CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application Serial No. 61/626072 filed September 20, 201 1, the disclosure of which is incorporated herein by this reference.

BACKGROUND OF THE INVENTION

Field of the Invention

[0002] This invention relates generally to methods and compositions for improving visual function and eye health and particularly to the use of combinations of lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E for improving visual function and eye health.

Description of Related Art

[0003] Carotenoids are organic pigments that are naturally occurring in plants, algae and various microorganisms. Animals do not produce carotenoids therefore they must obtain them from their diet. Lutein and Zeaxanthin are the two primary carotenoids found in the retina of the eye. The two compounds are isomers having identical chemical formulas. Zeaxanthin is the dominant component in the central macula and lutein is the dominant component in the peripheral retina. Lutein protects eyes from oxidative stress and the high-energy photons of blue light. Lutein and zeaxanthin can be derived from foods such as eggs, spinach, kale, turnip greens, romaine lettuce, broccoli and corn. Astaxanthin is a carotenoid with potent antioxidant properties. Astaxanthin can be found in sources such as microalgae, yeast, salmon, trout, krill, shrimp, and the feathers of some birds.

[0004] Beta-carotene is a red-orange pigment in many fruits and vegetables, such as carrots, mangoes, pumpkin, and sweet potatoes. Beta-carotene is a precursor to vitamin A. Vitamin C and vitamin E are essential nutrients for many animals. One of their many functions is to serves as antioxidants to lessen oxidative stress.

[0005] Many animals, including dogs and cats, have declined visual function, particularly during aging. Declined visual performance may result from the natural physiological changes associated with aging or from an eye related disorder such as retinal degeneration, cataract, or keratitis. These conditions can lead to impaired visual function, with partial or complete blindness. While there are various compounds and methods that attempt to combat these problems, there is a need for new methods and compounds for improving visual function and eye health.

SUMMARY OF THE INVENTION

[0006] It is, therefore, an object of the present invention to provide methods for improving visual function for animals.

[0007] It is a further object of the present invention to provide methods for improving eye health for animals. [0008] It is another object of the present invention to provide compositions suitable for improving visual function and eye health for animals.

[0009] It is another object of the invention to provide compositions and methods for promoting the health and wellness of animals.

[0010] It is yet another object of the present invention to provide compositions and methods for extending the prime years of an animal's life.

[0011] One or more of these or other objects are achieved by administering in conjunction to animals a visual function and/or eye health improving amount of two or more compounds selected from lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E.

[0012] 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

Definitions

[0013] The term "animal" means a human or other animal that could benefit from an improvement in visual function or eye health, including avian, bovine, canine, equine, feline, hicrine, human, murine, ovine, and porcine animals.

[0014] The term "companion animal" 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, extrovert display, and all of the other functions that humans need to share with animals of other species.

[0015] 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.

[0016] The term "in conjunction" means that lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, vitamin E, combination thereof, or other compound or composition 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.

[0017] The term "ophthalmic agent" means any compound or composition other than the compounds and compositions of the invention that are useful for improving visual function and eye health in animals.

[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 "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.

[0020] 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, cartons, bottles, packages of any type or design or material, over-wrap, shrink-wrap, affixed components {e.g., stapled, adhered, or the like), or combinations thereof. A single package may be containers of individual compounds or compositions of the present invention physically associated such that they are considered a unit for manufacture, distribution, sale, or use.

[0021] 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., a bag or other container containing one component and directions instructing the user to go to a website, contact a recorded message or a fax-back service, view a visual message, or contact a caregiver or instructor to obtain instructions on how to use the kit or safety or technical information about one or more components of a kit.

[0022] The term "quality of life" means the ability to enjoy normal life activities.

[0023] 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.

[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 would be healthy in the prime of its life for a relatively longer time.

[0025] The term "mg/kg/day" means milligrams per kilogram of body weight of an animal per day.

[0026] As used herein, ranges are used herein 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.

[0027] 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.

[0028] 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.

[0029] All percentages expressed herein are by weight of the total weight of the composition unless expressed otherwise.

[0030] 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.

[0031] 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.

[0032] 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

[0033] In one aspect, the invention provides methods for improving visual function and eye health of animals. The methods comprise administering in conjunction to the animal a visual function and eye health improving amount of two or more compounds selected from lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E. The invention is based on the discovery that retinal function improved in canines that were fed the compounds. In various embodiments, the methods comprise administering in conjunction to the animals a visual function and eye health improving amount of three, four, or five or more of lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E. In a preferred embodiment, the methods comprise administering in conjunction to the animals a visual function and eye health improving amount of lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E. [0034] In another aspect, the invention provides compositions suitable for improving visual function and eye health of animals. The compositions comprise two or more compounds selected from lutein, zeaxanthin, beta- carotene, astaxanthin, vitamin C, and vitamin E. In various embodiments, the compositions comprise three, four, or five or more compounds selected from lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E. In a preferred embodiment, the compositions comprise lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E.

[0035] In another aspect, the invention provides methods for extending the prime for an animal. The methods comprise administering in conjunction to the animal a visual function and eye health improving amount of two or more compounds selected from lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E, thereby extending the prime of the animal. In various embodiments, the methods comprise administering in conjunction to the animals a visual function and eye health improving amount of three, four, or five or more of lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E. In a preferred embodiment, the methods comprise administering in conjunction to the animals a visual function and eye health improving amount of lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E.

[0036] In another aspect, the invention provides methods for improving the quality of life of an animal. The methods comprise administering in conjunction to the animal a visual function and eye health improving amount of two or more compounds selected from lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E, thereby improving the quality of life of the animal. In various embodiments, the methods comprise administering in conjunction to the animals a visual function and eye health improving amount of three, four, or five or more of lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E. In a preferred embodiment, the methods comprise administering in conjunction to the animals a visual function and eye health improving amount of lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E.

[0037] In another aspect, the invention provides methods for promoting the health and wellness of the animal. The methods comprise administering in conjunction to the animal a visual function and eye health improving amount of two or more compounds selected from lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E, thereby promoting the health and wellness of the animal. In various embodiments, the methods comprise administering in conjunction to the animals a visual function and eye health improving amount of three, four, or five or more of lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E. In a preferred embodiment, the methods comprise administering in conjunction to the animals a visual function and eye health improving amount of lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E.

[0038] The inventions are based upon the discovery that animals who were administered the compounds or compositions of the present invention demonstrated better photoreceptor function and better visual function in comparison to animals that were not administered the compounds or compositions. [0039] In various embodiments, the animal is any animal that has a need for improving visual function and eye health. In one embodiment, the animal is a human or companion animal, preferably a canine or a feline. In another embodiment, the animal is an aging animal.

[0040] In some embodiments, lutein is administered in amounts of from about 0.1 to about 1000 mg/kg/day, preferably from about 0.5 to about 500 mg/kg/day.

[0041] In some embodiments, zeaxanthin is administered in amounts of from about 0.1 to about 1000 mg/kg/day, preferably from about 0.5 to about 500 mg/kg/day.

[0042] In some embodiments, beta-carotene is administered in amounts of from about 0.1 to about 1000 mg/kg/day, preferably from about 0.5 to about 500 mg/kg/day.

[0043] In some embodiments, astaxanthin is administered in amounts of from about 0.1 to about 1000 mg/kg/day, preferably from about 0.5 to about 500 mg/kg/day.

[0044] In some embodiments, vitamin C is administered in amounts of from about 0.1 to about 500 mg/kg/day, preferably from about 5 to about 200 mg/kg/day.

[0045] In some embodiments, vitamin E is administered in amounts of from about 0.3 to about 60 mg/kg/day, preferably from about 1.5 to about 50 mg/kg/day.

[0046] In one embodiment, lutein is administered in amounts of from about 0.1 to about 1000 mg/kg/day, zeaxanthin is administered in amounts of from about 0.1 to about 1000 mg/kg/day, beta-carotene is administered in amounts of from about 0.1 to about 1000 mg/kg/day, astaxanthin is administered in amounts of from about 0.1 to about 1000 mg/kg/day, vitamin C is administered in amounts of from about 0.1 to about 500 mg/kg/day, and vitamin E is administered in amounts of from about 0.3 to about 60 mg/kg/day.

[0047] In another embodiment, lutein is administered in amounts of from about 0.5 to about 500 mg/kg/day, zeaxanthin is administered in amounts of from about 0.5 to about 500 mg kg/day, beta-carotene is administered in amounts of from about 0.5 to about 500 mg/kg/day, astaxanthin is administered in amounts of from about 0.5 to about 500 mg/kg/day, vitamin C is administered in amounts of from about 5 to about 200 mg/kg/day, and vitamin E is administered in amounts of from about 1.5 to about 50 mg/kg/day.

[0048] 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. Most 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. [0049] 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.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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%.

[0057] 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.

[0058] When administered in a food composition, the amount of lutein as a percentage of the composition is from about 0.1 to about 40% of the food composition, preferably from about 3 to about 30%, more preferably from about 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% lutein.

[0059] When administered in a food composition, the amount of zeaxanthin as a percentage of the composition is from about 0.1 to about 40% of the food composition, preferably from about 3 to about 30%, more preferably from about 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%) zeaxanthin.

[0060] When administered in a food composition, the amount of beta-carotene as a percentage of the composition is from about 0.1 to about 40% of the food composition, preferably from about 3 to about 30%, more preferably from about 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%) beta-carotene.

[0061] When administered in a food composition, the amount of astaxanthin as a percentage of the composition is from about 0.1 to about 40% of the food composition, preferably from about 3 to about 30%, more preferably from about 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% astaxanthin.

[0062] When administered in a food composition, the amount of vitamin C as a percentage of the composition is from about 0.1 to about 40% of the food composition, preferably from about 3 to about 30%, more preferably from about 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% vitamin C.

[0063] When administered in a food composition, the amount of vitamin E as a percentage of the composition is from about 0.1 to about 40% of the food composition, preferably from about 3 to about 30%, more preferably from about 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% vitamin E.

[0064] 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 0.1 to about 90% of the supplement, preferably from about 3 to about 70%, more preferably from about 5 to about 60%.

[0065] 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 3 to about 70%, more preferably from about 5 to about 60%.

[0066] 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 by the animal of the compounds or compositions in an amount effective to accomplish the methods of the present invention.

[0067] 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 embodiment, lutein is administered in amounts of from about 10 to about 30 mg/day, zeaxanthin is administered in amounts of from about 1 to about 10 mg/day, beta-carotene is administered in amounts of from about 13 to about 30 mg/day, astaxanthin is administered in amounts of from about 1 to about 10 mg/day, vitamin C is administered in amounts of from about 150 to about 200 mg/day, and vitamin E is administered in amounts of from about 5 to about 500 mg/day.

[0068] 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.

[0069] 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., improving visual function; improving eye health; improving the quality of life; and promoting the health and wellness in an animal. Preferably, the compounds or compositions are administered to an animal on a regular basis.

[0070] In another aspect, the invention provides therapeutic compositions comprising the compounds of the present invention in a visual function and eye health amount. The therapeutic compositions contain the compounds and compositions of the present invention in amounts sufficient to administer the compositions of the present invention to an animal in amounts of from about 0.005 to about 1000 mg/kg/day, preferably from about 0.01 to about 500 mg/kg/day, most preferably from about 0.05 to about 250 mg/kg/day when the compositions are administered as anticipated or recommended for a particular composition. Typically, the compositions of the present invention comprise from about 1 to about 90% of a therapeutic composition, preferably from about 3 to about 70%, more preferably from about 5 to about 60%. In certain embodiments, the compositions of the present invention comprise over 90% of a therapeutic composition.

[0071] 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.

[0072] 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.

[0073] 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 ( CC2628; CNCM 1-2453), Bifidobacterium adolescentis (e.g., NCC2627), Bifidobacterium sp. NCC2657 or Enterococcus faecium SF68 (NCIMB 10415). The compositions comprising the compositions of the present invention contain probiotics in amounts sufficient to supply from about 10 ⁴ to about 10 ¹² cfu/animal/day, preferably from 10 ^s to about 10" cfu/animal/day, most preferably from 10 ⁷ to 10 ¹⁰ 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, EP1 143806B1, US7189390, EP148281 1B1, EP1296565B1, and US6929793. In a preferred embodiment, the probiotic is Enterococcus faecium SF68 (NCEMB 10415). In one embodiment, the probiotics are encapsulated in a carrier using methods and materials known to skilled artisans.

[0074] 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.

[0075] 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.

[0076] In a further aspect, the invention provides kits 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, two or more compounds selected from lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E; 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 improving visual function and eye health; (3) instructions for how to use the composition for improving visual function and eye health; (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. [0077] 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 improving visual function and eye health. 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.

[0078] In a further aspect, the invention provides a means for communicating information about or instructions for one or more of (1) using methods or compositions for improving visual function and eye health; (2) admixing two or more compounds selected from lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E or other components to produce a composition suitable for improving visual function and eye health; (3) using kits for improving visual function and eye health; (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 comprises 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. Preferably, the means is 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 FireWire device, a computer memory, and any combination thereof.

[0079] In another aspect, the invention provides methods for manufacturing a food composition comprising the compounds or compositions and one or more other ingredients suitable for consumption by an animal, e.g. , one or more of protein, fat, carbohydrate, fiber, vitamins, minerals, probiotics, prebiotics, and the like. The methods comprise admixing one or more ingredients suitable for consumption by an animal with the compounds or compositions. Alternatively, the methods comprise applying the compounds or compositions alone or in conjunction or combination with other ingredients onto the food composition, e.g., as a coating or topping. The compounds or compositions can be added at any time during the manufacture and/or processing of the food composition. The compounds or composition can be made according to any method suitable in the art.

[0080] In another aspect, the invention provides a package useful for containing the compounds and compositions of the invention. The package comprises at least one material suitable for containing two or more compounds selected from lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E; and 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 the compositions with beneficial properties relating to improving visual function and eye health in an animal. Typically, such device comprises the words "improving visual function," "maintaining visual function," "improving eye health," "maintaining eye health," 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.

[0081] In another aspect, the invention provides for use of the compositions comprising two or more compounds selected from lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E; to prepare a medicament for improving visual function and eye health in an animal; improving the quality of life; and promoting the health and wellness in an animal. Generally, medicaments are prepared by admixing a compound or composition, i.e., the compositions or a composition comprising the compositions, with excipients, buffers, binders, plasticizers, colorants, diluents, compressing agents, lubricants, flavorants, moistening agents, and other ingredients known to skilled artisans to be useful for producing medicaments and formulating medicaments that are suitable for administration to an animal.

EXAMPLES

[0082] The invention can be further illustrated by the following examples, although it will be understood that these 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

[0083] Animals: Twelve adult Beagles (six males and six females) between the ages of 6 to 8 years, with body condition scores between 4 and 5 (scale of 1-9), were recruited and fed to maintain their body weight.

[0084] Eye Examination: Ophthalmic evaluation was performed by a veterinary ophthalmologist via slit lamp biomicroscopy and indirect ophthalmoscope in both eyes of each dog. The dog's eyes were dilated with short-acting mydriatic eye drops, 1% tropicamide (Mydriacyl®), at least 15 minutes prior to examinations. Only dogs with a normal fundus appearance and without abnormalities of the eyes were included in the trial.

[0085] Foods and Treatments: A control dry food composition ("Dry Control") was created as shown in Table 1. A control wet food composition ("Wet Control") was created as shown in Table 2.

[0086] A test food composition ("Test Food") was created using the ingredients and the amounts shown in Table 3. This is a mixture of vitamin and non vitamin antioxidants using cellulose as the mixing medium. The sachets are produced in the same batch, with 20 gram of powder per sachet, and 3 g of powder per dog per day was weighted by technicians to be topped on the wet food for every morning to the treatment group. The control group dogs received the same wet food but without sachets.

[0087] Dogs were fed two meals per day; one in the morning around 8-9 AM and one in the evening around 4-5 PM. At the morning meal time, 2.75 oz of the Wet Control was fed to 6 dogs in a control group and 2.75 oz of the Wet Control topped with Test Food was fed to 6 dogs in the treatment group. After consuming the Wet Food and the Test Food, both treatment groups were offered the Dry Control for the remaining calorie ration of the meal. For the evening meal, only the Dry Control was offered. All dogs were fed Dry Control in amounts required to maintain their body weight.

[0088] Study Design: All dogs were fed the Dry Control to maintain their body weight during an initial one- month baseline period. The body weight of each dog was monitored weekly. The body weight did not change more than 10% during the last three weeks of the baseline period.

[0089] Randomization: After the baseline period, the dogs were randomized into two groups with 6 dogs per group based on their age, body weight, and gender. The groups were randomized to receive either Test Food or a control food composition. The results are shown in Table 4.

[0090] Feeding period (6 months): Dogs were fed to maintain their body weight. The body weight of each dog was monitored weekly and did not change more than 10% throughout the feeding study.

[0091] Electroretinography (ERG): At the baseline and at the end of the 6-month period, a standardized ERG was performed in the dogs. Portable, mini-Ganzfeld ERG equipment was used with an automated and standardized canine ERG protocol in the dogs under deep sedation. This ERG protocol was performed by a veterinary ophthalmologist using the following procedures:

Unilateral ERG recordings were performed with a portable ERG unit (HMsERG model 1000; RetVet Corp., Columbia, MO), with the mini-Ganzfeld dome positioned approximately 1 cm from the right tested eye in each dog. The dogs were deeply sedated by using medetomidine (Dexdomitor; Novartis, Pfizer Animal Health, Exton, PA), up to 23 microgram/10 kg, equivalent to 0.275 ml/10 kg, and prepared for the ERG session in ordinary room light. Heart and respiratory rates were closely monitored throughout the procedure, and the dogs were temperature controlled (the dogs were kept warm during the procedures with blankets).

The dog's head was positioned on a deflatable cushion to ensure complete stability. Maximum pupillary dilatation was provided for by the use of a short-acting mydriatic eye drop, 1% tropicamide (Mydriacyl), at least 15 minutes prior to the ERG procedure. A lid speculum was inserted to ensure that the nictitating membrane and the upper and lower eyelids did not interfere with light exposure of the maximally dilated pupils.

A platinum subdermal needle electrode (Model E2; Grass Instrument Division, Astro-Med, Inc., West Warwick, RI) was used for the ground electrode, positioned on the occipital crest, and for the reference electrode, positioned 3 to 4 cm from the lateral canthus, close to the base of the right ear. An active contact lens electrode (ERG-Jet; Universo Plastique, LKC Technologies Inc., Gaithersburg, MD) was placed on the cornea after instillation of one drop of 2% methylcellulose as a contact medium (Methocel ; Ciba Vision, Munich, Germany). The electrodes were connected to a preamplifier, and the signals were amplified with a band-pass filter between 0.3 and 300 Hz.

Each ERG session consisted of scotopic and photopic ERGs in accordance with the Dog Diagnostic Protocol, recommended by the European College of Veterinary Ophthalmology, primarily for evaluation of rod and cone function. This protocol was preprogrammed on the ERG unit and was executed automatically on initiation of the ERG session by the examiner. During 20 minutes of dark adaptation, scotopic low- intensity of light stimuli responses were elicited at 0.01 cd-s/m2); averaged responses to 10 flashes, given at 2-second intervals, were recorded for each time point. The light stimulus intensity was then increased to 3 cd-s/m2 and the averaged responses to four flashes at 10-second intervals were recorded. Thereafter, scotopic high-intensity responses were elicited, using 10 cd-s/m2; averaged responses to four flashes administered at 20-second intervals were recorded. The latter two recordings depict responses from both rods and cones. After 10 minutes of light adaptation, with a background luminance of 30 cd/m2, photopic single-flash responses were recorded using 3 cd-s/m2 of flash stimulus, averaging 32 flashes at an interval of 0.5 seconds, followed by evaluation of 30-Hz photopic flicker at the same light intensity stimulation. The latter two recordings were performed to evaluate cone and inner retinal function, respectively. Data were collected automatically on the compact flash card of the ERG unit, transferred to a computer, printed, and stored for further analysis. ERG curves in all recordings were evaluated, and the amplitudes and implicit times for the a- and b-waves were measured.

After termination of the ERG session an injection of atipamezole (Antisedan; Pfizer Inc. St Louis, MO) was administered intramuscularly to reverse the deep sedation. Each ERG session consisted of scotopic and photopic ERGs. Two different stimuli were used for scotopic ERGs: scotopic low stimulus strength (S) responses for rods and scotopic standard stimulus strenth (Ssd) responses for mixed rod and cone responses. The S responses were elicited using a 0.025 cd s/m2 single flash at 1, 5, 10, 15, and 20 min after dark adaptation (designated SI, S2, S3, S4, and S5, respectively). After the 20 min recording, the light stimulus strength was increased to 2.5 cd s/m2 and the Ssd responses were recorded. The photopic ERGs for evaluation of the cone system consisted of two different responses: after 10 min of light adaptation (background luminance: 25 cd/m2), a photopic single flash (P) response for evaluation of cones, and 31 Hz flicker (Pfl) responses for evaluation of the fast components of the cone pathways were recorded with a 2.5 cd s/m2 flash or flashes using the same 25 cd/m2 background luminance. The duration of the stimulus fash was 0.005 ms for the S response and 0.5 ms for the Ssd, P, and Pfl responses, respectively. For all procedures, the dogs were positioned in sternal recumbency throughout the recordings and the head positioned using a pack of towels. Conjunctival stay sutures were used to position the eyes and to avoid rotation of the globe.

[0092] The data are shown in Table 5. Referring to Table 5, the data show that there was a significant statistical difference observed in the photopic ERG parameters: Pc, a measure for cone function under light adapted conditions, between the treatment group and the control group. Comparing changes from post to pre- treatment levels, the dogs who received Test Food demonstrated an increase in a-wave and b-wave amplitudes, and a decrease in the implicit time for the a-wave, and a non-significant difference for the b-wave implicit time when compared to those in the control group of dogs (p < 0.05).

[0093] All ERG a-wave amplitudes obtained were increased in the treatment group compared to the control group, with significant improvements in the scotopic high (p < 0.05) and photopic standard intensity (p < 0.01) light stimulation responses. The implicit time for a-waves under various testing conditions decreased, but this was only statistically significant for the photopic standard intensity. For the b-wave amplitudes, all responses were increased similarly, with significant improvements in both the scotopic standard and high light intensity stimulation (p < 0.05 for both), and significant improvement in the responses of photopic single flash cone and 30 Hz flicker (p < 0.01 for both) recordings. The implicit times for b-waves under various testing conditions showed no significant differences despite a trend for a decreased implicit time with photopic standard intensity response.

[0094] Comparing the percentage of changes in both a-wave and b-wave amplitude in the treatment vs. control groups before and after the antioxidant supplementation, the control group had almost no change in Ssd, and decrease of -6.1% in Sh, -12.1% in Pc, and -22.3% in Pfl. This shows a decline in retinal function over the six-month time period. In comparison, the treatment group had an increase of 27.2% in Ssd, 22.7% in Sh, 14.4% in Pc, and 44.4% in Pfl. This shows an improvement in retinal function over this six-month treatment. [0095] Therefore, the data show that administering the appropriate amount of one or more of lutein, zeaxanthin, beta-carotene, astaxanthin, vitamin C, and vitamin E are effective for improving visual function and eye health of animals.

Vitamin C (mg) 180 mg/day 78.9 mg g or 236.8 mg/day 5.5 mg/g or 16.5 mg/day

Vitamin E (IU) 500 IU/day 183.7 IU/g or 551 IU/day 177 IU/g or 531 IU/day

Table 4

Table 5

[0096] 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.