Low-fat food composition

Abstract

The present disclosure relates to a low-fat, specifically an ultra-low-fat, extruded food composition for a canine, wherein said food composition includes about 16 g / Mcal or less of fat, and wherein said food composition has a moisture content of at least about 15% by weight as fed.

Description

LOW-FAT FOOD COMPOSITIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to European patent application no. EP 24185060.1 , filed on June 27, 2024, which is incorporated herein by reference in its entirety.FIELD OF THE DISCLOSURE

[0002] The present disclosure relates to the field of food compositions for companion animals. In particular, the present disclosure relates to the field of low-fat food compositions, more particularly of ultra-low-fat food compositions.BACKGROUND OF THE DISCLOSURE

[0003] The management of primary or secondary hyperlipidaemia, pancreatitis, and protein losing enteropathy (PLE) in canines poses significant challenges in veterinary medicine.

[0004] The American Heart Association recommends people with hyperlipidemia to limit saturated fat to less than 6% of daily calories and minimizing the amount of trans fat eaten.

[0005] Management of hyperlipidaemia in pets, is generally achieved by administration of low-fat diets containing less than 25 g / Mcal of fat in association with or without lipid-lowering drugs (Xenoulis PG, Steiner JM. J Small Anim Pract. 2015;56:595-605).

[0006] It was demonstrated for the first time that a low-fat diet in dry form, such as the Royal Canin® Gastrointestinal Low-fat, USA, containing 18.6 g / Mcal of fat, was effective in 44% of the tested dogs with hypertriglyceridemia in reducing serum triglyceride and cholesterol concentrations and shifting the lipoprotein profiles toward those of non-hyperlipidemic dogs in affected dogs when being fed for at least 2 months duration (Xenoulis et al., J Vet Intern Med. 2020 Nov;34(6):2605-2616).

[0007] In dogs with pancreatitis dietary fat is thought to be a major stimulus for the pancreas to secrete digestive enzymes, which may worsen pancreatic inflammation. A low-fat dog food can promote pancreatic healing while still providing all the nutrition dogs need to heal. In dogs with history of repeated bouts of pancreatitis, veterinarian may recommend continuing to feed a low-fat dog food to prevent flare-ups.

[0008] As for PLE, dietary management entails reducing lymphatic pressure by decreasing fat consumption.

[0009] T raditional approaches for managing such disorders involve feeding dogs with low-fat food compositions to mitigate the risk of exacerbating these disorders. However, a subset of dogs does not respond adequately to commercially available low- fat formulas, necessitating alternative dietary interventions. Indeed, addressing the technical challenge of substantially decreasing fat levels in canine food compositions while maintaining palatability and texture is a significant undertaking. For instance, one particular obstacle encountered involved reducing emulsifier content in the formula of the food composition. While emulsifier aids in stabilizing the extrusion process, it also serves as a fat source, complicating the manufacturing process.

[0010] Consequently, owners often resort to home-cooked diets to achieve lower lipid content in their pet's food. While this option offers perceived benefits such as greater control over ingredients and alignment with personal philosophies regarding diet, it is fraught with drawbacks. Home-prepared diets are often time-consuming to prepare and may lack consistency in nutritional composition. The inability to ensure precise levels of essential nutrients, including protein, fat, and vitamins, raises concerns about long-term health implications, including nutritional deficiencies.

[0011] Consequently, there exists a need for canine food compositions with ultra- low-fat content, specifically formulated to address hypertriglyceridemia, lymphangiectasia, pancreatitis, and PLE in canines, especially dogs.

[0012] There remains a need for canine food compositions with ultra-low-fat content, specifically formulated to be palatant and well-tolerated in term of digestibility.

[0013] There remains a need for canine food compositions with ultra-low-fat content, specifically formulated to be easily manufactured, despite their low-fat content.

[0014] There remains a need for canine food compositions with ultra-low-fat content, specifically formulated to be less expensive than the commercialized low-fat food compositions.

[0015] Such formulations would alleviate the burden on owners while ensuring the dietary requirements of affected canines are met, ultimately improving their overall health and quality of life.

[0016] The present disclosure has for purpose to satisfy all or part of the abovementioned needs.SUMMARY OF THE DISCLOSURE

[0017] An aspect of the present disclosure relates to a low-fat, specifically an ultra-low-fat, extruded food composition for a canine, wherein said food composition includes about 16 g / Mcal or less of fat, and wherein said food composition has a moisture content of at least about 15% by weight as fed.

[0018] Specifically, one of the objectives of the present disclosure is to provide a well-tolerated and palatable food composition that can be fed to canine requiring a daily fat restriction. In particular, an objective of the present disclosure is to provide a well-tolerated and palatable food composition that can be fed to canine affected with a fat-dependent disease in particular hyperlipidemia, lymphangiectasia, pancreatitis or protein losing enteropathy (PLE).

[0019] As it demonstrated in the example section, an ultra-low-fat food composition with no more than 16 g / Mcal of fat remains of good palatability and highly digestible by canines, especially dogs. Such an ultra-low-fat food composition can have the ability to improve the health of companion animals that are affected with hyperlipidemia, lymphangiectasia, pancreatitis or protein losing enteropathy (PLE).

[0020] In some embodiments, the low-fat, specifically ultra-low-fat, extruded food composition as described herein can include about 15 g / Mcal or less of fat.

[0021] In some embodiments, the low-fat, specifically ultra-low-fat, extruded food composition as described herein can include about 13 g / Mcal or less of fat.

[0022] In some other embodiments, the low-fat, specifically ultra-low-fat, extruded food composition as described herein can include about 12 g / Mcal or less of fat.

[0023] In some embodiments, the low-fat, specifically ultra-low-fat, extruded food composition as described herein can have a moisture content from about 15% to about 60% by weight as fed.

[0024] In some other embodiments, the low-fat, specifically ultra-low-fat, extruded food composition as described herein can have a moisture content from about 15% to about 30% by weight as fed.

[0025] In some embodiments, the ulow-fat, specifically ultra-low-fat, extruded food composition as described herein can have a Metabolizable energy level of about 3500 Kcal / kg.

[0026] In some other embodiments, the low-fat, specifically ultra-low-fat, extruded food composition as described herein can have a Metabolizable energy level of about 3000 Kcal / kg.

[0027] In some embodiments, the low-fat, specifically ultra-low-fat, extruded food composition as described herein can have a water activity (aw) of at least about 0.7.

[0028] In some embodiments, the low-fat, specifically ultra-low-fat, extruded food composition as described herein can have a density from about 350 g / l and about 450 g / i.

[0029] In some embodiments, the low-fat, specifically ultra-low-fat, extruded food composition as described herein can have a pH from about 4 to about 5.

[0030] In some embodiments, the low-fat, specifically ultra-low-fat, extruded food composition as described herein can further include from about 120 g / Mcal to about 170 g / Mcal of starch.

[0031] In some other embodiments, the low-fat, specifically ultra-low-fat, extruded food composition as described herein can further include from about 130 g / Mcal to about 160 g / Mcal of starch.

[0032] In some embodiments, the low-fat, specifically ultra-low-fat, extruded food composition as described herein can include from about 10 g / Mcal to about 24 g / Mcal of at least one acid.

[0033] In some embodiments, the low-fat, specifically ultra-low-fat, extruded food composition as described herein can include an emulsifier in an amount of about 1 g / Mcal or less.

[0034] In some embodiments, the low-fat, specifically ultra-low-fat, extruded food composition as described herein can be a functional complement or a nutritionally complete and balanced food composition.

[0035] In some embodiments, the low-fat, specifically ultra-low-fat, extruded food composition as described herein can be a pellet, in particular a kibble.

[0036] According to a further aspect, the present disclosure also relates to a low- fat, specifically an ultra-low-fat, extruded food composition as described herein for use in a method for treating and / or preventing a fat-dependent disease in a companion animal in need thereof.

[0037] According to a further aspect, the present disclosure also relates to a low- fat, specifically an ultra-low-fat, extruded food composition as described herein for use as a medicament.

[0038] According to a further aspect, the present disclosure also relates to the use of a low-fat, specifically an ultra-low-fat, extruded food composition as described herein for the manufacture of a medicament for treating and / or preventing a fatdependent disease in a companion animal in need thereof.

[0039] According to a further aspect, the present disclosure also relates to a method for treating and / or preventing a fat-dependent disease in a companion animal in need thereof, the method comprising at least a step of administering a low-fat, specifically an ultra-low-fat, extruded food composition to the canine.

[0040] According to a further aspect, the present disclosure also relates to a low- fat, specifically an ultra-low-fat, extruded food composition as described herein for use in nutritional support of a companion animal having, or suffering of, a fat-dependent disease.

[0041] In some embodiments, a fat-dependent disease can consist of a hyperlipidemia, a lymphangiectasia, a pancreatitis and / or a protein losing enteropathy (PLE).

[0042] According to a further aspect, the present disclosure also relates to a method of manufacturing a low-fat, specifically an ultra-low-fat, extruded food composition as described herein, the method comprising at least a step of mixing all the ingredients of the low-fat, specifically ultra-low-fat, extruded food composition together under super-heated steam.DETAILED DESCRIPTION OF THE DISCLOSUREDefinitions

[0043] The terms used in this disclosure generally have their ordinary meanings in the art, within the context of this disclosure and in the specific context where each term is used. Certain terms are discussed below, or elsewhere in the specification, to provide additional guidance in describing the compositions and methods of the disclosure and how to make and use them.

[0044] Exemplary methods and food compositions are described below, although methods and food compositions similar or equivalent to those described herein can also be used in the practice or testing of the present disclosure. Further, unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular.

[0045] Numeric ranges are inclusive of the numbers defining the range. Accordingly, the terms defined immediately below are more fully defined by reference to the specification in its entirety.

[0046] As used herein, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “an ingredient” can include one ingredient or a mixture of two ingredients or more. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein.

[0047] The term “about”, as used herein, means within an acceptable error range for the particular value as determined by one of ordinary skill in the art, which will depend in part on how the value is measured or determined, i.e., the limitations of the measurement system. In general, the term “about” can modify a numerical value above and below the stated value by a variance of, for instance, 10 percent, up or down (higher or lower).

[0048] As used herein, the terms “comprise”, “comprising”, “include”, “including” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a food composition, a process or a method that includes or comprises a list of products, nutrients or steps which does not include only those products, nutrients or steps but can include other products, nutrients, or steps not expressly listed or inherent to such food composition, process or method. The term “consisting of” implies the inclusion of the stated element(s), to the exclusion of any additional nutrients or steps. The term “consisting essentially of” implies the inclusion of the stated elements, and possibly other element(s) where the other element(s) do not materially affect the basic and novel characteristic(s) of the disclosure. It is understood that the different embodiments of the disclosure using the term “including” or equivalent cover the embodiments where this term is replaced with “consisting of” or “consisting essentially of”.

[0049] In the detailed description herein, references to “embodiment,” “an embodiment,” “one embodiment,” “in some embodiments,” or any other variation thereof, indicate that the described embodiment(s) can include a particular nutrient, or steps, but every embodiment might not necessarily include the particular nutrients, or steps. Further, when a particular nutrient, or steps is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such nutrients, or steps in connection with other embodiments whether or notexplicitly described. After reading the description, it will be apparent to one skilled in the relevant art(s) how to implement the disclosure in alternative embodiments.

[0050] As used herein, the terms “animal” or “companion animal” can be used interchangeably to refer to domestic animals. In particular, a companion animal can refer to a canine. In some embodiments, a canine can be a dog.

[0051] As used herein, the term “canine” encompasses animals, including companion animals selected from recognized dog breeds (some of which are further subdivided), which may can include afghan hound, airedale, akita, Alaskan malamute, basset hound, beagle, Belgian shepherd, bloodhound, border collie, border terrier, borzoi, boxer, bulldog, bull terrier, cairn terrier, chihuahua, chow, cocker spaniel, collie, corgi, dachshund, dalmatian, doberman, English setter, fox terrier, German shepherd, golden retriever, great dane, greyhound, griffon bruxellois, Irish setter, Irish wolfhound, King Charles spaniel, Labrador retriever, lhasa apso, mastiff, newfoundland, old English sheepdog, papillion, Pekingese, pointer, pomeranian, poodle, pug, rottweiler, St. Bernard, saluki, samoyed, schnauzer, Scottish terrier, Shetland sheepdog, shih tzu, Siberian husky, Skye terrier, springer spaniel, West Highland terrier, whippet, Yorkshire terrier, etc.

[0052] As used herein, the term “food composition” means a product or a composition or a diet that is intended for consumption by a companion animal, in particular a canine. A food composition contains one or more ingredients in order to incorporate one or more nutrients. Nutrients of a food composition can be typically, without limitation, proteins, fibers, carbohydrates, fats, vitamins and / or minerals, which can be used in combination in the body of an organism to sustain growth, repair and / or vital processes and / or to furnish energy (defined with the metabolizable energy (ME)). Carbohydrates includes NFE (Nitrogen free extract). A food composition as disclosed herein can further contain additives, such as a carrier, a diluent, and / or an excipient. A diluent can encompass water or broth or stock. Broth can generally be made by simmering meat, such as chicken, beef or fish, or vegetables in water. Stock can generally be made by simmering bones in water, and eventually with vegetables and / or meat. An excipient can encompass antioxidants, flavors, prebiotics, probiotics or taurine. A carrier can encompass meat carriers (chicken, turkey, beef, fish, etc.), grainbased carriers (rice, corn, wheat, barley), and / or vegetable carriers (potatoes, sweet potatoes, peas, carrots). In some embodiments, a food composition as described hereincan be a functional complement or a nutritionally complete and balanced food composition. In some embodiments, a food composition as described herein can be in a form of an extruded food composition.

[0053] As used herein, the term “extruded” or “extrude” for a food composition means that the food composition has been processed by, such as by being sent through, an extruder. Specifically, the raw ingredients of the manufacture of a food composition are subjected to high temperature, pressure, and mechanical force within an extruder device. This process results in the transformation of the raw ingredients into a cohesive mass that is forced through a die to form the desired shape, such as without limitation a kibble. An extruded food composition results in a uniformly textured food composition. Any type of extruder can be used, non-limiting examples of which include single screw extruders and twin-screw extruders. As non-limitative example, an extruded food composition as described herein can be obtained by processes or methods described in the published patent applications US20170332667A1 or US20170332669A1. In some embodiments, a food composition as described herein can be a dry extruded food composition or a semi-moist extruded food composition.

[0054] As used herein, the term “low-fat” for a food composition refers to a food composition or a diet that includes a significantly lower fat content compared to a reference food composition or diet. A reference food composition can be a standard or conventional food composition within the same product category as the low-fat food composition, intended for the same animal, and optionally under the same animal brand. Generally, a low-fat food composition includes less than about 9% by weight of fat. Specifically, a food composition can be considered to have a low-fat content when (a) the food composition includes less than about 9% by weight of fat and has a moisture content of less than about 20% by weight as fed, or when (b) the food composition includes less than about 7% by weight of fat and has a moisture content from about 20% to about 65% by weight as fed or when (c) the food composition includes less than about 4% by weight of fat and has a moisture content of more than 65% by weight as fed (Association of American Feed Control Officials. (AAFCO) Official Publication Association of American Feed Control Officials Incorporated. Association of American Feed Control Officials, 2012). In particular, it can be considered that a low-fat food composition can refer to a food composition including less than about 25.7 g / Mcal of fat. Illustratively, presuming a dry matter energy density of about 3500 kcal / kg(according to NRC 2006), a food composition can be considered to have a low-fat content when (a) the food composition includes less than about 25,7 g / Mcal of fat and has a moisture content of less than about 20% by weight as fed, or (b) the food composition includes less than about 20 g / Mcal of fat and has a moisture content from about 20% and about 65% by weight or (c) the food composition includes less than about 11 .4 g / Mcal of fat and has a moisture content of more than 65% by weight.

[0055] As used herein, an “ultra low-fat” for a food composition refers that a food composition or a diet including about 5% by weight or less of fat. An ultra-low-fat food composition refers to a food composition including no more than about 16 g / Mcal of fat. Typically, an ultra-low-fat food composition is encompassed within the definition of a low-fat food composition.

[0056] As used herein, the expression “nutritionally complete and balanced” food composition means that the composition comprises all the essential nutrients in appropriate proportions to meet an animal's dietary requirements for maintaining overall health and well-being. A nutritionally complete and balanced food composition can maintain the body weight of the animal without significant change with the Body Condition Score (BCS). A nutritionally complete and balanced animal food composition ensures that the animal receives all the necessary nutrients for optimal health, minimizing the risk of nutritional deficiencies or imbalances that could lead to health issues over time. Specifically, a nutritionally complete and balanced food composition can contain all known required nutrients for the intended recipient of the food composition, in all appropriate amounts and proportions based, for example, on recommendations of recognized and competent authorities in the field of cat nutrition, such as the Association of American Feed Control Officials (AAFCO) or the European Pet Food Industry Federation (FEDIAF), for complete and balanced pet nutrition. Therefore, a nutritionally adequate diet is a diet with which said animal can be fed as the sole ration and is capable of sustaining life without additional food (except water). In some embodiments, a nutritionally complete and balanced food composition as described herein can include nutrients and / or ingredients that are formulated to contribute to the nutritional properties of the food composition.

[0057] As used herein, the term “functional complement” refers to a food composition which provides nutritional components that are important for health maintenance. These food compositions contain compounds that are biologically active or bioavailable, such as probiotics, amino acids, multivitamins, and antioxidants, andoften are found to be useful for the treatment of disease and disorders or the maintenance of normal health states. Functional complements are not nutritionally complete food compositions, meaning that a functional complement does not provide the complete and balanced nutritional requirements to a companion animal.

[0058] In the context of the present disclosure, an "ingredient" or “component” refers to any individual substance that is included in the formulation of a food composition. An ingredient can be of various types, such as sources of proteins, carbohydrates, fats, vitamins, minerals, flavorings, preservatives, and / or other additives. An ingredient can be a raw material, a raw material by-product, an additive and / or a nutritional supplement. The selection and combination of ingredients can be critical in producing a complete and balanced food composition.

[0059] As used herein the term “providing” includes selling, supplying, administering, or feeding an animal, in particular a canine.

[0060] As used herein, the term “weight percent” or “wt%” or “by weight” is meant to refer to the quantity by weight of a nutrient in a food composition as a percentage on a dry matter basis of the food composition, unless otherwise specified. The specified amount of nutrients included in a food composition as described herein represents the amount present in the total quantity of raw materials provided as sources of said nutrients for producing the said food composition.

[0061] The expression “dry matter basis” or “DM” must be interpreted as a method of expressing the concentration of a nutrient in a food composition by expressing its concentration relative to its dry matter content (the concentration remaining once the moisture has been taken out). At the opposite, the expression “as fed” must be interpreted as a method of expressing the concentration of a nutrient in a food composition by expressing its concentration in the state it is fed, which includes moisture. It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate embodiments, can also be provided in combination in a single embodiment. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single embodiment, can also be provided separately or in any suitable sub-combination.

[0062] The term “palatability” or “palatant” means a relative preference of a companion animal for one food composition compared to another food composition which are proposed to the animal at the same time. Palatability refers to the overall willingness of an animal to eat a certain food composition. Advantageously, but notnecessarily, palatability further refers to the capacity of the eaten food composition to satisfy the animal. Whenever an animal shows a preference, for example, for one of two or more food compositions, the preferred food composition is more “palatable”, and has “enhanced palatability”. The relative palatability of one food composition compared to one or more other food compositions can be determined, for example, in side-by- side, free- choice comparisons, e.g., by relative consumption of the food compositions, or other appropriate measures of preference indicative of palatability. It can advantageously be determined by a standard testing protocol in which the animal has equal access to both food compositions such as a test called “two-bowl test”. Such preference can arise from any of the animal’s senses, but typically is related to, inter alia, taste, aftertaste, smell, mouth feel and / or texture.

[0063] As used herein, the term “palatability enhancer” means any material useful for enhancing the attractiveness and / or palatability of a food composition to a companion animal. Thus, a palatability enhancer can contribute to initial food appeal, for a companion animal, by its smell or odor; and / or to continued consumption by its smell, its taste, its after-taste and / or its texture. A material that enhances the attractiveness and / or palatability of a food composition can be, but is not limited to, a composition, a compound or a raw material that is both compatible with the food composition during processing and packaging, and compatible with the companion animal after ingestion, such as that it does not cause any significant issues for the companion animal. Such a material can be chemically synthesized. For instance, such a material can include, but is not limited to, a flavor, a fragrance, a chemical molecule, an aroma, an extract (e.g. yeast), a digest, a hydrolysate (e.g. poultry liver), a source of protein (e.g., poultry meal), a source of carbohydrate (e.g. rice flour), an aromatic cocktail, an alcohol, a fat or the like. A palatability enhancer can be a single material or a blend of materials. In some embodiments, a palatability enhancer can refer to a material which can be presented in a liquid form, a jelly form, a foam form, an oily form, a gel form, a solid form, a patch form, a powder form, a tab, an encapsulated form or any other suitable presentation.

[0064] As used herein, the terms “treating” or “treatment” in the present disclosure refers to the administration of a food composition according to the disclosure with the purpose to treat, alleviate, relieve, alter, remedy, ameliorate, improve, or affect a disease, the symptoms of a disease, the likelihood of a disease, or to prevent or delay the onset of the symptoms, complications, or otherwise arrest or inhibit furtherdevelopment of a disease in a statistically significant manner. More particularly, “treating” or “treatment” encompasses any approach for obtaining beneficial or desired results in an animal afflicted with a disease. Beneficial or desired clinical results can encompass, but are not limited to, alleviation or amelioration of one or more symptoms or conditions associated with a disease; diminishment or reduction of the severity of a disease or symptoms related to the disease; maintaining the stability (preventing deterioration) of a disease; delaying the progression or slowing down the progression of a disease; minimizing the recurrence of a disease; and remission, whether partial or total and whether detectable or undetectable. In other words, “treatment” as used herein includes any cure, amelioration, or reduction of a disease or related symptom. A “reduction” of a disease, or symptoms of a disease, means decreasing of the severity or frequency of the disease or symptoms of the disease, or elimination of a disease or symptoms of the disease. In the context of the present disclosure, a disease can be a fat-dependent disorder or disease. In some particular embodiments, a fat-dependent disease can be hyperlipidemia, lymphangiectasia, pancreatitis and / or protein losing enteropathy (PLE).

[0065] As used herein, the terms “prevent” or “preventing” (and grammatical variants thereof) with respect to a disease relate to prophylactic treatment of a disease, e.g., in a dog suspected to have hyperlipidemia, or at risk for developing hyperlipidemia. Prevention may include, but is not limited to, preventing, or delaying onset or progression of a disease and / or maintaining one or more symptoms of a disease at a desired or sub-pathological level. The term “prevent” does not require the 100% elimination of the possibility or likelihood of occurrence of the event. Rather, it denotes that the likelihood of the occurrence of the event has been reduced in the presence of a composition or method as described herein. More particular, “prevent” or “preventing” refers to a decrease in the risk of occurrence of a fat-dependent gastrointestinal disorder or symptoms thereof in an animal. As indicated above, the prevention may be complete, i.e., no detectable symptoms or disease, or partial, such that fewer symptoms or less severity of fat-dependent gastrointestinal disorder are observed than would likely occur absent treatment.

[0066] As used herein, “fat-dependent disorder” refers to a disorder caused by or worsen by a dietary fat consumption, in particular a dietary fat comprising more than about 25 g / Mcal of fat. In some embodiments, a fat-dependent disorder can behyperlipidemia, lymphangiectasia, lymphangiectasia, pancreatitis and / or protein losing enteropathy.

[0067] As used herein, “hyperlipidemia” (also sometimes referred to as hyperlipoproteinemia) is a disturbance of lipid metabolism that results in an elevation in lipids in the blood, particularly triglycerides (triacylglycerides) and / or cholesterol. Among companion animals, the most clinically relevant type of hyperlipidemia is the finding of an excess concentration of triglycerides in the blood, hypertriglyceridemia (or hypertriacylglyceridemia). Secondary hyperlipidemia is the most common form in dogs, and it results from endocrine disorders (i.e., diabetes mellitus, hypothyroidism, and hyperadrenocorticism), pancreatitis, protein-losing nephropathy, cholestasis, obesity, as well as other conditions. The use of certain drugs can also be a causal factor. Primary hyperlipidemia is less common in dogs but particularly prevalent in certain breeds.

[0068] It should be understood that every maximum numerical limitation given throughout this specification includes every lower numerical limitation, as if such lower numerical limitations were expressly written herein. Every minimum numerical limitation given throughout this specification will include every higher numerical limitation, as if such higher numerical limitations were expressly written herein. Every numerical range given throughout this specification will include every narrower numerical range that falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[0069] All lists of items, such as, for example, lists of nutriment or ingredients, are intended to and should be interpreted as Markush groups. Thus, all lists can be read and interpreted as items “selected from the group consisting of’ the list of items “and combinations and mixtures thereof.”Units

[0070] As used herein, the amount of the ingredients of the food composition according to the present disclosure are generally expressed as weight per Meal (megacalories) consisting of a weight amount of the said component by unit of Metabolizable Energy (ME) level of the total food composition, unless specifically expressed otherwise (such as, without limitation, in % by weight as fed).

[0071] As used herein, “g / l” means grams per liter.

[0072] As used herein, the ME parameter is intended to represent the energy value of a food composition that is directly metabolized after consumption. Within thescope of the present disclosure, the ME value can be measured by any suitable method known in the art.

[0073] Illustratively, the ME value can be measured using feeding trial. In practice, the gross energy (GE) of the food composition is determined in the laboratory, and the amounts of food eaten by the animals are recorded. The feces and urine from the animals are collected, and the energy in each is determined and called fecal energy (FE) and urinary energy (DE), respectively. The ME is then calculated as:ME (kcal / kg) = [GE - (FE + UE)] I Kg of food consumed.

[0074] Alternatively, the ME value can be measured by standard mathematical methods, taking into account, depending on the method, the percentage of crude fat (CF), of crude protein (CP), of NFE (carbohydrates) and / or of Total Dietary Fibers (TDF) in the food composition. In practice each percentage is multiplied by its respective Atwater Factors. The resulting sum is then multiplied by 10. The mathematical method can be represented by the following formula:ME (kcal / kg) = 10 x [(3.5 x CP) + (8.5 x CF) + (3.5 x NFE)].

[0075] In some embodiments, the ME can be determined according to the predictive equation proposed by the National Research Council (NRC) in 2006 which is shown to be more accurate than previous ones for animal food composition.

[0076] In some particular embodiments of the disclosure, especially for canine, the ME, in kcal / 100g, can be calculated as:ME = GE x [96.6 - (0.95 x TDF x 100 / DM) ] / 100 - (1.04 x CP) orME = GE x [91.2 - (1.43 x CF x 1001 DM) ] / 100) - (1.04 x CP) with GE = (5.7 x CP) + (9.4 x CF) + [4.1 x (NFE + CF)]

[0077] In some embodiments, a food composition as disclosed herein can have a Metabolizable Energy (ME) ranging from about 2500 kcal / kg to about 5,000 kcal / kg, as measured according to the NRC 2006.

[0078] In some embodiments, a food composition as described herein can have a Metabolizable Energy (ME) ranging from about 3,000 kcal / kg to 5,000 kcal / kg, or from about 3,200 kcal / kg to about 4,800 kcal / kg, or from about 3,300 kcal / kg to about 4,500kcal / kg or from about 3,400 kcal / kg to about 4,000 kcal / kg, as measured according to the NRC 2006.

[0079] In some embodiments, a low-fat food composition as disclosed herein can have a Metabolizable Energy (ME) of about 3,000 kcal / kg, or about 3,100 kcal / kg, or about 3,200 kcal / kg, or about 3,300 kcal / kg, or about 3,400 kcal / kg, or about 3,500 kcal / kg, or about 3,600 kcal / kg, or about 3,700 kcal / kg, or about 3,800 kcal / kg, or about 3,900 kcal / kg, or about 4,000 kcal / kg, or about 4,100 kcal / kg, or about 4,200 kcal / kg, as measured according to the NRC 2006.

[0080] In some embodiments, a low-fat food composition as disclosed herein can have a Metabolizable Energy (ME) of about 3,500 kcal / kg, or 3,400 kcal / kg, or 3,300 kcal / kg, or 3,200 kcal / kg, or 3,100 kcal / kg, or 3,000 kcal / kg, as measured according to the NRC 2006.

[0081] When the amount of components in a food composition is expressed as a percentage (%), a skilled person can convert it into grams per megacalorie using the following formula: Multiply the percentage of the ingredient as fed by 10, then by 1000, and finally divide by the metabolizable energy (ME) of the food as determined by the NRC 2006. In other words, the formula for converting to grams per megacalorie is: X g / Mcal = (% as fed *10*1000) / ME NRC 2006.

[0082] Alternatively, a skilled person will also be able to convert an amount of components expressed in grams per megacalorie into a percentage with the above formula.Formulation of the low-fat food composition

[0083] The food composition as described herein is a low-fat food composition, specifically an ultra-low-fat food composition. In particular, said food composition is palatable and well-tolerated for a canine.

[0084] In some embodiments, the food composition as described herein is a canine food composition. In particular, the food composition as described herein is a dog food composition.

[0085] In some embodiments, the food composition as described herein can be a nutritionally complete and balanced food composition, specifically a nutritionally complete and balanced ultra-low-fat food composition.

[0086] In some embodiments, the food composition as described herein can be a functional complement, specifically an ultra-low-fat functional complement.

[0087] In some embodiments, the food composition as described herein can be a food snack, specifically an ultra-low-fat food snack. Non-limiting examples of food snack can include snack bars, chews, crunchy treats, cereal bars, snacks, biscuits and sweet products.

[0088] In some embodiments, the food composition as described herein can be an extruded food composition.

[0089] The food composition according to the disclosure is an ultra-low-fat food composition as it includes no more than about 16 g / Mcal of fat.

[0090] As used herein, the expression “no more than about 16 g / Mcal of fat” means that 16 g / Mcal or less of fat are included in the food composition as described herein.

[0091] In some embodiments, a food composition as described herein can include about 16 g / Mcal or less, or about 15 g / Mcal or less, or about 14 g / Mcal or less, or about 13 g / Mcal or less, or about 12 g / Mcal or less of fat.

[0092] In some embodiments, a food composition as described herein can include from about 5 g / Mcal to 16 g / Mcal of fat, or about 5 g / Mcal to 15 g / Mcal of fat, or about 5 g / Mcal to 14 g / Mcal of fat, or about 5 g / Mcal to 13 g / Mcal of fat, or about 5 g / Mcal to 12 g / Mcal of fat.

[0093] In some embodiments, a food composition as described herein can include about 16 g / Mcal, 15.5 g / Mcal, 15 g / Mcal, 14.5 g / Mcal, 14 g / Mcal, 13.5 g / Mcal, 13 g / Mcal, 12.5 g / Mcal, 12 g / Mcal, 11.5 g / Mcal, 11 g / Mcal, 10.5 g / Mcal, 10 g / Mcal, 9.5 g / Mcal, 9 g / Mcal, 8.5 g / Mcal, 8 g / Mcal, 7.5 g / Mcal, 7 g / Mcal, 6.5 g / Mcal, 6 g / Mcal, 5.5 g / Mcal or 5 g / Mcal of fat.

[0094] In some particular embodiments, a food composition as described herein can include about 11 g / Mcal, or about 11.1 g / Mcal, or about 11 .2 g / Mcal, or about 11 .3 g / Mcal, or about 11 .4 g / Mcal, or about 11 .5 g / Mcal, or about 11 .6 g / Mcal, or about 11 .7 g / Mcal, or about 11 .8 g / Mcal, or about 11 .9 g / Mcal, or about 12 g / Mcal of fat.

[0095] As used herein, the expressions “fat”, “crude fat”, or “source of fat” are intended to refer to any food-acceptable fat and / or oil including digestible, partially digestible and nondigestible fats or oils that are present in a food composition. The fat in accordance with the present disclosure can be indifferently in a fluid form and / or in a solid form. The composition according to the disclosure can include fat from animal origin and / or from vegetal origin. Fat can be supplied by any suitable source known by those skilled in the art.

[0096] In some embodiments, a source of fat can be selected from vegetal fat, animal fat, or mixtures thereof.

[0097] A suitable vegetal source of fat for the purpose of the instant disclosure can include, without limitation, wheat fat, soya oil, sunflower, safflower, rapeseed, olive, borage, flaxseed, peanuts, blackcurrant seed, cottonseed, germ, corn germ as well as oils derived from these and any combination thereof.

[0098] A suitable animal source of fat for the purpose of the instant disclosure can include, for example and without limitation, meat, meat by-products such as chicken fat, turkey fat, beef fat, duck fat, pork fat, lamb fat, fish oil, krill oil, seafood, dairy, eggs and combinations thereof.

[0099] The fat content of food compositions according to the instant disclosure can be determined by any method known in the art.

[0100] Illustratively, the fat content can include a source of linoleic acid, alphalinoleic acid, arachidonic acid, omega-6 fatty acids, omega-3 fatty acids, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and a mixture thereof (EPA+DHA).

[0101] The food composition as described herein can include emulsifier in an amount that does not exceed about 1 g / Mcal.

[0102] In some embodiments, the food composition as described herein can include about 1 g / Mcal or less, or about 0.95 g / Mcal or less, or about 0.90 g / Mcal or less, or about 0.85 g / Meal or less, or about 0.80 g / Mcal or less, about 0.75 g / Mcal or less, or about 0.70 g / Mcal or less, or about 0.65 g / Mcal or less, or about 0.60 g / Mcal or less, or about 0.55 g / Mcal or less, or about 0.50 g / Mcal or less of emulsifier.

[0103] In some embodiments, the food composition as described herein can include from about 1 g / Mcal to about 0.80 g / Mcal of emulsifier.

[0104] In some embodiments, the food composition as described herein can include about 0.85 g / Mcal of emulsifier.

[0105] Illustratively, an emulsifier can encompass, without limitation, soy lecithin, egg lecithin, monoglycerides, and / or diglycerides.

[0106] The food composition as described herein can include other ingredients to provide a food composition suitable for fed an animal, especially a canine. For instance, the food composition as described herein can further include, but is not limited to, starch, protein, TDF, carbohydrates, vitamins, mineral and / or some additives.

[0107] Accordingly, the amount of the other components shall be present in an adequate amount to ensure maintenance of lean body mass of the animal while not being toxic for the animal.

[0108] In some embodiments, the food composition as described herein can be coated or uncoated. In some embodiments, when the food composition as described herein is coated, the coating composition does not include an additional palatability enhancer and the core of the food composition can, or not, include additional palatability enhancer. In some other embodiments, when the food composition is uncoated, the food composition can include an additional palatability enhancer. In some embodiments, when the food composition is uncoated, the food composition does not include additional palatability enhancer.

[0109] In some other embodiments, the food composition as described herein does not include any additional palatability enhancer. In particular, the food composition as described herein does not include flavor enhancers or taste additives.

[0110] Starch

[0111] For the food composition of the present disclosure, fat needs to be restricted but it is necessary to have an energy density adapted to animal needs, which is one of the reasons why a high level of starch is targeted. In such ultra-low-fat composition according to the present disclosure, one particular aspect is to compensate the missing calories from the low level of fat by a higher level of starch.

[0112] The food composition as described herein can include from about 120 g / Mcal to about 170 g / Mcal of starch.

[0113] In some particular embodiments, the food composition as described herein can include from about 130 g / Mcal to about 170 g / Mcal, or about 135 g / Mcal to about 170 g / Mcal, or about 135 g / Mcal to about 160 g / Mcal, or about 140 g / Mcal to about 160 g / Mcal of starch.

[0114] In some particular embodiments, the food composition as described herein can include about 120 g / Mcal, or about 125 g / Mcal, or about 130 g / Mcal, or about 135 g / Mcal, or about 140 g / Mcal, or about 145 g / Mcal, or about 150 g / Mcal, or about 155 g / Mcal, or about 160 g / Mcal, or about 165 g / Mcal or about 170 g / Mcal of starch.

[0115] In a particular embodiment, the food composition as described herein can include a single source of starch.

[0116] As some particular specific embodiments, the said single source of starch can be rice.

[0117] As some particular specific embodiments, the said single source of starch can be a single rice source.

[0118] As some particular specific embodiments, the said single source of starch can be a combination of several rice sources.

[0119] In some embodiments, said source of starch can be any type of rice.

[0120] In some embodiments, a rice source can include rice, broken rice grain, rice flour, whole grain rice, or a combination thereof. In some particular embodiments, the rice source can include broken rice grain, rice flour, or a combination thereof.

[0121] As defined herein, broken rice grain is intended to mean grains of rice that would have been considered as non-compliant for human food, and this whatever the reason (appearance, color, integrity, etc.). Broken rice grains can have an average particle size of about 2mm to about 5mm.

[0122] As defined herein, rice flour is intended to mean thin flour which can be obtained by mechanical grinding and sieving of broken rice. Rice flour can have an average particle size of about 150 pm.

[0123] According to an embodiment of the disclosure, the rice source can include at least about 30% by weight of rice flour.

[0124] According to an embodiment of the disclosure, the source of rice can include at least about 40%, particularly at least 50%, and more particularly at least 60% by weight of rice flour.

[0125] According to a particular embodiment of the disclosure, the source of rice can include at least about 60% by weight of rice flour.

[0126] According to some embodiments, a composition of the disclosure does not include any starch from a source other than rice, and more particularly from tapioca, corn, barley or wheat.

[0127] Proteins

[0128] A food composition according to the present disclosure, specifically an ultralow-fat food composition, can contain one or more distinct source(s) of proteins. In some particular embodiments, the low-fat , specifically ultra-low-fat, food composition as described herein can include a single source of proteins.

[0129] The composition of the disclosure can include from about 50 g / Mcal to about 85 g / Mcal of proteins.

[0130] The protein content of the composition of the disclosure shall be high enough to ensure maintenance of lean body mass. In some embodiments, a composition according of the disclosure can include from about 50 g / Mcal to about 85 g / Mcal of proteins, hydrolysed or non-hydrolysed.

[0131] In some embodiments, the food composition as described herein can include about 50 g / Mcal, about 51 g / Mcal, about 52 g / Mcal, about 53 g / Mcal, about 54 g / Mcal, about 55 g / Mcal, about 56 g / Mcal, about 57 g / Mcal, about 58 g / Mcal, about 59 g / Mcal, about 60 g / Mcal, about 61 g / Mcal, about 62 g / Mcal, about 63 g / Mcal, about 64 g / Mcal, about 65 g / Mcal, about 66 g / Mcal, about 67 g / Mcal, about 68 g / Mcal, about 69 g / Mcal, about 70 g / Mcal, about 71 g / Mcal, about 72 g / Mcal, about 73 g / Mcal, about 74 g / Mcal, about 75 g / Mcal, about 76 g / Mcal, about 77g / Mcal, about 78 g / Mcal, about 79 g / Mcal, about 80 g / Mcal, about 81 g / Mcal, about 82 g / Mcal, about 83 g / Mcal, about 84 g / Mcal or about 85 g / Mcal of protein.

[0132] In some embodiments, the composition of the disclosure can include from about 55 g / Mcal to about 85 g / Mcal, and more particularly from about 60 g / Mcal to about 80 g / Mcal of protein.

[0133] Proteins which are suitable for the compositions of the disclosure can be from vegetal origin or animal origin.

[0134] As animal source of proteins, it can be generally mentioned, without limitation, poultry, chicken, chicken meal, lamb, lamb meal, fish, fish meal, meat and bone meal, meat by-products, meat meal, turkey, blood plasma, insects, bone marrow, feather or a combination thereof.

[0135] As vegetal source of proteins, it can be generally mentioned, without limitation, soybean meal, soy protein isolate, rice, soy protein concentrate, maize gluten, wheat gluten, gluten, tofu, green lentils, carrot, potato, beets, corn gluten meal, corn protein concentrate or a combination thereof.

[0136] In one embodiment, a composition of the disclosure does not include nonhydrolysed proteins such as non-limitative example, from wheat gluten, dried egg, beef, chicken, yeast, potatoe protein and pea protein.

[0137] In some embodiments, proteins can include hydrolysed proteins. In particular, proteins can include at least about 20%; or about 30%, or about 40%, or about 50%, or about 60%, or about 70% or about 80% of hydrolysed proteins.

[0138] In some embodiments, a hydrolysed proteins can be from a vegetal origin, such as soja. In some embodiments, hydrolysed proteins from an animal origin, such as from feather and particularly from poultry feather, can be used. In some embodiments, a source of protein can be a feather hydrolysate, in particular a poultry feather hydrolysate.

[0139] Methods to hydrolyze proteins are well-known in the art. A hydrolysate can be produced by any known chemical or enzymatic method, such as, in non-limiting example, methods disclosed in US 5,589,357, US 4,879,131 , US 5,039,532 or EP 1 236 405 B1 (incorporated herein by reference).

[0140] In some embodiments, the hydrolysed proteins can have a molecular weight from about 1 ,000 Da to about 15,000 Da.

[0141] As used herein, the hydrolysed proteins can have a molecular weight from about 1 ,000 Da, about 1 ,250 Da, about 1 ,500 Da, about 1 ,750 Da, about 2,000 Da, about 2,250 Da, about 2,500 Da, about 2,750 Da, about 3,000 Da, about 3,250 Da, about 3,500 Da, about 3,750 Da, about 4,000 Da, about 4,250 Da, about 4,500 Da, about 4,750 Da, about 5,000 Da, about 5,250 Da, about 5,500 Da, about 5,750 Da, about 6,000 Da, about 6,250 Da, about 6,500 Da, about 6,750 Da, about 7,000 Da, about 7,250 Da, about 7,500 Da, about 7,750 Da, about 8,000 Da, about 8,250 Da, about 8,500 Da, about 8,750 Da, about 9,000 Da, about 9,250 Da, about 9,500 Da, about 9,750 Da, about 10,000 Da, about 10,250 Da, about 10,500 Da, about 10,750 Da, about 11 ,000 Da, about 11 ,250 Da, about 11 ,500 Da, about 11 ,750 Da, about 12,000 Da, about 12,250 Da, about 12,500 Da, about 12,750 Da, about 13,000 Da, about 13,250 Da, about 13,500 Da, about 13,750 Da, about 14,000 Da, about 14,250 Da, about 14,500 Da, about 14,750 Da or about 15,000 Da.

[0142] In some embodiments, the hydrolysed proteins can have a molecular weight from about 1 ,000 Da to about 11 ,000 Da, and particularly from about 2,000 Da to about 5,000 Da.

[0143] Fibers

[0144] A food composition according to the present disclosure, specifically an ultra-low-fat food composition, can contain one or more distinct source(s) of fibers and type of fibers. Generally, a food composition as described herein includes a plurality of sources of fibers.

[0145] The food composition can include from about 5 g / Mcal to about 35 g / Mcal of total dietary fibers (TDF).

[0146] The total dietary fibers (TDF) are the remnants of edible plant cell wall polysaccharides, lignin, and associated substances resistant to hydrolysis by alimentary tract enzymes. As used herein, the dietary fiber represents the indigestible part of plant foods.

[0147] The most common dietary fibers are lignin, cellulose, hemicellulose, pectin and gums.

[0148] Dietary fibers suitable for a composition of the present disclosure can include lignin, cellulose, hemicellulose, pectin, gums, beta-glucans or a combination thereof.

[0149] Illustratively, a source of dietary fiber suitable for implementing a composition according to the instant disclosure can include without limitation, wheat, soy, sunflower, safflower, rapeseed, olive, borage, flaxseed, peanuts, blackcurrant seed, cottonseed, wheat, germ, corn germ as well as oils derived from these, chicken crude fat, turkey crude fat, beef crude fat, duck crude fat, pork crude fat, lamb crude fat, fish oil or any meat, meat by-products, seafood, fish by-products, dairy, eggs or a mixture thereof.

[0150] As used herein total dietary fibers can include soluble fibers and insoluble fibers. Without being binding it is commonly accepted that soluble fibers can be defined as being resistant to digestion and absorption in the small intestine and undergo complete or partial fermentation in the large intestine. Without being binding, it is commonly accepted that insoluble fibers can be defined as non-starch polysaccharides that are resistant to digestion and absorption in the small intestine, and resistant to fermentation in the large intestine.

[0151] In practice, a suitable source of soluble fibers, for the purpose of the instant disclosure, can be selected from beet pulp, guar gum, chicory pulp, chicory root, psyllium, pectin, blueberry, cranberry, squash, apples, oats, beans, citrus, barley, and peas.

[0152] Illustratively, a suitable source of insoluble fibers, for the purpose of the instant disclosure, can be selected from cellulose, whole wheat products, wheat oat, corn bran, flax seed, grapes, celery, green beans, cauliflower, potato skins, fruit skins, vegetable skins, peanut hulls, and soy fiber.

[0153] As used herein, from about 5 g / Mcal to about 35 g / Mcal of total dietary fibers (TDF) can include about 5 g / Mcal, about 6 g / Mcal, about 7 g / Mcal, about 8 g / Mcal, about 9 g / Mcal, about 10 g / Mcal, about 11 g / Mcal, about 12 g / Mcal, about 13 g / Mcal, about 14 g / Mcal, about 15 g / Mcal, about 16 g / Mcal, about 17 g / Mcal, about 18 g / Mcal, about 19 g / Mcal, about 20 g / Mcal, about 21 g / Mcal, about 22 g / Mcal, about 23 g / Mcal, about 24 g / Mcal, about 25 g / Mcal, about 26 g / Mcal, about 27 g / Mcal, about 28 g / Mcal, about 29 g / Mcal, about 30 g / Mcal, about 31 g / Mcal, about 32 g / Mcal, about 33 g / Mcal, about 34 g / Mcal or about 35 g / Mcal of total dietary fibers (TDF).

[0154] In some particular embodiments, a food composition as described herein may include from about 10 g / Mcal to about 30 g / Mcal of TDF.

[0155] Carbohydrates or NFE

[0156] As used herein, and as conventionally admitted in the art, the Nitrogen Free Extract (NFE) consists of the soluble carbohydrate fraction that is present in a food composition, specifically an ultra-low-fat food composition, disclosed herein.

[0157] NFE encompasses soluble polysaccharides, starch, gums, mucilages and pectin, if present in the said food composition.

[0158] Thus, as it is conventionally admitted in the art, NFE does not include the insoluble carbohydrate fraction within the crude fiber material that may, in some embodiments, be present in the said food composition.

[0159] Typically, the content of a food composition in Nitrogen Free Extract can be determined by subtracting the content of each of the other components (protein, fat, crude fiber, ash) from the whole dry matter of the said food composition.

[0160] NFE, or carbohydrates, may be supplied under any suitable source(s), as known in the art. A suitable source of NFE may be selected from oat fiber, cellulose, peanut hulls, beet pulp, parboiled rice, corn starch, corn gluten meal, and any combination of those sources. Grains supplying carbohydrate include, but are not limited to, wheat, corn, barley, and rice.

[0161] In an embodiment, the food composition according to the present disclosure can include from about 130 g / Mcal to about 190 g / Mcal of NFE. In an embodiment, the food composition according to the present disclosure can include from about 150 g / Mcal to about 180 g / Mcal of NFE. In some embodiments, the food composition according to the present disclosure can include about 150 g / Mcal, or about155 g / Mcal, , or about 160 g / Mcal, or about 165 g / Mcal, or about 170 g / Mcal, or about 175 g / Mcal, or about 180 g / Mcal of NFE.Moisture and texture of the food composition

[0162] The food composition as described, specifically an ultra-low-fat food composition, herein has a moisture content of at least about 15% by weight as fed.

[0163] Without wishing to be bound by any theory, it is believed that an elevated moisture content of a low-fat food composition can contribute to maintain a good palatability for the animal, specifically in a low-fat, specifically an ultra-low-fat food composition including no more than 16 g / Mcal of fat as described herein.

[0164] A process for determining the moisture content of a food composition can include at least the steps of (i) selecting a representative sample of the food composition, (ii) weighing the sample, (iii) then subjecting the sample to complete dehydration in a temperature-controlled oven, typically around 100°C (degree Celsius), until all water is evaporated, (iv) after cooling in a desiccator, weighing again the dehydrated sample. The moisture content is then calculated using the formula: Moisture Content (%) = [(Initial Mass - Mass after dehydration) / Initial Mass] x 100.

[0165] In some embodiments, a food composition as described herein can have a moisture content from about 15% to about 65% by weight as fed.

[0166] In some embodiments, a food composition as described herein can have a moisture content from about 15% to about 50%, or from about 15% to about 40%, or from about 20% to about 30% by weight as fed.

[0167] In some embodiments, a food composition as described herein can have a moisture content of about 15%, or about 16%, or about 17%, or about 18%, or about 19%, or about 20%, or about 21%, or about 22%, or about 23%, or about 24%, or about 25% or about 26%, or about 27%, or about 28%, or about 29%, or about 30% by weight as fed.

[0168] In some embodiments, a food composition as described herein can have a water activity (aw) of at least about 0.7.

[0169] As used herein, the term “water activity” refers to the ratio of the partial vapor pressure of water in a food composition divided by the standard state partial vapor pressure of water. Several methods, known to the skilled person, may be employed to measure the water activity including a resistive electrolytic, a capacitance or a dew point hygrometer. Most preferably, it is referred to the method prescribed by the InternationalStandard Method ISO 21087 relating to determining water activity in animal food and animal feeding stuffs.

[0170] In some embodiments, a food composition as described herein can have a water activity (aw) from about 0.7 to about 0.9.

[0171] In some embodiments, a food composition as described herein can have a water activity (aw) of about 0.7, or about 0.8, or about 0.9.

[0172] In some embodiments, a food composition as described herein is extruded.

[0173] The extruded food composition may have no ingredient applied after extrusion. Thus, in some embodiments, a food composition as described herein can be in an extruded food composition without a coating layer.

[0174] In some embodiments, a food composition as described herein can be a kibble.

[0175] In some embodiments, a food composition as described herein can be an uncoated kibble. Which means that the kibble is devoid of a coating layer.

[0176] A food composition as described herein can have a density comprised between about 350 grams per liter (g / l) to about 450 g / l.

[0177] Extrusion for the manufacture of a food composition can allow for precise control over the density of the final product by adjusting the processing parameters such as temperature or pressure.

[0178] In some embodiments, a food composition as described herein can have a density of about 355 g / l, or about 360 g / l, or about 365 g / l, or about 370 g / l, or about375 g / l, or about 380 g / l, or about 385 g / l, or about 390 g / l, or about 395 g / l, or about400 g / l, or about 405 g / l, or about 410 g / l, or about 415 g / l, or about 420 g / l, or about425 g / l, or about 425 g / l, or about 430 g / l, or about 435 g / l, or about 440 g / l, or about445 g / l, or about 450 g / l.

[0179] The pH of a food composition may change over time due to factors such as moisture absorption, enzymatic activity, and microbial growth. In the context of the present disclosure, a food composition as described herein can have a pH from about 4 to about 5.

[0180] Without wishing to be bound by any theory, a pH between about 4 to about 5 is crucial for maintaining the quality and safety of the low-fat food composition as described herein, as it can influence factors such as texture, palatability, and shelf life.

[0181] In some embodiments, a food composition as described herein can have a pH of about 4, or about 4.1 , or about 4.2, or about 4.3, or about 4.4, or about 4.5, or about 4.6, or about 4.7, or about 4.8, or about 4.9, or about 5.

[0182] Measuring the pH of a food composition is conventional for a skilled person in the food industry. Typically, it can be used a conventional pH meter.

[0183] Acids can be used to adjust the pH of the food composition to a level that is optimal in the present disclosure.

[0184] Thus, in some embodiments, the food composition as described herein can include at least one acid. In particular, an acid can be selected from, without limitation, lactic acid, malic acid, citric acid, gluconic acid, or a combination thereof.

[0185] In some embodiments, the acid can be lactic acid.

[0186] In some embodiments, the food composition as described herein can include from about 10 g / Mcal to about 24 g / Mcal, or from about 13 g / Mcal to about 20 g / Mcal, of at least one acid.

[0187] In some embodiments, the food composition as described herein can include about 13 g / Mcal, or about 14 g / Mcal, or about 15 g / Mcal, or about 16 g / Mcal, or about 17 g / Mcal, or about 18 g / Mcal, or about 19 g / Mcal, or about 20 g / Mcal of at least one acid.

[0188] In some particular embodiments, a food composition as described herein can consist of an extruded food composition. In some particular embodiments, an extruded food composition as described herein can consist of a dry extruded food composition or a semi-moist extruded food composition.

[0189] Typically, a semi-moist food composition is the final product of a process allowing a moisture content value that is intermediate between a dry food and a wet food. In some embodiments, the said process can include a step of adding a humectant agent.Manufacturing process

[0190] The present disclosure also relates to a method of manufacturing a low- fat, specifically an ultra-low-fat, food composition for a canine as defined above including at least a step of mixing all the ingredients together under super-heated steam.

[0191] "Superheated steam" or “Super-Heated Steam” refers to a state of water vapor that exists at a temperature higher than its boiling point at a given pressure, without the presence of liquid water.

[0192] Considering the low-fat content of the food composition and the role of fat in dog’s palatabil ity , the food composition as described herein can be produced at least part in the presence of Super-Heated Steam (SHS). Any process using super-heated steam can be used to produce a food composition according to the present invention. As non-limitative examples, a food composition as described herein can be obtained using a Super-Heated Steam (SHS) such as described in the published patent applications US8484933B2, US10006714B2, US8827671 B2, US20150367972A1 , US20170332667A1 , and / or US20170332669A1 , incorporated herein by reference.

[0193] In some particular embodiments, the method of manufacturing an extruded low-fat, specifically an ultra-low-fat, food composition as defined herein can include at least the steps of:(i) mixing one or more ingredients together, thereby obtaining a mixture;(ii) introducing the mixture into an extruder device;(iii) subjecting the mixture to super-heated steam within said extruder device to initiate cooking;(iv) extruding the cooked mixture through a die to form an extruded food composition;(v) drying said extruded food composition.

[0194]

[0195] The extruded product can be manufactured by providing a gaseous atmosphere (the air or specific gas environment around the mixture during manufacturing) with super-heated steam.

[0196] In some embodiments, the temperature of the gaseous atmosphere providing by the super-heated steam can be of about 100° C or more, or about 120° C or more, 140° C, or about 160° C or more, or about 180° C or more, or about 200° C or more, or about 220° C or more. In some embodiments, the temperature of the gaseous atmosphere providing by the super-heated steam can be from about 100°C to 500°C, or from about 100°C to 400°C, or from about 100°C to 300°C, or from about 100°C to 220°C, or from about 100°C to 200°C.

[0197] In some embodiments, the gaseous atmosphere during the manufacturing process can be at ambient atmospheric pressure (1 atm or about 101 .3 kilopascals), or lower than the ambient atmospheric pressure, or higher than the ambient atmospheric pressure.

[0198] In some embodiments, the gaseous atmosphere can be a mixture of a first component consisting of air and / or another gas, and a second component consisting of water vapor.

[0199] In some embodiments, the gaseous atmosphere can have a steam content of at least about 50% by weight, or about 60% by weight, or about 70% by weight, or about 80% by weight, or about 90% by weight, or about 95% by weight, or about 98% by weight, or about 99% by weight. The gaseous atmosphere can have an oxygen content of less than about 15% by volume, or about 10% by volume, or about 8% by volume, or about 5% by volume, or about 2% by volume or about 1% by volume.

[0200] In some embodiments, the drying step (v) can imply the use of superheated steam to reduce moisture content.

[0201] Illustratively, an extruder device that can be suitable for manufacturing a food composition as described herein can be the Wenger X-185 Extruder or the twin screws extruder Buhler 42. Any other extruder can be used by the person skilled in the art.

[0202] In some embodiments, the extruded food composition obtained from step (v) can have a kibble shape.

[0203] In some embodiments, the extruded food composition obtained from step (v) can have no ingredient applied after extrusion. Otherwise said, in some embodiments, the extruded food composition obtained from step (v) is uncoated.

[0204] In some embodiments, a coating layer can be applied on a part or the entire surface of the food composition, generally a kibble, to enhance flavor or palatability of the food composition. In some embodiments, the extruded food composition obtained from step (v) is optionally coated. The coating can be liquid, powder, or a combination thereof. The coating is generally applied using a spray system. In some embodiments, the coating does not include additional palatability enhancer.

[0205] In some embodiments, the extruded food composition obtained from step (v), either coated or uncoated, can be subsequently packaged for distribution.

[0206] The packaging may be a sealed package. The material of the package can be paper, card, plastic or foil and / or may be a tin, screw-topped jar or film pouch pack. The package can be hermetically sealed. One packaging can be vacuum packaging. The food product can be packaged under aseptic conditions (e.g. in thepresent of super-heated steam) or can be processed to achieve sterile conditions (e.g. by irradiation).Uses and methods of low-fat food compositions

[0207] The present disclosure further relates to a low-fat, specifically an ultra- low-fat, food composition according to the disclosure or obtained with the manufacturing method according to the disclosure for use in a method for treating and / or preventing a fat-dependent disease in a companion animal, specifically a canine, in need thereof.

[0208] The present disclosure also relates to a low-fat, specifically an ultra-low- fat, food composition according to the disclosure or obtained with the manufacturing method according to the present disclosure for use in nutritional support of a companion animal, specifically a canine, suffering from a fat-dependent disease.

[0209] The present disclosure also relates to a method for the treatment and / or the prevention of a fat-dependent disease, particularly hyperlipidemia, lymphangiectasia, pancreatitis, lymphangiectasia and / or protein losing enteropathy (PLE), comprising at least a step of administering to a companion animal, specifically a canine, in need thereof a low-fat food composition according to the present disclosure or obtained with the manufacturing method of the present disclosure.

[0210] Finally, the present disclosure further relates to a method for reducing the likelihood of occurrence of a fat-dependent disease in a companion animal, specifically a canine, said method including at least a step of providing to the companion animal a low-fat, specifically an ultra-low-fat, food composition according to the present disclosure or obtained with the manufacturing method of the present disclosure.

[0211] In some embodiments, the companion animal is affected by, or at risk to be affected by, a fat-dependent disease.

[0212] In some embodiments, the companion animal is not known to suffer from a fat-dependent disease.

[0213] In some embodiments, a low-fat, specifically an ultra-low-fat, food composition as described herein for its use can be formulated to be administered to the companion animal daily as part of its diet.

[0214] In some embodiments, the low-fat, specifically ultra-low-fat, food composition can be fed to a companion animal one or more times per day. For example,and not by way of limitation, the low-fat, specifically ultra-low-fat, food composition can be administered once, twice, three, four, five or more times a day.

[0215] In some embodiments, the low-fat, specifically ultra-low-fat, food composition as described herein can be fed to a companion animal thrice every day, twice every day, once every day or once every two days.

[0216] In some embodiments, the low-fat, specifically ultra-low-fat, food composition can be fed to a companion animal in a constant manner, e.g., where the companion animal fed on a constantly available supply of the low-fat, specifically ultra- low-fat, food composition.

[0217] In the field of companion animal nutrition, it is well-established that those skilled in the art possess the knowledge and expertise to adapt the formulation of a food composition to align with specific feeding recommendations for the target animal. For instance, if the recommendation specifies that a dog should be fed once a day, twice a day, and / or only on specific days of the week, the skilled person can readily modify the food composition accordingly.

[0218] In some embodiments, a low-fat, specifically an ultra-low-fat, food composition as described herein can be provided to the canine over a period of 3 months or more, or 4 months or more, or 5 months or more, or 6 months or more, or 7 months or more, or 8 months or more, or 9 months or more, or 10 months or more, or 11 months or more, or 12 months or more.

[0219] In some embodiments, a low-fat, specifically an ultra-low-fat, food composition as described herein can be provided to the animal during a longer period of time, such as during 12 months or more, or 18 months of more, or 24 months or more, either (i) according to a feeding schedule wherein the animal exclusively fed the food composition as described herein or (ii) according to a feeding schedule wherein the animal alternating the low-fat, specifically ultra-low-fat, food composition described herein and another food composition.EXAMPLES

[0220] The present assay demonstrates the palatability and the digestibility in a panel of dogs of an ultra-low-fat food composition according to the present disclosure. They also describe the ongoing clinical study aiming at demonstrating the efficacy of the ultra-low-fat formula in decreasing blood lipid level of dogs affected by severe hyperlipidemia.Example 1 : Palatability assay

[0221] The palatability of an ultra-low-fat food composition formula (test) was compared to the commercialized Royal Canin® Gastrointestinal low fat dry dog food (control). The number of animals used for the test is 32 dogs.Table 1 : Part of the key ingredients of the tested food compositions

[0222] The ultra-low-fat food composition formula was manufactured by performing the SHS technology, as described, for instance, in US20170332669A1 and US20170332667A1 , incorporated herein by reference.

[0223] The palatability of the test and control food compositions was measured using the “Two Bowl Test”.

[0224] In this assay test kibbles and the corresponding control kibbles were placed in their respective bowls and presented simultaneously to the animals. The bowls are left with the animal for a set duration of time, commonly 15 min to 30 min for dry dog food compositions. The amount of product offered in each bowl is the same.

[0225] A first assay was performed in the morning after an overnight fast and a second assay was performed in the afternoon changing the position of kibbles presentation.

[0226] Palatability was evaluated regarding the first consumed food composition (named “1 st choice”) and the first finished food composition (name “preferred product”). Each food composition is classified alongside the others as a function of its consumption. Thus, the possible results are preference for test kibble, control kibble or neither.

[0227] The results of the two-bowl test assessing palatability are presented on Table 2 below.Table 2: Two-bowl test results

[0228] All the 32 dogs tested ate the full portion proposed, corresponding to half of the daily ration for each dog. The two diets showed similar (no significant difference) palatability, even if dogs had a little preference (58% vs. 42%) for the test low-fat food composition formula.

[0229] Consequently, it has been shown that, contrary to the common knowledge of the person skilled in the art, the food composition of the disclosure is still palatable and appealing to dogs despite its very low amount of fat.Example 2: Digestibility assay

[0230] The digestibility assay was performed on a panel of 8 dogs. The dogs were fed the test ultra-low-fat food composition formula (as prepared in example 1 ) for 10 days in an amount for each dog calculated according to their weight and body condition score in order to cover the energy needs of each animal.

[0231] All animals included in the study were stool graded daily during the fecal collection phase thanks to the fecal score scale.

[0232] According to the consistency of their faeces, the faeces were separated into 5 categories: Inacceptable / soft, Acceptable / soft, optimal, Acceptable / Hard and Inacceptable / Hard.

[0233] . The results are reported in Table 3 (the percentage corresponds to the number of dogs present in each category, compared to the total number of dogs).Table 3: Details distribution of stool quarters for the panel of dogs

[0234] Results show that 95% of dogs had optimal or acceptable stool quality after been fed with the ultra-low-fat food composition for 10 days. Therefore, the results show that the ultra-low-fat food composition of the disclosure is well tolerated by the dogs and digestible.Example 3: Efficacy trial

[0235] The present example consists in an in-vivo efficacy trial to assess the efficacy of an ultra-low-fat composition in reducing hyperlipidemia in dogs affected by sever primary hyperlipidemia.

[0236] The study has a screening phase to identify suitable study dog participants investigating the inclusion and exclusion criteria, followed by experimental phase which only considers the suitable enrolled candidates.

[0237] During the screening phase, initial consultation of breeders occurs and once their agreement to potential enrolment of their dog for this research study is obtained, the associated screening phase can begin. The veterinarian performs a complete clinical examination, and blood sample collection after a 12-hour fasting period (sample set 1 ) which is used to investigate the presence of severehypertriglyceridemia and to identify at least twelve (12) suitable candidate dogs according to the inclusion / exclusion criteria. Diagnostic testing of this screening blood sample includes serum triglycerides, Complete Blood Chemistry (CBC), serum biochemistry profile, thyroid profile (i.e., total T4, cTSH, free T4 by equilibrium dialysis), baseline cortisol, serum bile acids concentrations and Spec cPL. Dogs with primary hypertriglyceridemia, defined as serum triglycerides over 300 mg / dL, that meet all the criteria for enrollment mentioned below will be chosen to continue with the study.

[0238] Two (2) to four (4) weeks later, twelve (12) of the dogs identified with severe primary hypertriglyceridemia are subject to another clinical examination. A blood, urine and a first fecal sample after a 12-hour fasting period (sample set 2) is collected to confirm the results obtained in phase 1 and to investigate the variability of hypertriglyceridemia over time.

[0239] Of those dogs, where the results of sample set 2 confirmed severe primary hypertriglyceridemia, twelve (12) dogs are provided with the experimental diet.

[0240] Owners are instructed to gradually change their dogs’ current diet to the newly assigned study diet over the duration of 4-7 days.

[0241] After the dogs received the experimental diet for the duration of 4 weeks, a third clinical examination is performed, and a third blood sample after a 12-hour fasting period are collected.

[0242] About eight (8) weeks after the beginning of the study, a fourth clinical visit is performed, and a blood and fecal sample after a 12-hour fasting period are collected.

[0243] Recruitment of dogs into this trial is ongoing. This is a multicentric study, including dogs from six (6) different European countries: Greece, Romania, Croatia, Czech Republic, Austria and France.

[0244] The initial finding of this study indicates that the prevalence of hyperlipidemia in the examined European countries is lower than the previously estimated 30% observed in the United States (Xenoulis PG, Suchodolski JS, Levinski MD, Steiner JM. J Vet Intern Med. 2007 Nov-Dec;21 (6):1224-30).

[0245] In this study, out of 164 dogs screened, only four (4) had hyperlipidemia. For this reason, the recruitment is taking longer than expected. Out of the four dogs included, two completed the 8-week follow-up while two are currently ongoing.

[0246] In the four dogs tested, the low-fat composition of the disclosure is effective in reducing the level of blood triglycerides after 4 weeks (Table 4).Table 4: Details distribution of stool quarters for the panel of dogsConclusion

[0247] Despite the low prevalence, the trial demonstrated promising results. In the four dogs tested, the ultra-low-fat composition of the present disclosure effectively reduced blood triglyceride levels after 4 weeks of dietary intervention. Specifically, Dog 1 showed a reduction from 224 mg / dL to 170 mg / dL, Dog 2 from 600 mg / dL to 166 mg / dL, Dog 3 from 504 mg / dL to 326 mg / dL, and Dog 4 from 340 mg / dL to 239 mg / dL. These results suggest that the experimental diet significantly lower triglyceride levels in dogs with severe primary hyperlipidemia.

[0248] Overall, the study provides evidence supporting the efficacy of the ultra- low-fat composition in treating hyperlipidemia in dogs.REFERENCESXenoulis PG, Steiner JM. Canine hyperlipidaemia. J Small Anim Pract. 2015;56:595-605Xenoulis PG, Cammarata PJ, Walzem RL, Suchodolski JS, Steiner JM. Effect of a low-fat diet on serum triglyceride and cholesterol concentrations and lipoprotein profiles in Miniature Schnauzers with hypertriglyceridemia. J Vet Intern Med. 2020 Nov;34(6):2605-2616US20170332667US20170332669A1US 5,589,357US 4,879,131US 5,039,532EP 1 236 405 B1US8484933B2US10006714B2US8827671 B2US20150367972A1Xenoulis PG, Suchodolski JS, Levinski MD, Steiner JM. Investigation of hypertriglyceridemia in healthy Miniature Schnauzers. J Vet Intern Med. 2007 Nov- Dec;21 (6): 1224-30. doi: 10.1892 / 07-051.1. PMID: 18196730.

Claims

CLAIMS1 . A low-fat extruded food composition for a canine, wherein said food composition includes about 16 g / Mcal or less of fat, and wherein said food composition has a moisture content of at least about 15% by weight as fed.

2. The low-fat food composition according to claim 1 , wherein said food composition includes about 13 g / Mcal or less, preferentially about 12 g / Mcal or less, of fat.

3. The low-fat food composition according to claim 1 or 2, wherein said food composition has a moisture content comprised from about 15% to about 60% by weight as fed, preferentially from about 15% to about 30% by weight as fed.

4. The low-fat food composition according to any one of the preceding claims, wherein said food composition has a Metabolizable energy level of about 3500 Kcal / kg, preferentially about 3000 Kcal / kg.

5. The low-fat food composition according to any one of the preceding claims, wherein said composition has a water activity (aw) of at least about 0.7.

6. The low-fat food composition according to any one of the preceding claims, wherein said composition has a density from about 350 g / l to about 450 g / L7. The low-fat food composition according to any one of the preceding claims, wherein said food composition has a pH from about 4 to about 5.

8. The low-fat food composition according to any one of the preceding claims, further including from about 120 g / Mcal to about 170 g / Mcal of starch.

9. The low-fat food composition according to any one of the preceding claims, wherein said food composition includes from about 10 g / Mcal to about 24 g / Mcal of at least one acid.

10. The low-fat food composition according to any one of the preceding claims, wherein said food composition includes an emulsifier in an amount of about 1 g / Mcal or less.

11. The low-fat food composition according to any one of the preceding claims, wherein said food composition is a nutritionally complete and balanced food composition.

12. The low-fat food composition according to any one of the preceding claims, wherein said food composition is a kibble.

13. The low-fat food composition according to any one of the preceding claims, for use in a method for treating and / or preventing a fat-dependent disease in a companion animal in need thereof, in particular the fat-dependent disease consists of hyperlipidemia, lymphangiectasia, pancreatitis and / or protein losing enteropathy (PLE).

14. The low-fat food composition according to any one of the preceding claims, for use in nutritional support of a companion animal having a fat-dependent disease, in particular hyperlipidemia, pancreatitis, lymphangiectasia and / or protein losing enteropathy (PLE).

15. A method of manufacturing a low-fat extruded food composition for a companion animal as defined in any one of claims 1 to 12, comprising at least a step of mixing all the ingredients together under super-heated steam.

16. A method for the treatment and / or the prevention of a fat-dependent disease comprising at least a step of administering to a companion animal in need thereof a low- fat food composition according to any one of claims 1 to 11 or thereof a low-fat food composition obtained with the manufacturing method of claim 15.

17. The method of claim 16, wherein the fat-dependent disease consists of hyperlipidemia, lymphangiectasia, pancreatitis, lymphangiectasia and / or protein losing enteropathy (PLE).

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