Compositions and methods for providing health benefits in animal bodies using mackerel oil

Abstract

The present disclosure provides compositions and methods for using South Ocean mackerel oil to provide health benefits to animals. For example, a pet food composition for treating an inflammatory condition in a companion animal may comprise South Ocean mackerel oil and a preservative.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application Serial No. 63 / 406,583, filed on September 14, 2022, the disclosure of which is incorporated herein by reference in its entirety. Background Art

[0003] Omega-3-fatty acids are known to be beneficial to mammals. These benefits include those found in the following: U.S. Patent No. 5,776,913, which discloses a specific diet containing omega-3 fatty acids that can improve metabolic disorders in animals with cancer; U.S. Patent No. 9,119,826, which discloses a specific diet containing omega-3 fatty acids for treating cardiovascular disorders; U.S. Publication No. 2004 / 0235948, which discloses a specific diet containing omega-3 fatty acids for treating diabetes; and U.S. Patent No. 5,434,183, which discloses a specific diet containing omega-3 fatty acids for treating inflammation (including arthritis). Omega-3-fatty acids are typically exemplified as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), alpha-linolenic acid and octadecatetraenoic acid. EPA and DHA are generally considered to be the most important and meaningful of long-chain omega-3 fatty acids. Typically, these long-chain fatty acids are present or completely absent in a relatively low, almost tiny amount in a typical pet food composition. The fatty acid composition of the food consumed by companion pets, such as dogs and cats, directly affects the biological levels of fatty acids found in their blood.

[0004] Natural products with relatively high levels of ω-3 unsaturated fatty acids (such as EPA and DHA) can be derived from marine oils, such as salmon, anchovies, sardines and herrings. Such natural oils can be concentrated to even higher percentages of ω-3-fatty acids. However, such products also contain a large amount of ω-6 fatty acids, which increase the levels of eicosanoids and leukotrienes, which can provide overactive inflammatory and immunological responses, leading to deleterious effects. In addition, further processing of oil may be cost-prohibitive.

[0005] In particular, low levels of the ω-6 fatty acid arachidonic acid are key nutrients for mammalian health. However, at higher levels, it is known to cause harmful overactive inflammatory and immunological responses. This harmful response is known to be regulated by the ω-3 fatty acid equivalents of arachidonic acid or the precursors of this ω-3 fatty acid.

[0006]

[0006] Therefore, there is a need for methods and compositions that utilize omega-3 fatty acids to provide health benefits in an effective and cost-effective manner that avoids the above-mentioned problems. Summary of the invention

[0007] In one embodiment, a composition for providing a health benefit to an animal may include mackerel oil and a preservative.

[0008] In another embodiment, a method of making a pet food composition may include blending mackerel oil and a preservative with at least one of a protein, a fat, and a carbohydrate to form the pet food composition.

[0009] In another embodiment, a method of providing a health benefit to an animal may include administering to the animal a food composition comprising mackerel oil and a preservative.

[0010] In various embodiments, such health benefits may include treating or preventing inflammatory conditions such as inflammation, arthritis, irritated skin, swollen gums, allergies, asthma, autoimmune diseases, celiac disease, glomerulonephritis, hepatitis, inflammatory bowel disease, reperfusion injury, transplant rejection, gout, myositis, scleroderma, systemic lupus erythematosus, vasculitis, psoriasis; or treating or preventing other health conditions such as cancer, heart disease, diabetes, kidney disease, and cognitive impairment.

[0011] Other and further objects, features and advantages of the present invention will be apparent to those skilled in the art. DETAILED DESCRIPTION

[0012] definition

[0013] The term "animal" means any animal in need of the health benefits disclosed herein, including humans, avian animals, bovine animals, canine animals, equine animals, feline animals, caprine animals, lycanthid animals, murine animals, ovine animals, or porcine animals. In one aspect, the animal can be a mammal. In another aspect, the animal can be a companion animal.

[0014] The term "companion animal" refers to domesticated animals such as cats, dogs, rabbits, guinea pigs, ferrets, hamsters, mice, gerbils, horses, cows, goats, sheep, donkeys, pigs, etc. In one aspect, the companion animal can be a canine. In another aspect, the companion animal can be a canine and / or a feline.

[0015] The term "eicosatetraenoic acid" or "ETA" refers to all-cis-8,11,14,17-eicosatetraenoic acid, PubChemCID 11722594, CAS Registry Number 2091-26-1.

[0016] The term "Southern Ocean mackerel oil" refers to oil derived from at least one of the following: Trachurus declivis (Greenback horse mackerel) and / or Chilean horse mackerel Trachurus murphyi (Chilean bamboo In one embodiment, the mackerel may be farmed in waters south of 20°S latitude. In one aspect, the mackerel may be farmed in waters south of 40°S latitude. In some embodiments, the oil may be derived, at least in part, from other mackerel species, including New Zealand bamboo shoots, Fish (Trachurus novaezelandiae) (Yellowtail Bamboo Yellowtail horse mackerel), Scomberomorus commerson (Narrow-barred Spanish mackerel), Scomberomorus queenslandicus (Queensland school mackerel), and species of Scomber, Scomberomorus, Grammatorcynus, Acanthocybium, and Bamboo mackerel. In some embodiments, the oil of mackerel can be used for the production of oil. The oil of mackerel can be used for the production of oil. The oil of mackerel can be used for the production of oil. The oil of mackerel can be used for the production of oil. The oil of mackerel can be used for the production of oil. The oil of mackerel can be used for the production of oil. The oil of mackerel can be used for the production of oil.

[0017] The term "therapeutically effective amount" refers to an amount of a compound disclosed herein that is capable of (i) treating or preventing a particular disease, condition or disorder, (ii) alleviating, ameliorating or eliminating one or more symptoms of a particular disease, condition or disorder, or (iii) preventing or delaying the onset of one or more symptoms of a particular disease, condition or disorder described herein.

[0018] The term "treatment" includes both prophylactic treatment (ie preventive treatment) and palliative treatment.

[0019] The term "in combination" refers to administering the food compositions, components thereof, or other compositions disclosed herein to an animal by: (1) administering them together in the form of a single food composition, or (2) administering them separately at the same or different frequencies, using the same or different routes of administration, at about the same time, or on a regular basis. "Regularly" refers to administering the food composition, components thereof, or other compositions on a schedule that is acceptable for the particular compound or composition. "On a regular basis" generally refers to administering the food composition, components thereof, or other compositions at the same time or within about 72 hours of each other.

[0020] Unless the context indicates otherwise, the terms "food" or "food product" or "food composition" refer to a product or composition intended for ingestion by animals, including humans, and that provides nutrition to the animal.

[0021] The term "carbohydrate" refers to digestible carbohydrates, such as sugars and starches, and does not include fibers, such as cellulose or fermentable fibers.

[0022] The term "regularly" refers to at least monthly administration, and in one aspect, refers to at least weekly administration. In certain embodiments, more frequent administration or consumption may be performed, such as twice or three times per week. In one aspect, the administration regimen may include consumption at least once per day.

[0023] The term "single package" means that the multiple components of a kit are physically associated in or with one or more containers and are considered a unit for manufacture, packaging, sale, or use. Containers include, but are not limited to, bags, boxes, cartons, bottles, packaging (such as shrink wrap), binding or otherwise attached components, or combinations thereof. A single package can be a container of a food composition or components thereof that are physically associated so that they are considered a unit for manufacture, packaging, sale, or use.

[0024] The term "virtual packaging" means that the components of the kit are associated by instructions on one or more physical or virtual kit components that instruct a user how to obtain other components (e.g., in a bag or other container that holds one component); and by instructions that have the following functions: instructing the user to visit a website, contact a recording message or callback service, view a visual message, or contact a caregiver or instructor to obtain instructions on how to use the kit or safety or technical information about one or more components of the kit.

[0025] The term "about" refers to a value of ±20%; in one aspect, ±10%; in another aspect, ±5%; and in a particular aspect, ±2%. For example, in one aspect (where "about" is a value of ±20%), the phrase "about 10% to about 20%" may include a range of 8% to 24% or 12% to 16%, including any subranges therein.

[0026] As used herein, embodiments, aspects, and examples using "comprising" language or other open language may be replaced with "consisting essentially of and "consisting of" embodiments.

[0027] When referring to food compositions, the term "complete and balanced" refers to a food composition that contains all known essential nutrients in appropriate amounts and proportions, based on the recommendations of recognized authorities in the field of animal nutrition, and is therefore capable of being used as a sole source of dietary intake to sustain life or promote production without the addition of supplementary sources of nutrition. Nutritionally balanced pet foods and animal food compositions are well known and widely used in the art, for example, complete and balanced food compositions formulated according to standards established by the Association of American Feed Control Officials (AAFCO). In one embodiment, the term "complete and balanced" may be defined according to the AAFCO definition published on January 1, 2022.

[0028] Unless otherwise specifically stated, all percentages expressed herein are calculated by weight on a dry matter basis of the composition. Those skilled in the art will recognize that the term "dry matter basis" refers to the concentration or percentage of an ingredient in a composition measured or determined after removing any free water in the composition.

[0029] As used herein, the ranges used herein are abbreviated ranges to avoid having to list and describe each value within the range. Any appropriate value within the range can be selected, and when appropriate, the upper limit, lower limit or end value of the range can be selected.

[0030] Unless the context indicates otherwise, all dosages used herein refer to the amount of the ingredient or component or active ingredient per time period, per unit animal body weight. For example, in one embodiment, the mackerel oil dosage can be expressed as mg / kgBW / day or g / kgBW / day.

[0031] As used herein, the singular form of a word includes the plural form and vice versa, unless the context clearly dictates otherwise. Thus, references to "a," "an," and "the" generally include the plural form of the corresponding term. For example, reference to a "supplement," "method," or "food" includes a plurality of such "supplements," "methods," or "foods." Similarly, the words "include," "comprise," and "contain" are to be interpreted inclusively rather than exclusively. Similarly, the terms "include," "comprises," and "or" should all be considered inclusive unless the context clearly prohibits such an interpretation. Similarly, the term "example" (especially when followed by a list of terms) is exemplary and illustrative only and should not be considered exclusive or exhaustive.

[0032] The methods, compositions and other advances disclosed herein are not limited to the specific methods, protocols and reagents described herein, as these specific methods, protocols and reagents may vary, as will be appreciated by those skilled in the art. In addition, the terminology used herein is for the purpose of describing specific embodiments only and is not intended to limit and will not limit the scope of the disclosure or protection of the claims.

[0033] Unless otherwise defined, all technical terms, technical terms and acronyms used herein have the meanings commonly understood by those of ordinary skill in the art to which the invention belongs or in which these terms are used. Although any compositions, methods, articles or other means or materials similar or equivalent to those described herein may be used in the practice of the present invention, certain compositions, methods, articles or other means or materials are described herein.

[0034] All patents, patent applications, publications, technical and / or scholarly papers, and other references cited or mentioned herein are incorporated herein by reference in their entirety to the extent permitted by law. The discussion of these references is intended only to summarize the assertions made therein. We do not admit that any of these patents, patent applications, publications, or references, or any portion thereof, is relevant, substantial, or prior art. We specifically reserve the right to challenge the accuracy and relevance of any assertion that these patents, patent applications, publications, and other references are relevant, substantial, or prior art. DETAILED DESCRIPTION

[0036] The methods and compositions of the present invention are based on the discovery that mackerel oil provides a unique blend of omega-3 fatty acids and omega-6 fatty acids that can be used in foods in a more cost-effective manner to provide a variety of health benefits. In particular, in one embodiment, mackerel oil can be farmed from waters around South Australia.

[0037] Specifically, in one embodiment, a pet food composition for treating an inflammatory disorder in a companion animal may include mackerel oil and a preservative.

[0038] Usually, mackerel oil can be present in food composition with therapeutic effective amount, to provide expected health benefit to animal.In one embodiment, mackerel oil is present in composition with about 0.1% to about 10% amount.In other aspects, mackerel oil can be present in composition with 0.1%, 0.5%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 6.5% or 7% to about 0.5%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 6.5%, 7%, 7.5%, 8%, 8.5%, 9%, 9.5% or 10%.

[0039] Typically, South Sea mackerel oil may include at least 3% eicosatetraenoic acid (ETA). In addition, in some embodiments, the oil may have a high ratio of ω-3 fatty acids to ω-6 fatty acids, such as about 4:1 to about 8:1. In one embodiment, South Sea mackerel oil may be cultured from South Australian waters (South Australian mackerel oil) and may include at least 30% ω-3 fatty acids and no more than 5% ω-6 fatty acids. In one aspect, South Australian mackerel oil may include at least 3% eicosatetraenoic acid (ETA), at least 1% stearatetraenoic acid (SDA), at least 8% eicosapentaenoic acid (EPA), at least 15% docosahexaenoic acid (DHA) and at least 2% docosapentaenoic acid (DPA).

[0040] Typically, food compositions and methods of the present invention can provide health benefits to animals, including such conditions associated with inflammatory conditions. In one embodiment, such conditions can be selected from the group consisting of: inflammation, arthritis, irritating skin, gingival swelling, allergy, asthma, autoimmune disease, celiac disease, glomerulonephritis, hepatitis, inflammatory bowel disease, reperfusion injury, transplant rejection, gout, myositis, scleroderma, systemic lupus erythematosus, vasculitis and psoriasis. In addition, the composition can treat various related conditions, including members selected from the group consisting of: cancer, heart disease, diabetes, nephropathy and cognitive impairment. Such cognitive impairment includes brain aging, age-related cognitive impairment, including short-term memory loss, reduced learning ability, reduced learning rate, reduced attention, reduced motor performance and / or dementia.

[0041] Generally speaking, the composition can be used in a therapeutically effective amount to provide the desired benefit. In one embodiment, the daily dose can be in the range of about 0.06mg to about 50mg South Sea mackerel oil (SOMO) / kg body weight / day (SOMO / kgBW / day), which can effectively alleviate the obstacle and illness currently described in companion animals and / or the symptoms associated with such obstacle / illness, and also will maintain health. More preferably, the dosage range of about 6mg SOMO / kgBW / day to about 40mg SOMO / kgBW / day, and most preferably, the dosage range of about 9mg SOMO / kgBW / day to about 30mg SOMO / kgBW / day can be effective. Therefore, in one aspect, dogs can accept SOMO of about 0.01g / day to about 1.5g / day. In one aspect, the dosage level of cats can be the amount required for the level of reaching 0.03g / kgBW / day SOMO, although higher amounts may also be suitable.

[0042] In one embodiment, the dosage of ETA may be in the range of 1.8 μg / kg body weight / day (ETA / kgBW / day) to about 1.5 mg / kg body weight / day (ETA / kgBW / day). In another embodiment, the dosage of SDA may be in the range of 0.6 μg / kg body weight / day (SDA / kgBW / day) to about 0.5 mg / kg body weight / day (SDA / kgBW / day). In another embodiment, the dosage of EPA may be in the range of 4.8 μg / kgBW / day (EPA / kgBW / day) to about 4 mg / kg body weight / day (EPA / kgBW / day). In another embodiment, the dosage of DHA may be in the range of 9 μg / kg body weight / day (DHA / kgBW / day) to about 7.5 mg / kg body weight / day (DHA / kgBW / day). In another embodiment, the dosage of DPA may be in the range of 1.2 μg / kg body weight / day (DPA / kgBW / day) to about 1 mg / kg body weight / day (DPA / kgBW / day). For example, in one aspect, a typical 25Kg dog may receive an average of about 45 μg to 37.5 mg of ETA per day; 15 μg to 12.5 mg of SDA; 120 μg to 100 mg of EPA; 225 μg to 188 mg of DHA; and 30 μg to 25 mg of DPA per day.

[0043] Additionally, the compositions of the present invention may be administered in an amount providing a therapeutically effective amount of stearatetraenoic acid, eicosapentaenoic acid, docosahexaenoic acid, and / or docosapentaenoic acid to treat or alleviate the conditions / disorders disclosed herein.

[0044] In one embodiment, the amount of SOMO per 1000 kcal of pet food product for treating and / or alleviating the presently described disorders and conditions and / or symptoms associated with such disorders / conditions in companion animals can generally be from about 3.7 mg SOMO / 1000 kcal pet food to about 3000 mg SOMO / 1000 kcal pet food. More preferably, an amount of 35 mg SOMO / 1000 kcal to 2000 mg SOMO / 1000 kcal, and most preferably, an amount of 180 mg SOMO / 1000 kcal to 1500 mg SOMO / 1000 kcal pet food product can be effective.

[0045] In other embodiments, other dosages may typically be from about 0.11 mg ETA / 1000 kcal to about 90 mg ETA / 1000 kcal; from about 0.03 mg SDA / 1000 kcal to about 30 mg SDA / 1000 kcal; from about 0.29 mg EPA / 1000 kcal to about 240 mg SDA / 1000 kcal; from about 0.55 mg DHA / 1000 kcal to about 450 mg DHA / 1000 kcal and / or from about 0.07 mg DHA / 1000 kcal to about 60 mg DPA / 1000 kcal. More preferably, a dosage of about 1.05 mg ETA / 1000 kcal to about 60 mg ETA / 1000 kcal; about 0.35 mg SDA / 1000 kcal to about 20 mg SDA / 1000 kcal; about 2.8 mg EPA / 1000 kcal to about 160 EPA / 1000 kcal; about 5.25 mg DHA / 1000 kcal to about 300 mg SDA / 1000 kcal; and / or about 0.7 mg DPA / 1000 kcal to about 40 mg DPA / 1000 kcal. Most preferably, a dosage of about 5.4 mg ETA / 1000 kcal to about 45 mg ETA / 1000 kcal; about 1.8 mg SDA / 1000 kcal to about 15 mg SDA / 1000 kcal; about 14.4 mg EPA / 1000 kcal to about 120 mg SDA / 1000 kcal; about 27 mg DHA / 1000 kcal to about 225 mg SDA / 1000 kcal; and / or about 3.6 mg DPA / 1000 kcal to about 30 mg DPA / 1000 kcal.

[0046] The composition of the present invention can be any composition suitable for animals, including food compositions, supplements, treats, pharmaceutical compositions, and the like. In one embodiment, the composition can be a food composition. In one aspect, the composition can be a staple food composition. In another aspect, the composition can be a supplement. In one embodiment, the animal can be a human or a companion animal. In one aspect, the animal can be a companion animal. In another aspect, the animal can be a feline. In one aspect, the animal can be a canine. In another aspect, the animal can be a human. Therefore, the methods and compositions of the present invention can be directed to and / or formulated for such animals, for example, formulated for canines or felines.

[0047] In one embodiment, the composition can be a food composition. In one aspect, the composition can also include protein, fat, carbohydrate and fiber. In another embodiment, the composition can also include additives that can effectively treat the currently disclosed illness. Such additives can include any drug treatment or nutritional ingredients.

[0048] Typically, the food composition of the present invention comprises protein. Protein can be a crude protein material, and can include plant protein (such as soy flour, soy protein concentrate, corn gluten meal, wheat gluten, cottonseed and peanut meal) or animal protein (such as casein, albumin and meat protein). Examples of meat protein that can be used for the present invention include beef, pork, lamb, horse meat, poultry, fish and mixtures thereof. In one embodiment, the food composition can include about 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55% or even 60% to about 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60% or even 65% of the amount of protein, including various sub-ranges within these amounts. In one aspect, protein can be about 20% to about 50% of the food composition.

[0049] Generally, any type of carbohydrate can be used in food compositions.The example of suitable carbohydrate includes grain or cereal, such as rice, corn, millet, sorghum, alfalfa, barley, soybean, canola, oats, wheat, rye, triticale and mixtures thereof.Composition can also optionally include other materials, such as dry whey and other dairy byproducts.In one embodiment, carbohydrate accounts for about 5% to about 70% of food compositions.In another embodiment, carbohydrate accounts for about 20% to about 50% of food compositions.In other aspects, carbohydrate can exist with about 5%, 10%, 15%, 20%, 25%, 30%, 35% or even 40% to about 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60, 65% or 70% amount.

[0050] Usually, food composition comprises fat.This fat can comprise mackerel oil or material except mackerel oil.The example of suitable fat comprises animal fat and vegetable fat.In one aspect, fat source can be animal fat source, such as tallow or poultry fat.Also can use vegetable oil, such as corn oil, sunflower oil, safflower oil, grape seed oil, soybean oil, olive oil and other oils rich in monounsaturated fatty acid and polyunsaturated fatty acid.In one embodiment, food composition can comprise the fat of about 10%, 15%, 20%, 25%, 30% or even 35% to about 15%, 20%, 25%, 30%, 35%, 40%, 45% or even 50% amount, be included in various sub-ranges within these amounts.In one aspect, fat accounts for about 5% to about 40% of food composition.

[0051] Can be administered as needed, as desired, regularly or intermittently. In one aspect, the food composition can be administered to the animal regularly. In one aspect, it can be administered at least weekly. In another aspect, the administration regimen can include at least one daily consumption. Typically, the composition can be administered to the animal based on achieving at least one health benefit disclosed herein or treating or alleviating one of the disorders / disorders disclosed herein, including symptoms of such disorders / disorders. In another embodiment, the composition can be administered for a long time, i.e., at least 6 months. In other aspects, the long term can be at least 1 year, 2 years, 3 years, or the life span of the animal.

[0052] According to the methods currently described, administration (including administration as part of a dietary regimen) can continue from the birth of an animal to adulthood. In various embodiments, the animal can be a human or a companion animal (such as a dog or cat). In certain embodiments, the animal can be a young or growing animal. In other embodiments, when the animal has reached about 10%, 20%, 30%, 40% or 50% of its estimated or expected life span, administration can be started, for example, regularly or regularly for a long time. In some embodiments, the animal may have reached 40%, 45% or 50% of its expected life span. In other embodiments, the animal can be older, reaching 60%, 66%, 70%, 75% or 80% of its possible life span. The determination of life span can be based on mortality statistics, calculations, estimates, etc., and can take into account known past, present and future influences or factors that can have a positive or negative impact on life span. When determining life span, species, sex, body size, genetic factors, environmental factors and stressors, current and past health status, past and present nutritional status, stressors, etc. considerations can also affect or be taken into account.

[0053] Such administration can be carried out for a time required to achieve one or more purposes described herein (e.g., to treat or alleviate the symptoms of the conditions / disorders described herein or associated therewith). Other administration amounts may be appropriate and can be determined based on the initial weight of the animal as well as other variables such as species, sex, breed, age, desired health benefits, etc.

[0054] The moisture content of such food compositions generally varies according to the nature of the food compositions. The food compositions may be dry compositions (e.g., kibble), semi-wet compositions, wet compositions, or any mixture thereof. In one embodiment, the composition may be a pet food composition, which may be a complete and nutritionally balanced pet food in one aspect. In this embodiment, the pet food may be a "wet food," "dry food," or "medium moisture" content food. "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 similar in composition to wet food, but has a limited moisture content, typically in the range of about 5% to about 15% or 20% (typically in the form of small biscuit-like kibble). In one embodiment, the composition may have a moisture content of about 5% to about 20%. Dry food includes various foods of various moisture contents, making them relatively storage-resistant and anti-microbial or fungal deterioration or contamination. Moreover, in one aspect, the dry food composition may be an extruded food product for humans or companion animals.

[0055] The food composition may also include one or more fiber sources. Such fiber sources include soluble, insoluble, fermentable and non-fermentable fibers. Such fiber may be from plant sources (such as marine plants), but microbial fiber sources may also be used. A variety of soluble or insoluble fibers may be used, which will be known to those of ordinary skill in the art. The fiber source may be beet pulp (derived from beets), gum arabic, gum talha, psyllium, rice bran, carob bean gum, citrus pulp, pectin, oligofructose, short-chain oligofructose, manno-oligofructose, soy fiber, arabinogalactan, galactooligosaccharide, arabinoxylan or a mixture thereof.

[0056] Alternatively, the fiber source may be fermentable fiber. Fermentable fiber has previously been described as beneficial to the immune system of companion animals. Fermentable fiber or other compositions known to those skilled in the art that provide prebiotics to promote the growth of probiotics in the intestine may also be incorporated into the composition to help enhance the beneficial effects described herein or to enhance the immune system of the animal.

[0057] In some embodiments, the ash content of the food composition ranges from less than 1% to about 15%. In one aspect, the ash content can be from about 5% to about 10%.

[0058] Typically, the food composition may be suitable for consumption by animals (including humans and companion animals, such as dogs and cats) as a meal, dietary component, snack, or treat. Such compositions may include complete foods intended to provide the necessary dietary requirements for animals. Examples of such food compositions include, but are not limited to, dry foods, wet foods, beverages, bars, frozen prepared foods, shelf-prepared foods, and refrigerated prepared foods.

[0059] The food composition may also further comprise one or more substances, such as vitamins, minerals, antioxidants, probiotics, prebiotics, salts and functional additives (such as flavor enhancers, colorants, emulsifiers and antimicrobial or other preservatives). Minerals that can be used for such compositions include, for example, calcium, phosphorus, potassium, sodium, iron, chlorine, boron, copper, zinc, magnesium, manganese, iodine, selenium, etc. Examples of additional vitamins that can be used in the present invention include fat-soluble vitamins such as A, D, E and K. In various embodiments, it may be useful to include inulin, amino acids, enzymes, coenzymes, etc.

[0060] In various embodiments, the food composition may contain increased levels of at least one or more antioxidants, particularly natural antioxidants such as tocopherols (including vitamin E), flavonoids (including anthocyanins); carotenoids, including astaxanthin, lutein and zeaxanthin; phenols and polyphenols, rosemary and other plant extracts. The presence of increased levels of antioxidants helps protect the mackerel oil from oxidation and helps ensure its effectiveness until the end of the product's shelf life.

[0061] In various embodiments, the food composition contains at least one of the following components: (1) one or more probiotics; (2) one or more inactivated probiotics; (3) one or more components of inactivated probiotics that promote health benefits similar to or identical to probiotics, such as proteins, lipids, glycoproteins, etc.; (4) one or more prebiotics; and (5) combinations thereof. The probiotics or components thereof can be incorporated into the food composition (e.g., uniformly or non-uniformly distributed in the composition) or applied to the food composition (e.g., topically applied with or without a carrier). Such methods are known to those skilled in the art, such as those described in US5968569 and related patents.

[0062] Typical probiotics include, but are not limited to, probiotic strains selected from Lactobacilli, Bifidobacteria or Enterococci, such as Lactobacillus reuteii, Lactobacillus acidophilus, Lactobacillus animalis, Lactobacillus ruminis, Lactobacillus johnsonii, Lactobacillus casei, Lactobacillus paracasei, Lactobacillus rhamnosus, Lactobacillus fermentum, and Bifidobacterium sp., Enterococcus faecium, and Enterococcus sp.

[0063] Typically, the food composition may contain an amount of probiotics sufficient to provide about 10 4 to about 10 12 cfu / animal / day, in one aspect, 10 5 to about 10 11 cfu / animal / day, and in one particular aspect, 10 7 Up to 10 10 cfu / animal / day. When probiotics are killed or inactivated, the amount of the probiotics killed or inactivated or its components should produce a beneficial effect similar to that of live microorganisms. Many such probiotics and their benefits are well known to those skilled in the art, such as described in EP1213970B1, EP1143806B1, US7189390, EP1482811B1, EP1296565B1 and US6929793. In another embodiment, probiotics can be encapsulated in a carrier using methods and materials well known to those skilled in the art.

[0064] As mentioned above, the food composition may contain one or more prebiotics, such as oligofructose, oligodextrose, galacto-oligosaccharide, oligomalto-oligosaccharide, oligoxylose, oligosaccharide soy sugar, lactose sucrose, oligolactose, lactulose and isomaltulose. In one embodiment, the prebiotic may be chicory root, chicory root extract, inulin or a combination thereof. Typically, prebiotics may be administered in an amount sufficient to actively stimulate the healthy microbial population in the intestinal tract and to breed these "beneficial" bacteria. Typical amounts are in the range of about 1 gram to about 10 grams per serving, or in the range of about 5% to about 40% of the recommended daily dietary fiber for animals. Probiotics and prebiotics may be a part of the composition by any suitable means. Typically, the agent may be mixed with the composition, or applied to the surface of the composition, for example, by spraying or spraying. When the agent is a part of the kit, the agent may be mixed with other substances or in its own packaging. Typically, the food composition contains about 0.1% to about 10% prebiotics, in one aspect, about 0.3% to about 7% prebiotics, and in one particular aspect, about 0.5% to 5% prebiotics, based on dry matter. Prebiotics can be incorporated into the composition using methods known to those skilled in the art, such as the methods described in US5952033.

[0065] Those skilled in the art can determine the appropriate amounts of food ingredients, vitamins, minerals, probiotics, prebiotics, antioxidants, or other ingredients for preparing a particular composition to be administered to a particular animal. Such skilled persons can consider the species, age, size, weight, health, etc. of the animal when determining how best to formulate a particular composition containing such ingredients. Other factors that may be considered include the desired dose of each component, the average consumption of a particular type of composition by different animals (e.g., based on species, weight, activity / energy requirements, etc.), and the manufacturing requirements of the composition.

[0066] In another aspect, the present disclosure provides a kit suitable for administering a food composition to an animal. Depending on the kit components, the kit includes one or more of the following components in separate containers in a single package or in separate containers in a virtual package: (1) one or more ingredients suitable for animal consumption; (2) instructions on how to combine the ingredients and other kit components to produce a composition that can be used to provide health benefits as described herein; (3) instructions on how to use the food composition to obtain such benefits; (4) one or more probiotics; (5) one or more inactivated probiotics; (6) one or more inactivated probiotic components that promote health benefits similar to or identical to probiotics, such as proteins, lipids, glycoproteins, etc.; (7) one or more prebiotics; (8) equipment for preparing or combining kit components to produce a composition suitable for administration to an animal; and (9) equipment for administering the combined or prepared kit components to an animal. In one embodiment, the kit contains one or more ingredients suitable for animal consumption. In another embodiment, the kit includes instructions on how to combine the ingredients to produce a composition that can be used to obtain health benefits as described herein.

[0067] When the kit includes a virtual package, the kit is limited to providing instructions in conjunction with one or more physical kit parts in a virtual environment. The kit contains enough components to obtain health benefits as described herein. Typically, the kit components can be mixed before the animal eats. The kit can contain kit components in any form in a variety of combinations and / or mixtures. In one embodiment, the kit includes a container for food for animal consumption. The kit may include additional items, such as equipment for mixing ingredients or equipment for holding mixtures, such as food bowls. In another embodiment, the food composition can be mixed with other nutritional supplements (such as vitamins and minerals) that promote animal health. Each component can be provided in a separate container in a single package, or in different packages, in the form of a mixture of each component. In one embodiment, the kit includes one or more other ingredients suitable for animal consumption. In one aspect, this type of kit may include instructions describing how to combine ingredients to form a food composition for animal consumption, typically by mixing ingredients or by applying optional additives to other ingredients to form a food composition, such as by spraying nutritional supplements on the food composition.

[0068] In another aspect, the present invention may provide a device for communicating information or instructions about one or more of the following: (1) using the food composition to obtain one of the health benefits described herein; (2) contact information for consumers to use when they have questions about the methods and compositions described herein; and (3) nutritional information about the food composition. The communication device can be used to provide guidance on the benefits of using the methods and compositions of the present invention and to communicate approved methods for administering the food composition to animals. The device includes one or more of a physical or electronic document, a digital storage medium, an optical storage medium, an audio presentation, an audiovisual display, or a visual display containing the information or instructions. In one aspect, the device can be selected from a displayed website, a visual display kiosk, a brochure, a product label, a package insert, an advertisement, a flyer, a bulletin, an audio tape, a video tape, a DVD, a CD-ROM, a computer readable chip, a computer readable card, a computer readable disk, a USB device, a FireWire device, a computer memory, and any combination thereof.

[0069] The present disclosure also contemplates a method for manufacturing a food composition. In one embodiment, the method for manufacturing a pet food composition may include blending mackerel oil and a preservative with at least one of protein, fat, and carbohydrate to form a food composition. In other aspects, the method for manufacturing a food composition may include one or more other ingredients suitable for animal consumption, such as protein, fat, carbohydrate, fiber, vitamin, mineral, probiotic, prebiotic, etc., and the method includes blending one or more ingredients in the ingredients suitable for animal consumption. The composition may be prepared according to any suitable method in the art, including blending, preconditioning, extrusion, emulsification, etc.

[0070] Additionally, methods of treating inflammatory disorders include administering to an animal a food composition containing mackerel oil, including any of those described herein.

[0071] In another aspect, the packaging that can be used to hold the composition as described herein may include at least one material suitable for holding food compositions and a label attached to the packaging, the label comprising one or more words, pictures, designs, acronyms, slogans, phrases or other patterns or combinations thereof, for indicating that the contents of the packaging include food compositions. In some embodiments, the label attached to the packaging comprises one or more words, pictures, designs, acronyms, slogans, phrases or other patterns or combinations thereof, for indicating that the contents of the packaging contain food compositions, and the food compositions have the beneficial properties associated with the health benefits as described herein. In one aspect, such patterns may include the words "for inflammation", "treatment of inflammation", "delayed onset of arthritis" or equivalent or similar expressions printed on the packaging. Any packaging configuration and packaging material suitable for holding the composition may be used herein, such as bags, boxes, bottles, jars, pouches, etc. manufactured by paper, plastics, foil, metal, etc. In one embodiment, according to the label, the packaging comprises a food composition suitable for a specific animal (such as humans, canines or felines), in one aspect, a companion animal food composition comprising a dog or cat. In one embodiment, the packaging can be a jar or a pouch comprising food compositions as described herein. In various embodiments, the packaging also includes at least one window, which allows to observe the package contents without opening the packaging. In some embodiments, the window can be a transparent portion of a packaging material. In other embodiments, the window can be a missing portion of a packaging material.

[0072] In further embodiments that will be apparent to those skilled in the art, mackerel oil may provide additional essential nutrients such as other essential fatty acids to help deliver the complete and balanced nutrition required by a cat or dog.

[0073] Example

[0074] The present invention can be further illustrated by the following examples, but it should be understood that these examples are included herein for illustrative purposes only and are not intended to limit the scope of the present invention unless otherwise specifically stated.

[0075] Example 1 - Pet food containing mackerel oil

[0076] The pet food is manufactured by blending the ingredients of Table 1 and then extruding to form kibbles. Optionally, the kibbles may be further coated and / or dried to provide increased palatability and / or moisture properties.

[0077] Table 1

[0078] Element weight% protein 20% to 65% carbohydrate 10% to 50% Fat 5% to 30% fiber 1% to 15% South Sea Mackerel Oil 0.1% to 10% Vitamins / Minerals 0.5% to 3% water 0% to 10%

[0079] The kibble can be administered to companion animals to provide a therapeutically effective amount of mackerel oil for providing a variety of health benefits to the animal, including inflammation, arthritis, irritated skin, swollen gums, allergies, asthma, autoimmune diseases, celiac disease, glomerulonephritis, hepatitis, inflammatory bowel disease, reperfusion injury, transplant rejection, gout, myositis, scleroderma, systemic lupus erythematosus, vasculitis, and / or psoriasis.

[0080] This specification has disclosed certain embodiments of the present invention. Although specific terms are used, these terms are used only in a general and descriptive sense and not for limiting purposes. The scope of the present invention is set forth in the claims. Obviously, many modifications and variations of the present invention are possible in accordance with the above teachings. Therefore, it should be understood that the present invention may be implemented in other forms than those specifically described within the scope of the appended claims.

Claims

1. A pet food composition for treating an inflammatory condition in a companion animal, the pet food composition comprising mackerel oil and a preservative.

2. The composition of claim 1, wherein the mackerel oil is present in the composition in an amount of about 0.1% to about 10%.

3. The composition of claim 1, wherein the mackerel oil comprises at least 30% omega-3 fatty acids and no more than 5% omega-6 fatty acids.

4. The composition of claim 1, wherein the mackerel oil comprises at least 3% eicosatetraenoic acid, at least 1% stearatetraenoic acid, at least 8% eicosapentaenoic acid, at least 15% docosahexaenoic acid, and at least 2% docosapentaenoic acid.

5. The composition of claim 1, wherein the composition further comprises protein in an amount of about 20% to about 50%.

6. The composition of claim 1, wherein the composition further comprises carbohydrates in an amount of about 5% to about 70%.

7. The composition of claim 1, wherein the composition further comprises fat in an amount of about 5% to about 40%.

8. The composition according to claim 1, wherein the composition is a staple food composition.

9. The composition of claim 1, wherein the composition is a supplement.

10. The composition of claim 1, wherein the inflammatory disorder is selected from the group consisting of inflammation, arthritis, irritated skin, swollen gums, allergies, asthma, autoimmune diseases, celiac disease, glomerulonephritis, hepatitis, inflammatory bowel disease, reperfusion injury, transplant rejection, gout, myositis, scleroderma, systemic lupus erythematosus, vasculitis, psoriasis.

11. The composition according to claim 1, wherein the composition is capable of treating a member selected from the group consisting of cancer, heart disease, diabetes, kidney disease and cognitive impairment.

12. A method of making a pet food composition, the method comprising blending mackerel oil and a preservative with at least one of a protein, a fat and a carbohydrate to form the pet food composition.

13. The method of claim 12, wherein the mackerel oil is present in the composition in an amount of about 0.1% to about 10%.

14. The method of claim 12, wherein the pet food composition is a staple food composition.

15. The method of claim 12, wherein the pet food composition is a supplement.