method of claim 77 wherein the carotenoids are administered to the animal in amounts of from about 0.1 to about 100 mg/kg/day.

83. The method of claim 77 wherein the UFA are ALA, EPA, DPA, DHA, another n-3 fatty acid from any source, or combinations thereof.

84. The method of claim 77 wherein the UFA are from a fish oil source.

85. The method of claim 77 wherein the UFA are EPA, DHA, or combination thereof.

86. The method of claim 77 wherein the UFA are administered to the animal in amounts of from about 0.01 to about 5000 mg/kg/day.

87. The method of claim 77 wherein the UFA are administered to the animal in amounts of from about 0.05 to about 2500 mg/kg/day.

88. The method of claim 77 wherein the UFA are administered to the animal in amounts of from about 0.1 to about 500 mg/kg/day

89. The method of claim 77 wherein the carotenoids are lutein, zeaxanthin, beta carotene, astaxanthin, or combinations thereof and the UFA are DHA, EPA, or combination thereof.

90. The method of claim 77 wherein the carotenoids are administered to the animal in amounts of from about 0.001 to about 5000 mg/kg/day and the UFA are administered to the animal in amounts of from about 0.01 to about 5000 mg/kg/day.

91. The method of claim 77 wherein the carotenoids are administered to the animal in amounts of from about 0.01 to about 500 mg/kg day and the UFA are administered to the animal in amounts of from about 0.05 to about 2500 mg/kg/day.

92. The method of claim 77 wherein the carotenoids are administered to the animal in amounts of from about 0.1 to about 100 mg/kg day and the UFA are administered to the animal in amounts of from about 0.1 to about 500 mg/kg/day.

93. A method for extending the prime for an animal comprising administering in conjunction to the animal one or more carotenoids and one or more unsaturated fatty acids (UFA) in an amount effective for reducing food intake in the animal, thereby extending the prime of the animal.

94. A method improving the quality of life of an animal comprising administering in conjunction to the animal one or more carotenoids and one or more unsaturated fatty acids (UFA) in an amount effective for reducing food intake in the animal, thereby improving the quality of life of an animal.

95. A method for promoting the health and wellness of an animal comprising administering in conjunction to the animal one or more carotenoids and one or more unsaturated fatty acids (UFA) in an amount effective for reducing food intake in the animal, thereby promoting the health and wellness of an animal.

96. A composition useful for one or more of promoting satiety, promoting lean body mass growth, or preventing obesity in an animal comprising one or more carotenoids and one or more UFA in an amount effective for promoting satiety, promoting lean body mass growth, or preventing obesity in the animal.

97. A pharmaceutical or nutraceutical composition comprising the composition of claim 133 and one or more pharmaceutically or nutraceutically acceptable-carriers, diluents, or excipients.

98. A kit suitable for administering in conjunction a composition to an animal comprising in separate containers in a single package or in separate containers in a virtual package, as appropriate for the kit component, one or more carotenoid and one or more UFA; and one or more of (1) one or more ingredients suitable for consumption by an animal; (2) instructions for how to combine the compounds and other kit components to produce a composition useful for promoting satiety, promoting lean body mass growth, preventing obesity, improving the quality of life, extending the prime, or promoting the health and wellness in an animal; (3) instructions for how to use the composition for promoting satiety, promoting lean body mass growth, preventing obesity, improving the quality of life, extending the prime, or promoting the health and wellness in an animal; (4) one or more probiotics; (5) one or more inactivated probiotics; (6) one or more components of inactivated probiotics that promote health benefits similar to or the same as the probiotics, e.g., proteins, lipids, glycoproteins, and the like; (7) one or more prebiotics; (8) a device for preparing or combining the kit components to produce a composition suitable for administration to an animal; and (9) a device for administering the combined or prepared kit components to an animal.

99. The kit of claim 98 wherein the carotenoids and UFA are in a sachet.

100. A means for communicating information about or instructions for one or more of (1) using methods or compositions for promoting satiety, promoting lean body mass growth, preventing obesity, improving the quality of life, extending the prime, or promoting the health and wellness in an animal; (2) admixing one or more carotenoid and one or more UFA or other components to produce a composition suitable for promoting satiety, promoting lean body mass growth, preventing obesity, improving the quality of life, extending the prime, or promoting the health and wellness in an animal; (3) using kits for promoting satiety, promoting lean body mass growth, preventing obesity, improving the quality of life, extending the prime, or promoting the health and wellness in an animal; (4) contact information for consumers to use if they have a question regarding the methods and compositions; and (5) nutritional information about the composition; the means comprising one or more of a physical or electronic document, digital storage media, optical storage media, audio presentation, audiovisual display, or visual display containing the information or instructions.

101. The means of claim 100 selected from the group consisting of a displayed website, a visual display kiosk, a brochure, a product label, a package insert, an advertisement, a handout, a public announcement, 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 Fire Wire device, a computer memory, and any combination thereof.

102. A package comprising at least one material suitable for containing one or more carotenoid and one or more UFA; a label affixed to the material containing a word or words, picture, design, acronym, slogan, phrase, or other device, or combination thereof, that indicates that the package contains a composition with beneficial properties relating to promoting satiety, promoting lean body mass growth, preventing obesity, improving the quality of life, extending the prime, or promoting the health and wellness in an animal.

103. The package of claim 102 further comprising the compounds.

104. The package of claim 102 further comprising at least one window.

105. A use of a composition comprising one or more carotenoid and one or more UFA; to prepare a medicament for promoting satiety; promoting lean body mass growth; preventing obesity; improving the quality of life; extending the prime; or promoting the health and wellness in an animal.

106. A method for manufacturing a composition comprising one or more carotenoid and one or more UFA, and one or more ingredients suitable for consumption by an animal comprising admixing one or more ingredients suitable for consumption by an animal with one or more carotenoid and one or more UFA, or applying one or more carotenoid and one or more UFA separately or in combination onto the composition.