Low fat hypoallergenic food compositions for companion animals

Abstract

The present disclosure provides a low-fat, low-sensitization, comprehensive nutritional food composition for a companion animal, comprising: from about 50 to about 80 g / Mcal of a protein comprising at least about 80% of hydrolyzed protein; from about 120 to about 180 g / Mcal of a starch, said starch being from at least one rice source; a total dietary fiber (TDF) of from about 10 to about 30 g / Mcal; and less than about 25 g / Mcal of fat. The compositions may be used in companion animals suffering from food adverse reactions (AFR), such as nutritional support for companion animals suffering from hyperlipidemia, lymphangiectasia or any form of fat intolerance, fat malabsorption and / or chronic bowel disease.

Description

[0001] 1. Cross-references to related applications

[0002] This application claims priority to European Patent Application No. 23167128.0, filed on 6 April 2023, the contents of which are incorporated herein by reference in their entirety. 2. Technical Field

[0004] This disclosure relates to low-fat, low-allergenic nutritional food compositions for achieving fat restriction in companion animals suffering from adverse food reactions (AFR), such as in cases of hyperlipidemia, lymphangiectasia or any form of fat intolerance, fat malabsorption and / or nutritional support for chronic enteropathy, particularly in cases of protein-losing enteropathy. 3. Background Technology

[0006] Protein-losing enteropathy (PLE) is a syndrome of excessive loss of intestinal protein secondary to diseases affecting the intestinal mucosa and surrounding structures. Although the exact mechanisms leading to protein loss are not well described in veterinary medicine, it may result from altered intestinal permeability, direct mucosal erosion or ulceration with altered lymphatic function, and direct loss of protein-rich lymph.

[0007] Although there are many potential causes of PLE, idiopathic inflammatory bowel disease and intestinal lymphangiectasia (IL) are considered the most common causes of PLE in dogs.

[0008] Nutritional management is considered a pillar of treatment in patients with PLE. Dietary therapy is equally important in dogs with PLE. While novel or hydrolyzed protein diets are generally recommended for dogs with inflammatory bowel disease (IBD), strict fat restriction is typically advised for dogs with IL. Therefore, dietary choices can be challenging when managing patients with histopathological evidence of both IBD and lymphangiectasia, as commercially available hydrolyzed diets often contain significantly more fat than those typically recommended for dogs with lymphangiectasia.

[0009] US Patent Publication No. 2017 / 0332669 discloses an extruded packaged pet food product for use in a low-fat diet. Notably, this disclosure does not teach a low-allergenic diet using hydrolyzed protein. European Patent Application No. 3 639674 discloses a low-allergenic pet food having a limited, at most 30% by weight starch content, wherein the lower starch content is associated with a lower energy density.

[0010] Therefore, there is still a need for nutritionally complete food compositions suitable for companion animals, which combine one or more dietary restrictions, including low-fat and low-allergenic diets.

[0011] In particular, a nutritionally complete food composition that is still low in fat but can also be recommended for companion animals that require a hydrolyzed protein diet (such as animals with food adverse reactions) is still needed.

[0012] There is also a need for nutritionally complete food compositions that are low in allergens and fat and can be recommended for companion animals with hyperlipidemia.

[0013] There is also a need for nutritionally complete food compositions that are low in allergens and fat and can be recommended for companion animals with fat intolerance or poor fat assimilation.

[0014] In particular, while such a nutritionally complete food composition is low in fat, it should remain palatable, well tolerated by pets, and easy to produce. 4. Summary of the Invention

[0016] According to a first aspect, this disclosure relates to a low-fat, low-allergenic, nutritionally complete food composition for companion animals, comprising: about 50 g / Mcal to about 80 g / Mcal of protein, said protein comprising at least about 80% hydrolyzed protein; about 120 g / Mcal to about 180 g / Mcal of starch, said starch being derived from at least one rice source; about 10 g / Mcal to about 30 g / Mcal of total dietary fiber (TDF); and less than about 25 g / Mcal of fat.

[0017] According to another aspect, this disclosure relates to a method for manufacturing a low-fat, low-allergenic, nutritionally complete food composition for companion animals, the method comprising at least the step of mixing all the ingredients together.

[0018] According to another aspect, this disclosure relates to a low-fat, low-allergenic nutritionally complete food composition according to this disclosure or obtained by the methods of this disclosure, for use in providing nutritional support to companion animals suffering from adverse food reactions.

[0019] This disclosure further relates to low-fat, low-allergenic nutritionally complete food compositions according to or obtained by methods according to this disclosure, for use in providing nutritional support to companion animals suffering from fat intolerance and / or fat assimilation disorders.

[0020] On the other hand, it relates to low-fat, low-allergenic nutritionally complete food compositions according to the present disclosure or obtained by the methods according to the present disclosure, for use in providing nutritional support to companion animals suffering from hyperlipidemia. 5. Detailed Implementation

[0022] One of the purposes of this disclosure is to provide new, well-tolerated dietary food compositions that can be fed to companion animals that require more than one dietary restriction, including low-fat and low-allergenic diets.

[0023] For clarity and not limitation, this detailed description is divided into the following sub-sections:

[0024] 5.1 Definition

[0025] 5.2 units

[0026] 5.3 Low-fat, low-allergenic food compositions

[0027] 5.4 Uses and methods for preparing low-fat, low-allergenic food compositions

[0028] 5.1. Definition

[0029] Within the context of this subject matter and in the specific context in which each term is used, the terms used herein generally have their common meaning in the art. Certain terms are defined below to provide additional guidance in describing compositions and methods of the disclosed subject matter and how to prepare and use such compositions and methods.

[0030] Unless the context clearly specifies otherwise, the singular forms “an” and “the” as used in the specification and appended claims include plural indicators. Thus, for example, a reference to “compound” includes mixtures of compounds.

[0031] As used herein, the terms “about” or “approximately” mean within an acceptable margin of error for a particular value as determined by one of ordinary skill in the art, depending in part on how that value was measured or determined. Right now Limitations of the measurement system. For example, according to practice in the art, “about” can mean within three or more standard deviations. Alternatively, “about” can mean a range of up to 10%, more preferably up to 5%, and even more preferably up to 1% of a given value.

[0032] As used herein, the terms “comprising,” “including,” “containing,” “having,” or any other variation thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but may include other elements not explicitly listed or inherent to such a process, method, article, or apparatus.

[0033] In the detailed description of this article, the terms "implementation plan," "an implementation plan," "one implementation plan," and "in various implementation plans" are used interchangeably. waitThe references indicate that the described embodiments may include specific features, structures, or characteristics, but not every embodiment necessarily includes such features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiment. Moreover, when a specific feature, structure, or characteristic is described in connection with an embodiment, whether explicitly stated or not, it is assumed that the influence of such feature, structure, or characteristic on other embodiments is within the knowledge of those skilled in the art. After reading this specification, those skilled in the art will understand how to implement this disclosure in alternative embodiments.

[0034] As used herein, “companion animal” or “pet” refers to domestic or wild animals. In some implementations, it may refer to canines, including dogs, or felines, including cats.

[0035] As used herein, the term "feline" encompasses animals including cheetahs, cougars, jaguars, leopards, lions, lynxes, ligers, tigers, black panthers, lynxes, leopard cats, saber-toothed tigers, karakkales, servals, and pet cats. As used herein, cats include wildcats and domestic cats. In a particular embodiment, the cat is a domestic cat.

[0036] As used herein, the term "canines" encompasses animals including pets selected from recognized breeds (some of which are further subdivided), such as Afghan Hounds, Irish Terriers, Akitas, Alaskan Malamutes, Basset Hounds, Beagles, Belgian Shepherds, Bloodhounds, Border Collies, Border Terriers, Russian Wolfhounds, Boxers, Bulldogs, Bull Terriers, Cairn Terriers, Chihuahuas, Chow Chows, Cocker Spaniels, Collies, Corgis, Dachshunds, Dalmatians, Doberman Pinschers, English Setters, and Fox Terriers. German Shepherd, Golden Retriever, Great Dane, Greyhound, Brussels Griffon, Irish Setter, Irish Wolfhound, Cavalier King Charles Spaniel, Labrador Retriever, Lhasa Apso, Mastiff, Newfoundland, Old England Shepherd, Papillon, Pekingese, Pointer, Pomeranian, Poodle, Pug, Rottweiler, Saint Bernard, Saluki, Samoyed, Schnauzer, Scottish Terrier, Shetland Sheepdog, Shih Tzu, Siberian Husky, Skye Terrier, Springer Spaniel, West Highland White Terrier, Whippet, Yorkshire Terrier, etc.

[0037] As used herein, the terms "food composition" or "diet" encompass all food ingredients, diets, foods, or materials that may contain protein, carbohydrates, and / or crude fat. Foods may also contain supplements or additives, such as minerals, vitamins, and flavorings. Such food compositions can be nutritionally complete. In certain embodiments, the food composition according to this disclosure is a nutritionally complete food composition.

[0038] As used herein, the term "wet food" or "wet food composition" generally refers to a food composition having a moisture content of about 30% by weight or more (typically greater than about 40% by weight) relative to the total weight of the food composition. In some embodiments, the wet food composition may have a moisture content of less than about 90% by weight relative to the total weight of the food composition. Typically, it is the final product of a process that includes a final sterilization step rather than a final drying step. In some embodiments, the wet food is composed of chunks, more specifically chunks in gravy. In some embodiments, the wet food is composed of chunks and gravy, chunks in jelly, loaf, mousse, terrine, or bite.

[0039] "Large chunks and gravy" products include pre-made meat granules prepared by making minced meat, passing it under pressure through a nozzle, and subsequently cooking it. Cooked meat or other products are cut into large chunks, which are then mixed with gravy or sauce. The two components are then filled into a container (usually a jar or bag), which is sewn or sealed and sterilized. Unlike ground loaf, the large chunks and gravy composition is prepared with physically separated, discrete large chunks ( Right now (Meat flakes and cereal flakes). These discrete particles exist in the gravy-type liquid in the final container. When served, chunks and gravy products flow out of the can and can be easily mixed with other dry products. While chunks and gravy products offer better integrity for individual ingredients, their heterogeneous formulation is sometimes unpopular with consumers.

[0040] Wet food compositions are typically packaged in canned containers and are perceived as “wet” due to their moisture content. Two types of wet compositions are well known in the art. The first is referred to in the art as “ground meat cake.” Meat cake products are typically prepared by contacting a mixture of components under heat to produce a substantially homogeneous intracellular honeycomb-like mass, or “ground meat cake.” The ground meat cake mass is then packaged into cylindrical containers, such as cans. When packaged, the ground meat cake is shaped like a container, so that it must be cut open when provided to companion animals.

[0041] In some embodiments, the wet food composition may be packaged. In this way, consumers can identify the ingredients of the food product from the packaging and confirm that it is suitable for the specific pet in question. The packaging may be metal, plastic, paper, or cardboard.

[0042] As used herein, the term "dry food" or "dry food composition" generally refers to a food composition having a moisture content of less than about 12% by weight (and typically less than about 7% by weight) relative to the total weight of the food composition. In some embodiments, the dry food according to this disclosure may have a moisture content of up to about 12% by weight. In some embodiments, the dry food may have a moisture content of about 7% by weight or less (such as about 5% by weight). In some embodiments, the dry food may have a moisture content of more than about 3% by weight relative to the total weight of the food composition. For example, the embodiments provided herein illustrate a dry food having a moisture content of about 9.5% by weight relative to the total weight of the food composition. In some embodiments, the dry food may be in the form of a coarsely ground food. In some embodiments, such as, but not limited to, coarsely ground food may include pellets, pellets, pet food chunks, dehydrated meat, meat analogues, vegetables, and combinations thereof. In some embodiments, such as, but not limited to, coarsely ground food may include pet treats, such as dried meat or vegetables, raw hides, and biscuits.

[0043] Dry food compositions can be made by mixing and kneading ingredients together to create a consistent, cookable dough. Typically, it can be the final product of a process that includes an extrusion step followed by a drying step. The production process of dry pet food can often be accomplished through baking and / or extrusion. The dough is typically fed into a machine called an expander and / or extruder, which uses pressurized steam or hot water to cook the ingredients. While inside the extruder, the dough is subjected to extreme pressure and high temperatures. The dough can then be pushed through a mold (holes of a specific size and shape) and cut with a knife. The expanded dough blocks are then processed into dry foods (such as coarse-ground foods) by passing them through a dryer, which reduces the moisture content to a predetermined target, ensuring the food's stability until consumption. The product / coarse-ground food can then be coated with fats, oils, minerals, vitamins, a mixture of natural extracts, flavorings, and optionally sealed in packaging.

[0044] As used herein, the term "coarse abrasive" includes pellets such as components of animal feed (e.g., dog and cat food), typically having a moisture or water content of less than 12% by weight relative to the total weight of the coarse abrasive. The texture of coarse abrasive can vary from hard to soft. The internal structure of coarse abrasive can vary from expanded to dense. Coarse abrasive can be formed by an extrusion process. For example, coarse abrasive can be formed from a core and a coating to create coated coarse abrasive, also known as coated coarse abrasive. It should be understood that when the term "coarse abrasive" is used, it can refer to uncoated coarse abrasive or coated coarse abrasive.

[0045] The production process of dry food is typically accomplished through baking and / or extrusion. Dough is usually fed into a machine called an expander and / or extruder, which uses pressurized steam or hot water to cook the ingredients. While inside the extruder, the dough is subjected to extreme pressure and high temperatures. The dough is then pushed through a mold (holes of a specific size and shape) and cut with a knife. The expanded dough blocks are then processed into coarse grinders by passing them through a dryer, which reduces the moisture content to a predetermined target, thus ensuring the food's stability until consumption. The coarse grinders can then be coated with a mixture of fats, oils, minerals, vitamins, and natural extracts, and optionally sealed in packaging. In some embodiments, the dry food composition is packaged. In this way, consumers can identify the ingredients of the food product from the packaging and confirm that it is suitable for the specific pet in question. For example Dog. Packaging can be metal, plastic, paper, or cardboard.

[0046] In a particular embodiment, the composition is a dry food composition, especially in the form of a coarsely ground food.

[0047] As used herein, the term "semi-moist food" or "semi-moist food composition" generally refers to a food composition having an intermediate moisture content of about 12% to about 30% by weight relative to the total weight of the food composition. Therefore, such a semi-moist food composition is generally the final product of a process that allows moisture content values ​​between those of dry and wet foods. In some embodiments, the process may include a step of adding a humectant. In some embodiments, the process may include an extrusion step and a subsequent superheated steam (SHS) treatment step. In some embodiments, the semi-moist food according to this disclosure may contain more than about 12% by weight and at most about 30% by weight of moisture relative to the total weight of the food composition. In some embodiments, the semi-moist food composition may have about 11% to about 20% by weight of moisture and / or about 0.64 to about 0.75 water activity relative to the total weight of the food composition. In some embodiments, the semi-moist food composition may have about 11% to about 20% by weight of moisture and about 0.64 to about 0.75 water activity relative to the total weight of the food composition.

[0048] As used herein, the term "hypoallergenic food composition" refers to a composition that produces substantially limited or no allergic reactions upon consumption. The hypoallergenic food compositions disclosed herein can be dry or wet food compositions. In particular, hypoallergenic food compositions can be dry food compositions.

[0049] In this disclosure, the terms "hypoallergenic nutritionally complete dry food composition", "food composition" and "composition" may be used interchangeably to refer to the hypoallergenic nutritionally complete dry food composition of this disclosure.

[0050] As used herein, a “low-fat food composition” means a composition or diet with a significantly lower fat content than a conventional diet. In Europe, according to Commission Regulation (EU) 2020 / 354 of 4 March 2020, a low-fat diet is defined as a diet with ≤110 g / kg fat in a complete feed, 12% moisture content, and a dry matter energy density of 3500 kcal / kg (according to the NRC06 equation based on crude fiber). This dry matter energy density, when converted to low-fat, means ≤35.7 g / Mcal of fat (MENRC06). In the United States, low-fat is defined for products with <20% moisture and <9% fat, assuming a dry matter energy density of 4000 kcal / kg (according to the NRC 85 equation). This dry matter energy density, when converted to low-fat, means <22.5–28 g / Mcal of fat (ME NR85). While not binding, low-fat can be considered to mean a fat content of <25 g / Mcal.

[0051] As used herein, “nutritional complete” means that the compositions of this disclosure provide companion animals with a complete and balanced nutritional requirement. Specifically, a nutritionally complete food composition contains all known nutrients required by the intended recipient of the food composition, in appropriate amounts and proportions based on recommendations from, for example, authoritative regulatory bodies in the field of animal nutrition. A nutritionally complete food composition may contain a carrier, diluent, or excipient. The carrier, diluent, or excipient may be selected according to its intended use and suitability for animal use. As used herein, “nutritional support” means that this disclosure can be used to overcome any nutritional deficiencies in the diet of a companion animal, enabling the companion animal to have a complete daily intake of nutritious food.

[0052] As used herein, the term "adverse food reaction" refers to an abnormal or exaggerated response in a companion animal to an ingested food composition that may result in decreased appetite, leading to refusal to eat. Adverse food reaction responses can be immune-mediated, known as food allergies. These negative responses can also be non-immune-mediated, known as food intolerances. Illustratively, adverse food reactions encompass pruritus (commonly referred to as itching) and can lead to additional dermatological signs such as hair loss, seborrhea, or pyoderma.

[0053] As used herein, the term "allergic reaction" or "allergy" is an individual's immune response to a clinically altered dietary allergen. Symptoms of an allergic reaction can affect the skin system (e.g., urticaria, angioedema, pruritus), respiratory system (e.g., wheezing, cough, laryngeal edema, nasal discharge, tearing / itchy eyes), gastrointestinal system (e.g., vomiting, abdominal pain, diarrhea), and / or cardiovascular system (if a systemic reaction occurs). Allergic reactions to a food composition can trigger adverse food reactions in companion animals fed that food composition.

[0054] In some implementations, adverse food reactions can consist of damage to the skin, respiratory, gastrointestinal, and / or cardiovascular systems. Skin damage may include urticaria, angioedema, hair loss, seborrhea, pyoderma, and / or pruritus. Respiratory damage may include wheezing, cough, laryngeal edema, nasal discharge, and / or tearing / itchy eyes. Gastrointestinal damage may include vomiting, abdominal pain, and / or diarrhea. Cardiovascular damage may include angina, heart attack, and / or heart failure.

[0055] As used in this article, “hyperlipidemia” (sometimes also called hyperlipoproteinemia), “endocrine disorder”, or “lipid metabolism disorder” refers to a lipid metabolism disorder that results in elevated levels of lipids, particularly triglycerides (triglycerides) and / or cholesterol, in the blood. In companion animals, the most clinically relevant type of hyperlipidemia is hypertriglyceridemia (or hypertriglyceridemia) characterized by excessively high levels of triglycerides in the blood. The main causes of hyperlipidemia can be genetic or familial. The predominant forms in companion animals can be idiopathic hyperlipidemia in small Schnauzers and hyperchylomicronemia in cats. Secondary hyperlipidemia may be associated with endocrine disorders (i.e., diabetes, hypothyroidism, and hyperadrenocorticism) or pancreatitis.

[0056] As used in this article, "fat intolerance" is a condition that makes companion animals unable to tolerate normal levels of fat.

[0057] As used herein, “fat assimilation” or “fat malabsorption” refers to a condition that interferes with or disrupts the digestion and / or absorption of fat in companion animals. Dietary fat is one of the most complex nutrients to be processed in the gastrointestinal tract. Because this process involves multiple organs and multiple steps, disruption of fat digestion and absorption can occur in several gastrointestinal disorders. The resulting fat assimilation not only interferes with fat absorption but also with the absorption of fat-soluble vitamins, minerals, and bile salts. Assimilated fats and bile acids are hydroxylated and uncoupled by colonic bacteria to produce potent secretagogues. Uncoupled bile acids and hydroxylated fatty acids can be toxic to the colonic mucosa, causing increased mucosal permeability, altered peristalsis, and secretory diarrhea. Companion animals suffering from this type of diarrhea may rapidly dehydrate, develop electrolyte abnormalities, and experience rapid weight loss.

[0058] Animals with fat intolerance and / or poor fat assimilation may exhibit signs such as diarrhea and weight loss, or in more severe cases, steatorrhea (excessive excretion of fat in feces, resulting in large, pale, oily and foul-smelling feces).

[0059] As used in this article, “lymphangiectasia” or “intestinal lymphangiectasia (IL)” is a condition characterized by dilation, obstruction, and / or dysfunction of the lymphatic vessels in the small intestine. Dogs with IL often suffer from diarrhea, weight loss, vomiting, and fluid retention secondary to intestinal protein loss. Canine IL can occur as a primary condition or as a consequence of another condition that leads to altered lymphatic flow, such as chronic inflammatory bowel disease (CIE).

[0060] 5.2. Units

[0061] Unless otherwise specifically expressed (such as, but not limited to, in % for feeding), the amount of components in the compositions disclosed herein is generally expressed in weight / Mcal (megacal).

[0062] As used herein, the amount of a component expressed in weight / Mcal consists of the amount of said component in total animal food composition in terms of metabolizable energy (ME).

[0063] As used herein, the ME parameter is intended to represent the energy value of a food composition that is directly metabolized after consumption. Within the scope of this disclosure, the ME value can be measured by any suitable method known in the art.

[0064] Illustratively, a feeding trial can be used to measure the ME value. In practice, the total energy (GE) of the food is determined in the laboratory, and the amount of food consumed by the animal is recorded. Feces and urine of the animal are collected, and the energy of each is determined, referred to as fecal energy (FE) and urinary energy (UE), respectively. The ME can then be calculated as:

[0065]

[0066] Alternatively, the ME value can be measured mathematically, particularly taking into account the percentages of crude fat (CF), crude protein (CP), and non-fat protein (NFE) (carbohydrates) in the composition. In practice, each percentage is multiplied by its respective Atwater Factor. The sum of the results is then multiplied by 10. The mathematical method can be expressed by the following formula:

[0067] .

[0068] To calculate nutrient content based on energy, we need the diet's energy density (in kcal / kg) and the concentration of nutrients in the diet (in % or mg / kg). Nutrient values ​​can be calculated using the following formula:

[0069] or

[0070] For example, a diet containing 180 mg / kg of zinc has an energy density of 3900 kcal / kg, meaning that there are 180 mg of zinc in 3900 kcal. Therefore, for 1000 kcal (Mcal): the nutrient value of zinc = 180 / 3900 × 1000 = 46 mg / Mcal.

[0071] In some implementations, ME can be determined using a predictive equation proposed by the National Research Council (NRC) in 2006, which has been shown to be more accurate than previous equations used for animal food compositions (Calvez et al.). PLoS One (2019).

[0072] In specific embodiments of this disclosure, particularly for felines, ME, expressed in kcal / 100g, can be calculated as:

[0073]

[0074] or

[0075]

[0076]

[0077] In specific embodiments of this disclosure, particularly for canines, ME, expressed in kcal / 100g, can be calculated as:

[0078]

[0079] or

[0080]

[0081]

[0082] 5.3. Low-fat, low-allergenic food compositions

[0083] This disclosure provides low-fat, low-allergenic food compositions. As can be seen from the examples below, low-fat, low-allergenic, nutritionally complete pet food compositions containing hydrolyzed protein, rice-derived starch, fiber, and less than about 25 g / Mcal of fat have been demonstrated to maintain good palatability, be highly digestible, and have the ability to improve the health of companion animals affected by gastrointestinal disorders.

[0084] 5.3.1. Protein

[0085] The food compositions according to this disclosure may contain one or more different protein sources. In certain embodiments, the food compositions as described herein may contain a single protein source. In some embodiments, the compositions of this disclosure contain about 50 g / Mcal to about 80 g / Mcal of protein.

[0086] The protein content of the compositions disclosed herein should be sufficiently high to ensure maintenance of lean body mass in animals. In some embodiments, the compositions according to this disclosure may contain hydrolyzed or non-hydrolyzed protein in an amount ranging from about 50 g / Mcal to about 80 g / Mcal. In specific embodiments, the compositions disclosed herein may contain protein at about 55 g / Mcal to about 80 g / Mcal, about 55 g / Mcal to about 75 g / Mcal, about 60 g / Mcal to about 80 g / Mcal, or about 60 g / Mcal to about 75 g / Mcal. In some embodiments, this disclosure may contain about 70 g / Mcal of protein.

[0087] As used herein, protein content in the range of approximately 50 g / Mcal to approximately 80 g / Mcal can include 50 g / Mcal, 51 g / Mcal, 52 g / Mcal, 53 g / Mcal, 54 g / Mcal, 55 g / Mcal, 56 g / Mcal, 57 g / Mcal, 58 g / Mcal, 59 g / Mcal, 60 g / Mcal, 61 g / Mcal, 62 g / Mcal, 63 g / Mcal, 64 g / Mcal, 65 g / Mcal, 66 g / Mcal, 67 g / Mcal, 68 g / Mcal, 69 g / Mcal, 70 g / Mcal, 71 g / Mcal, 72 g / Mcal, 73 g / Mcal, 74 g / Mcal, 75 g / Mcal, 76 g / Mcal, 77 g / Mcal, 78 g / Mcal, 79 g / Mcal, and 80 g / Mcal.

[0088] The proteins used in the compositions of this disclosure can be of plant or animal origin. Any suitable animal protein source may be used, including but not limited to poultry, chicken, chicken meal, mutton, mutton meal, fish, fish meal, meat and bone meal, meat by-products, meat meal, turkey, plasma, insects, bone marrow, and feathers. Any suitable plant protein source may be used, including but not limited to soybeans, chickpeas, corn, rice, lentils, or barley.

[0089] In some embodiments, the compositions of this disclosure do not contain non-hydrolyzed proteins. In specific embodiments, the compositions of this disclosure do not contain non-hydrolyzed proteins derived from wheat gluten, egg powder, beef, chicken, yeast, potato protein, and pea protein.

[0090] In some embodiments, the compositions disclosed herein comprise about 50 to about 80 g / Mcal of protein, said protein comprising at least about 80% hydrolyzed protein, which means The protein content of the compositions according to this disclosure may comprise at least about 80%, at least about 85%, at least about 90%, at least about 95%, at least about 98%, at least about 99%, or at least about 100% hydrolyzed protein by weight of the total protein in the composition. As used herein, a protein containing at least 80% hydrolyzed protein may include a protein containing about 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or 100% hydrolyzed protein by weight of the total protein in the composition.

[0091] In some embodiments, hydrolyzed plant proteins, such as, in particular, soybeans, may be used. In specific embodiments, hydrolyzed proteins derived from feathers, particularly poultry feathers, may be used. In specific embodiments, the sole protein source is feather hydrolysates, particularly poultry feather hydrolysates.

[0092] In certain embodiments, hydrolyzed protein is the sole protein source in the compositions of this disclosure. In some embodiments, the compositions of this disclosure may contain hydrolyzed plant protein as the sole protein source. In certain embodiments, the hydrolyzed protein is derived from a single protein source. In some embodiments, the single protein source may be selected from plant protein sources, particularly from soybean, chickpea, corn, rice, lentils, or barley. In some embodiments, the single protein source may be feather hydrolysate, particularly poultry feather hydrolysate.

[0093] Methods for hydrolyzing proteins are well known. Hydrolysates can be produced by any known chemical or enzymatic method, such as, in non-limiting examples, the methods disclosed in US 5,589,357, US 4,879,131, US 5,039,532 or EP 1 236405 B1, which are incorporated herein by reference.

[0094] In some embodiments, the hydrolyzed protein may have a molecular weight in the range of about 1,000 Da to about 15,000 Da, about 1,000 Da to about 11,000 Da, about 1,000 Da to about 5,000 Da, about 2,000 Da to about 15,000 Da, about 2,000 Da to about 11,000 Da, or about 2,000 Da to about 5,000 Da.

[0095] As used herein, the range from about 1,000 Da to about 15,000 Da includes 1,000 Da, 1,250 Da, 1,500 Da, 1,750 Da, 2,000 Da, 2,250 Da, 2,500 Da, 2,750 Da, 3,000 Da, 3,250 Da, 3,500 Da, 3,750 Da, 4,000 Da Da, 4,250 Da, 4,500 Da, 4,750 Da, 5,000 Da, 5,250 Da, 5,500 Da, 5,750 Da, 6,000 Da, 6,250 Da, 6,500 Da, 6,750 Da, 7,000 Da, 7,250 Da, 7,500 Da, 7,750Da, 8,000 Da Da, 8,250 Da, 8,500 Da, 8,750 Da, 9,000 Da, 9,250 Da, 9,500 Da, 9,750 Da, 10,000 Da, 10,250 Da, 10,500 Da, 10,750 Da, 11,000 Da, 11,250 Da, 11,500 Da, 11,750 Da, 12,000 Da, 12,250 Da, 12,500 Da Da, 12,750 Da, 13,000 Da, 13,250 Da, 13,500 Da, 13,750 Da, 14,000 Da, 14,250 Da, 14,500 Da, 14,750 Da and 15,000 Da.

[0096] 5.3.2. Fibers

[0097] The food compositions according to this disclosure may contain one or more different fiber sources and fiber types. Typically, the food compositions described herein contain multiple fiber sources.

[0098] Total dietary fiber (TDF) is the residue of edible plant cell wall polysaccharides, lignin, and related substances after hydrolysis by digestive enzymes. As used herein, dietary fiber represents the indigestible portion of plant-based foods. The most common dietary fibers are lignin, cellulose, hemicellulose, pectin, and gums. Dietary fibers suitable for the compositions of this disclosure may include lignin, cellulose, hemicellulose, pectin, gums, β-glucan, or combinations thereof.

[0099] In some embodiments, the food composition contains about 10 g / Mcal to about 30 g / Mcal, about 10 g / Mcal to about 20 g / Mcal, about 20 g / Mcal to about 30 g / Mcal, or about 15 g / Mcal to about 25 g / Mcal, about 15 g / Mcal to about 20 g / Mcal, or about 16 g / Mcal of total dietary fiber (TDF).

[0100] As used herein, approximately 10 g / Mcal to approximately 30 g / Mcal can include 10 g / Mcal, 11 g / Mcal, 12 g / Mcal, 13 g / Mcal, 14 g / Mcal, 15 g / Mcal, 16 g / Mcal, 17 g / Mcal, 18 g / Mcal, 19 g / Mcal, 20 g / Mcal, 21 g / Mcal, 22 g / Mcal, 23 g / Mcal, 24 g / Mcal, 25 g / Mcal, 26 g / Mcal, 27 g / Mcal, 28 g / Mcal, 29 g / Mcal, and 30 g / Mcal.

[0101] Illustratively, dietary fiber sources suitable for implementing compositions according to this disclosure include rice husks, corn and corn by-products, soybean husks, beet pulp, dried potato products, cellulose, wheat bran, peanut shells, pectin, and mixtures thereof.

[0102] As used herein, total dietary fiber can include soluble and insoluble fiber. While not restrictive, soluble fiber is generally considered to be resistant to digestion and absorption in the small intestine and undergoes complete or partial fermentation in the large intestine. While not restrictive, insoluble fiber is generally considered to be non-starch polysaccharides resistant to digestion and absorption in the small intestine and fermentation in the large intestine.

[0103] In some embodiments, for the purposes of this disclosure, suitable sources of soluble fiber may be selected from beet pulp, guar gum, chicory pulp, chicory root, psyllium, pectin, blueberries, cranberries, pumpkin, apples, oats, legumes, citrus fruits, barley, and peas.

[0104] In a particular embodiment, for the purposes of this disclosure, a suitable source of insoluble fiber may be selected from cellulose, whole wheat products, wheat and oats, corn bran, flaxseed, grapes, celery, green beans, cauliflower, potato peels, fruit peels, vegetable peels, peanut shells, and soybean fiber.

[0105] 5.3.3. Carbohydrates or NFE

[0106] As used herein and as is conventionally recognized in the art, nitrogen-free extracts (NFEs) consist of soluble carbohydrate portions present in the food compositions disclosed herein. If present in said food compositions, NFEs encompass soluble polysaccharides, starches, gums, mucilages, and pectins.

[0107] Therefore, as is conventionally acknowledged in the art, NFE does not contain the insoluble carbohydrate portion within the coarse fibrous material, which may be present in the food composition in some embodiments.

[0108] Typically, the content of nitrogen-free extracts in a food composition is determined by subtracting the content of each other component (protein, crude fat, crude fiber, ash) from the total dry matter of the food composition.

[0109] NFE or carbohydrates can be supplied from any suitable source known in the art. Suitable sources of NFE may be selected from oat fiber, cellulose, peanut shells, beet pulp, parboiled rice, corn starch, corn gluten meal, and any combination of those sources. Cereals that supply carbohydrates include, but are not limited to, wheat, corn, barley, and rice.

[0110] In certain embodiments, the composition according to this disclosure may contain NFE of about 130 g / Mcal to about 190 g / Mcal, about 130 g / Mcal to about 160 g / Mcal, about 130 g / Mcal to about 150 g / Mcal, about 140 g / Mcal to about 190 g / Mcal, about 140 g / Mcal to about 160 g / Mcal, about 140 g / Mcal to about 150 g / Mcal, or about 145 g / Mcal.

[0111] As used herein, NFE contents ranging from approximately 130 g / Mcal to approximately 190 g / Mcal can include 130 g / Mcal, 131 g / Mcal, 132 g / Mcal, 133 g / Mcal, 134 g / Mcal, 135 g / Mcal, 136 g / Mcal, 137 g / Mcal, 138 g / Mcal, 139 g / Mcal, 140 g / Mcal, 141 g / Mcal, 142 g / Mcal, 143 g / Mcal, 144 g / Mcal, 145 g / Mcal, 146 g / Mcal, 147 g / Mcal, 148 g / Mcal, 149 g / Mcal, 150 g / Mcal, 151 g / Mcal, 152 g / Mcal, 153 g / Mcal, 154 g / Mcal, 155 g / Mcal, 156 g / Mcal, 157 ... g / Mcal, 158 g / Mcal, 159 g / Mcal, 160 g / Mcal, 161 g / Mcal, 162 g / Mcal, 163 g / Mcal, 164 g / Mcal, 165gg / Mcal, 166 g / Mcal, 167 g / Mcal, 168 g / Mcal, 169 g / Mcal, 170 g / Mcal, 171 g / Mcal, 172g / Mcal, 173 g / Mcal, 174 g / Mcal, 175 g / Mcal, 176 g / Mcal, 177 g / Mcal, 178 g / Mcal, 179g / Mcal, 180 g / Mcal, 181 g / Mcal, 182 g / Mcal, 183 g / Mcal, 184 g / Mcal, 185 g / Mcal, 186g / Mcal, 187 g / Mcal, 188 g / Mcal, 189 g / Mcal and 190 g / Mcal.

[0112] 5.3.4. Starch

[0113] Digestible carbohydrates provide the body with an important energy source in the form of glucose, the primary energy form for tissues such as the brain and red blood cells. Digestible carbohydrates include complex carbohydrates, such as starch (polysaccharide), and sugars (monosaccharides and disaccharides). When carbohydrate supply is limited, glucose can also be synthesized from proteins and other compounds. Adequate starch in the diet can conserve protein.

[0114] For the compositions of this disclosure, fat needs to be limited, but the fat must have the highest possible energy density, which is one reason for targeting high levels of starch. In contrast to other alternatives that consider, for example, the metabolizable energy levels of carbohydrates (such as starch) compared to protein, increasing starch levels has been preferred for this purpose. From a nutritional perspective, dietary carbohydrates (such as starch) provide a highly digestible energy source and conserve protein. This means that while the body uses carbohydrates to provide the energy it needs, dietary protein is spared for this purpose and remains available to provide essential amino acids, build and repair body tissues, and support a healthy immune system. Furthermore, increasing the amount of protein may negatively impact palatability (as hydrolyzed protein is known to be unpalatable).

[0115] The compositions disclosed herein comprise starch at a concentration of about 120 g / Mcal to about 180 g / Mcal, about 120 g / Mcal to about 160 g / Mcal, about 140 g / Mcal to about 180 g / Mcal, about 140 g / Mcal to about 160 g / Mcal, or about 130 g / Mcal to about 150 g / Mcal. In some embodiments, the starch is derived from at least one rice source.

[0116] In certain embodiments, the food composition described herein comprises a starch source. In some embodiments, the starch source is rice. In a particular embodiment, the starch source is a rice source.

[0117] In some embodiments, the starch source is a combination of several rice sources. In certain embodiments, the starch source can be any type of rice. In some embodiments, the rice is not whole rice.

[0118] In some embodiments, the rice source may include rice, broken rice grains, rice flour, whole rice grains, or combinations thereof. In a particular embodiment, the rice source may include broken rice grains, rice flour, or combinations thereof.

[0119] As defined herein, broken rice grains are intended to refer to rice grains that are considered to be non-compliant with human food standards for any reason (appearance, color, integrity, etc.). Broken rice grains can have an average particle size of about 2 mm to about 5 mm.

[0120] As defined herein, rice flour refers to fine powder that can be obtained by mechanically grinding and sieving broken rice. Rice flour can have an average particle size of approximately 150 µm.

[0121] According to embodiments of this disclosure, the rice source may comprise at least about 30%, at least about 40%, at least about 50%, or at least about 60% rice flour by weight of the total amount of rice source in the composition.

[0122] As used herein, the rice source may comprise approximately 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 85%, 83%, 84%, 85%, 86% by weight of the total amount of rice source in the composition. 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or 100% rice noodles.

[0123] According to some embodiments, the compositions disclosed herein do not contain any starch from sources other than rice, and more specifically, from cassava, corn, barley, or wheat.

[0124] 5.3.5. Fat

[0125] As used herein, the terms “fat,” “crude fat,” or “fat source” are intended to refer to any food-acceptable fat and / or oil. Fat according to this disclosure may be in fluid and / or solid form. Compositions according to this disclosure may contain fats from animal and / or plant sources. Fat may be supplied from any suitable source known to those skilled in the art. The fat content of food compositions according to this disclosure can be determined by any method known in the art.

[0126] In certain embodiments, the composition according to this disclosure comprises less than about 25 g / Mcal of fat, less than about 24 g / Mcal, less than about 22 g / Mcal, or less than about 20 g / Mcal of fat. In some embodiments, the composition according to this disclosure may comprise about 10 to about 24 g / Mcal of fat, about 15 to about 22 g / Mcal of fat, or about 18 to about 20 g / Mcal of fat.

[0127] As used herein, less than about 25 g / Mcal of fat can include fat contents of about 25 g / Mcal, 24 g / Mcal, 23 g / Mcal, 22 g / Mcal, 21 g / Mcal, 20 g / Mcal, 19 g / Mcal, 18 g / Mcal, 17 g / Mcal, 16 g / Mcal, 15 g / Mcal, 14 g / Mcal, 13 g / Mcal, 12 g / Mcal, 11 g / Mcal, or about 10 g / Mcal.

[0128] In certain embodiments, the fat source is selected from vegetable fats, animal fats, or mixtures thereof. Suitable vegetable fat sources for the purposes of this disclosure may include, but are not limited to, wheat fat, soybean oil, sunflower seed, safflower, rapeseed, olive, borage, flaxseed, peanut, blackcurrant seed, cottonseed, germ, corn germ, and oils derived from these and any combination thereof. Suitable animal fat sources for the purposes of this disclosure may include, for example, but not limited to, meat, meat by-products such as chicken fat, turkey fat, beef fat, duck fat, pork fat, lamb fat, fish oil, krill oil, seafood, dairy products, eggs, and combinations thereof.

[0129] Illustratively, fat content may include sources of linoleic acid, α-linoleic acid, arachidonic acid, ω-6 fatty acids, ω-3 fatty acids, eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and mixtures thereof (EPA+DHA).

[0130] In certain embodiments, the compositions according to this disclosure may comprise EPA+DHA at about 0.2 g / Mcal to about 1 g / Mcal, about 0.3 g / Mcal to about 0.8 g / Mcal, about 0.4 g / Mcal to about 0.6 g / Mcal, or about 0.4 g / Mcal.

[0131] In embodiments, the composition according to this disclosure may contain linoleic acid (LA) of about 3 g / Mcal to about 8 g / Mcal, particularly about 4 g / Mcal to about 6 g / Mcal, and more particularly about 4.5 g / Mcal.

[0132] 5.3.6. Ash content

[0133] In some embodiments, the composition according to this disclosure may contain ash of about 5 g / Mcal to about 8 g / Mcal, about 6 g / Mcal to 7 g / Mcal, or about 6.2 g / Mcal.

[0134] Within the scope of this disclosure, ash is intended to refer to minerals such as calcium, phosphorus, sodium, chloride, potassium, and magnesium.

[0135] 5.3.7. Other ingredients

[0136] The compositions according to this disclosure may also contain one or more trace elements, particularly those selected from iron, copper, manganese, zinc, iodine, and selenium. The compositions according to this disclosure may also contain one or more vitamins, particularly those selected from vitamin A, vitamin D, vitamin E, ascorbic acid, vitamin K, thiamine, riboflavin, pantothenic acid, niacin, pyridoxine, folic acid, biotin, vitamin B12, and choline.

[0137] In some embodiments, the food compositions according to this disclosure may also contain a source of antioxidants. As used herein, the term "antioxidant" is intended to refer to a substance capable of reacting with and neutralizing free radicals. Illustrative examples of such substances include, but are not limited to, carotenoids (including beta-carotene, lycopene, and lutein), selenium, coenzyme Q10 (ubiquinone), tocotrienols, soy isoflavones, S-adenosylmethionine, glutathione, taurine, N-acetylcysteine, vitamin E, vitamin C, alpha-lipoic acid, and L-carnitine.

[0138] In some embodiments, the composition may also contain at least one flavoring agent, particularly a natural flavoring agent. In a particular embodiment, the flavoring agent may be of protein origin.

[0139] According to a particular embodiment, the compositions disclosed herein may also contain one or more additional ingredients selected from colorants, flavoring agents, fillers, preservatives (such as antioxidants including lutein or beta-carotene), vitamins (such as choline), amino acids (such as taurine), trace elements (such as zinc), and minerals.

[0140] 5.4. Uses and methods for preparing low-fat, low-allergenic food compositions

[0141] This disclosure also relates to a method for manufacturing a low-fat, low-allergenic, nutritionally complete food composition for companion animals as defined above, the method comprising at least the step of mixing all the ingredients together.

[0142] Given the low fat content of this composition and the role of fat in canine palatability, maximum available fat should be applied to the exterior of the product to maintain palatability. On the other hand, the application of low fat at the coating layer needs to be carefully managed to deliver good uniformity and ensure proper palatability performance.

[0143] This disclosure further relates to low-fat, low-allergenic, nutritionally complete food compositions according to or obtained using the methods of this disclosure, for use in providing nutritional support to companion animals suffering from adverse food reactions. This disclosure also relates to low-fat, low-allergenic, nutritionally complete food compositions according to or obtained using the methods of this disclosure, for use in providing nutritional support to companion animals suffering from fat intolerance and / or impaired fat assimilation.

[0144] This disclosure further relates to a low-fat, low-allergenic nutritionally complete food composition obtained using the methods of this disclosure, for use in providing nutritional support to companion animals suffering from hyperlipidemia.

[0145] This disclosure further relates to a method for reducing clinical signs of fat intolerance and / or impaired fat assimilation in companion animals, the method comprising at least the step of providing the companion animal with a low-fat, low-allergenic, nutritionally complete food composition according to or obtained by the method of this disclosure.

[0146] This disclosure further relates to a method for reducing the likelihood of fat intolerance and / or impaired fat assimilation in companion animals, the method comprising at least the step of providing the companion animal with a low-fat, low-allergenic, nutritionally complete food composition according to or obtained by the method of this disclosure.

[0147] This disclosure also relates to a method for reducing clinical signs of hyperlipidemia in companion animals, the method comprising at least the step of providing the companion animal with a low-fat, low-allergenic, nutritionally complete food composition according to or obtained by the method of this disclosure.

[0148] This disclosure also relates to a method for reducing the likelihood of hyperlipidemia in companion animals, the method comprising at least the step of providing the companion animal with a low-fat, low-allergenic, nutritionally complete food composition according to or obtained by the methods of this disclosure.

[0149] This disclosure also relates to a method for reducing clinical signs of adverse food reactions in companion animals, the method comprising at least the step of providing the companion animal with a low-fat, low-allergenic, nutritionally complete food composition according to or obtained by the method of this disclosure.

[0150] Finally, this disclosure relates to a method for reducing the likelihood of adverse food reactions in companion animals, the method comprising at least the step of providing the companion animal with a low-fat, low-allergenic, nutritionally complete food composition according to or obtained by the method of this disclosure.

[0151] This disclosure also relates to low-fat, low-allergenic nutritionally complete food compositions obtained according to or by the methods of this disclosure for the prevention or treatment of fat intolerance and / or impaired fat assimilation in companion animals.

[0152] This disclosure further relates to low-fat, low-allergenic nutritionally complete food compositions obtained according to or by the methods of this disclosure for the prevention or treatment of hyperlipidemia in companion animals.

[0153] Finally, this disclosure relates to low-fat, low-allergenic nutritionally complete food compositions obtained according to or by the methods of this disclosure, for the prevention or treatment of adverse food reactions in companion animals.

[0154] As used herein, the term "treating" includes alleviating and / or eliminating symptoms associated with a particular condition or symptom. In the context of this disclosure, the term "prevention" means reducing the risk or probability of a given phenomenon to a lesser extent, such as in this disclosure: fat intolerance and / or poor fat anabolic kinase, hyperlipidemia and / or adverse food reactions.

[0155] 6. Example

[0156] Example 1: Manufacturing the dry food composition of this disclosure

[0157] The dry food composition according to this disclosure is prepared according to the method described below.

[0158] As a non-limiting example, the composition has the following formula (g / Mcal and % at feeding) as shown in Table 1:

[0159]

[0160] It includes at least about 30% rice noodles.

[0161] Considering a dietary energy density of approximately 3500 kcal / kg

[0162] Mix the ingredients according to the proportions shown in the table above, starting with the dry ingredients and then the wet ingredients.

[0163] The composition was prepared using a classic extrusion process:

[0164] 1. Ingredients: Mix dry ingredients to obtain powder, and provide the production line throughput.

[0165] 2. Pretreatment: The powder is hydrated and precooked by injecting water and steam. The remaining liquid is added. The average retention time is approximately 3 minutes. At the pretreatment outlet, the powder and water are combined and preheated (to approximately 85-90°C), but still in powder form, without any clumping, lumps, or agglomeration.

[0166] 3. Extrusion: The final step in cooking and shaping (cutting). Add the required amount of remaining steam / water. Final cooking with mechanical energy.

[0167] Set the final process parameters to limit viscosity in the pre-processor and avoid clogging of the feed pipe between the pre-processor and the extruder. Adjust the water and steam in the pre-processor to achieve good hydration uniformity but a low powder temperature.

[0168] The final cooking process takes place primarily within the extruder through disturbances introduced by the screw and the plate opening area. As a result, this formulation achieves a higher specific mechanical energy (SME 50-55) compared to previously obtained specific mechanical energy.

[0169] Example 2: Palatability Study – Comparison of the food composition of this disclosure with commercially available hypoallergenic pet food compositions Comparison between

[0170] The palatability of the compositions of this disclosure is determined using a "two-basin test." This test allows for the determination of food palatability based on an animal's food preference between two different food products.

[0171] A group of 33 dogs were fed the food composition of this disclosure (Product A) prepared as described in Example 1 and a commercially available food composition: Purina Proplan Canine Hypoallergenic® (Product B). All 33 dogs ate the food normally.

[0172] Place product A and product B in their respective food bowls and serve them to each animal simultaneously. Leave the food bowls with the animals for 20 minutes. The amount of food product provided in each bowl should be sufficient to meet the animal's daily calorie intake. Test twice daily. Fresh water should always be available. Collect and weigh any remaining food products to determine how much of each food product the animal consumed. Each food product is then sorted together with the other food products based on its consumption.

[0173] Palatability is measured based on dietary preferences: the percentage of animals that prefer product A compared to the percentage of animals that prefer product B, and the percentage of animals that have no preference (no choice).

[0174] result

[0175] The results of the two-basin test for assessing palatability are presented in Table 2 below.

[0176]

[0177] In summary, the food compositions of this disclosure were accepted by the dogs in the test group. In fact, the food compositions of this disclosure are clearly superior to other commercially available hypoallergenic canine food compositions.

[0178] In particular, it has been shown that, contrary to common sense for those skilled in the art, although the compositions of this disclosure have not only low levels of fat but also high levels of hydrolyzed protein (hydrolyzed protein is known to be unappealing to dogs), they are still palatable and appealing to dogs.

[0179] Example 3: Digestibility study of the food composition disclosed herein

[0180] The purpose of this study is to analyze the digestibility of the food composition of this disclosure by analyzing the feces of dogs after feeding them a diet containing such food composition.

[0181] This study included a group of 9 dogs.

[0182] Each dog was fed a food composition prepared as in Example 1 in an amount calculated based on the dog's weight and body score conditions to meet the energy requirements of each animal.

[0183] Due to the fecal scoring scale, feces were graded daily for all animals included in the study during the fecal collection phase.

[0184] Based on the consistency of feces, feces are classified into 5 categories: very soft, soft, best, very hard, and hard.

[0185] The results are provided in Table 3 below (the percentages correspond to the number of dogs present in each category compared to the total number of dogs):

[0186]

[0187] In summary, it has been demonstrated that dogs given the food composition of this disclosure tolerate the food composition well in terms of digestibility.

[0188] Example 4: Clinical Study – Administration of the disclosed food composition to dogs with gastrointestinal disorders

[0189] The primary objective of this study is to evaluate the efficacy of the food compositions disclosed herein and to assess the opinions of veterinarians and pet owners regarding the food compositions disclosed herein.

[0190] plan

[0191] It included a group of 17 dogs, 15 of whom completed the study.

[0192] The selection criteria are as follows:

[0193] - Dogs that visit a veterinary clinic for gastrointestinal symptoms (diarrhea ± vomiting).

[0194] -Age: 1-12 years old

[0195] - Proper vaccination, deworming, and treatment of external parasites (fleas, ticks, etc.) are essential.

[0196] - I am not currently taking any medication.

[0197] - Chronic enteropathy: Adult animals exhibiting loose or watery stools at least twice a week for at least 2 weeks, accompanied by at least one or more of the following signs: - Increased frequency of defecation - Increased stool volume - Vomiting; dogs with an adjusted CCEAI (non-albumin) >= 5. or Recurrent enteropathy: Adult animals present with soft or loose stools, accompanied by one or more of the following additional signs: increased frequency of defecation, increased stool volume, vomiting, and at least one episode of soft or loose stools within the past year (excluding GI symptoms known to be caused by ingestion of inappropriate elements, stress, or known concomitant diseases). The dog's adjusted CCEAI (without albumin) is >= 5.

[0198] - Approval is granted to animals that have previously been treated with one or more regimens (anti-inflammatory, antibiotic) and have not fully responded to the treatment.

[0199] The exclusion or withdrawal criteria are as follows:

[0200] - Severe complications.

[0201] -Refuses to eat, insufficient food intake (MER < 80% within 3 days) or requires tube feeding.

[0202] - Symptoms worsened during the trial.

[0203] - Use of prohibited drugs

[0204] - Exclusion criteria: - Undesirable weight loss exceeding 15% within the first few months.

[0205] -treat

[0206] o Only dietary therapy was administered during the trial (= Only diet was tested, no other medications were used).

[0207] - Prohibited drugs:

[0208] Short-acting and long-acting (injectable or oral) steroids,

[0209] o Essential fatty acid supplements, prebiotics, and probiotics.

[0210] o Antibiotic treatment.

[0211] -Use may be permitted during the research period if determined by a veterinarian:

[0212] - Treatments that do not affect the GI tract: shampoos, ear cleaners, ear drops, etc.

[0213] Supportive treatment, such as antiemetics and fluid replacement.

[0214] - Deworming medication

[0215] During the program, the dogs are fed a diet of the disclosed food composition in amounts calculated based on their weight and body score to meet each animal's energy requirements. Veterinarians and pet owners assess the dogs' general health at least at the following times:

[0216] Inclusion visit (V0), at D0: Veterinary researchers conduct a full clinical examination and complete the GI questionnaire.

[0217] Follow-up veterinary visit at 1 month (V1): Follow up / collect feedback from the owner on food consumption, and conduct a veterinary clinical examination to obtain information on symptom evolution.

[0218] +Final visit at 2 months (V2), a: Same as V0 + collect feedback from the owner + evaluate product efficacy.

[0219] In addition, the efficacy of the food composition diet was assessed by veterinarians and pet owners during follow-up veterinary visits (V1) and final visits (V2).

[0220] Veterinary assessment criteria (in V0, V1, and V2):

[0221] - Physical examination, including the dog's weight and BCS (Body Condition Score) and hydration status (if dehydration <5%, it is adequate / if dehydration 5%-8%, it is borderline / if dehydration >8%, it is inadequate).

[0222] - Evaluation of signs of GI (gastrointestinal) discomfort: presence or absence of diarrhea, vomiting, black or bloody stools, mucus in stools, abdominal pain, tenesmus, abnormal behavior, or any other GI-related clinical signs.

[0223] -GI Symptom Assessment Scale (adapted from validated scoring systems such as the Canine Inflammatory Bowel Disease Activity Index (CIBDAI))

[0224] Pet owner assessment criteria (at V0, day 7, V1, and V2):

[0225] - Digestive system signs score: appetite, vomiting / nausea, stool consistency, bowel movement frequency, pain / discomfort.

[0226] - Quality of Life (QoL) score: activity level, play / hunting, interaction with other pets / family members, grooming, and well-being.

[0227] For each item, it must be scored from 0 = normal to 3 = severe change, thus establishing the GI score and QoL score.

[0228] result

[0229] Results of veterinary assessment

[0230] Veterinarians used the CCECAI index to assess each dog's clinical index activity scores at V0, V1, and V2.

[0231] The results showed that after two months of treatment with the dietary composition disclosed herein, 83% of the dogs had a reduction of at least one point in their clinical activity score.

[0232] Pet owner assessment results

[0233] All dogs that completed the 2-month trial reported improvement or resolution of gastrointestinal symptoms.

[0234] Overall, owners did not seem to notice the impact of chronic intestinal disease on their pets' quality of life. However, generally speaking, after two months, the dogs' anxiety was reported to have decreased slightly. Furthermore, over 80% of pet owners reported an improvement in their quality of life after one month.

Claims

1. A low-fat, hypoallergenic nutritionally complete food composition for a companion animal comprising: a) from about 50 g / Mcal to about 80 g / Mcal of protein, said protein comprising at least about 80% hydrolyzed protein, b) from about 120 g / Mcal to about 180 g / Mcal of starch from at least one rice source, c) from about 10 g / Mcal to about 30 g / Mcal of total dietary fiber (TDF), and d) less than about 25 g / Mcal of fat.

2. The low-fat, hypoallergenic nutritionally complete food composition of claim 1, wherein the at least one rice source comprises rice, rice fragments, rice flour, whole rice kernels, or combinations thereof.

3. The low-fat, hypoallergenic nutritionally complete food composition of claim 1, wherein the at least one rice source comprises at least about 30% rice flour.

4. The low-fat, hypoallergenic nutritionally complete food composition of claim 1, wherein the protein comprises at least about 95% hydrolyzed protein.

5. The low-fat, hypoallergenic nutritionally complete food composition of claim 1, wherein the hydrolyzed protein has a molecular weight in the range of from about 1,000 Da to about 15,000 Da, particularly from about 1,000 Da to about 11,000 Da, and particularly from about 2,000 Da to about 5,000 Da.

6. The low-fat, hypoallergenic nutritionally complete food composition of claim 1, wherein the hydrolyzed protein is from a single protein source.

7. The low-fat, hypoallergenic nutritionally complete food composition of claim 6, wherein the single protein source is selected from a plant protein source, particularly a plant protein source selected from soy, chickpea, corn, rice, lentil, or barley.

8. The low-fat, hypoallergenic nutritionally complete food composition of claim 6, wherein the single protein source is a feather hydrolysate, particularly a poultry feather hydrolysate.

9. The low-fat, hypoallergenic nutritionally complete food composition of claim 1, wherein the fat source is selected from a plant fat, an animal fat, or a mixture thereof.

10. The low-fat, hypoallergenic nutritionally complete food composition of claim 9, wherein the plant fat source is selected from wheat fat, soybean oil, sunflower, safflower, rapeseed, olive, borage, flaxseed, peanut, blackcurrant seed, cottonseed, germ, corn germ, and oils derived therefrom, and any combination thereof.

11. The low-fat, hypoallergenic nutritionally complete food composition of claim 9, wherein the animal fat source comprises meat, meat by-products such as chicken fat, turkey fat, beef fat, duck fat, pork fat, lamb fat, fish oil, krill oil, seafood, dairy products, egg, or combinations thereof.

12. The low-fat, hypoallergenic nutritionally complete food composition of claim 1, wherein the dietary fiber (TDF) comprises lignin, cellulose, hemicellulose, pectin, gum, beta-glucan, or combinations thereof.

13. The low-fat, low-allergenicity nutritionally complete food composition of claim 1, wherein the composition further comprises one or more additional ingredients selected from the group consisting of: colorants; flavorants; fillers; preservatives, such as antioxidants including lutein or beta carotene; vitamins, such as choline; amino acids, such as taurine; trace elements, such as zinc; and minerals.

14. The low-fat, low-allergenicity nutritionally complete food composition of claim 1, wherein the composition is a dry food composition, in particular in the form of a kibble.

15. A method of manufacturing a low-fat, low-allergenicity nutritionally complete food composition for companion animals, wherein the low-fat, low-allergenicity nutritionally complete food composition comprises: a) about 50 g / Mcal to about 80 g / Mcal of protein, the protein comprising at least about 80% of hydrolyzed protein, b) about 120 g / Mcal to about 180 g / Mcal of starch from at least one rice source, c) about 10 g / Mcal to about 30 g / Mcal of total dietary fiber (TDF), and d) less than about 25 g / Mcal of fat; wherein the manufacturing method comprises at least one step of mixing all ingredients together.

16. The low-fat, low-allergenicity nutritionally complete food composition of claim 1, wherein the low-fat, low-allergenicity nutritionally complete food is for companion animals with adverse food reactions.

17. The low-fat, low-allergenicity nutritionally complete food composition of claim 1, wherein the low-fat, low-allergenicity nutritionally complete food composition is for nutritional support of companion animals with fat intolerance and / or poor fat assimilation.

18. The low-fat, low-allergenicity nutritionally complete food composition of claim 1, wherein the low-fat, low-allergenicity nutritionally complete food is for nutritional support of companion animals with hyperlipidemia.

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