METHODS FOR REDUCING FOOD INTAKE AND DECREASING APPETITE

IN ANIMALS

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 60/727,365 filed on October 17, 2005, which is incorporated herein by reference.

FIELD OF THE INVENTION

[0002] The invention relates generally to methods and compositions for modulating food intake and appetite in animals and particularly to the use of oleate compounds to modulate food intake and appetite in animals.

BACKGROUND OF THE INVENTION

[0003] When developing foods for animals, consideration is given to the dietary intake of crude protein, carbohydrates, fat, vitamins and minerals necessary to maintain health. Fats are an important component of any diet as they provide energy, serve structural functions at the cellular level, act as carriers for fat soluble vitamins, and supply the essential fatty acids that are not adequately synthesized by particular animal species. Dietary fats generally improve palatability and provide an acceptable texture to foods. [0004] Dietary fats, however, have received a bad reputation in the recent past for contributing to obesity in humans and non-human animals, including companion animals such as cats and dogs.

[0005] Companion animals considered overweight and/or obese are increasing in number such that it is now estimated that in the U.S., between 25% and 40% of companion animals are considered overweight or obese. An animal is considered overweight if it weighs more than 10% above its ideal body weight, and obese if it weighs more than 15% above its 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. [0006] 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.

[0007] Gastrointestinal disorders can be associated with obesity and include without limitation gastritis, inflammatory bowel disease, colitis, scours, and diarrhea. Such disorders can be painful, can cause mild to severe dehydration, and can ultimately result in hospitalization and/or death of the animal. Various drugs are available to treat such conditions; however such drugs often require prescriptions and/or can have undesirable side effects.

[0008] There is, therefore, a need for new approaches for reducing food intake, decreasing appetite, or treating gastrointestinal disorders, including such disorders that are obesity-related. There is, in particular, a continuing need for such approaches that do not depend entirely on the administration of drugs.

SUMMARY OF THE INVENTION

[0009] The invention provides methods of reducing food intake in animals by feeding the animals a food supplement comprising a food intake reducing amount of at least one oleate compound prior to a meal.

[0010] The invention also provides methods for decreasing appetite in animals by feeding the animals a food supplement comprising an appetite decreasing amount of at least one oleate compound.

[0011] The invention further provides food supplements comprising, per serving thereof, one to a plurality of treats that comprise at least one oleate compound in a total amount per serving effective, upon feeding the supplement to an animal, to reduce food intake, decrease appetite, inhibit weight gain, and/or prevent or treat an obesity-related gastrointestinal disorder in the animal.

[0012] The invention also provides methods for inhibiting weight gain in an animal by feeding to the animal a food supplement within about 12 hours prior to mealtimes. The

supplement comprises, per serving thereof, one to a plurality of treats that comprise at least one oleate compound in a total amount per serving effective to inhibit weight gain in the animal.

[0013] The invention further provides methods for controlling weight of an animal by providing a nutritional regimen comprising (a) feeding to the animal a food supplement comprising a weight controlling effective amount of at least one oleate compound within about 12 hours prior to mealtimes and (b) feeding the animal at mealtimes a low fat food.

[0014] The invention also provides methods for preventing or treating a gastrointestinal disorder in an animal by feeding to the animal a food supplement comprising a gastrointestinal disorder preventing or treating effective amount of at least one oleate compound.

[0015] The invention further provides articles of manufacture comprising (a) a package containing a food supplement that comprises at least one oleate compound; and (b) a means for communicating information about or instructions for feeding the supplement to an animal to reduce food intake, decrease appetite, inhibit weight gain, and/or prevent or treat an obesity-related gastrointestinal disorder in the animal, said communicating means being attached to or enclosed in the package.

[0016] The invention also provides kits comprising (a) a package containing a food supplement comprising at least one oleate compound; and (b) a means for communicating information about or instructions for feeding the supplement to an animal to reduce food intake, decrease appetite, inhibit weight gain, and/or prevent or treat an obesity-related gastrointestinal disorder in the animal.

[0017] The invention further provides means for communicating information about or instructions for feeding a food supplement comprising at least one oleate compound to an animal to reduce food intake, decrease appetite, inhibit weight gain, and/or prevent or treat an obesity-related gastrointestinal disorder in the animal, the means comprising a label, a brochure, an advertisement, a package insert, a computer-readable digital or optical medium, an audio presentation, a visual presentation, or one or more pages on a website, containing the information or instructions.

[0018] Additional or alternative advantages and benefits of the present invention will be apparent to one skilled in the art from reading this specification.

DETAILED DESCRIPTION OF THE INVENTION

[0019] The present invention, in various embodiments, provides methods for reducing food intake and decreasing appetite in animals; food supplements for reducing food intake and decreasing appetite in animals; methods for controlling weight in animals; and methods and food supplements for treating gastrointestinal disorders in animals. [0020] The term "oleate compound" means non-glyceryl and non-amide derivatives of oleic acid, including but not limited to the free acid form, salts, non-glyceryl esters, other derivatives known in the art, and mixtures thereof. In one embodiment, the oleate compound is selected from the group consisting of oleic acid, ethyl oleate, sodium oleate, and mixtures thereof. Illustratively, the oleate compound is oleic acid. Oleic acid is an 18- carbon monounsaturated fatty acid (c/s-C18:l ω-9), and the major monounsaturated fatty acid in human diets. Plant sources of oleate compounds include, but are not limited to, high oleic peanuts, high oleic sunflower seeds, soybeans, almonds, olives, avocados, rapeseed, flax seed, cottonseed, coconut, linseed, palm, cocoa butter, corn, canola, and oils derived from these plant sources. Animal sources of oleate compounds include, but are not limited to, chicken fat and lard.

[0021] The methods of the invention comprise feeding to an animal a food supplement comprising at least one oleate compound. In various embodiments, the supplement contains the oleate compound in an amount of from about 35% to about 100% of total crude fat, or in an amount of from about 5% to about 20% of the supplement on a dry matter basis. A food supplement according to various other embodiments comprise at least one oleate compound in an amount of at least about 35% of total crude fat, or in an amount of from about 5% to about 20% of the supplement on a dry matter basis. [0022] The phrase "reducing food intake" with respect to a factor external to an animal means a reduction in the amount of food consumed, relative to the amount of food consumed by the animal in the absence of that factor. A food intake reducing amount of an oleate compound is an amount of the oleate compound that, when consumed by an animal, causes the animal to reduce the amount of food consumed.

[0023] The phrase "decreasing appetite" with respect to a factor external to an animal means a decrease in the animal's appetite, relative to the animal's appetite in the absence of that factor. An appetite decreasing amount of an oleate compound is an amount of the oleate compound that, when consumed by an animal, causes the animal's appetite to decrease.

[0024] Gastrointestinal disorders include but are not limited to gastritis, inflammatory bowel disease, colitis, scours, diarrhea, and any other gastrointestinal disorder known in the art.

[0025] Generally, food supplements as used herein include, for example, a food used with another feed to improve nutritive balance or performance of the total. Supplements include compositions that are fed undiluted as a supplement to other feeds or offered free choice with other parts of an animal's ration and separately available. Food supplements may be in various forms including, for example, treats, kibbles, powders, liquids, syrups, pills, encapsulated compositions, etc. In a particular embodiment, a food supplement useful herein comprises one to a plurality of treats.

[0026] In one embodiment, the invention provides methods for reducing food intake by an animal. The method comprises feeding to the animal a food supplement comprising a food intake reducing amount of at least one oleate compound.

[0027] In another embodiment, the invention provides a method for decreasing appetite in an animal. The method comprises feeding to the animal a food supplement comprising an appetite decreasing amount of at least one oleate compound.

[0028] In a further embodiment, the invention provides a method for inhibiting weight gain in an animal comprising feeding to the animal a food supplement within about 12 hours prior to mealtimes. The supplement comprises, per serving thereof, one to a plurality of treats that comprise at least one oleate compound in a total amount per serving effective to inhibit weight gain in an animal. Illustratively, the supplement is fed to the animal within about 3 hours, or within about 1 hour, or immediately prior to mealtimes.

[0029] In yet another embodiment, the invention provides a method for controlling weight in an animal. The method comprises providing a nutritional regimen that comprises

(a) feeding to the animal a food supplement comprising a weight controlling effective amount of at least one oleate compound within about 12 hours prior to mealtimes and (b) feeding the animal at mealtimes a low fat food. The nutritional regimen should be maintained for a weight controlling effective period, for example, for at least about one month, illustratively for at least about 6 months, for at least about 1 year, or for substantially the remainder of an animal's life.

[0030] In a further embodiment, a method for preventing or treating a gastrointestinal disorder in an animal comprises feeding to the animal a food supplement comprising a

gastrointestinal disorder preventing or treating effective amount of at least one oleate compound.

[0031] The invention provides a food supplement comprising, per serving thereof, one to a plurality of treats that comprise at least one oleate compound in a total amount per serving effective, upon feeding the supplement to an animal, to reduce food intake, decrease appetite, inhibit weight gain, and/or prevent or treat an obesity-related gastrointestinal disorder. In some embodiments, the treats are nutritionally and/or organoleptically adapted for feeding to canines or felines.

[0032] Treats as used herein include, for example, compositions that are given to an animal to eat during a non-mealtime. Treats are advantageous over pills as treats are a simpler method of causing an animal to ingest a desired substance. For example, treats are typically consumed voluntarily by an animal, while pills often need to be compulsorily administered. Treats include, without limitation, dog bones, dog biscuits, cat treats, etc. Nutritional treats contain one or more nutrients in addition to the at least one oleate compound. Alternatively, a treat may contain substantially no nutrient other than the at least one oleate compound.

[0033] In preparing a food supplement useful herein, the components are adjusted so that the oleate compound is present in the supplement at a desired percentage. For example, the oleate compound can be present in a supplement in an amount of from about 35% to about 100% total crude fat, or in an amount of from about 5% to about 20% of the supplement on a dry matter basis.

[0034] The oleate compound can, for example, be incorporated into the supplement during formulation or coated onto the supplement. An oleate compound can, if desired, be present in the supplement in encapsulated form.

[0035] Optionally, an oleate comprising food supplement as described herein may further comprise one or more antioxidants and/or one or more polyunsaturated fatty acids. The one or more polyunsaturated fatty acids can comprise, for example, an omega-3 fatty acid such as docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA). [0036] The methods, compositions, and supplements of the present invention are useful to a variety of animal species, including human and non-human animals such as non- human primates {e.g., monkeys, chimpanzees, etc.), companion animals (e.g., dogs, cats, horses, etc.), farm animals (e.g., goats, sheep, pigs, cattle, etc.), laboratory animals (e.g., mice, rats, etc.), birds (e.g., domestic birds such as canaries, parrots, etc. and commercial

birds such as chickens, ducks, geese, turkeys, etc.), rodents {e.g., hamsters, guinea pigs, gerbils, rabbits, hedgehogs, ferrets, chinchillas, etc.) and wild, exotic, and zoo animals {e.g., wolves, bears, deer, etc.). In various embodiments, the animal is a vertebrate, for example a fish, a bird, a reptile, or a mammal. Illustratively, among mammals, the animal can be a member of the order Carnivora, including without limitation canine and feline species. The invention is useful for animals of any age, breed, and occupation, including adult animals, senior animals, geriatric animals, overweight animals, obese animals, animals having a tendency toward obesity, and animals with gastrointestinal disorders. [0037] In some embodiments, the animal is a companion animal. A "companion animal" herein is an individual animal of any species kept by a human caregiver as a pet, or any individual animal of a variety of species that have been widely domesticated as pets, including dogs {Canis familiaris) and cats {Felis domesticus), whether or not the individual animal is kept solely or partly for companionship. Thus, "companion animals" herein include working dogs, farm cats kept for rodent control, etc., as well as pet dogs and cats.

[0038] hi another embodiment, the invention provides an article of manufacture comprising a package containing a food supplement that comprises at least one oleate compound. Any form of package appropriate to the nature of the composition can be used, including without limitation, a can, a jar, a pouch, a bag, a bag in a box, etc. The article of this embodiment further comprises a means for communicating information about or instructions for administering the composition to an animal to reduce food intake, decrease appetite, inhibit weight gain, or prevent or treat an obesity-related gastrointestinal disorder in the animal. The communicating means is attached to or enclosed in the package. Any suitable form of communicating means can be employed, for example a document such as a label, brochure, advertisement or package insert, a computer-readable digital or optical medium such as a diskette or CD, an audio presentation, for example on an audiotape or CD, or a visual presentation, for example on a videotape or DVD. The communicating means can refer to further information located elsewhere, such as on a website. [0039] hi yet another embodiment of the invention, a kit comprises a package as described above containing a food supplement that comprises at least one oleate compound. The kit of this embodiment further comprises a communicating means as described above. The communicating means can be provided together with or separately

from the package, and can take any suitable form, such as those described above including one or more pages on a website.

[0040] Such a communicating means, comprising, for example, a document such as a label, brochure, advertisement or package insert, a computer readable digital or optical medium such as a diskette or CD, an audio presentation, for example on an audiotape or CD, a visual presentation, for example on a videotape or DVD, and/or one or more pages on a website, is itself a still further embodiment of the invention.

[0041] Except where stated otherwise, all percentages recited herein are weight percentages on a dry matter basis. The phrase "dry matter basis" means the component concentration in the composition after any moisture in the composition is removed. [0042] The invention is not limited to the particular methodology, protocols, and reagents described herein because they may vary. Further, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the present invention. As used herein and in the appended claims, the singular forms "a," "an," and "the" include plural reference unless the context clearly dictates otherwise, e.g., reference to "an animal" includes a plurality of such animals. The terms "comprise", "comprises", and "comprising" are to be interpreted inclusively rather than exclusively.

[0043] Unless defined otherwise, all technical and scientific terms and any acronyms used herein have the same meanings as commonly understood by one of ordinary skill in the art in the field of the invention. Although any methods and materials similar or equivalent to those described herein can be used in the practice of the present invention, the preferred methods, devices, and materials are described herein.

[0044] All patents, patent applications, and publications mentioned herein are incorporated herein by reference to the extent allowed by law for the purpose of describing and disclosing the compositions, compounds, methods, and other information reported therein that might be used with the present invention. However, nothing herein is to be construed as an admission that the invention is not entitled to antedate such disclosure by virtue of prior invention.

EXAMPLES

[0045] The invention can be further illustrated by the following examples of preferred embodiments thereof, 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. The following example is merely illustrative, and does not limit this disclosure in any way.

Example 1

[0046] Dogs were maintained on a low fat diet and given a treat containing oleic acid prior to their daily meal. After an adjustment period, the dogs consuming the high oleic acid treat voluntarily consumed less food than the dogs fed a treat not containing oleic acid.

[0047] In the specification, there have been disclosed typical preferred embodiments of the invention and, 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 being set forth in the following claims. Obviously many modifications and variations of the present 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.