Feline food composition

Abstract

The present application discloses a full nutritional feline food composition comprising EPA / DHA and a carbohydrate. These full nutritional feline food compositions may be used in dry or wet food compositions. The composition is useful for the prevention and / or treatment of cardiac hypertrophy in felines, such as cats.

Description

[0001] This application is a divisional application of an application with an application date of January 30, 2020, international application number PCT / US2020 / 015808, national application number 202080027766.2, and invention name “Feline Food Composition”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority from European Patent Application No. EP 19305123.2 filed on February 1, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0004] The presently disclosed subject matter relates to the field of nutritionally complete food compositions for preventing and / or treating cats suffering from cardiac hypertrophy. Background Art

[0005] Hypertrophic cardiomyopathy (HCM) is the most common heart disease in cats, especially in older cats, and is the most common cause of heart failure in this species (Riesen et al., 2007, Schweizer Archiv fur Tierheilkunde; Vol. 149: 65-71 Rush et al., 1998, Veterinary Clinics of North America: Small Animal Practice Nov. 1998; 28: 1459-1479). The disease is characterized by cardiac hypertrophy, which is an abnormal enlargement or thickening of the heart muscle. Although most affected cats are thought to have no clinical symptoms for a long time (called asymptomatic hypertrophic cardiomyopathy or aHCM), a portion of cats develop serious complications such as congestive heart failure and cardiac death (Fox et al., 2018, Circulation 92(9): 2645-2651). aHCM is characterized by left ventricular hypertrophy, thickening of the ventricular septum and left ventricular wall (LVW), impaired diastolic filling, and left atrial enlargement. In addition, the diagnosis is based on echocardiographic measurement of the maximum thickness of the ventricular septum or left ventricular wall (Fox, 1995, Circulation 92(9):2645-2651).

[0006] Furthermore, it is known that cardiac and renal function are closely related across cat breeds. It has been observed that the prevalence of aHCM as well as chronic kidney disease (CKD) increases with age in cats. Therefore, adaptive treatment of aHCM should also consider possible CKD, whether asymptomatic or not.

[0007] Treatments proposed in the art may be suitable for intervention or drug therapy. For example, EP2514421 discloses the use of torsemide in treating symptoms caused by HCM. In addition, WO2010060874 discloses the use of phosphodiesterase type III inhibitors and Ca2+-sensitizers to treat HCM, although the therapeutic effect is not satisfactory and is still being tested at the time of application. There has been little progress in treating cats with aHCM. Until recently, there was no available data to prove the therapeutic benefits of mild or moderate aHCM cats (Fox et al., 2015, Journal of Veterinary Cardiology (J. Vet. Cardiology), Vol. 17: S150-S158).

[0008] Further studies have shown that diet or certain nutrients can alter the phenotypic expression of cardiomyopathy in genetically susceptible individuals (Freeman et al. 2014, Journal of Veterinary Internal Medicine (J. Vet. Intern. Med.), Vol. 28: 847-856). For example, Freeman et al. tested three different groups of cats (Group A, Group B, and Group C) using two diets (e.g., dry diet and wet diet) based on commercially available cat food compositions. For each group, commercially available dry and wet diets that were similar to each other in nutrient distribution and composition were selected. The test was conducted on cats with HCM, but without clinical symptoms of heart disease (e.g., aHCM). Group C had significantly reduced interventricular septal thickness in systole (IVS), left atrial (LA) size, and left atrial to aorta ratio (LA / Ao), and body weight was also significantly reduced. However, group C showed non-statistically significant reductions in left ventricular free wall thickness in diastole (LVWd) and interventricular septal thickness in diastole (IVSd), in particular. In conclusion, Freeman et al. failed to demonstrate any significant effect of these commercial diets on the treatment of aHCM.

[0009] Therefore, there remains a need for new food compositions for preventing or treating cardiac hypertrophy.

[0010] There remains a need for food compositions that do not affect renal function in cats with cardiac hypertrophy, particularly asymptomatic hypertrophic cardiomyopathy.

[0011] There remains a need for a food composition that does not affect renal function in cats with cardiac hypertrophy, particularly asymptomatic hypertrophic cardiomyopathy, and without pre-existing chronic kidney disease.

[0012] There remains a need for compositions for preventing or treating cardiac hypertrophy, particularly asymptomatic hypertrophic cardiomyopathy, which do not affect renal function.

[0013] The presently disclosed subject matter is directed to satisfying all or part of these needs. Summary of the invention

[0014] A first aspect of the present disclosure relates to a nutritionally complete feline food composition comprising EPA / DHA and carbohydrates for preventing and / or treating cardiac hypertrophy, wherein:

[0015] (a) The nutritionally complete food composition consists of a dry food composition, wherein the dry food composition comprises:

[0016] (i) EPA / DHA in an amount of at least about 0.5 grams per megacalorie (g / Mcal); and

[0017] (ii) Nitrogen-Free extract in an amount not exceeding about 60 g / Mcal

[0018] Extract, NFE); or

[0019] (b) the nutritionally complete food composition consists of a wet food composition comprising:

[0020] (i) EPA / DHA in an amount of at least about 1.0 g / Mcal; and

[0021] (ii) nitrogen free extract (NFE) in an amount not exceeding about 35 g / Mcal.

[0022] In some embodiments, the nutritionally complete feline food as a dry food comprises starch in an amount not exceeding about 50 g / Mcal.

[0023] In some embodiments, the nutritionally complete feline food as a wet food comprises starch in an amount not exceeding 20 g / Mcal.

[0024] In some embodiments, a nutritionally complete feline food composition comprising EPA / DHA and carbohydrates for use in a method of preventing and / or treating cardiac hypertrophy comprises:

[0025] (a) The nutritionally complete food composition consists of a dry food composition, wherein the dry food composition comprises:

[0026] (i) EPA / DHA in an amount of at least about 0.5 g / Mcal;

[0027] (ii) starch in an amount not exceeding about 50 g / Mcal; or

[0028] (b) the nutritionally complete food composition consists of a wet food composition comprising:

[0029] (i) EPA / DHA in an amount of at least about 1.0 g / Mcal;

[0030] (ii) starch in an amount not exceeding about 20 g / Mcal.

[0031] In addition, the above embodiments include a nutritionally complete feline food composition comprising EPA / DHA and carbohydrates for use in a method of preventing and / or treating cardiac hypertrophy, wherein:

[0032] (a) The nutritionally complete food composition consists of a dry food composition, wherein the dry food composition comprises:

[0033] (i) EPA / DHA in an amount of at least about 0.5 g / Mcal;

[0034] (ii) a nitrogen-free extract (NFE) in an amount not exceeding about 60 g / Mcal, said NFE comprising starch in an amount not exceeding 50 g / Mcal; or

[0035] (b) the nutritionally complete food composition consists of a wet food composition comprising:

[0036] (i) EPA / DHA in an amount of at least about 1.0 g / Mcal; and

[0037] (ii) a nitrogen free extract (NFE) in an amount not exceeding about 35 g / Mcal, the NFE comprising starch in an amount not exceeding about 20 g / Mcal.

[0038] In some embodiments, the nutritionally complete feline food composition as a dry food further comprises protein in an amount of at least about 115 g / Mcal.

[0039] In some embodiments, the nutritionally complete feline food composition as a dry food further comprises fat in an amount ranging from about 20 g / Mcal to about 45 g / Mcal.

[0040] In some embodiments, the nutritionally complete feline food composition as a dry food further comprises arginine in an amount not exceeding about 9 g / Mcal.

[0041] In some embodiments, the nutritionally complete feline food as a wet food comprises starch in an amount not exceeding about 20 g / Mcal.

[0042] In some embodiments, the nutritionally complete feline food composition as a wet food further comprises protein in an amount of at least about 117 g / Mcal.

[0043] In some embodiments, the nutritionally complete feline food composition as a wet food further comprises fat in an amount ranging from about 20 g / Mcal to about 45 g / Mcal.

[0044] In some embodiments, the nutritionally complete feline food composition as a wet food further comprises arginine in an amount not exceeding about 9 g / Mcal.

[0045] In some embodiments, the nutritionally complete feline food composition is used to reduce thickening of the heart wall.

[0046] In some embodiments, the nutritionally complete feline food composition is used to reduce the blood concentration of insulin like growth factor I (IGF-I).

[0047] In some embodiments, the nutritionally complete feline food composition is used to reduce the blood concentration of cardiac Troponin I (cTnI).

[0048] In some embodiments, the nutritionally complete feline food composition is used to prevent and / or treat a cat suffering from cardiac hypertrophy.

[0049] In some embodiments, the nutritionally complete feline food composition is used to prevent and / or treat a cat with cardiac hypertrophy, wherein the cat has asymptomatic hypertrophic cardiomyopathy, and wherein the cat has asymptomatic hypertrophic cardiomyopathy in the absence of LA remodeling.

[0050] In some embodiments, the nutritionally complete feline food composition of the present disclosure is used for the prevention and / or treatment of a cat, wherein the composition does not cause a significant change in the feline's body weight.

[0051] A second aspect of the present disclosure further relates to a nutritionally complete feline food composition as defined above and throughout this specification.

[0052] A third aspect of the present disclosure is also directed to a method for treating cardiac hypertrophy in a cat with asymptomatic hypertrophic cardiomyopathy, the method comprising at least the step of feeding the cat with a nutritionally complete feline food composition.

[0053] Another aspect of the present disclosure is also directed to a method for treating cardiac hypertrophy in a cat with asymptomatic hypertrophic cardiomyopathy, the method comprising at least the step of making a feeding recommendation comprising a nutritionally complete feline food composition.

[0054] The present disclosure also relates to a nutritionally complete feline food composition comprising EPA / DHA, carbohydrates and protein for use in a method for preventing and / or treating chronic kidney disease (CKD), wherein

[0055] (a) A nutritionally complete feline food composition consists of a dry food composition comprising:

[0056] (i) EPA / DHA in an amount of at least about 0.5 g / Mcal;

[0057] (ii) a nitrogen free extract (NFE) in an amount not exceeding about 60 g / Mcal; and

[0058] (iii) at least about 115 g / Mcal of protein; or

[0059] (b) A nutritionally complete feline food composition consisting of a wet food composition comprising:

[0060] (i) EPA / DHA in an amount of at least about 1.0 g / Mcal;

[0061] (ii) nitrogen free extract (NFE) in an amount not exceeding about 35 g / Mcal; and

[0062] (iii) protein in an amount of at least about 117 g / Mcal.

[0063] In some embodiments, a nutritionally complete feline food composition consists of a nutritionally complete feline food composition of the present disclosure.

[0064] The present disclosure also relates to a nutritionally complete feline food composition, as described above in the present disclosure, comprising EPA / DHA, carbohydrates and protein, for use in a method of preventing and / or treating chronic kidney disease in cats with aHCM, particularly elderly cats with aHCM.

[0065] The cats considered may or may not have chronic kidney disease.

[0066] In some embodiments, the present disclosure is directed to a nutritionally complete feline food composition comprising EPA / DHA in an amount of at least about 0.5 g / Mcal and a nitrogen-free extract in an amount of no more than about 60 g / Mcal, wherein the composition is a dry food composition.

[0067] In certain specific embodiments, the dry food composition comprises starch in an amount not exceeding about 50 g / Mcal.

[0068] In certain specific embodiments, the dry food composition comprises protein in an amount of at least about 115 g / Mcal.

[0069] In certain specific embodiments, the dry food composition comprises fat in an amount from about 20 g / Mcal to about 45 g / Mcal.

[0070] In certain specific embodiments, the dry food composition comprises arginine in an amount not exceeding about 9 g / Mcal.

[0071] In some embodiments, the present disclosure is directed to a nutritionally complete feline food composition comprising EPA / DHA in an amount of at least about 1.0 g / Mcal and a nitrogen-free extract in an amount of no more than about 35 g / Mcal, wherein the composition is a wet food composition.

[0072] In certain specific embodiments, the wet food composition comprises starch in an amount not exceeding about 20 g / Mcal.

[0073] In certain specific embodiments, the wet food composition comprises protein in an amount of at least about 117 g / Mcal.

[0074] In certain specific embodiments, the wet food composition comprises fat in an amount from about 20 g / Mcal to about 45 g / Mcal.

[0075] In certain specific embodiments, the wet food composition comprises arginine in an amount not exceeding about 9 g / Mcal.

[0076] In certain embodiments, the present disclosure provides a method for preventing and / or treating cardiac hypertrophy in a feline in need thereof, the method comprising providing a nutritionally complete feline food composition to the feline.

[0077] In certain specific embodiments, the feline is a cat.

[0078] In certain specific embodiments, the cat has asymptomatic hypertrophic cardiomyopathy. DETAILED DESCRIPTION

[0079] The present disclosure provides nutritious foods for treating and / or preventing cardiac hypertrophy. In certain embodiments, the nutritious foods disclosed herein can be used to treat and / or prevent felines, especially asymptomatic hypertrophic cardiomyopathy (aHCM) in cats. The nutritional products disclosed in the present application can act on the progression of heart wall thickening, limit spontaneous heart disease, and maintain a good nutritional state (body weight and body condition score (Body Condition Score, BCS)). In certain embodiments, the nutritional products provided by the present application can maintain cats, particularly the proper renal function of elderly cats. In certain embodiments, the nutritional products can not affect the renal function of HCM cats with or without chronic kidney disease (CKD).

[0080] The subject matter of the present disclosure has been achieved by providing a nutritionally complete feline food composition available in wet or dry form, which contains a large amount of EPA / DHA and an appropriate amount of nitrogen-free extract. As shown in the examples of the present application, when provided to cats with cardiac hypertrophy, especially cats with aHCM, this nutritionally complete feline food composition is well tolerated and significantly reduces the thickening of the heart wall, especially the thickening of the interventricular septum (IVS) and the thickening of the left ventricular wall (LVW).

[0081] As shown in the examples of the present application, the complete nutritional feline food composition of the present disclosure results in a reduction in the thickness of the heart wall of a feline experiencing cardiac hypertrophy. In certain embodiments, as shown herein, the complete nutritional feline food composition results in a reduction in the thickness of the ventricular septum and the left ventricular wall of a feline suffering from cardiac hypertrophy, including a feline in the early stages of a disease involving cardiac hypertrophy. In particular, a complete nutritional diet as disclosed in the present application has been shown to reduce cardiac hypertrophy in felines in the early stages of aHCM, i.e., in the asymptomatic HCM stage.

[0082] The unexpected beneficial effects of the complete nutritional food composition disclosed in the present application are also demonstrated by: (i) regulation of heart rate, (ii) reduction in circulating troponin-I levels, (iii) reduction in peak insulin levels without causing changes in mean insulin levels, (iv) no adverse effects on renal function, and (v) reduction in circulating IGF-1 levels, which beneficial effects indicate that myocardial changes caused by cardiac hypertrophy, i.e., HCM, and especially aHCM, are reversed.

[0083] In certain embodiments, as shown in the Examples, the nutritionally complete feline food compositions of the present disclosure act at very early stages of cardiac hypertrophy, including at very early stages of HCM, as evidenced by the various aforementioned beneficial effects elicited in felines undergoing increased thickness of the heart walls, particularly the septum and left ventricular walls, in the absence of left atrial (LA) remodeling.

[0084] As provided in the examples below, it was surprisingly and advantageously discovered that while food compositions comprising large amounts of protein are generally associated with worse CKD outcomes, the nutritionally complete food compositions of the present disclosure do not affect renal function in cats with HCM.

[0085] The present disclosure also relates to a complete nutritional feline food composition, which contains a large amount of EPA / DHA and an appropriate amount of nitrogen-free extract. This composition can be used to treat or prevent cardiac hypertrophy in animals, and more particularly in animals suffering from aHCM. In certain embodiments, the animal is a feline. In certain embodiments, the animal is a cat. The complete nutritional food composition of the present disclosure can also be used to treat felines suffering from cardiac hypertrophy, including methods for treating felines suffering from aHCM. In certain embodiments, the complete nutritional food composition of the present disclosure is a dry feline food composition. In certain embodiments, the nutritionally complete food of the present disclosure is a dry cat food composition. In certain other embodiments, the complete nutritional feline food composition of the present disclosure is a wet food composition. In certain embodiments, the complete nutritional food composition of the present disclosure is a wet cat food composition.

[0086] In certain embodiments, the present disclosure is directed to a nutritionally complete feline food composition comprising EPA / DHA in an amount of at least about 0.5 g / Mcal and a nitrogen-free extract (NFE) in an amount of no more than about 60 g / Mcal for preventing and / or treating cardiac hypertrophy.

[0087] In certain embodiments, the present disclosure relates to a dry nutritionally complete feline food composition comprising EPA / DHA and carbohydrates, and use thereof for preventing and / or treating cardiac hypertrophy, wherein the EPA / DHA is present in an amount of at least about 0.5 g / Mcal and the nitrogen-free extract is present in an amount of no more than about 60 g / Mcal.

[0088] In certain embodiments, the present disclosure relates to a wet nutritionally complete feline food composition comprising EPA / DHA and carbohydrates, and use thereof for preventing and / or treating cardiac hypertrophy, wherein the EPA / DHA is present in an amount of at least about 1.0 g / Mcal and the nitrogen-free extract is present in an amount of no more than about 35 g / Mcal.

[0089] In certain embodiments, the present disclosure relates to a nutritionally complete feline food composition comprising EPA / DHA and carbohydrates, and use thereof for preventing and / or treating cardiac hypertrophy, wherein the nutritionally complete food composition comprises a dry food composition comprising EPA / DHA in an amount of at least about 0.5 g / Mcal and a nitrogen-free extract in an amount of no more than about 60 g / Mcal, or the nutritionally complete feline food composition comprises a wet food composition comprising EPA / DHA in an amount of at least about 1.0 g / Mcal and a nitrogen-free extract in an amount of no more than about 35 g / Mcal.

[0090] definition

[0091] The terms used in this specification generally have their ordinary meanings in the art in the context of the present disclosure and in the specific context in which each term is used. Certain terms are discussed below or elsewhere in the specification to provide additional guidance when describing the compositions and methods of the present disclosure and how to make and use them.

[0092] As used in the specification and the appended claims, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a compound" includes a mixture of compounds.

[0093] As used herein, the term "about" or "approximately" means within an acceptable error range for a 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. For example, "about" may mean within 3 or more than 3 standard deviations, according to practice in the art. Alternatively, "about" may mean a range of up to 10%, more preferably up to 5%, and more preferably up to 1% of a given value.

[0094] As used herein, the terms "animal" or "pet" may be used, for example, to refer to domestic or wild animals. In certain embodiments, these terms may refer to a cat or feline.

[0095] As used herein, the terms "comprises," "comprising," or any other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that includes a list of elements includes not only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

[0096] In the detailed description herein, references to "an embodiment," "one embodiment," "an embodiment," "in various embodiments," etc. indicate that the described embodiment may include a particular feature, structure, or characteristic, but each embodiment may not necessarily include the particular feature, structure, or characteristic. Furthermore, these phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in conjunction with an embodiment, it is considered to be within the knowledge of those skilled in the art to affect such features, structures, or characteristics in relation to other embodiments, whether or not explicitly described. After reading the specification, it will be apparent to those skilled in the relevant art how to implement the present disclosure in alternative embodiments.

[0097] As used herein, the term "EPA / DHA" refers to a fatty acid or fatty acid mixture consisting of (i) only eicosapentaenoic acid (EPA), (ii) only docosahexaenoic acid (DHA), or (iii) a combination of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA).

[0098] As used herein, the amount of a component expressed as weight / Mcal refers to the weight of the component in units of metabolizable energy (ME) of the total food composition. Metabolizable energy can generally be determined according to standard methods, in particular according to European Standard EN 16967 (ICS.65.120) of July 2017.

[0099] As used herein, the term "food composition" or "diet" refers to a material containing protein, carbohydrates and / or fat, which is used in an organism to maintain growth, repair and life processes and provide energy. Food may also include supplementary substances or additives, such as minerals, vitamins and condiments (see Merriam-Webster's Collegiate Dictionary, 10th Edition, 1993). In a specific embodiment, the feline food composition according to the present disclosure is composed of a complete nutritional food composition, which provides a complete and balanced nutritional requirement for felines, especially cats. Therefore, the food composition as described herein is a complete feline food; for example, a complete cat food, i.e., a nutritionally adequate feed, which the feline, such as the cat, can use as the sole ration and can maintain life without additional food (except water). In addition, the complete nutritional feline food composition does not cause a significant change in the weight and / or body condition score (BCS) of the feline, i.e., the cat. The food composition may include a carrier, a diluent or an excipient. Depending on the intended use, a carrier, diluent or excipient may be selected that is suitable for use with animals, particularly felines such as cats.

[0100] Illustratively, a nutritionally complete food composition as described herein may include, but is not limited to, cereal and plant protein extracts, fiber, oils and fats, protein, chicory pulp, yeast and its parts, minerals, vitamins, preservatives, antioxidants, water, arginine, sodium.

[0101] As used herein, the terms "dry food", "wet food" and "semi-wet food" refer to complete nutritional feline food products, which include any product consumed by a feline in its diet. In certain embodiments, the feline food is a cooked product. It can contain meat or animal-derived materials (e.g., beef, chicken, turkey, lamb, fish, plasma, bone marrow, etc. or one or more thereof). Alternatively, the product can be meatless (and in certain embodiments can include meat substitutes such as soy, corn gluten or soy products) to provide a protein source.

[0102] As used herein, the term "feline" includes animals selected from the group consisting of cheetahs, cougars, jaguars, leopards, lions, lynxes, ligers, tigers, black panthers, bobcats, ocelots, saber-toothed tigers, caracals, servals, and cats, including pet animals, including elderly pet animals. As used herein, cats include wild cats and domestic cats. In a specific embodiment, the cat is a domestic cat. In a more specific embodiment, the cat is an elderly cat.

[0103] As used herein, "cardiac hypertrophy" refers to an abnormal enlargement or thickening of the myocardium, which is caused by an increase in the size of cardiomyocytes and changes in other myocardial components (e.g., the extracellular matrix) due to chronic and increased stress on the heart. Cardiac hypertrophy includes HCM, which is characterized by left ventricular hypertrophy with thickening of the ventricular septum and left ventricular wall. If the hypertrophy is mild and focal, cats can remain asymptomatic for a long time (aHCM). However, if the hypertrophy is severe, the ventricle will be difficult to expand, accompanied by increased left-sided cardiac filling pressures and left atrial dilation (LA remodeling to cope with increased pressure). HCM in cats can be secondary to pressure overload caused by systemic hypertension or outflow tract obstruction, and can also be secondary to hormonal stimulation, such as hyperthyroidism and hypergrowth hormone / acromegaly.

[0104] According to the present disclosure, HCM includes aHCM.

[0105] As used herein, "chronic kidney disease" (CKD) refers to a type of kidney disease in which kidney function is gradually lost over a period of months to years. Initially, there are generally no symptoms. Complications may include an increased risk of heart disease.

[0106] As used herein, a significant change or difference or decrease or increase is reproducible (p-value < 0.05), i.e., a change or difference or decrease or increase is consistently observed for the parameters tested, including, for example, but not limited to, those tested in Table 8). The measurement of p-values ​​is known to the skilled person, depending on the available values ​​and experimental conditions.

[0107] As used herein, a non-significant change or difference or decrease is not reproducible (p value>0.05), i.e., a change or difference or decrease that is consistently observed in the parameters tested, including, for example, but not limited to, those tested in Table 8).

[0108] As used herein, the term "providing" means selling, supplying, administering or feeding.

[0109] As used herein, "does not affect" with respect to a given physiological function is intended to mean that one or more parameters defining that physiology and its state do not change significantly over time, with or without any adjunctive treatment.

[0110] As used herein, the term "weight percent" or "wt%" or "by weight" refers to (i) the amount of an ingredient / component by weight in a composition as a percentage of the total weight of the composition; or (ii) the amount of an ingredient / component by weight in a material as a percentage of the weight of the final material or product.

[0111] Food ingredients

[0112] The food compositions of the present disclosure may include a variety of components. Non-limiting examples of components that may be incorporated into the food compositions of the present disclosure are listed below.

[0113] EPA / DHA

[0114] In certain embodiments, the composition may include eicosapentaenoic acid and / or docosahexaenoic acid. As used herein, the term "EPA / DHA" refers to a fatty acid or fatty acid mixture consisting of (i) only eicosapentaenoic acid (EPA), (ii) only docosahexaenoic acid (DHA), or (iii) a combination of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA). Thus, the amount of "EPA / DHA" may refer to any of the following: (i) the amount of EPA in the absence of DHA, (ii) the amount of DHA in the absence of EPA, or (iii) the combined amount of EPA and DHA.

[0115] Thus, a nutritionally complete feline food composition as disclosed herein comprises EPA, or DHA, or a combination of EPA and DHA at a specific EPA / DHA weight per unit metabolizable energy of the total food composition.

[0116] In certain embodiments of the present disclosure, when a nutritionally complete feline food contains "X g / Mcal" of EPA / DHA, the feline food may contain X g / Mcal of EPA and no DHA. According to these embodiments, X g / Mcal EPA / DHA is equal to X mg / Mcal EPA and no DHA.

[0117] In certain other embodiments of the present disclosure, a nutritionally complete feline food comprises "X g / Mcal" of EPA / DHA, which may comprise X g / Mcal of DHA and no EPA. According to these other embodiments, X mg / Mcal EPA / DHA is equal to X mg / Mcal DHA, no EPA.

[0118] In certain embodiments of the present disclosure, a complete feline food comprises "X g / Mcal" of EPA / DHA, and the feline food may comprise a combination of EPA and DHA of X g / Mcal. According to these embodiments, both EPA and DHA are present in the composition. In addition, in these embodiments, there are no specific requirements for the respective amounts of EPA and DHA present in the EPA / DHA combination. For example, but not by way of limitation, the weight / energy ratio of EPA to DHA may be in the range of about 0.0001 to about 1000.

[0119] The properties of mixtures containing EPA / DHA have been described in the past in several documents, for example: for the treatment of thrombosis, hypercholesterolemia, myocardial ischemia (WO87 / 03899), for the prevention of arteriosclerosis, cerebral infarction, hyperlipidemia, myocardial infarction (EP0228314), for the prevention of atherosclerosis, as an antithrombotic agent, as an antihypertensive agent (JP62091188), for thrombotic conditions, platelet aggregation, autoimmune syndromes, acute and chronic inflammation disease, atherosclerosis, myocardial infarction, venous thrombosis, hyperlipidemic state, hypertension, lesions and occlusions caused by vasomotor spasm, diabetes (WO87 / 02247), prevention of side effects of nonsteroidal anti-inflammatory drugs (EP0195570), prevention and management of diabetic complications (JP60-248610), hypercholesterolemia, hypertriglyceridemia (DE3438630), as an anticoagulant for hypercholesterolemia (BE899184).

[0120] In certain embodiments, EPA / DHA is present in the dry food compositions of the present disclosure in an amount of at least about 0.5 g / Mcal. In certain embodiments, EPA / DHA is present in the dry food compositions of the present disclosure in an amount of at least about 0.5 g / Mcal, at least about 1.0 g / Mcal, at least about 1.5 g / Mcal, at least about 2.0 g / Mcal, at least about 2.5 g / Mcal, at least about 3.0 g / Mcal, at least about 3.5 g / Mcal, at least about 4.0 g / Mcal, at least about 4.5 g / Mcal, at least about 5.0 g / Mcal, at least about 5.5 g / Mcal, at least about 6.0 g / Mcal, at least about 6.5 g / Mcal, at least about 7.0 g / Mcal, at least about 7.5 g / Mcal, at least about 8.0 g / Mcal, at least about 8.5 g / Mcal, at least about 9.0 g / Mcal, at least about 9.5 g / Mcal, or at least about 10 g / Mcal.

[0121] In some embodiments, EPA / DHA is present in the wet food composition in an amount of at least about 1.0 g / Mcal. In some embodiments, EPA / DHA is present in the wet food composition in an amount of at least about 1.0 g / Mcal, at least about 1.5 g / Mcal, at least about 2.0 g / Mcal, at least about 2.5 g / Mcal, at least about 3.0 g / Mcal, at least about 3.5 g / Mcal, at least about 4.0 g / Mcal, at least about 4.5 g / Mcal, at least about 5.0 g / Mcal, at least about 5.5 g / Mcal, at least about 6.0 g / Mcal, at least about 6.5 g / Mcal, at least about 7.0 g / Mcal, at least about 7.5 g / Mcal, at least about 8.0 g / Mcal, at least about 8.5 g / Mcal, at least about 9.0 g / Mcal, at least about 9.5 g / Mcal, or at least about 10 g / Mcal.

[0122] Nitrogen Free Extract (NFE)

[0123] In certain embodiments, the composition may include a nitrogen-free extract (NFE). As used herein and as known in the art, NFE includes a soluble carbohydrate portion. The nutritionally complete feline food composition disclosed herein includes NFE.

[0124] If NFE is present in the food composition of the presently disclosed subject matter, the NFE may include a variety of soluble polysaccharides, starches, gums, mucilages, and pectins. As is conventionally known in the art, NFE does not include the insoluble carbohydrate portion contained in the crude fiber material, which in some embodiments may be present in the food composition.

[0125] Typically, the amount of NFE in a food composition is determined by subtracting the content of each of the other components (protein, fat, crude fiber, ash) from the total dry matter of the food composition.

[0126] In certain embodiments, when the qualitative and quantitative characteristics of a food composition are expressed as energy density (e.g., metabolizable energy density in grams / Mcal), the NFE content is determined by subtracting the energy value of each other component (protein, fat, crude fiber, ash) from the energy value of the entire food composition.

[0127] In certain embodiments, when the qualitative and quantitative characteristics of a food composition are expressed as weight percentages (e.g., weight percentages based on the total weight of dry matter of the composition), the NFE content is determined by subtracting the weight percentages of other ingredients (protein, fat, crude fiber, ash) from the total weight of the food composition.

[0128] In certain embodiments, NFE is present in the dry food composition of the present disclosure in an amount of no more than about 60 g / Mcal. In certain embodiments, NFE is present in the dry food composition of the present disclosure in an amount of no more than about 60 g / Mcal, no more than about 55 g / Mcal, no more than about 50 g / Mcal, no more than about 45 g / Mcal, no more than about 40 g / Mcal, no more than about 35 g / Mcal, no more than about 30 g / Mcal, no more than about 25 g / Mcal, no more than about 20 g / Mcal, no more than about 15 g / Mcal, or no more than about 10 g / Mcal.

[0129] In certain embodiments, NFE is present in the wet food composition of the present disclosure in an amount of no more than about 35 g / Mcal, no more than about 30 g / Mcal, no more than about 25 g / Mcal, no more than about 25 g / Mcal, no more than about 20 g / Mcal, no more than about 15 g / Mcal, or no more than about 10 g / Mcal.

[0130] carbohydrate

[0131] In certain embodiments, the composition may include carbohydrates. As used herein, the term "carbohydrate" refers to a mixture of polysaccharides and sugars that are metabolized into energy when hydrolyzed in vivo. The carbohydrate content in the food composition can be determined by a variety of methods known to those skilled in the art. Carbohydrates can be provided in any form of a variety of carbohydrate sources known to those skilled in the art, including starch (any variety, corn, wheat, barley, etc.) beet pulp (beet pulp) (containing a small amount of sugar) and psyllium.

[0132] starch

[0133] An important source of nitrogen-free extracts included in the nutritionally complete feline food compositions of the present disclosure consists of starch. One skilled in the art will appreciate that a variety of starches are suitable for use in the compositions of the present disclosure.

[0134] In certain embodiments, the term "starch" as used herein refers to a polysaccharide composed of straight-chain starch and amylopectin. Starch is present in many plant tissues in the form of granules, typically between 1 μm and 100 μm in diameter, depending on the plant source. Chemically, starch is a polysaccharide composed of α-D-pyranose glucopyranosyl units linked together with α-D(1-4) and / or α-D(1-6) bonds, and consists of two molecular types: straight-chain starch, a linear polyglucan composed of approximately 1000 α-D(1-4) linked glucoses; and amylopectin, i.e., a branched glucan, composed of approximately 4000 glucoses, with branches appearing in the form of α-D(1-6) bonds.

[0135] As used herein, starch includes various crystal structures of A-type, B-type and C-type starch, which contain different proportions of amylopectin. A-type starch is mainly found in cereals, while B-type starch is mainly found in tubers and starch rich in amylose. C-type starch consists of a mixture of A and B forms and is mainly found in beans.

[0136] Generally speaking, digestible starch is broken down (hydrolyzed) in the small intestine by the enzymes α-amylase, glucoamylase, and sucrase-isomaltase to produce free glucose, which is then absorbed.

[0137] The starch included in the nutritionally complete feline foods disclosed herein can be any starch suitable for dietary purposes.

[0138] In fact, the native starch contained in the starting materials used to prepare the nutritionally complete feline food composition as described herein is susceptible to changes during the manufacturing process. However, it is shown herein that regardless of the conditions used in the manufacturing method (e.g., dry, wet or semi-wet), and therefore regardless of the physicochemical changes that the starch may undergo during processing, the resulting final feline food fully exerts its beneficial effects on cardiomyopathy, including hypertrophic cardiomyopathy (HCM), and in particular on asymptomatic HCM.

[0139] The specific amount of starch included in the nutritionally complete feline food compositions described in the present disclosure consists of the amount of starch contained in the total amount of raw materials provided for producing the food composition.

[0140] However, the amount of starch included in the nutritionally complete feline food composition disclosed herein is equal to the total amount of starch included in the starting materials used to prepare the feline food composition.

[0141] If not known in advance, the starch content of the starting materials used to prepare the nutritionally complete feline food composition described herein can be determined according to conventional techniques known in the art, and in particular according to known polarimetry, for example according to NF EN ISO 10520.

[0142] In certain embodiments, the starting material may further comprise modified starch or pregelatinized starch, and the starch content may also be determined according to NF EN ISO 15914.

[0143] The present disclosure provides a complete nutritional feline food composition comprising EPA / DHA and a nitrogen-free extract. The complete nutritional feline food composition disclosed herein comprises a large amount of EPA / DHA and an appropriate amount of nitrogen-free extract. The complete nutritional feline food composition may comprise a wet food product, a semi-wet food product or a dry food product. It is shown herein that a dry or wet food composition comprising a large amount of EPA / DHA and an appropriate amount of nitrogen-free extract reduces the thickening of the heart wall in felines with cardiac hypertrophy and especially cats with HCM or aHCM), and particularly the thickening of the interventricular septum (IVS), and more particularly the thickening of the interventricular septum (IVSd) and the left ventricular wall (LVW) measured at the end of diastole, and more particularly the thickening of the left ventricular wall (LVWd) measured at the end of diastole.

[0144] protein

[0145] In certain embodiments, the complete nutrition feline food composition of the present disclosure may include a large amount of protein. The protein content of the composition according to the present disclosure may be high enough to ensure that lean body mass is maintained. According to the complete nutrition feline food composition of the present disclosure, one or more different protein sources may be included. Generally, the complete nutrition feline food composition as described herein includes a variety of proteins, which are included in the protein source that can be used for the manufacturing process. In certain embodiments, the protein contained in the complete nutrition feline food composition is in natural form. In certain other embodiments, the protein can exist in the form of at least partial hydrolysis, including almost completely hydrolyzed protein. In certain embodiments, the complete nutrition feline food composition according to the present disclosure can be incorporated with protein in the form of meat or animal source materials, such as beef, chicken, turkey, mutton, fish, plasma, bone marrow, etc., or one or more thereof). In certain other embodiments, the complete nutrition feline food composition as described herein can be meatless and can include meat substitute protein sources such as soybeans, corn gluten or any other protein-containing soy products to provide a protein source. In certain embodiments, the complete nutrition feline food composition of the present disclosure may include additional protein sources, such as soy protein concentrate, milk protein, gluten, etc.

[0146] Fat

[0147] In certain embodiments, a nutritionally complete feline food composition according to the present disclosure may further comprise a nutritionally adequate amount of fat.

[0148] The expression "fat" used in this specification includes one or more fats and / or one or more oils acceptable to any food, no matter how their consistency at room temperature is, that is, no matter the "fat" exists in the form of a substantially fluid or exists in a substantially solid form. According to the composition of the present disclosure, fat of animal and / or plant origin may be included. Fat can be provided by any of a variety of sources known to those skilled in the art. Plant fat sources include but are not limited to wheat, sunflower, safflower, rapeseed, olive, borage, linseed, peanut, blackcurrant, cottonseed, wheat, germ, corn germ, and oil derived from these and other plant fat sources. Animal sources include, for example, but not limited to chicken fat, turkey fat, beef fat, duck fat, pork fat, mutton fat, etc., fish oil or any meat, meat by-products, seafood, dairy products, eggs, etc. The fat content of food can be determined by a variety of methods known to those skilled in the art.

[0149] Arginine

[0150] In certain embodiments of the present disclosure, the complete nutritional feline food composition according to the present invention may also include arginine in an amount sufficient to maintain the health of the feline. Arginine is an essential nutrient for cats. Specifically, arginine provides a unique example of a very important nutrient, so much so that a meal without dietary arginine can lead to death. On the other hand, high levels of arginine can be decomposed in nitric oxide (NO) and cause inflammation. It is easy to understand that arginine is generally contained in the protein contained in complete feline foods. Therefore, in most embodiments, arginine is not added as a specific supplement for meeting the arginine amount requirement of the complete nutritional feline food as disclosed herein.

[0151] sodium

[0152] In certain embodiments of the present disclosure, a complete nutritional feline food composition comprises sodium (Na+). In a specific embodiment, a small amount of sodium is used. Sodium is a mineral essential for life. Sodium is present in the blood and the fluid surrounding cells to maintain the cell environment and prevent cell swelling or dehydration. Sodium is also important for maintaining proper nerve and muscle cell function. Therefore, a specific sodium content in cat food is suitable for healthy cats. The sodium content in the feline food composition can be balanced with energy, other minerals, vitamins, fats, proteins and carbohydrates in an appropriate proportion. Sodium sources include, for example, but are not limited to meat, poultry, fish and eggs. Sodium sources can also be in the form of table salt.

[0153] fiber

[0154] In certain embodiments of the present disclosure, a nutritionally complete feline food composition comprises one or more dietary fibers.

[0155] As used herein, the term "fiber" is similar to "dietary fiber" and should be interpreted as total fiber for the purposes of this disclosure, meaning that it includes soluble fiber and insoluble fiber. Soluble fiber can be defined as non-starch polysaccharides that resist digestion and absorption in the small intestine and are fully or partially fermented in the large intestine, in contrast to insoluble fiber, which can be defined as non-starch polysaccharides that resist digestion and absorption in the small intestine and resist fermentation in the large intestine. Soluble fiber is believed to have a prebiotic effect by providing short-chain fatty acids as an energy source to colonocytes. Insoluble fiber is believed to contribute to transit and ballast effects.

[0156] Non-limiting examples of fiber include a first group including beet pulp, guar gum, chicory root, psyllium, pectin, blueberry, cranberry, pumpkin, apple, oat, beans, citrus, barley, peas, or a combination thereof; and a second group including cellulose, whole-wheat products, wheat oats, corn bran, flaxseed, grapes, celery, green beans, cauliflower, potato peels, fruit peels, vegetable peels, peanut shells, soy fiber, or a combination thereof. In a specific embodiment, the complete nutritional feline food composition of the present disclosure comprises chicory pulp or cellulose.

[0157] In certain non-limiting embodiments, a nutritionally complete feline food composition as described herein may include fiber in an amount of at least about 0.5 weight percent based on the total weight of dry matter.

[0158] Unless otherwise stated, weight percentages expressed herein are by weight of the total weight of the dry matter food composition.

[0159] Other Ingredients

[0160] In certain embodiments, a nutritionally complete feline food as described herein may further include supplemental substances or additives, such as minerals, vitamins, and flavorings (see Merriam-Webster's Collegiate Dictionary, 10th Edition, 1993).

[0161] In certain embodiments, a complete nutritional feline food as described herein may include ash. The ash may include minerals, such as calcium, phosphorus, sodium, chlorine, potassium, magnesium, or a combination thereof. Ash content, if specified as a result of an analytical measurement of a feline food composition as described herein, is a measurement of the total amount of minerals contained therein. Mineral content is a measurement of the amount of specific inorganic components contained therein, including calcium (Ca), sodium (Na), potassium (K), and chlorine (Cl).

[0162] It should be readily understood that each embodiment of a nutritionally complete feline food composition encompassed by the present disclosure comprises a plurality of ingredients, each ingredient being included in the composition at a given weight percentage compared to the total weight of dry matter of the nutritionally complete feline food composition.

[0163] In certain embodiments, a nutritionally complete feline food composition as disclosed herein comprises protein, carbohydrates, fat, one or more EPA / DHA sources, optionally fiber, and optionally one or more other ingredients, such as vitamins, minerals, etc., based on the total weight of the dry matter of the feline food composition, wherein the sum of the weight of each ingredient contained is 100 weight %.

[0164] Dry food composition

[0165] In certain embodiments, a nutritionally complete feline food composition as described herein comprises a dry food composition comprising EPA / DHA in an amount of at least about 0.5 g / Mcal and (ii) a nitrogen-free extract in an amount of no more than about 60 g / Mcal.

[0166] In certain embodiments, a nutritionally complete feline dry food composition comprises EPA / DHA in an amount of about 0.6 g / Mcal.

[0167] Without wishing to be bound by any particular theory, it is understood that very high amounts of EPA / DHA, such as amounts above about 10 g / Mcal, can cause potential adverse effects, which may include altered hemostasis due to anti-aggregation effects on platelets, vitamin E deficiency, lipid peroxidation, and mild diarrhea.

[0168] In certain embodiments, the nitrogen-free extract is present in a nutritionally complete feline dry food composition according to the present disclosure in an amount of at least about 1 g / Mcal.

[0169] Starch is one of the sources of nitrogen-free extracts included in the nutritionally complete feline dry food composition according to the present disclosure.

[0170] In certain embodiments, a nutritionally complete feline dry food composition according to the present disclosure comprises starch in an amount not exceeding about 50 g / Mcal.

[0171] In certain embodiments, the starch is provided by a cereal source. Certain non-limiting embodiments of starch sources include staple foods such as potatoes, wheat, corn (maize), rice, and cassava.

[0172] In certain embodiments, a nutritionally complete feline dry food composition comprises protein in an amount of at least about 115 g / Mcal.

[0173] In certain embodiments, a nutritionally complete feline dry food composition comprises protein in an amount of about 125 g / Mcal.

[0174] In certain embodiments, a nutritionally complete feline dry food composition comprises fat in an amount ranging from about 20 g / Mcal to about 45 g / Mcal.

[0175] In certain embodiments, a nutritionally complete feline dry food composition of the present disclosure comprises fat in an amount ranging from about 30 g / Mcal to about 40 g / Mcal, or from about 30 g / Mcal to about 35 g / Mcal.

[0176] In certain non-limiting embodiments, the dry food composition comprises fat in an amount of about 35 g / Mcal.

[0177] In certain embodiments, a nutritionally complete feline dry food composition comprises arginine in an amount not exceeding about 9 g / Mcal.

[0178] In certain embodiments, a nutritionally complete feline dry food composition comprises arginine in an amount of about 8 g / Mcal.

[0179] In certain embodiments, a nutritionally complete feline dry food composition comprises sodium (Na+) in an amount of no more than about 0.7 g / Mcal. In certain embodiments, a nutritionally complete feline dry food composition comprises sodium in an amount of about 0.68 g / Mcal.

[0180] In certain embodiments, the amount of sodium in the nutritionally complete feline dry food composition is at least about 0.19 g / Mcal.

[0181] In certain embodiments, a nutritionally complete feline dry food composition comprises one or more ingredients selected from the group consisting of barley, psyllium and its derivatives, starch, and native wheat gluten.

[0182] According to one illustrative embodiment, a nutritionally complete feline dry food composition comprises one or more components selected from the group consisting of (i) barley in an amount of at least about 45 g / Mcal, (ii) psyllium and its derivatives in an amount of at least about 3.50 g / Mcal, (iii) starch in an amount of no more than about 40 g / Mcal, (iv) native wheat gluten in an amount of at least about 50 g / Mcal, and (v) combinations thereof.

[0183] There are two varieties of barley, distinguished by the number of flower rows on the ear. Two-row barley has a central floret that produces the kernels and side flowers that are usually sterile. While six-row barley has a higher protein content and is more suitable for animal feed, two-row barley has a higher sugar content and is therefore more commonly used for malt production.

[0184] As used herein, "plantain and its derivatives" refers to a plant called Plantago psyllium and its derivatives, such as psyllium tegument.

[0185] As used herein, "native wheat gluten" refers to the unmodified carbohydrate component derived from wheat.

[0186] As is generally recognized, dry pet food is the end product of a process that includes an extrusion step and a subsequent drying step.

[0187] In certain embodiments, a nutritionally complete dry feline food according to the present disclosure has a moisture content of up to about 12%. In some embodiments, the dry feline food has a moisture content of about 7% or less, such as about 5%. In certain non-limiting embodiments, a nutritionally complete dry feline food has a moisture content of greater than about 3%. The embodiment describes a nutritionally complete dry feline food having a moisture content of about 5.5%. Specifically, the dry food composition may have a moisture content of less than about 10%.

[0188] In certain embodiments, the dry food has a kibble form. Non-limiting examples of kibble foods include granules, pellets, pet food chunks, dehydrated meat, meat analogs, vegetables, and combinations thereof; and pet treats such as meat or vegetable jerky, rawhide, and biscuits.

[0189] The dry complete nutrition feline food composition of the present disclosure can be made by mixing the ingredients together and kneading them to make a consistent dough that can be cooked. The process of making dry pet food is usually completed by baking and / or extrusion. The dough is usually sent to a machine called an expander and / or extruder, which uses pressurized steam or hot water to cook the ingredients. In the extruder, the dough is under extreme pressure and high temperature. The dough is then pushed through a die (a hole of a specific size and shape) and then cut off with a knife. The puffed dough piece is made into a kibble by passing it through a dryer to reduce the moisture to a specified target, ensuring that the food remains stable before consumption. The kibble can then be sprayed with fat, oil, minerals, vitamins, natural extract mixtures, and optionally sealed into a package.

[0190] In some embodiments, the dry complete nutritional feline food composition is packaged. In this way, the consumer can identify the ingredients in the food from the packaging and confirm that it is suitable for the particular pet in question. In some embodiments, the packaging can be metal, plastic, paper or card.

[0191] Wet food composition

[0192] In certain embodiments, the nutritionally complete food composition of the present disclosure is a wet food composition comprising (i) EPA / DHA in an amount of at least about 1.0 g / Mcal and (ii) a nitrogen-free extract in an amount of no more than about 35 g / Mcal.

[0193] In certain embodiments, a nutritionally complete feline wet food composition comprises about 1.8 g / Mcal EPA / DHA.

[0194] Very large amounts of EPA / DHA, such as amounts above 10 g / Mcal, have been proposed to cause potential adverse effects that may include altered hemostasis due to antiaggregatory effects on platelets, vitamin E deficiency, lipid peroxidation, and mild diarrhea.

[0195] In a specific embodiment, the nitrogen-free extract is present in the nutritionally complete feline wet food composition according to the present disclosure in an amount of about 32 g / Mcal.

[0196] In a specific embodiment, the nitrogen-free extract is present in the nutritionally complete feline wet food composition according to the present disclosure in an amount of at least about 1 g / Mcal.

[0197] Starch is one of the sources of nitrogen-free extracts included in the nutritionally complete feline wet food composition according to the present disclosure.

[0198] In certain specific embodiments, a nutritionally complete feline wet food composition according to the present disclosure comprises starch in an amount not exceeding about 20 g / Mcal.

[0199] In certain embodiments, the starch is provided by a cereal source. Certain non-limiting embodiments of starch sources include staple foods such as potatoes, wheat, corn (maize), rice, and cassava.

[0200] In certain embodiments, a nutritionally complete feline wet food composition comprises protein in an amount of at least about 117 g / Mcal.

[0201] In certain embodiments, a nutritionally complete feline wet food composition comprises protein in an amount of about 133 g / Mcal.

[0202] In certain embodiments, a nutritionally complete feline wet food composition comprises fat in an amount ranging from about 20 g / Mcal to about 45 g / Mcal.

[0203] In certain specific embodiments, the nutritionally complete feline dry food composition of the present disclosure comprises fat in an amount ranging from about 30 g / Mcal to about 45 g / Mcal, about 35 to about 43 g / Mcal, about 40 to about 42 g / Mcal, or about 30 g / Mcal to about 40 g / Mcal. In certain embodiments, the nutritionally complete feline dry food composition of the present disclosure comprises fat in an amount ranging from about 30 g / Mcal to about 35 g / Mcal.

[0204] Illustratively, in certain non-limiting embodiments, the wet food composition comprises fat in an amount of about 41 g / Mcal.

[0205] In an alternative embodiment, the nutritionally complete feline wet food composition comprises arginine in an amount not exceeding about 9 g / Mcal.

[0206] In one illustrative embodiment, the nutritionally complete feline wet food composition includes arginine in an amount of about 7.3 g / Mcal.

[0207] In certain embodiments, a nutritionally complete feline wet food composition comprises sodium (Na) in an amount not exceeding about 0.7 g / Mcal. + ). In certain embodiments, a nutritionally complete feline wet food composition of the present disclosure comprises sodium in an amount of about 0.60 g / Mcal.

[0208] In a specific embodiment, a nutritionally complete feline wet food composition of the present disclosure comprises sodium in an amount of about 0.19 g / Mcal.

[0209] In certain embodiments, a nutritionally complete feline wet food composition comprises one or more components selected from the group consisting of psyllium and derivatives thereof, starch, plant-derived protein, and combinations thereof.

[0210] As an illustrative embodiment, a nutritionally complete feline wet food composition comprises at least (i) psyllium and its derivatives in an amount of at least about 0.1 g / Mcal, (ii) cereal-derived starch in an amount not exceeding about 20 g / Mcal, and (iv) plant-derived protein in an amount of at least about 30 g / Mcal.

[0211] Plant sources of protein include, but are not limited to, those from nuts, seeds, oily fruits, spirulina, chlorella, klamath, soy, peanuts, pumpkin seeds, almonds, beans, fenugreek, chickpeas, chia seeds, quinoa, buckwheat, oat bran, wheat, corn, potatoes, etc.

[0212] As is generally recognized, wet pet food is the end product of a process that includes a terminal sterilization step (rather than a drying step).

[0213] In certain embodiments, a nutritionally complete wet feline food according to the present disclosure has a moisture content of greater than about 30%. In some embodiments, the wet feline food has a moisture content of about 40% or more. For example, but not by way of limitation, embodiments provided herein describe nutritionally complete wet feline food having a moisture content of 80%. Specifically, the wet food composition has a moisture content of more than 30%.

[0214] In a particular embodiment, the wet food consists of chunks, more particularly chunks in gravy. In a particular embodiment, the wet food consists of chunks and gravy, chunks in jelly, loaf, mousse, terrine or bite-form.

[0215] "Chunk and gravy" products include pre-made meat particles that are prepared by preparing a meat paste and cooking the meat paste through a gun under pressure. Products such as cooked meat are cut into large chunks that are ultimately mixed with a gravy or sauce. The two ingredients are then packed into containers, usually cans or bags, which are then sewn or sealed and sterilized. In contrast to ground bread cubes, chunk and gravy compositions are prepared with physically separate, discrete chunks (i.e., chunks of ground meat and cereals). These discrete particles are present in a gravy-type liquid in the final container. When consumed, the chunk and gravy product flows out of the can and is easily mixed with other dry products. While chunk and gravy products allow for better integrity of the individual ingredients, the heterogeneous formulation of chunk and gravy products is sometimes undesirable.

[0216] Wet food compositions are typically packaged in can-like containers and are considered "wet" in appearance due to the moisture contained therein. Two types of wet compositions are well known in the art. The first is known in the art as "ground bread." Bread products are typically prepared by contacting a mixture of multiple ingredients under heat to produce a substantially uniform intracellular cellular mass or "ground bread." The ground bread is then packaged into a cylindrical container, such as a can. When packaged, the ground bread takes the shape of the container and must therefore be cut when provided to a companion animal.

[0217] In some embodiments, the dry complete nutritional feline food composition is packaged. In this way, the consumer can identify the ingredients in the food from the packaging and confirm that it is suitable for the particular pet in question. In some embodiments, the packaging can be metal, plastic, paper or card.

[0218] Semi-moist food composition

[0219] In an alternative embodiment, a nutritionally complete food composition as described herein consists of a semi-moist food composition comprising (i) EPA / DHA in an amount of at least about 0.5 g / Mcal and (ii) a nitrogen-free extract in an amount of no more than about 40 g / Mcal.

[0220] As is generally recognized, semi-moist pet food is the end product of a process that allows obtaining a moisture content value between dry pet food and wet pet food. In some embodiments, the process may include a step of adding a humectant. In some embodiments, the method includes an extrusion step and a subsequent superheated stream (SHS) treatment step.

[0221] In some embodiments, a nutritionally complete semi-moist feline food according to the present disclosure contains more than about 12% and up to about 30% moisture. In an illustrative embodiment, the semi-moist food composition has about 11% to about 20% moisture and / or a water activity of about 0.64 to about 0.75.

[0222] In certain non-limiting embodiments, the semi-moist food may be obtained using a superheated flow (SHS) process, such as the processes or methods described in published patent applications WO2009 / 018990, WO2009 / 018996, WO2010 / 112097, WO2014 / 122072, WO2016 / 071372 and / or WO2016 / 071367.

[0223] In certain embodiments, the semi-moist food product consists of soft, semi-moist kibble.

[0224] Use of nutritionally complete feline food composition

[0225] The present disclosure further provides for the use of a nutritionally complete feline food composition as described herein for preventing and / or treating cardiac hypertrophy in felines, especially cats, particularly preventing and / or treating hypertrophic cardiomyopathy (HCM), including asymptomatic HCM.

[0226] In certain embodiments, the present disclosure relates to a nutritionally complete feline food composition comprising EPA / DHA and a nitrogen-free extract for preventing and / or treating cardiac hypertrophy, wherein the nutritionally complete food composition consists of a dry food composition comprising EPA / DHA in an amount of at least about 0.5 g / Mcal and the nitrogen-free extract in an amount of no more than about 60 g / Mcal, or the nutritionally complete food composition consists of a wet food composition comprising: EPA / DHA in an amount of at least about 1.0 g / Mcal and the nitrogen-free extract in an amount of no more than about 35 g / Mcal.

[0227] As previously mentioned, cardiac hypertrophy is characterized by hypertrophy of the heart wall, and more specifically hypertrophy of the left ventricle, with thickening of the interventricular septum and left ventricular wall. Cardiac hypertrophy can be diagnosed in a variety of ways, as is known to those skilled in the art. Cardiac hypertrophy can be diagnosed by measuring the maximum thickness of the heart wall by echocardiography. Specifically, the maximum thickness of the heart wall is measured in 3 areas of the interventricular septum (IVSd) during diastole and in 2 areas of the left ventricular wall (LVWd) during diastole.

[0228] Cardiac troponin (cTnI) is a sensitive and specific marker of myocardial damage and is increased in cats with asymptomatic hypertrophic cardiomyopathy (aHCM). Therefore, increased blood concentrations of cardiac troponin I are associated with the time of cardiac death in cats. In addition, blood concentrations of insulin-like growth factor I (IGF-1) are also associated with hypertrophic heart measurements. In addition, with increased left-sided cardiac filling pressures and dilation of the left atrium (LA remodeling in response to increased pressure), cardiac distensibility becomes abnormal (stiffening). Cats without LA remodeling are in the earliest stage of HCM, aHCM. Cats with LA remodeling are in a slightly more advanced stage of aHCM, but are still in the early asymptomatic stage of aHCM.

[0229] As described in detail elsewhere in this specification, and as shown in the Examples, the nutritionally complete feline food compositions described herein produce positive effects on various physiological parameters associated with myocardial changes caused by cardiac hypertrophy, especially HCM, including in its early stages when there are no obvious symptoms (i.e., asymptomatic cardiac hypertrophy, including asymptomatic HCM (aHCM)).

[0230] Notably, the nutritionally complete feline foods described herein had no effect on inflammatory status as measured in the treated felines, particularly SAA in the treated cats.

[0231] Furthermore, as shown in the Examples herein, no undesirable effects were observed in felines fed a nutritionally complete food as described herein over a period of one year or longer.

[0232] Thus, a nutritionally complete feline food composition as described herein can be used to prevent or treat cardiac hypertrophy, regardless of the type of physiological defect or physiological disorder causing it. Illustratively, cardiac hypertrophy that can be prevented or treated by a nutritionally complete food composition according to the present disclosure can be after blood pressure overload due to systemic hypertension or outflow tract obstruction, or can be after hormonal stimulation, such as in hyperthyroidism or hypergrowth hormone or acromegaly, or even caused by the specific genetic background of the feline, e.g., cats.

[0233] In certain embodiments, a nutritionally complete feline food composition is used to reduce thickening of the heart wall.

[0234] In certain embodiments, a nutritionally complete feline food composition is used to reduce blood concentrations of insulin-like growth factor I (IGF-I).

[0235] In certain embodiments, a nutritionally complete feline food composition is used to reduce blood concentrations of cardiac troponin I (cTnI).

[0236] In certain embodiments, a nutritionally complete feline food composition is used to regulate heart rate.

[0237] The nutritionally complete feline food composition of the present disclosure is particularly useful for preventing and / or treating cats with cardiac hypertrophy. In a specific embodiment, the cat is affected by aHCM. In certain embodiments, the cat is affected by aHCM in the absence of LA remodeling. In certain other embodiments, the cat is affected by aHCM in the presence of LA remodeling.

[0238] Treatment

[0239] The present disclosure also provides a method for preventing and / or treating cardiac hypertrophy in a feline suffering from aHCM. In certain embodiments, the method comprises at least the step of feeding the feline with a nutritionally complete feline composition as defined in the present disclosure.

[0240] As shown in the examples, the nutritionally complete feline food composition as described herein allows for the prevention and / or treatment of cardiac hypertrophy, regardless of whether the food composition is a dry food or a wet food. In certain embodiments, the beneficial effects are obtained in (i) felines fed only with the dry food described herein, (ii) felines fed only with the wet food described herein, and (iii) felines fed with both the dry food and the wet food (i.e., a "dry / wet mix").

[0241] In certain embodiments, a nutritionally complete feline food composition of the present disclosure is provided to a feline, such as a cat, on a daily basis.

[0242] In certain embodiments, a nutritionally complete feline food composition as disclosed herein can be provided to a feline being treated as the only nutritionally complete food during the treatment period. According to these embodiments, the nutritionally complete feline food composition is provided to the animal daily during the treatment period.

[0243] In certain other embodiments, the nutritionally complete feline food composition described herein may be provided to the feline being treated alternately with a second feline food composition. In certain embodiments, the second feline food composition is also a nutritionally complete feline food composition. The second nutritionally complete food composition may be selected from known feline food compositions, including a wide variety of commercial feline food compositions, such as any of a wide variety of commercial cat food compositions.

[0244] According to these other embodiments, the nutritionally complete feline food composition is provided every other day, thus according to a schedule of every two days. In another aspect of these other embodiments, the nutritionally complete feline food composition is provided according to a schedule of every three, four, five, six or seven days.

[0245] It should be understood that in the daily practice of feeding felines, especially cats, animal owners are unable to systematically feed their animals a nutritionally complete feline food composition on a daily basis.

[0246] In certain embodiments, when an animal is fed a nutritionally complete feline food composition as described herein every other day, a beneficial effect of preventing or treating HCM, and particularly preventing or treating aHCM, is provided. Feeding an animal once every three, four, five, six, or seven days reduces the beneficial effect, which may require a longer treatment time.

[0247] Without wishing to be bound by any particular theory, effective prevention or treatment of cardiac hypertrophy, such as fully effective prevention or treatment of HCM, including fully effective treatment of aHCM, requires providing a feline, such as a cat, with a complete nutritional food composition as described herein every other day or every day.

[0248] The period of time for feeding with a nutritionally complete feline food composition as described herein can range from a few weeks to several years, depending, among other things, on the severity of the cardiac hypertrophy.

[0249] As already pointed out elsewhere in this specification, cardiac hypertrophy can be caused by systemic hypertension. In certain embodiments, where the onset of a hypertensive state is a recent event and where cardiac hypertrophy is therefore minimal (e.g., in the aHCM stage), a short period of treatment may be sufficient to restore the normal thickness of the heart wall, especially the normal thickness of the ventricular septum and / or left ventricular wall. In these embodiments, animals may be simultaneously treated with antihypertensive agents to prevent new onsets of cardiac hypertrophy, such as to prevent new onsets of HCM.

[0250] In certain other embodiments, the animal to be treated is provided a food regimen over a longer period of time, e.g., over a period of 12 months or more, e.g., 18 months or more, or e.g., 24 months or more, (i) according to a feeding schedule comprising providing the feline, e.g., cat, with only the nutritionally complete feline food composition described herein or (ii) according to a schedule alternating the nutritionally complete feline food composition described herein and another feline food composition.

[0251] In certain embodiments, a nutritionally complete feline food composition described herein is provided to a feline for a longer period of time, such as two years or more. In certain embodiments, a nutritionally complete feline food composition is provided to a feline throughout the life of the feline, such as a cat.

[0252] The present disclosure also includes a method of preventing or treating cardiac hypertrophy in a cat with HCM, the method comprising at least the step of making a feeding recommendation comprising a nutritionally complete feline composition as defined in the present disclosure.

[0253] The methods of the present disclosure do not affect renal function in cats affected by aHCM or HCM.

[0254] The method of the present disclosure may further comprise the step of making a feeding recommendation comprising a nutritionally complete feline composition as defined in the present disclosure.

[0255] Example

[0256] The presently disclosed subject matter will be better understood by reference to the following examples, which are provided as illustrations of the disclosure and not as limitations.The materials and methods used in the examples are summarized below.

[0257] abbreviation:

[0258] 2d 2-dimensional

[0259] aHCM Asymptomatic hypertrophic cardiomyopathy

[0260] DHA Docosahexaenoic acid

[0261] EPA Eicosapentaenoic acid

[0262] HCM Hypertrophic cardiomyopathy

[0263] IVSd Interventricular septum during diastole

[0264] LVWd Left ventricular wall in diastole

[0265] A. Materials and Methods

[0266] A.1. Purpose

[0267] The purpose of this clinical trial was to investigate the effects of a novel nutritionally complete feline food composition high in EPA / DHA and moderate amounts of nitrogen-free extracts on heart wall thickness in cats treated for aHCM.

[0268] A.2. Clinical research

[0269] The control diets were named Dune (dry food formula) and Sloot (wet food formula).

[0270] The test diets were named Beach (dry formula) and Lake (wet formula).

[0271] The food composition is given as dry only, wet only, or a dry / wet mix, depending on the cat's preference.

[0272] Table 1 provides information on cats included in the clinical study. A total of 44 cats were included in the clinical study, all of which were diagnosed with aHCM. As shown in Table 2, 23 cats were fed the test food composition (Beach / Lake) and 21 cats were fed the control food composition (Dune / Sloot).

[0273] Table 1: Cluster follow-up studies

[0274]

[0275] Table 2: Group distribution

[0276] Food ingredient distribution total Only dry Only wet Dry / Wet Mix Beach / Lake (test diet) 23 11 2 10 Dune / Sloot (control diet) 21 4 0 17

[0277] Cats were given the choice of dry-only, wet-only, or a dry / wet mix at the start of the study, based on preference. They received the diets for 12 months and were examined (echocardiogram, blood measurements, BW, BCS) after 6 and 12 months.

[0278] The compositions of the test dry food composition (BEACH), the control dry food composition (DUNE), the test wet food composition (LAKE), and the control wet food composition (SLOOT) are described in Table 3.

[0279] Food ingredients are expressed in terms of energy density, more specifically, in terms of metabolizable energy (ME). Therefore, the food ingredients in the present disclosure are expressed in terms of weight per megacalorie and have been determined by standard EN 16967:2017E (European Standard EN 16967, Animal feeding stuffs: Methods of sampling and analysis-Predictive equations for metabolizable energy in feed materials and compound feed (pet food) for cats and dogs including dietetic food; July 2017).

[0280] The following parameters were measured:

[0281] -2d-IVSd-max corresponds to the maximum thickness of the interventricular septum during diastole measured using the 2D mode.

[0282] -2d-IVSd n regions ≥6 mm corresponds to the number of regions with a diastolic septal thickness of at least 6 mm measured using the 2D mode.

[0283] -2d-IVSd Regional Sum corresponds to the sum of thicknesses measured in three separate regions of the ventricular septum during diastole measured with the 2D mode.

[0284] -2d-LVWd-max corresponds to the maximum thickness of the left ventricular wall during diastole measured using the 2D mode.

[0285] -2d-LVWdN areas ≥6 mm corresponded to the number of areas with diastolic left ventricular wall thickness of at least 6 mm measured using the 2D mode.

[0286] -2d-LVWD Regional Sum corresponds to the sum of thicknesses measured in two separate areas of the left ventricular wall during diastole measured with the 2D mode.

[0287] -2d-IVSd and LVFW (n regions ≥ 6 mm) correspond to the sum of thicknesses measured in five separate regions of the diastolic ventricular septum and diastolic left ventricular wall using the 2D mode.

[0288] -M-IVSd corresponds to the diastolic interventricular septum thickness measured by M-mode.

[0289] -M_LVFWd corresponds to the thickness of the left ventricular free wall in diastole measured by M-mode.

[0290] -LA_max_diameter corresponds to the maximum diameter of the left atrium.

[0291] -LA_max_diameter>16 corresponds to a maximum diameter of the left atrium greater than 16 mm.

[0292] -LA / Ao corresponds to the left atrium to aortic root ratio.

[0293] - LA / Ao>1.5 corresponds to a left atrium to aortic root ratio greater than 1.5.

[0294] - LA ≥ 16 mm and / or LA / Ao ≥ 1.5 n cases (0 / 1 / 2 criteria) corresponds to the number of cases with a left atrial diameter of at least 16 mm and / or a left atrial aortic root ratio greater than 1.5.

[0295] - LVIDd corresponds to the left ventricular internal dimension in diastole.

[0296] -LVIDs correspond to the left ventricular internal dimensions during systole.

[0297] -The murmur level corresponds to the heart sound produced when blood flows through one of the heart valves.

[0298] - Murmur level n cases: <3 or ≥3 corresponds to the number of cases with a murmur lower than 3 or a murmur of at least 3.

[0299] - The E / A wave corresponds to the ratio of the gravitational peak velocity blood flow in early diastole (E wave) to the peak velocity blood flow in late diastole (A wave).

[0300] - Heart rate corresponds to cat heart rate.

[0301] -Maximum LVOT corresponds to the velocity in the left ventricular outflow tract.

[0302] -Maximum RVOT corresponds to the velocity in the right ventricular outflow tract.

[0303] -Insulin corresponds to the blood concentration of insulin.

[0304] -IGF-1 corresponds to the blood concentration of IGF-1.

[0305] -SAA corresponds to the blood concentration of serum amyloid A.

[0306] -NT-proBNP corresponds to the blood concentration of N-terminal pro-B-type natriuretic peptide.

[0307] -cTnI corresponds to the blood concentration of troponin I, which is a marker of myocardial cell damage and an indicator of the development of heart failure and cardiac death.

[0308] -Weight corresponds to the weight of the cat.

[0309] -BCS corresponds to the cat's body condition score (BCS indicates the cat's weight and health status).

[0310] - Serum creatinine concentration corresponds to the level of creatine in the blood.

[0311] -The serum concentration of blood urea nitrogen (BUN) corresponds to the level of nitrogen in the blood that comes from the waste product urea.

[0312] -Serum phosphate concentration corresponds to the level of phosphate in the blood.

[0313] - Serum fibroblast growth factor-23 (FGF-23) serum concentration corresponds to the level of FGF-23 in the blood.

[0314] The thickness of the heart was measured using 2D or M-mode ultrasound in 3 areas of the interventricular septum and 2 areas of the left ventricular free wall.

[0315] Serum concentration parameters of creatinine, BUN, phosphate and FGF-23 allow the measurement of renal excretory function.

[0316] A.3. Methods used to measure different parameters

[0317] Echocardiography (2D, M-mode and color flow, spectral and tissue Doppler) was performed in conscious cats without chemical restraints. Right parasternal 4- and 5-chamber long- and short-axis views were obtained at different levels (papillary muscles, mitral valve, and aortic valve). In addition, left apical 4- and 5-chamber views were obtained with spectral Doppler focusing on mitral inflow, pulmonary venous flow, left ventricular outflow (LVOT), and aortic flow.

[0318] Cranial right and left parasternal views of the right ventricular outflow tract (RVOT) and pulmonary artery were obtained from these regions for spectral Doppler; measurements were made from the images that optimized RVOT / PA flow.

[0319] After placing the cursor on the 2D image, obtain the left ventricle, mitral valve, and left atrium / aorta M-mode. M-mode measurements use the leading edge to leading edge method.

[0320] 2D measurements of the ventricular septum, left ventricular cavity, and left ventricular free wall at end-diastole and end-systole were performed on the short-axis view at the level of the papillary muscles, using the blood-endocardial interface and the myocardial-epicardial interface to guide cursor placement.

[0321] 2D left atrial and aortic dimensions were obtained in the right parasternal short-axis view during diastole.

[0322] 2D septum and left ventricular free wall measurements were obtained in right parasternal short-axis and long-axis (4 or 5 chamber) views of the left ventricle at end-diastole (Freeman, Rush et al. 2014).

[0323] IVSd was measured at the basal, mid, and apical regions, and LVWd was measured at the basal and mid regions in the right parasternal long-axis 4- or 5-chamber view, to optimize any focal hypertrophy. Measurements were recorded as the maximum measured thickness (max-), the sum of the thickness measured in five separate regions (sum-), and the number of regions with a thickness ≥6 mm (n-).

[0324] For spectral Doppler measurements, for pulsed wave (or continuous wave if aliasing is significant), the following velocities are recorded: mitral inflow E and A wave velocities, providing adequate separation, left ventricular outflow, aorta, right ventricular outflow, and pulmonary artery velocities.

[0325] For pulmonary venous flow, peak systolic and diastolic positive and atrial reverse wave velocities were recorded. The duration of the atrial reverse wave was compared with the duration of the mitral A wave. Because the sample venous flow in the left ventricular outflow tract enables recording of both left ventricular outflow and mitral inflow, pulsed wave Doppler allows measurement of the time from aortic valve closure to the onset of the mitral E wave (isovolumetric relaxation time; IVRT).

[0326] Using color M-mode in the left ventricle, in the left apical 4-chamber view, the mitral inflow is assessed with the M-mode cursor aligned with the mitral inflow column. The Nyquist limit is lowered until the core of the mitral inflow (E) is aliased and color M-mode is acquired.

[0327] The slope is measured using the red-blue interface of the early mitral inflow wave in the absence of color change to obtain the mitral flow propagation velocity (Schober, Fuentes et al. 2003).

[0328] From the left apical 4-chamber view, aligned with the longitudinal motion of the IVS, LVFW (and RVFW) in sequence, a sample volume was placed in the myocardium at the level of the AV annulus, PW-TDI spectra were obtained, and peak S', E', and A' velocities were measured.

[0329] General hypertrophy was defined as thickness ≥6 mm in all regions of IVSd and LVWd.

[0330] Left atrial enlargement was defined as LAmax ≥ 16 mm (Schober and Maerz 2006) and / or LAmax / Ao ≥ 1.5 mm (Abbott and MacLean 2006).

[0331] HCM is diagnosed when the thickest end-diastolic interventricular septum (IVSd) or left ventricular free wall (LVWd) segment, or both, is >6 mm measured in M ​​or 2D mode (Fox, Liu et al. 1995), and indicators of HCM such as systolic anterior motion of the mitral valve, left atrial enlargement, or increased aortic velocity may be found simultaneously.

[0332] Blood concentrations of troponin I and IGF-1 were analyzed by CLIA method using Advia Centaur XP, using kits from Siemens, reference: Siemens, ADVIA Centaur Assay(5 -Testreagenzpackungen mit ADVIA TnI-Ultra TM Binary Lite-Reagenz), 02790309 and Immulite 2000 / XPI.

[0333] Serum concentrations of creatinine were measured according to the kinetic colorimetric assay (Jaffe without deproteinization) using an AU480 chemistry analyzer (Beckman Coulter).

[0334] Serum concentrations of blood urea nitrogen (BUN) were measured by the powered UV test using an AU480 chemistry analyzer (Beckman Coulter).

[0335] Serum concentrations of phosphate were measured using an AU480 chemistry analyzer (Beckman Coulter) according to the photometric UV assay method (ammonium-phosphomolybdate-complex, UV-test).

[0336] Serum concentrations of serum fibroblast growth factor 23 (FGF23) were measured using a two-step sandwich enzyme-linked immunosorbent assay (ELISA) and a FGF23 ELISA kit (Kainos Laboratories, Inc.).

[0337] A.4. Tested food compositions

[0338] Table 3 provides the components and their amounts included in the food compositions tested.

[0339] Table 3: Tested compositions

[0340]

[0341] "% DM": weight percentage, based on the total weight of dry matter of the food composition

[0342] "g / Mcal": Metabolic energy density, expressed as g / Mcal

[0343] "NFE": Nitrogen Free Extract

[0344] "Starch": Starch contained in the starting (raw) materials used to make a food composition. The starch content is included in the NFE content of the food composition.

[0345] "Other nutrients" mainly include vitamins and minerals.

[0346] "ND": Not disclosed

[0347] “NR”: Not relevant

[0348] Example 1: A nutritionally complete food composition reduces heart wall thickening in cats with aHCM

[0349] 1.1. Provide complete feline food in the form of dry food, wet food and mixed dry / wet food

[0350] Mean values ​​of thickened ventricular septum and left ventricular wall and blood analyses (IGF-1 and Troponin I) were measured at 0, 6 and 12 months in the test group (Beach / Lake) and fed all feeding types (dry, wet, mixed dry / wet) and are shown in Table 4.

[0351] Table 4 Average values ​​(all feeding type combinations: dry, wet, dry / wet mixed)

[0352]

[0353] The results described in Table 4 indicate that a nutritionally complete feline diet resulted in a reduction in cardiac wall thickness, particularly in the ventricular septum and left ventricular wall in cats with aHCM.

[0354] 1.2. Complete cat food provided as dry food and wet food (dry / wet mix)

[0355] Mean values ​​for thickened ventricular septum and left ventricular wall and blood analysis (IGF-1 and Troponin I) in the test population (Beach / Lake) and those fed only the wet / dry blend composition were measured at 0, 6 and 12 months and are shown in Table 5 below.

[0356] Table 5: Average values ​​(mixed dry / wet only)

[0357]

[0358] The results described in Table 5 indicate that nutritionally complete feline food provided freely as wet and dry food resulted in decreased thickness of the heart wall, particularly in the ventricular septum and left ventricular wall in cats with aHCM.

[0359] 1.3. Complete cat food in dry food form

[0360] Mean values ​​for thickened ventricular septum and left ventricular wall and blood analyses (IGF-1 and Troponin I) in the test population (Beach / Lake) and those fed the dry composition alone were measured at 0, 6 and 12 months and are shown in Table 6 below.

[0361] Table 6: Average values ​​(dry only)

[0362] parameter 0 month (start) 6 Months of Test Diet 12 Months of Test Diet 2d-IVSd-max(mm) 6.91 6.73 6.32 2d-IVSd n areas ≥ 6 mm 2.27 1.91 1 2d-IVSd area sum (mm) 19.19 17.96 16.3 2d-LVWd-max(mm) 6.2 5.89 5.56 2d-LVWd n areas ≥ 6 mm 0.73 0.64 0.82 2d-LVWd area total (mm) 11.61 11.46 10.74 2d-IVSd and LVFW (n area ≥ 6 mm) 3 2.55 1.82 IGF-1 (ng / mL) 522.6 416.6 346.0 cTnI (ng / mL) 1.10 0.16 0.16

[0363] The results described in Table 6 indicate that nutritionally complete feline food provided ad libitum as a dry food resulted in reduced heart wall thickness, particularly in the ventricular septum and left ventricular wall in cats with aHCM.

[0364] 1.4. Complete feline food in wet food form

[0365] Mean values ​​for thickened ventricular septum and left ventricular wall and blood analyses (IGF-1 and Troponin I) in the test population (Beach / Lake) and those fed the wet composition alone were measured at 0, 6 and 12 months and are shown in Table 7 below.

[0366] Table 7: Average values ​​(wet only)

[0367] parameter 0 month (start) 6 Months of Test Diet 12 Months of Test Diet 2d-IVSd-max(mm) 6.75 6.45 5.85 2d-IVSd n areas ≥ 6 mm 2 1 0 2d-IVSd area sum (mm) 18.5 16.95 15.5 2d-LVWd-max(mm) 6.1 4.55 4.75 2d-LVWd n areas ≥ 6 mm 1 0 0 2d-LVWd area total (mm) 12.10 8.55 9.1 2d-IVSd and LVFW (n area ≥ 6 mm) 3 1 0 IGF-1 (ng / mL) 300 308 357.5 cTnI (ng / mL) 0.12 0.06 0.07

[0368] The results described in Table 7 indicate that nutritionally complete feline food provided ad libitum as a wet food resulted in a reduction in cardiac wall thickness, particularly in the ventricular septum and left ventricular wall in cats affected with aHCM.

[0369] 1.5. P values ​​for food ingredient effects

[0370] The P values ​​for the effect of the food composition in the entire population of cats with aHCM are shown in Table 8 below.

[0371] Table 8: P values ​​for the overall group effect (bold values ​​are significant at P < 0.05)

[0372]

[0373]

[0374]

[0375] For better understanding, "fixed effects" are the effects of food composition and time and the interactions between food composition and time on the test parameters. "Slice diet" is a comparison between time points within one food composition (test or control). The p value is the risk of error by saying that the time points are significantly different, and the p value is corrected for 3 time points.

[0376] The results showed that the food composition has been shown to reverse the thickening of the ventricular septum and left ventricular wall during diastole in cats with asymptomatic HCM (aHCM). The 'mean number of thickened areas above the 6 mm cut-off' was reduced by 50% in '3 areas of the ventricular septum' and 40% in '5 areas of the ventricular septum and left ventricular wall together'. The 'mean thickness of the left ventricular wall' was reduced to below the 6 mm cut-off.

[0377] Furthermore, the food composition has been shown to significantly reduce blood levels of IGF-1 as well as significantly reduce blood levels of cardiac troponin I (cTnI).

[0378] Furthermore, the results showed no significant changes in body weight and BCS of the cats. Therefore, the food composition is nutritionally complete.

[0379] Example 2: A nutritionally complete food composition reduces LA remodeling in cats with asymptomatic HCM Thickening of the heart wall

[0380] The P values ​​for the effect of food composition in cats with asymptomatic HCM in the presence of left atrial remodeling are shown in Table 9 below.

[0381] Table 9: Presence of LA remodeling. P values ​​for the effect (bold values ​​are significant at P < 0.05)

[0382]

[0383]

[0384] The P values ​​for the effect of the food composition in cats with aHCM in the absence of left atrial remodeling are shown in Table 10 below.

[0385] Table 10: No left atrial remodeling. P values ​​for the effect (bold values ​​are significant at P < 0.05)

[0386]

[0387]

[0388] The results showed that the food composition was also shown to reverse the septal and left ventricular wall thickening in diastole in cats with aHCM in the absence of LA remodeling. In fact, cats without LA remodeling showed the same results as the intact group, while cats with LA remodeling only showed an effect on the average number of thickened areas exceeding the 6 mm cut-off value in 3 areas of the septum (2d-IVSdN areas ≥ 6 mm) and the sum of the thickness values ​​measured in 2D mode in three separate areas of the septum in diastole (2d-IVSd sum), but not in the septum and left ventricular wall 5 areas measured together (2d-IVSd and LVFWn areas ≥ 6 mm), nor on the mean thickness of the left ventricular wall (2d-LVWd-max). The reduction of cTnI was present in cats with and without LA remodeling. This can be explained by the fact that cats without LA remodeling are in the early stages of the disease, without stiffening of the heart, and are still susceptible to the dietary effects.

[0389] Example 3: Nutritionally complete feline food composition does not affect renal function in cats with aHCM.

[0390] Surprisingly, it was found that high amounts of protein, namely dry food compositions comprising protein in an amount of at least 115 g / Mcal and wet food compositions comprising protein in an amount of at least 117 g / Mcal, had no deleterious effects on renal function in cats with aHCM.

[0391] Serum concentrations of creatinine, BUN, phosphate, and fibroblast growth factor-23 (FGF-23) were measured in unsedated, fasting cats before and after being fed the assigned food compositions for 6 and 12 months (Table 11).

[0392] The one-sample Wilcoxon signed-rank test analyzed whether serum concentrations at baseline were below the upper limit of the laboratory reference range. Two-way repeated-measures ANOVA compared measured variables with time (baseline, 6, and 12 months) and with the control and test groups at a significance level of 5%. Results are expressed as medians (ranges).

[0393] Serum concentrations of 4 parameters were significantly below the upper limit of the laboratory reference range at baseline (P < .0001). There was a significant diet-time interaction for BUN (blood urea nitrogen) (P = 0.0013), with significant increases after 6 and 12 months of feeding the test food composition, but there were no significant changes in creatinine, phosphate, or FGF-23 over time in either group, and a few cats had serum concentrations above the reference range at each time point.

[0394] The results in Table 11 are as follows:

[0395] - For creatinine, there were significant differences only between test month 12 and control month 0, and between test month 12 and control month 12. However, there were no differences over time in the test and control groups.

[0396] - For BUN: there were significant differences only between test month 0 and test month 6, and between test month 0 and test month 12. However, there were no differences in the control group over time, and no differences between the test and control groups at different time points.

[0397] - For phosphate: there were significant differences only between test month 0 and test month 6, and between test month 0 and test month 12. However, there were no differences in the control group over time, and no differences between the test and control groups at different time points.

[0398] - For FGF23: There was a significant difference only between the test group at 12 months and the control group at 6 months. However, there were no changes over time within the test group or within the control group. There were no differences between the other time points in the test group and the other time points in the control group.

[0399] Table 11: Results of serum creatinine, BUN, phosphate and FGF-23 concentrations

[0400]

[0401] Different superscript letters ("a", "b", and "ab") indicate significant intra-group and inter-group differences at different time points. Square brackets indicate the number of cats with serum concentrations ≥ the upper limit of the reference range.

[0402] 《(xx)》:(minimum range - maximum range)

[0403] "b" is clearly different from "a"

[0404] “ab” is not significant

[0405] Therefore, feeding a nutritionally complete food composition containing high amounts of protein over a 12-month period had no adverse effects on renal function in cats with aHCM.

[0406] Although the subject matter disclosed herein and its advantages have been described in detail, it should be understood that various changes, substitutions and modifications may be made herein without departing from the spirit and scope of the present application as defined by the appended claims. In addition, the scope of the present application is not intended to be limited to the specific embodiments of the processes, machines, manufactures, material compositions, means, methods and steps described in the specification. As one of ordinary skill in the art will easily understand from the subject matter disclosed herein, the processes, machines, manufactures, material compositions, means, methods or steps that currently exist or will be developed later and perform substantially the same functions or achieve substantially the same results as the corresponding embodiments described herein may be utilized according to the subject matter disclosed herein. Therefore, the appended claims are intended to include such processes, machines, manufactures, material compositions, means, methods or steps within their scope.

[0407] For any patents, patent applications, publications, product descriptions, and protocols cited throughout this application, the disclosures of all of these are incorporated herein by reference in their entirety for all purposes.

[0408] References

[0409] Abbott, JA and HN MacLean (2006). “Two-dimensional echocardiographic assessment of the feline left atrium.” J Vet Intern Med 20(1):111-119.

[0410] Freeman, LM, JERush, SM Coolingham and BJ Bulmer (2014). “A randomized study assessing the effect of diet in cats with hypertrophic cardiomyopathy.” J Vet Intern Med 28(3):847-856.

[0411] Fox, PR, SK Liu and BJ Maron (1995). “Echocardiographic assessment of spontaneously occurring feline hypertrophic cardiomyopathy. An animal model of human disease.” Circulation 92(9):2645-2651.

[0412] Fox PR, Keene BW et al. International collaborative study to assess cardiovascular risk and evaluate long-term health in cats with preclinical hypertrophic cardiomyopathy and apparently healthy cats: The REVEAL Study. Journal of Veterinary Internal Medicine: April. 2018; 32(3): 930-943.

[0413] Riesen SC, Kovacevic A, Lombard CW, et al. Prevalence of heart disease in symptomatic cats: an overview from 1998 to 2005. Schweizer Archiv fur Tierheilkunde 2007;149:65-71.

[0414] Rush JE. Therapy of feline hypertrophic cardiomyopathy (1998). Veterinary Clinics of North America: Small Animal Practice; 28: 1459-1479

[0415] Schober, KE, VL Fuentes and JD Bonagura (2003). “Comparison between invasive hemodynamic measurements and noninvasive assessment of left ventricular diastolic function by use of Dopple rechocardiography in healthy anesthetized cats.” Am J Vet Res 64(1):93-103.

[0416] Schober, KE and I. Maerz (2006). “Assessment of left atrial appendage flow velocity and its relation to spontaneous echocardiographic contrast in 89 cats with myocardial disease.” J Vet Intern Med 20(1):120-130.

Claims

1. A complete nutritional feline food composition, comprising eicosapentaenoic acid / docosahexaenoic acid (EPA / DHA) and carbohydrates, for preventing and / or treating cardiac hypertrophy, wherein: (a) The nutritionally complete feline food composition is composed of a dry food composition, which comprises: (i) EPA / DHA in an amount of at least about 0.5 g / Mcal; and (ii) a nitrogen-free extract in an amount not exceeding about 60 g / Mcal; or (b) The nutritionally complete feline food composition consists of a wet food composition, which comprises: (i) EPA / DHA in an amount of at least about 1.0 g / Mcal; and (ii) a nitrogen-free extract in an amount not exceeding about 35 g / Mcal.

2. A nutritionally complete feline food composition for use thereof according to claim 1, wherein the nutritionally complete feline food composition consists of a dry food composition; and wherein the dry food composition comprises starch in an amount not exceeding about 50 g / Mcal.

3. A nutritionally complete feline food composition for use thereof according to any one of claims 1 and 2, wherein the nutritionally complete feline food composition consists of dry food; and Wherein the dry food composition comprises protein in an amount of at least about 115 g / Mcal.

4. A nutritionally complete feline food composition for use thereof according to any one of claims 1 to 3, wherein the nutritionally complete feline food composition consists of a dry food composition; and wherein the dry food composition comprises fat in an amount of about 20 g / Mcal to about 45 g / Mcal.

5. A nutritionally complete feline food composition for use thereof according to claim 1, wherein the nutritionally complete feline food composition consists of a wet food composition; and wherein the wet food composition comprises starch in an amount not exceeding about 20 g / Mcal.

6. A nutritionally complete feline food composition for use thereof according to any one of claims 1 and 5, wherein the nutritionally complete feline food composition consists of wet food; and wherein the wet food composition comprises protein in an amount of at least about 117 g / Mcal.

7. A nutritionally complete feline food composition for use thereof according to any one of claims 1, 5 and 6, wherein the nutritionally complete feline food composition consists of a wet food composition; and wherein the wet food composition comprises fat in an amount of about 20 g / Mcal to about 45 g / Mcal.

8. A nutritionally complete feline food composition for use according to any one of claims 1 to 7 for the prevention and / or treatment of cats suffering from cardiac hypertrophy.

9. A nutritionally complete feline food composition for use thereof according to claim 8, wherein the cat suffers from asymptomatic hypertrophic cardiomyopathy.

10. A nutritionally complete feline food composition for use thereof according to claim 8 or 9, wherein the cat suffers from asymptomatic hypertrophic cardiomyopathy in the absence of LA remodeling.

11. A nutritionally complete feline food composition, wherein: (a) The nutritionally complete feline food composition is composed of a dry food composition, which comprises: (i) EPA / DHA in an amount of at least about 0.5 g / Mcal; and (ii) a nitrogen-free extract in an amount not exceeding about 60 g / Mcal; or (b) The nutritionally complete feline food composition consists of a wet food composition, which comprises: (i) EPA / DHA in an amount of at least about 1.0 g / Mcal; and (ii) a nitrogen-free extract in an amount not exceeding about 35 g / Mcal.

12. The nutritionally complete feline food composition of claim 11, wherein the nutritionally complete feline food composition consists of a dry food composition; and wherein the dry food composition comprises starch in an amount not exceeding about 50 g / Mcal.

13. The nutritionally complete feline food composition of claim 11 or 12, wherein the nutritionally complete feline food composition consists of a dry food composition; and Wherein the dry food composition comprises protein in an amount of at least about 115 g / Mcal.

14. The nutritionally complete feline food composition according to any one of claims 11 to 13, wherein the nutritionally complete feline food composition consists of a dry food composition; and wherein the dry food composition comprises fat in an amount of about 20 g / Mcal to about 45 g / Mcal.

15. The nutritionally complete feline food composition of claim 11, wherein the nutritionally complete feline food composition consists of a wet food composition; and wherein the wet food composition comprises starch in an amount not exceeding about 20 g / Mcal.

16. A nutritionally complete feline food composition according to claim 11 or 12, wherein the nutritionally complete feline food composition consists of a wet food composition; and wherein the wet food composition comprises protein in an amount of at least about 117 g / Mcal.

17. A nutritionally complete feline food composition according to claim 11 or any one of claims 15 and 16, wherein the composition consists of wet food; and wherein the wet food composition comprises fat in an amount of about 20 g / Mcal to about 45 g / Mcal. 18.(a) (i) EPA / DHA in an amount of at least about 0.5 g / Mcal; and (ii) a nitrogen-free extract in an amount not exceeding about 60 g / Mcal; Use for preparing a complete nutritional feline food composition, wherein the complete nutritional Feline food composition consisting of dry food composition or (b) (i) EPA / DHA in an amount of at least about 1.0 g / Mcal; and (ii) a nitrogen-free extract in an amount not exceeding about 35 g / Mcal Use for preparing a complete nutritional feline food composition, wherein the complete nutritional Feline food composition consisting of wet food composition The complete nutritional feline food composition is used to prevent and / or treat cats in need The heart of animals of the family Triidae is enlarged.

19. Use according to claim 18, wherein the nutritionally complete feline food composition is a composition as defined in any one of claims 11 to 17.

20. The use according to claim 18 or 19, wherein the composition is used for preventing and / or treating cats suffering from cardiac hypertrophy.

21. The use according to claim 20, wherein the cat has asymptomatic hypertrophic cardiomyopathy in the absence of LA remodeling.

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