Animal food compositions for skin barrier recovery

Abstract

The present disclosure provides a food composition for canine including from about 9.1g / Mcal to about 10.5g / Mcal of linoleic acid; from about 2.5g / Mcal to about 4g / Mcal of histidine; from about 1.0g / Mcal to about 3.0g / Mcal of EPA and / or DHA; and at least one vitamin selected from vitamin B6, vitamin C or vitamin E.

Description

Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 ANIMAL FOOD COMPOSITIONS FOR SKIN BARRIER RECOVERYCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This patent application claims the benefit of priority to European Patent Application No. EP 25152267.8, filed on January 16, 2025, the entirety of which is incorporated herein by reference.FIELD OF THE DISCLOSURE

[0002] The present disclosure relates to the field of animal food compositions, preferentially companion animal food composition for treating or preventing a disease or disorder, in particular a disrupted Trans-Epidermal-Water-Loss (TEWL) associated disease or disorder, causing a skin or dermatological disorder. The present disclosure also relates to the non-therapeutic use of companion animal food compositions for sustaining or improving a healthy condition of a healthy animal's skin.BACKGROUND OF THE DISCLOSURE

[0003] Skin health is a vital aspect of overall well-being for companion animals, particularly dogs and cats. Their skin, being thinner than that of humans, is more vulnerable to various dermatological conditions, especially those related to disruptions in skin barrier function. Transepidermal water loss (TEWL) is a well-established measure of skin barrier integrity and is widely used to assess the effectiveness of dietary interventions aimed at maintaining or restoring a healthy skin barrier.

[0004] The skin plays a critical role in protecting animals from dehydration, environmental stressors, and temperature fluctuations. Maintaining an optimal skin condition is essential for pet owners, a compromised skin barrier can lead to visible discomfort for the companion animal and increased anxiety for both the animal and the owner. Therefore, providing effective solutions to maintain and improve skin health remains a priority.

[0005] It is known in the art that dietary factors, mainly in the form of food supplement, have a major role in the maintenance of healthy coat and skin of companion animals (Parke eta!., Dermatol Pract concept 2021).

[0006] US 2021 / 337830 relates to the use of linoleic acid and zinc in diets or foodstuffs for pets to improve their skin quality or treat dermatological disorders.

[0007] US 7,297,677 B2 provides an animal food composition comprising a combination of pantothenic acid, nicotinamide, histidine, choline and inositol; for improving the skin barrier function of an animal. Recent regulatory changes in theAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 European Union have led to the removal of several key ingredients, such as inositol, previously included in animal food formulations designed to support skin health. These changes have created a need for alternative nutritional compositions that can still provide measurable benefits to skin condition, particularly with respect to improving skin barrier function and minimizing TEWL.

[0008] Therefore, it remains a need for developing a novel set of nutrients or a food composition intended to sustain or improve skin conditions of healthy companion animals, in particular of healthy canines.

[0009] It remains a need for developing a novel set of nutrients or a food composition intended to sustain or improve the coat softness of healthy companion animals, in particular of healthy canines.

[0010] It remains a need for developing a novel set of nutrients or a food composition intended to sustain or improve the coat shine of healthy companion animals, in particular of healthy canines.

[0011] It remains a need for developing a novel set of nutrients or a food composition intended to reduce the dandruff of healthy companion animals, in particular of healthy canines.

[0012] It remains a need for developing a novel set of nutrients or a food composition intended to treat or prevent Transepidermal water loss (TEWL) associated disease or disorder in companion animals, in particular in canines.

[0013] It remains a need for developing a novel set of nutrients or a food composition intended to treat or prevent disruptions in skin barrier function of companion animals, in particular of canines, in need thereof.

[0014] It remains a need for developing a novel set of nutrients intended or a food composition to treat or prevent skin dehydration in companion animals, in particular in canines.

[0015] By offering a new nutritional solution that addresses skin health challenges, the present disclosure provides a solution enhancing the skin and coat condition of companion animal while adhering to regulatory standards.SUMMARY

[0016] A first aspect of the present disclosure relates to a food composition for canine, in particular a canine food composition, comprising:- from about 9.1g / Mcal to about 10.5g / Mcal of linoleic acid;- from about 2.5g / Mcal to about 4.0g / Mcal of histidine;Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 - from about 1.0g / Mcal to about 3.0g / Mcal of EPA and / or DHA; and- at least one vitamin selected from vitamin B6, vitamin C or vitamin E.

[0017] In some embodiments, the food composition as disclosed herein can comprise from about 10. Omg / Mcal to about 20. Omg / Mcal of vitamin B6; from about 50. Omg / Mcal to about 100. Omg / Mcal of vitamin C; and / or from about 200. Omg / Mcal to about 250. Omg / Mcal of vitamin E.

[0018] In some embodiments, the food composition as disclosed herein can further comprise from about 0.2g / Mcal to about 1.0g / Mcal of Alpha-Linolenic Acid.

[0019] In some embodiments, the food composition as disclosed herein specifically comprises:- from about 9.1 g / Mcal to about 10.5g / Mcal of linoleic acid;- from about 2.5g / Mcal to about 4g / Mcal of histidine;- from about 1.Og / Mcal to about 3.0g / Mcal of EPA and / or DHA;- from about 10.0mg / Mcal to about 20.0mg / Mcal of vitamin B6, and optionally, from about 50.0mg / Mcal to about 100.0mg / Mcal of vitamin C and / or from about 200.0mg / Mcal to about 250. Omg / Mcal of vitamin E.

[0020] In some embodiments, the food composition as disclosed herein can further comprise protein, fat, and fiber, and optionally carbohydrates.

[0021] In some embodiments, the food composition as disclosed herein can be a nutritionally complete and balanced food composition or a functional complement.

[0022] In some embodiments, the food composition as disclosed herein can consist of a dry food composition.

[0023] In some embodiments, the food composition as disclosed herein can consist of an extruded dry food composition.

[0024] In some embodiments, the food composition as disclosed herein can consist of a kibble.

[0025] Another aspect of the present disclosure relates to the use, in particular the non-therapeutic use, of a food composition as disclosed herein, for sustaining or improving a healthy skin condition of a canine, in particular a healthy canine. In particular, the combination of linoleic acid, histidine, EPA / DHA, the at least one vitamin, and optionally alpha-linoleic acid, are the sole active agents in the food composition.

[0026] In some embodiments, the skin condition as disclosed herein can consists of the coat softness, the coat shine, the dandruff, the skin barrier, and / or theAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 overall coat and skin condition. In particular, the skin condition as disclosed herein can consists of sustaining or improving the coat softness, sustaining or improving the coat shine, reducing the dandruff, sustaining or improving the skin barrier, and / or sustaining or improving the overall coat and skin condition of a healthy canine.

[0027] Another aspect of the present disclosure relates to the food composition as disclosed herein for use as a medicament. Preferably, the combination of linoleic acid, histidine, EPA / DHA, the at least one vitamin, and optionally alpha-linoleic acid, are the sole active agents in the food composition.

[0028] Another aspect of the present disclosure relates to the food composition as disclosed herein for use in a method for managing and / or treating and / or preventing a disrupted Trans-Epidermal-Water-Loss (TEWL) associated disease or disorder in a canine in need thereof. In some embodiments, the combination of linoleic acid, histidine, EPA / DHA, the at least one vitamin, and optionally alpha-linoleic acid, are the sole active agents in the food composition.

[0029] In some embodiments, a disrupted TEWL associated disease or disorder can consist of a skin condition characterized by skin dehydration.

[0030] In some embodiments, a disrupted TEWL associated disease or disorder can consist of a skin condition characterized by a compromised skin barrier.

[0031] In some embodiments, a disrupted TEWL associated disease ordisorder can be selected from ichthyosis vulgaris, diaper rash, dry skin, scaly skin, seborrheic dermatitis, atopic dermatitis, eczema, flea allergic dermatitis, bacterial skin infection, fungal skin infection, reactive skin, skin inflammatory conditions, in particular psoriasis, rosacea, perioral dermatitis, perianal dermatitis, alopecia, ringworm, and / or contact dermatitis.

[0032] Another aspect of the present disclosure relates to the use of linoleic acid, histidine, EPA / DHA and at least one vitamin selected from vitamin B6 (Pyridoxine), vitamin C, and vitamin E, in the manufacture of a medicament or a canine food composition for the treatment or prevention of a disrupted Trans-Epidermal-Water-Loss (TEWL) associated disease or disorder in a canine in need thereof.

[0033] Another aspect of the present disclosure relates to the use of linoleic acid, histidine, EPA / DHA and at least one vitamin selected from vitamin B6 (Pyridoxine), vitamin C, and vitamin E, in the manufacture of a medicament or a canine food composition for the treatment or prevention of a disrupted Trans-Epidermal-Water-Loss (TEWL) associated disease or disorder in a canine in need thereof,Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 wherein linoleic acid can be provided at a level from about 9.1g / Mcal to about 10.5g / Mcal, Histidine can be provided at a level from about 2.5g / Mcal to about 4.0g / Mcal, and EPA / DHA can be provided at a level from about 1.0g / Mcal to about 3.0g / cal.

[0034] Another aspect of the present disclosure relates to a method of manufacturing a food composition as disclosed herein, comprising at least the steps of:- mixing at least Linoleic acid, histidine, EPA / DHA and at least one vitamin selected from vitamin B6 (Pyridoxine), vitamin C, and vitamin E in the recited specific amounts, thereby obtaining a mixture, and- heating the mixture, thereby obtaining a food composition.

[0035] In some embodiments, the mixture in step (a) further comprises ingredients suitable to provide a nutritionally complete and balanced food composition, optionally including at least one or more source(s) of proteins, fibers, carbohydrates, vitamins, and minerals in amounts suitable to meet the nutritional requirements of canines.DESCRIPTION OF THE FIGURES

[0036] Figure 1 illustrates the protocol of the study and the schedule of sampling over the study period.

[0037] Figure 2 illustrates the mean TEWL measurements taken at regular time intervals during the 12-week assessment period (with 95% Confidence Intervals). Plots show values for both legs of the study combined in the TEST and CONTROL groups. Abscissa: Time of the study in weeks. Ordinate: Measured TEWL level in dogs expressed in g / hr / m2.

[0038] Figure 3 illustrates the mean rate of change of TEWL from the Baseline (Time zero) measurement at all subsequent timepoints (with 95% Confidence Intervals).

[0039] Figure 4 illustrates the concentration of Natural Moisturising Factor extracted from the superficial epidermis of dogs fed either the Test diet (black line) or Control diet (Grey line). Figure 4A: Natural Moisturising Factor. Figure 4B: Histidine.Figure 4C: Trans-UCA. Figure 4D: cis-UCA. Figure 4E: PCA.

[0040] Figure 5 illustrates the outcomes for the coat assessments. Figure 5A shows coat Softness scores attributed to dogs fed the test diet (black line) vs control diet (grey line). Figure 5B shows Shine scores attributed to dogs fed the test dietAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 (black line) vs control diet (grey line). Figure 5C shows Overall Coat Score of dogs fed test diet (black line) vs control diet (grey line).DETAILED DESCRIPTION

[0041] The present disclosure describes a food composition including, as active agents, a combination of linoleic acid, histidine, EPA / DHA, and a vitamin in a specific amount range aiming at sustaining or improving a skin condition of a healthy canine, or at treating or preventing skin disorders in canines, particularly skin disorders associated with disrupted T ransepidermal water loss (TEWL) and impaired skin barrier function. The formulation is designed to enhance the skin’s ability to retain moisture and protect against external stressors, improving the overall health and appearance of the skin and coat. The effectiveness of this food composition has been demonstrated by evaluating an experimental model where skin barrier function is mildly disrupted using detergent-induced stress, with TEWL as the primary parameter to assess skin health of the canine.

[0042] It is demonstrated the advantage of said combination of linoleic acid, histidine, EPA / DHA, and vitamin (B6, C and / or E) specific levels, included in a food composition according to the present disclosure, to accelerate recovery of skin barrier function following detergent-induced disruption in canines. As shown in the examples, canines fed said food composition exhibit a faster normalization of transepidermal water loss (TEWL) compared with canines fed a control diet. The recovery of TEWL in canines receiving said food composition occurs up to two weeks earlier than in canines receiving the control diet.

[0043] It is demonstrated the advantage of said combination of linoleic acid, histidine, EPA / DHA, and vitamin (B6, C and / or E) specific levels, included in a food composition according to the present disclosure, to promote restoration of epidermal natural moisturizing factor (NMF) concentrations following detergent-induced skin stress. The restoration of epidermal NMF concentrations is associated with the accelerated reduction of TEWL observed in canines fed said food composition.

[0044] It is demonstrated the advantage of said combination of linoleic acid, histidine, EPA / DHA, and vitamin (B6, C and / or E) specific levels, included in a food composition according to the present disclosure, to improve coat quality in canines subjected to detergent-induced stress.

[0045] Canines fed the food composition according to the present disclosure show increased coat softness and shine compared with canines fed the control diet.Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1

[0046] It is demonstrated the advantage of said combination of linoleic acid, histidine, EPA / DHA, and vitamin (B6, C and / or E) specific levels, included in a food composition, according to the present disclosure to reduce dandruff immediately following a detergent washing protocol on canines. The reduction in dandruff demonstrates the ability of said combination of nutrients to mitigate the dehydrating effects of detergent exposure on the skin and coat.

[0047] The composition of US 7,297,677, named “prior-art composition”, was previously used to support skin health in canines. This prior-art composition included inositol as an active component, which is no longer permitted for supplementation due to regulatory constraints. The combination of linoleic acid, histidine, EPA / DHA, and vitamin (B6, C and / or E) specific levels in the food composition according to the present disclosure was developed as a replacement for this prior-art composition. Compared with the prior-art composition, said food composition demonstrates a faster recovery of epidermal barrier function following detergent-induced disruption. The accelerated normalization of TEWL, demonstrated with said food composition, was not reported for the prior-art composition, suggesting an improvement in the recovery process with said food composition.Definitions

[0048] The terms used in this specification generally have their ordinary meanings in the art, within the context of this disclosure and in the specific context where each term is used. Some terms are discussed below, or elsewhere in the specification, to provide additional guidance in describing the compositions and methods of the disclosure and how to make and use them.

[0049] 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” can include one compound or a mixture of two compounds or more. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein.

[0050] The term “about” or “approximately”, as used herein, means within an acceptable error range for the particular value as determined by one of ordinary skill in the art, which will depend in part on how the value is measured or determined, i.e. , the limitations of the measurement system. For example, “about” can mean within 3 or more than 3 standard deviations, per the practice in the art. Alternatively, “about”Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 can modify a numerical value above and below the stated value by a variance of 10%, or of 5%, or of 1 %.

[0051] As used herein, the terms “comprises,” comprising,”, “include”, “including” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, food composition, or apparatus that comprises a list of elements (products, nutrients, steps, etc.) does not include only those elements but can include other elements not expressly listed or inherent to such process, method, food composition, or apparatus. The term “consisting of” implies the inclusion of the stated element(s), to the exclusion of any additional element(s). The term “consisting essentially of’ implies the inclusion of the stated elements, and possibly other element(s) where the other element(s) do not materially affect the basic and novel characteristic(s) of the disclosure. It is understood that the different embodiments of the disclosure using the term “including” or equivalent cover the embodiments where this term is replaced with “consisting of” or “consisting essentially of”.

[0052] As used herein, the term "active agent" refers to a component, or combination of components, of the food composition that exerts a biological activity that directly or indirectly contributes for producing the intended therapeutic or healthimproving effect. In some embodiments, linoleic acid, histidine, ERA and / or DHA, and at least one vitamin selected from vitamin B6 (Pyridoxine), vitamin C, and vitamin E; and optionally Alpha-Linolenic Acid, are the sole active agents of the food composition. In some embodiments, linoleic acid, histidine, EPA and / or DHA, vitamin B6 (Pyridoxine), and optionally vitamin C and / or vitamin E, and further optionally Alpha-Linolenic Acid, are the sole active agents of the food composition.

[0053] In the detailed description herein, references to “embodiment,” “one embodiment,” “in some embodiments,” etc., indicate that the embodiment(s) described can include a particular feature, structure, or characteristic, but every embodiment might not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described. After readingAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 the description, it will be apparent to one skilled in the relevant art(s) how to implement the disclosure in alternative embodiments.

[0054] As used herein, the term “weight percent” or “wt %” or “by weight” is meant to refer to the quantity by weight of a constituent / component / ingredient in a food composition as a percentage of the total weight of the food composition. More specifically, as used herein, unless specifically provided otherwise, the term “% by weight,” means the quantity in percentage by weight of the food composition on dry matter basis. Any exception will be clearly specified in the present specification. When the “% by weight,” does not refer to the food composition but to another referential, such as a specific component of the food composition, it will be specified.

[0055] As used herein, the term “food composition” or “diet” means a product that is intended and suitable for consumption by a companion animal, in particular a canine or a feline. A food composition contains one or more ingredients in order to incorporate one or more nutrients. Nutrients of a food composition can be typically, without limitation, proteins, fibers, carbohydrates, fats, vitamins and / or minerals, which can be used in combination in the body of an organism to sustain growth, repair and / or vital processes and / or to furnish energy (defined with the metabolizable energy (ME)). (See Merriam- Webster's Collegiate Dictionary, 10th Edition, 1993). A food composition as described herein can be a functional complement or a nutritionally complete and balanced food composition. The sum of the weight of each of the constituents comprised in a food composition should amounting, on a dry matter basis, to a total of 100%. In some preferred embodiments, the food composition as described herein is a canine food composition.

[0056] As used herein, the expression nutritionally complete and balanced” for a food compositions means that the food composition comprises all the essential nutrients in appropriate proportions to meet an animal's dietary requirements for maintaining overall health and well-being. A nutritionally complete and balanced food composition can maintain the body weight of the animal without significant change with the Body Condition Score (BCS). A nutritionally complete and balanced animal food composition ensures that the animal receives all the necessary nutrients for optimal health, minimizing the risk of nutritional deficiencies or imbalances that could lead to health issues overtime. Specifically, a nutritionally complete and balanced food composition can contain all known required nutrients for the intended recipient of the food composition, in all appropriate amounts and proportions based, for example, onAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 recommendations of recognized and competent authorities in the field of cat nutrition, such as the Association of American Feed Control Officials (AAFCO) or the European Pet Food Industry Federation (FEDIAF), for complete and balanced pet nutrition. Therefore, a nutritionally adequate feed is a feed with which the said animal, e.g., the said dog, can be fed as the sole ration and is capable of sustaining life without additional food (except water). In some embodiments, a nutritionally complete and balanced food composition as described herein can include nutrients and / or ingredients that are formulated to contribute to the nutritional properties of the food composition.

[0057] As used herein, a “food supplement” or “food complement” refers to a concentrated source of nutrients, such as but not limited to vitamins and minerals, substances for nutritional or physiological purposes, or plants and plant preparations intended to compensate for deficiencies in an animal’s regular diet. In some embodiments, a food supplement is marketed in the form of capsules, lozenges, tablets, pills, powder packets or liquid forms (ampoules, vials with droppers).

[0058] As used herein, the terms “animal” or “companion animal” can be used interchangeably to refer to domestic animals. In particular, a companion animal can refer to a canine ora feline. In some embodiments, a canine can be a dog and a feline can be a cat.

[0059] The term “healthy companion animal,” as used herein, refers to a companion (pet) animal that is not affected with any skin disorder or disease. For instance, a healthy companion animal can be a healthy dog. As used herein, “healthy dogs” consists of dogs which are not affected with any skin disorder or disease. Skin disorders or diseases encompass dermatitis, psoriasis, atopic dermatitis, cutaneous form of food allergy, pruritic diseases, bacterial folliculitis, and furunculosis. Dermatitis encompasses allergic dermatitis (such as flea-bite allergic dermatitis or cutaneous adverse food reaction), atopic dermatitis (such as environmental atopy), pyoderma (bacterial infection), mange (demodectic and sarcoptic) and immune or auto-immune dermatitis. As used herein, a skin disease or disorder can be a disrupted Trans-Epidermal-Water-Loss (TEWL) associated disease or disorder. Disrupted TEWL associated disease or disorder can encompasse ichthyosis vulgaris, diaper rash, dry skin, scaly skin, seborrheic dermatitis, atopic dermatitis, eczema, flea allergic dermatitis, bacterial skin infection, fungal skin infection, reactive skin, skinAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 inflammatory conditions, in particular psoriasis, rosacea, perioral dermatitis, perianal dermatitis, alopecia, ringworm and contact dermatitis.

[0060] As used herein, the term “canine” encompasses animals, including companion animals, more particularly dogs selected from recognized dog breeds (some of which are further subdivided), which can include afghan hound, airedale, akita, Alaskan malamute, basset hound, beagle, Belgian shepherd, bloodhound, border collie, border terrier, borzoi, boxer, bulldog, bull terrier, cairn terrier, chihuahua, chow, cocker spaniel, collie, corgi, dachshund, dalmatian, doberman, English setter, fox terrier, German shepherd, golden retriever, great dane, greyhound, griffon bruxellois, Irish setter, Irish wolfhound, King Charles spaniel, Labrador retriever, lhasa apso, mastiff, newfoundland, old English sheepdog, papillion, Pekingese, pointer, pomeranian, poodle, pug, rottweiler, St. Bernard, saluki, samoyed, schnauzer, Scottish terrier, Shetland sheepdog, shih tzu, Siberian husky, Skye terrier, springer spaniel, West Highland terrier, whippet, Yorkshire terrier, etc.

[0061] As used herein, the terms “treating” or “treatment” in the present disclosure refers to the administration of a food composition according to the disclosure with the purpose to treat, alleviate, relieve, alter, remedy, ameliorate, improve, or affect a disease or disorder, the symptoms of a disease or disorder, the likelihood of a disease or disorder, or to prevent or delay the onset of the symptoms, complications, or otherwise arrest or inhibit further development of a disease in a statistically significant manner. More particularly, “treating” or “treatment” encompasses any approach for obtaining beneficial or desired results in an animal afflicted with a disease or disorder. Beneficial or desired clinical results can encompass, but are not limited to, alleviation or amelioration of one or more symptoms or conditions associated with a disease or disorder; diminishment or reduction of the severity of a disease or disorder or symptoms related to the disease or disorder; maintaining the stability (preventing deterioration) of a disease or disorder; delaying the progression or slowing down the progression of a disease or disorder; minimizing the recurrence of a disease or disorder; and remission, whether partial or total and whether detectable or undetectable. In other words, “treatment” as used herein includes any cure, amelioration, or reduction of a disease, or disorder, or related symptom. A “reduction” of a disease or disorder, or symptoms of a disease or disorder, means decreasing of the severity or frequency of the disease, or disorder, orAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 symptoms of the disease or disorder, or elimination of a disease, or disorder, or symptoms of the disease or disorder.

[0062] In the context of the present disclosure, a disease or disorder can be a disrupted Trans-Epidermal-Water-Loss (TEWL) associated disease or disorder, or any complication directly linked thereof. A disrupted Trans-Epidermal Water Loss (TEWL) refers to an imbalance in the natural process by which water passes from the inner layers of the skin to the external environment through the epidermis, the outermost skin layer. Normally, this process is regulated by the skin's natural barrier, which keeps the skin hydrated and protects it from external irritants and pathogens. When TEWL is disrupted, the skin barrier becomes compromised, which could lead to, without limitation; an increased water loss, resulting in dehydration of the skin, ora dryness of the skin, or irritation and inflammation (animals may exhibit redness, itching, or discomfort), an increased susceptibility to infection, for instance bacteria, fungi, and allergens. The causes of a disrupted TEWL can come from, but are not limited to, allergies, parasites, extreme temperatures, low humidity, excessive bathing, detergent, products not designed for companion animals, or nutritional deficiencies. The symptoms of a disrupted Trans-Epidermal-Water-Loss (TEWL) associated disease or disorder can be, without limitation, dry skin, flaky skin, scratching, licking, redness, thinning coat, and / or hot spots. In some embodiments, the associated complications of a disrupted Trans-Epidermal-Water-Loss (TEWL) associated disease can include, but are not limited to, the dehydration of the skin, dry skin, flaky skin, redness, itching, bacterial infection, fungi infection, and allergy.

[0063] A number of diseases or disorders associated with a disrupted Trans-Epidermal-Water-Loss (TEWL) can be selected from, but are not limited to, ichthyosis vulgaris, diaper rash, dry skin, scaly skin, seborrheic dermatitis, atopic dermatitis, eczema, flea allergic dermatitis, bacterial skin infection, fungal skin infection, reactive skin, skin inflammatory conditions, in particular psoriasis, rosacea, perioral dermatitis, perianal dermatitis, alopecia, ringworm and contact dermatitis.

[0064] As used herein, the term “preventing”, can also include the reduction of a likelihood of occurrence, or of re-occurrence, of a given condition or disease in an animal.

[0065] As used herein, the term "skin condition" may refer to skin properties of a companion animal such as skin hydration, skin texture, skin elasticity, skinAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 integrity, skin barrier, coat softness, coat shine, dandruff and overall coat and skin condition of the companion animal.

[0066] As used herein, “sustaining healthy skin condition” means maintaining skin condition or quality at a substantially stable level with time, e.g., maintaining trans-epidermal water loss level at a substantially stable level with time. As used herein, "improving healthy skin condition" means achieving a measurable improvement of skin condition or quality, e.g., achieving a measurable decrease in trans-epidermal water loss (TEWL). A person of skill in the art will select the known methods of measuring the TEWL, for instance with Tewameter.

[0067] A person of skill in the art will select the known methods of measuring the improvement of skin condition (e.g., methods described in the Examples). Illustratively, improvement of skin condition or skin quality may be assessed by measuring a decrease in the trans-epidermal water loss (TEWL), as shown in the examples herein.

[0068] As used herein, the term “dry food” or “dry food composition” generally refers to a food or composition having a moisture content of less than about 12% by weight, relative to the total weight of the food composition, and commonly even less than about 7% by weight, relative to the total weight of the food composition. In some particular embodiments, dry food according to the present disclosure has a moisture content of at most about 12% by weight. In some embodiments, the said dry food has a moisture content of about 7% by weight or less, such as about 5% by weight. In some particular embodiments, the dry food has a moisture content of more than about 3% by weight, relative to the total weight of the food composition. For instance, the Examples provided herein illustrate a dry food having a moisture content of about 9.5% by weight, relative to the total weight of the food composition. In some embodiments, the dry food consists of a kibble. In some embodiments, for example and without limitation, kibbles can include particulates; pellets; pieces of pet food, dehydrated meat, meat analog, vegetables, and combinations thereof; and pet snacks, such as meat or vegetable jerky, rawhide, and biscuits. The dry food composition can be manufactured by mixing together ingredients and kneading in order to make consistent dough that can be cooked. In general, it can be the final product of a process including an extrusion step followed by a drying step.

[0069] The process of creating a dry food is usually done by baking and / or extruding. The dough is typically fed into a machine called an expander and / orAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 extruder, which uses pressurized steam or hot water to cook the ingredients. While inside the extruder, the dough is under extreme pressure and high temperatures. The dough is then pushed through a die (specifically sized and shaped hole) and then cut off using a knife. The puffed dough pieces are made into kibble by passing it through a dryer so that moisture is dropped down to a defined target ensuring stability of the food until consumption. The kibble can then be sprayed with fats, oils, minerals, vitamins, the natural extracts cocktail and optionally sealed into packages. In some embodiments, the dry food composition is packaged. In this way, the consumer is able to identify, from the packaging, the ingredients in the food product and confirm that it is suitable for the particular pet, e.g., dog, in question. The packaging can be metal, plastic, paper or card.

[0070] According to some embodiments, the moisture content of food composition according to the specification can be determined by a Loss on Drying Method, including the steps of:- Weighing a sample of a food composition, thereby obtained the total weight; - Heating, such as 135 ± 2 °C for 240 minutes, the sample of step a) in an oven until the moisture is all driven off, thereby obtained a dry sample;- Weighing the dry sample; thereby obtained the dry weight;- Calculating the difference between the total weight and the dry weight, thereby obtaining the moisture weight, as:Moisture weight = (total weight) - (dry weight)Units

[0071] All weight percentages expressed herein are by weight of the total weight of dry matter of the food composition unless expressed otherwise.

[0072] An amount of a component as expressed as gram per megacalories (g / Mcal) consists of a weight amount of the said component by unit of Metabolizable Energy (ME) of the food composition.

[0073] As used herein, the ME parameter is intended to represent the energy value of a food composition that is directly metabolized after consumption. Within the scope of the present disclosure, the ME value can be measured by any suitable method known in the art.

[0074] Illustratively, the ME value can be measured using feeding trial. In practice, the gross energy (GE) of the food is determined in the laboratory, and theAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 amounts of food eaten by the animals are recorded. The feces and urine from the animals are collected, and the energy in each is determined and called fecal energy (FE) and urinary energy (UE), respectively. The ME is then calculated as:ME (kcal / kg) = [GE - (FE + UE)] / Kg of food consumed.

[0075] Alternatively, the ME value can be measured by a mathematical method, in particular taking into account the percentage of crude fat (CF), of crude protein (CP), and NFE (carbohydrates) in the composition. In practice each percentage is multiplied by its respective Atwater Factors. The resulting sum is then multiplied by 10. The mathematical method can be represented by the following formula:ME (kcal / kg) = 10 x [(3.5 x CP) + (8.5 x CF) + (3.5 x NFE)].

[0076] Metabolizable Energy is conventionally determinable according to standard methods, and especially according to the National Research Council (NRC), nutrient requirements of dogs and cats, 2006, academy press, Washington DC.

[0077] In some embodiments, a food composition as disclosed herein can have a Metabolizable Energy (ME) ranging from about 3,500 kcal / kg to about 4,500 kcal / kg, as measured according to the NRC 2006. In some embodiments, a food composition as disclosed herein can have a Metabolizable Energy (ME) ranging of about 3,500 kcal / kg, about 3,600 kcal / kg, about 3,700 kcal / kg, about 3,800 kcal / kg, about 3,900 kcal / kg, about 4,000 kcal / kg, about 4,100 kcal / kg, about 4,200 kcal / kg, about 4,300 kcal / kg, about 4,400 kcal / kg, or about 4,500 kcal / kg, as measured according to the NRC 2006.

[0078] When the amount of nutritional ingredients in a food composition is expressed as a percentage (%), a skilled person can convert it into grams per megacalorie using the following formula: Multiply the percentage of the ingredient as fed by 10, then by 1000, and finally divide by the metabolizable energy (ME) of the food composition as determined by the NRC 2006. In other words, the formula for converting to grams per megacalorie is X g / Mcal = (% as fed *10*1000) / ME NRC 2006.

[0079] Alternatively, the skilled person will also be able to convert an amount of ingredient expressed in grams per megacalorie into a percentage with the above formula.

[0080] It is well known that the daily amount of food to be fed to an animal, may depend on the animal’s weight. This is particularly true for canines and felines such as dogs and cats.Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 Food composition

[0081] The present disclosure relates to a set / com bi nation of nutrients including from about 9.1g / Mcal to about 10.5g / Mcal of Linoleic Acid; from about 2.5g / Mcal to about 4.0g / Mcal of Histidine; from about 1.0g / Mcal to about 3.0g / Mcal of EPA and / or DHA; and a specific amount of at least one vitamin selected from vitamin B6 (Pyridoxine), vitamin C, or vitamin E. This set of nutrients can be included in a food composition, in particular a canine food composition. In some embodiments, the set / combination of nutrients, as described herein, does not comprise inositol.

[0082] The present disclosure relates to a food composition including a set of nutrients as described herein.

[0083] The present disclosure relates to a food composition for canine including from about 9.1g / Mcal to about 10.5g / Mcal of Linoleic Acid; from about 2.5g / Mcal to about 4.0g / Mcal of Histidine; from about 1.0g / Mcal to about 3.0g / Mcal of EPA and / or DHA; and at least one vitamin selected from vitamin B6 (Pyridoxine), vitamin C, or vitamin E.

[0084] The present disclosure relates to a food composition for canine including from about 9.1g / Mcal to about 10.5g / Mcal of Linoleic Acid; from about 2.5g / Mcal to about 4.0g / Mcal of Histidine; from about 1.0g / Mcal to about 3.0g / Mcal of EPA and / or DHA; and from about 10.0mg / Mcal to about 20.0mg / Mcal of vitamin B6 (Pyridoxine).

[0085] The present disclosure relates to a food composition for canine including from about 9.1g / Mcal to about 10.5g / Mcal of Linoleic Acid; from about 2.5g / Mcal to about 4.0g / Mcal of Histidine; from about 1.0g / Mcal to about 3.0g / Mcal of EPA and / or DHA; and from about 50.0mg / Mcal to about 100.0mg / Mcal of vitamin C.

[0086] The present disclosure relates to a food composition for canine including from about 9.1g / Mcal to about 10.5g / Mcal of Linoleic Acid; from about 2.5g / Mcal to about 4.0g / Mcal of Histidine; from about 1.0g / Mcal to about 3.0g / Mcal of EPA and / or DHA; from about 200. Omg / Mcal to about 250. Omg / Mcal of vitamin E.

[0087] The present disclosure relates to a food composition for canine including from about 9.1g / Mcal to about 10.5g / Mcal of Linoleic Acid; from about 2.5g / Mcal to about 4.0g / Mcal of Histidine; from about 1.0g / Mcal to about 3.0g / Mcal of EPA and / or DHA; from about 10. Omg / Mcal to about 20. Omg / Mcal of vitamin B6 (Pyridoxine), and, optionally, at least one vitamin selected from vitamin C or vitamin E.Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1

[0088] The food composition according to the present disclosure can be prepared according to the techniques which are well known to a person skilled in the art.

[0089] In some embodiments, the food composition, as described herein, does not comprise inositol.

[0090] In some embodiments, the food composition is a canine food composition.

[0091] In some embodiments, the food composition can be dry or wet.

[0092] In some embodiments, the food composition can be an extruded food composition.

[0093] In some embodiments, the food composition can have a moisture content of about 5% to about 12% by weight or preferably of about 8% to about 12% by weight.

[0094] In some embodiments, the food composition can have a moisture content of about 5.0%, or about 5.5%, or about 6.0%, or about 6.5% or about 7.0%, or about 7.5%, or about 8.0%, or about 8.5%, or about 9.0%, or about 9.5%, or about 10.0%, or about 10.5%, or about 11.0%, or about 11.5%, or about 12.0% by weight.

[0095] For example, and not by the way of limitation, the examples provided herein illustrate a dry food composition having a moisture content of about 10.0% by weight.

[0096] In some embodiments, the food composition can be a kibble, pellets or biscuits.

[0097] In some embodiments, the dry food composition can be nutritionally complete and balanced.

[0098] A specificity of the food composition of the disclosure is its combination of macro- and / or micronutrients in specific amounts.

[0099] In general, the food composition as disclosed herein includes linoleic acid, histidine, ERA and / or DHA, at least one vitamin selected from vitamin B6 (Pyridoxine), vitamin C or vitamin E, and optionally Alpha-Linolenic Acid.Linoleic Acid

[0100] The food composition as disclosed herein includes from about 9.1 g / Mcal to about 10.5g / Mcal of Linoleic Acid.

[0101] As used herein, the term “linoleic acid” refers to a polyunsaturated omega-6 fatty acid. Linoleic acid is an unsaturated fatty acid chemically designated asAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 c / s,c / s-9,12-octadecadienoic acid, with the chemical formula C18H32O2. Typically, linoleic acid can be extracted from animal fat or vegetable oils. For measuring the content of linoleic acid in a food composition, the one skilled in the art can refer to any of well-known techniques. For example, a method based upon the norm NF EN ISO 5508 / 5509 via chromatography in gaseous phase can be used.

[0102] In some embodiments, a linoleic acid source can be selected from plant oils, nuts, seeds, animal product or combinations thereof.

[0103] In some embodiments, a linoleic acid source can be selected from sunflower oil, safflower oil, corn oil, soybean oil, canola oil, peanut oil, grapeseed oil, sesame oil, walnuts, almonds, peanuts, chia seeds, sunflower seeds, pumpkin seeds, flaxseeds, poultry fat (like chicken and turkey), egg yolks, meat, or combinations thereof.

[0104] In some embodiments, a linoleic acid source can be selected from soybean oil and / or poultry fat.

[0105] In some embodiments, the food composition described herein can include about 9.1 g / Mcal, about 9.2 g / Mcal, about 9.3 g / Mcal, about 9.4 g / Mcal, about 9.5 g / Mcal, about 9.6 g / Mcal, about 9.7 g / Mcal, about 9.8 g / Mcal, about 9.9 g / Mcal, about 10.0 g / Mcal, about 10.1 g / Mcal, about 10.2 g / Mcal, about 10.3 g / Mcal, about 10.4 g / Mcal, or about 10.5 g / Mcal of linoleic acid.Histidine

[0106] The food composition as disclosed herein also includes from about 2.5g / Mcal to about 4.0g / Mcal of histidine.

[0107] As used herein “histidine” refers to an a-amino acid with the chemical formula C6H9N3O2, characterized by an imidazole functional group, which imparts unique chemical properties such as buffering capacity and metal ion coordination. It is classified as an essential amino acid.

[0108] In some embodiments, a source of histidine can be a natural and / or a synthetic source.

[0109] In some embodiments, histidine can be derived from meat (beef, pork, chicken), Fish (tuna, salmon, mackerel), dairy products (milk, cheese, yogurt), eggs, plants (soybeans, lentils, chickpeas), whole grains (wheat, rice, quinoa), nuts and seeds (sunflower seeds, peanuts), or microorganisms engineered to produce histidine through fermentation, such as Corynebacterium glutamicum or Escherichia coli.Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1

[0110] In some embodiments, the food composition described herein can include about 2.5 g / Mcal, about 2.6 g / Mcal, about 2.7 g / Mcal, about 2.8 g / Mcal, about 2.9 g / Mcal, about 3.0 g / Mcal, about 3.1 g / Mcal, about 3.2 g / Mcal, about 3.3 g / Mcal, about 3.4 g / Mcal, about 3.5 g / Mcal, about 3.6 g / Mcal, about 3.7 g / Mcal, about 3.8 g / Mcal, about 3.9 g / Mcal, or about 4.0 g / Mcal of histidine.EPA and / or DHA

[0111] The food composition as disclosed herein also includes from about 1.0g / Mcal to about 3.0g / Mcal of EPA and / or DHA.

[0112] Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are long-chain omega-3 polyunsaturated fatty acids (PUFAs) characterized by their respective chemical structures. EPA, chemically known as 5,8,11,14,17-eicosapentaenoic acid, has a molecular formula of C20H3002 and contains five cis double bonds located at the 5th, 8th, 11th, 14th, and 17th carbon positions in its chain. DHA, chemically known as 4,7,10,13,16,19-docosahexaenoic acid, has a molecular formula of C22H32O2 and contains six cis double bonds located at the 4th, 7th, 10th, 13th, 16th, and 19th carbon positions.

[0113] As used herein, the term “EPA and / or DHA” designates a fatty acid ora mixture of fatty acids consisting of (i) only eicosapentaenoic acid (EPA), (ii) only docosahexaenoic acid (DHA) or (iii) a combination of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA).

[0114] In some embodiments, a source of EPA and / or DHA can be fish oil, algal oil, krill oil eggs, or combinations thereof.

[0115] In some embodiments, the food composition described herein can include about 1.0 g / Mcal, 1.1 g / Mcal, 1.2 g / Mcal, 1.3 g / Mcal, 1.4 g / Mcal, 1.5 g / Mcal, 1.6 g / Mcal, 1.7 g / Mcal, 1.8 g / Mcal, 1.9 g / Mcal, 2.0 g / Mcal, 2.1 g / Mcal, 2.2 g / Mcal, 2.3 g / Mcal, 2.4 g / Mcal, 2.5 g / Mcal, 2.6 g / Mcal, 2.7 g / Mcal, 2.8 g / Mcal, 2.9 g / Mcal, or about 3.0 g / Mcal of EPA and / or DHA.Vitamins

[0116] The food composition as disclosed herein also includes at least one vitamin selected from vitamin B6 (Pyridoxine), vitamin C or vitamin E.

[0117] In some embodiments, the food composition can include vitamin B6 or vitamin C or vitamin E. In some embodiments, the food composition can includeAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 vitamin B6 and vitamin C. In some embodiments, the food composition can include vitamin B6 and vitamin E. In some embodiments, the food composition can include vitamin E and vitamin C. In some embodiments, the food composition can include vitamin B6 and vitamin C and vitamin E.

[0118] As used herein, “vitamin B6” refers to a group of chemically related compounds, including pyridoxine, pyridoxal, and pyridoxamine. The primary form, pyridoxine, has the chemical formula C8HnNO3, characterized by a pyridine ring substituted with hydroxymethyl and hydroxyl groups. In some embodiments, vitamin B6 is pyridoxine.

[0119] In some embodiments, a source of vitamin B6 can be in any form. In some embodiments, a source of vitamin B6 can be liquid, semi-solid or solid.

[0120] A source of vitamin B6 can be selected from an animal source, a plant source and / or a synthetic source. In some embodiments, a source of vitamin B6 can be selected from chicken, turkey, pork liver, salmon, sweet potatoes, rice, grains, cereals, pyridoxine hydrochloride or combinations thereof.

[0121] In some embodiments, the food composition described herein can include from about 10.0mg / Mcal to about 20.0mg / Mcal, or from about 12.0mg / Mcal to about 18.0mg / Mcal, or from about 13.0mg / Mcal to about 17.0mg / Mcal of vitamin B6.

[0122] In some embodiments, the food composition described herein can include about 10.0 mg / Mcal, about 10.5 mg / Mcal, about 11.0 mg / Mcal, about 11.5 mg / Mcal, about 12.0 mg / Mcal, about 12.5 mg / Mcal, about 13.0 mg / Mcal, about 13.5 mg / Mcal, about 14.0 mg / Mcal, about 14.5 mg / Mcal, about 15.0 mg / Mcal, about 15.5 mg / Mcal, about 16.0 mg / Mcal, about 16.5 mg / Mcal, about 17.0 mg / Mcal, about 17.5 mg / Mcal, about 18.0 mg / Mcal, about 18.5 mg / Mcal, about 19.0 mg / Mcal, about 19.5 mg / Mcal, or about 20.0 mg / Mcal of vitamin B6.

[0123] As used herein, “vitamin C”, also known as ascorbic acid, refers to a water-soluble vitamin essential having the chemical formula C6H8O6, and its structure includes a six-carbon lactone ring with hydroxyl groups.

[0124] In some embodiments, a source of vitamin C can be in any form. In some embodiments, a source of vitamin C can be liquid, semi-solid or solid.

[0125] A source of vitamin C can be a plant source or a synthetic source. In some embodiments, a source of vitamin C can be kale, spinach, bell peppers, broccoli, ascorbic acid additive, sodium ascorbate, calcium ascorbate or combinations thereof.Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1

[0126] In some embodiments, the food composition described herein can include from about 50.0mg / Mcal to about 200.0mg / Mcal, or from about 50.0mg / Mcal to about 150.0mg / Mcal, or from about 50.0mg / Mcal to about 100.0mg / Mcal of vitamin C. In some embodiments, the food composition described herein can include from about 50.0mg / Mcal to about 100.0mg / Mcal, or from about 60.0mg / Mcal to about 90.0mg / Mcal or from about 70.0mg / Mcal to about 80.0mg / Mcal of vitamin C.

[0127] In some embodiments, the food composition described herein can include about 50.0mg / Mcal, about 55.0mg / Mcal, about 60.0mg / Mcal, about 65.0mg / Mcal, about 70.0mg / Mcal, about 75.0mg / Mcal, about 80.0mg / Mcal, about 85.0mg / Mcal, about 90.0mg / Mcal, about 95.0mg / Mcal, or about 100.0mg / Mcal of vitamin C.

[0128] As used herein, “vitamin E” refers to a fat-soluble vitamin that encompasses tocopherols (alpha-tocopherol) and tocotrienols. The chemical formula for alpha-tocopherol is C29H5o02, featuring a chromanol ring and a hydrophobic phytyl side chain.

[0129] In some embodiments, vitamin E can be a tocopherol or a tocotrienol. In some embodiments, vitamin E can be alpha-tocopherol, (d-x ordl-oc) beta-tocopherol (d-,B or dl-), gamma-tocopherol (dot or dim), delta-tocopherol, alpha-tocotrienol, beta-tocotrienol, gamma-tocotrienol or delta-tocotrienol.

[0130] In some embodiments, vitamin E is alpha-tocopherol.

[0131] In some embodiments, a source of vitamin E can be in any form. In some embodiments, a source of vitamin E can be liquid, semi-solid or solid.

[0132] A source of vitamin E is not limiting. In some embodiments, a source of vitamin E can be a plant source or a synthetic source. In some embodiments, a source of vitamin E can be sunflower oil, safflower oil, wheat germ oil, almonds, sunflower seeds, tocopherol acetate (Alpha-tocopherol acetate or dl-alpha-tocopherol), or combinations thereof.

[0133] In some embodiments, the food composition described herein can include from about 150.0mg / Mcal to about 250.0mg / Mcal, or from about 200.0mg / Mcal to about 250.0mg / Mcal, or from about 210.0mg / Mcal to about 240.0mg / Mcal or from about 215.0mg / Mcal to about 235.0mg / Mcal or from about 215.0mg / Mcal to about 255.0mg / Mcal of vitamin E.

[0134] In some embodiments, the food composition described herein can include about 200.0mg / Mcal, about 205.0mg / Mcal, about 210.0mg / Mcal, aboutAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 215.0mg / Mcal, about 220.0mg / Mcal, about 225.0mg / Mcal, about 230.0mg / Mcal, about 235.0mg / Mcal, about 240.0mg / Mcal, about 245.0mg / Mcal, or about 250.0mg / Mcal of vitamin E.Alpha-linolenic acid

[0135] In some embodiments, the food composition described herein can also include alpha-linolenic acid.

[0136] As used herein, alpha-linolenic acid” or ALA refers to a polyunsaturated omega-3 fatty acid with the molecular formula CI8H30O2. It is chemically classified as an 18-carbon fatty acid with three cis double bonds located at the 9th, 12th, and 15th carbon atoms from the carboxyl end, denoted by its systematic name (9Z,12Z,15Z)-octadeca-9,12,15-trienoic acid. The structure features a carboxylic acid functional group (-COOH) at one end and a methyl group (-CH3) at the other, with a hydrocarbon chain containing the three double bonds.

[0137] A source of alpha-linolenic acid can be a plant source and / or a synthetic source. In some embodiments, a source of alpha-linolenic acid can be selected from flaxseed, chia seeds, canola oil, soybean oil, walnuts, alpha-linolenic acid supplement, or combinations thereof.

[0138] A source of alpha-linolenic acid can be in any form. In some embodiments, a source of alpha-linolenic acid can be liquid, semi-solid or solid.

[0139] In some embodiments, the food composition described herein can include from about 0.2g / Mcal to about 1.5g / Mcal of alpha-linolenic acid, such as for example from about 0.5g / Mcal to about 1 ,5g / Mcal.

[0140] In some embodiments, the food composition described herein can include about 0.2g / Mcal, 0.25g / Mcal, 0.3g / Mcal, 0.4g / Mcal, 0.5g / Mcal, 0.6g / Mcal, 0.7g / Mcal, 0.8g / Mcal, 0.9g / Mcal, 1.0 g / Mcal, 1.1g / Mcal, 1.2g / Mcal, 1.3g / Mcal, 1 ,4g / Mcal or about 1 ,5g / Mcal of alpha-linolenic acid.Supplementary Ingredients, Substances or Additives

[0141] In some embodiments, the food composition as described herein can be nutritionally complete and balanced; and can also contain supplementary ingredients, substances or additives, for example, protein, fat, fibers, NFE, ash, minerals, vitamins or condiments.ProteinAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1

[0142] In some embodiments, a food composition according to the present disclosure can further contain a protein source.

[0143] In some embodiments, the protein level is high enough so as to ensure maintenance of lean body mass of the canine. In some embodiments, the food composition of the present disclosure can contain one or more distinct protein sources.

[0144] In some embodiments, the food composition as described herein can include a plurality of proteins that are contained in a protein source which is used in the manufacture process.

[0145] In some other embodiments, the food composition as described herein can include a plurality of proteins from a plurality of protein sources.

[0146] In some embodiments the protein is not hydrolyzed. In some other embodiments a protein can be present in an at least partially hydrolysed form, or even completely hydrolyzed. In some embodiments, the food composition or the kit according to the present disclosure can incorporate proteins under the form of meat or animal derived material (such as, but not limited to beef, chicken, turkey, lamb, fish, blood plasma, marrow bone etc. or combinations thereof). In some other embodiments, the food composition or the kit as described herein can be meat-free. In some embodiments, such meat-free compositions / kits include a meat substitute protein source such as soya, maize gluten or any other protein-containing soya product in order to provide a protein source. In some embodiments, the food composition as disclosed herein can include additional protein sources such as soya protein concentrate, milk proteins, gluten etc.

[0147] In some embodiments, the food composition as described herein can include from about 10% to about 40% by weight of protein, on a dry matter basis.

[0148] In some embodiments, the food composition as described herein can include about 10%, or about 11%, or about 12%, or about 13%, or about 14%, or about 15%, or about 16%, or about 17%, or about 18%, or about 19%, or about 20%, or about 21%, or about 22%, or about 23%, or about 24%, or about 25%, or about 26%, or about 27%, or about 28%, or about 29%, or about 30%, or about 31%, or about 32%, or about 33%, or about 34%, or about 35%, or about 36%, or about 37%, or about 38%, or about 39%, or about 40% by weight of protein, on a dry matter basis.Fat

[0149] A food composition according to the present disclosure can further contain a nutritionally appropriate amount of fat.Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1

[0150] In some embodiments, a food composition according to the present disclosure can further contain a fat source.

[0151] The term “fat” as used in the present specification refers to any food-acceptable fat(s) and / or oil (s) irrespective of their consistency at room temperature, i.e. , irrespective whether said “fat” is present in essentially fluid form or in essentially solid form. The food composition according to the present disclosure can include fat of animal and / or vegetable origin. Fat can be supplied by any of a variety of sources known by those skilled in the art. Plant fat sources include, without limitation, wheat, sunflower, safflower, rapeseed, olive, borage, flaxseed, peanuts, blackcurrant seed, cottonseed, wheat, germ, corn germ as well as oils derived from these and other plant crude fat sources. Animal sources include, for example and without limitation, chicken fat, turkey fat, beef fat, duck fat, pork fat, lamb fat, fish oil or any meat, meat byproducts, seafood, dairy, eggs. Fat content of foods can be determined by any number of methods known by those of skill in the art.

[0152] In some embodiments, the food composition as described herein can include from about 7% to about 17% by weight of fat, on a dry matter basis.

[0153] In some embodiments, the food composition as described herein can include about 5.0%, or about 5.5%, or about 6.0%, or about 6.5%, or about 7.0%, or about 7.5%, or about 8.0%, or about 8.5%, or about 9.0%, or about 9.5%, or about 10.0%, or about 10.5%, or about 11.0%, or about 11.5%, or about 12.0%, or about 12.5%, or about 13.0%, or about 13.5%, or about 14.0%, or about 14.5%, or about 15.0%, or about 15.5%, or about 16.0%, or about 16.5%, or about 17.0% by weight of fat, on a dry matter basis.Fibers

[0154] Fibers are optionally included in the food composition disclosed herein. In some embodiments, a food composition according to the present disclosure can further contain a fibers source.

[0155] The expression “fibers” is used herein similarly to “dietary fibers” and shall be interpreted for the purpose of the present disclosure as Total Dietary Fibers (TDF), meaning that it includes soluble fibers and insoluble fibers. Soluble fiber, as used herein, refers to a fiber that is resistant to digestion and absorption in the small intestine and undergo complete or partial fermentation in the large intestine. In contrast, insoluble fiber refers to non-starch polysaccharides that are resistant to digestion and absorption in the small intestine, and resistant to fermentation in theAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 large intestine. Soluble fibers are considered as having a prebiotic effect by providing short chain fatty acids as a source of energy to colonocytes. Insoluble fibers are considered as useful for transit and ballast effect. As non-limiting examples of fibers include a first group, which includes beet pulp, guar gum, chicory root, psyllium, pectin, blueberry, cranberry, squash, apples, oats, beans, citrus, barley, or peas, and a second group, which includes cellulose, whole wheat products, wheat oat, corn bran, flax seed, grapes, celery, green beans, cauliflower, potato skins, fruit skins, vegetable skins, peanut hulls, and soy fiber. Crude fiber refers to the indigestible portion of plant material such as cellulose, hemicellulose, and lignin.

[0156] In some embodiments, the food composition as described herein can include from about 0.5% to about 10% by weight of TDF, on a dry matter basis.

[0157] In some embodiments, the food composition as described herein can include about 0.5%, about 1.0%, about 1.5%, about 2.0%, about 2.5%, about 3.0%, about 3.5%, about 4.0%, about 4.5%, about 5.0%, or about 5.5%, or about 6.0%, or about 6.5%, or about 7.0%, or about 7.5%, or about 8.0%, or about 8.5%, or about 9.0%, or about 9.5%, or about 10.0% by weight of TDF, on a dry matter basis.

[0158] In some embodiments, the food composition as described herein can include from about 0.5% to about 10% by weight of crude fibers, on a dry matter basis.

[0159] In some embodiments, the food composition as described herein can include about 0.5%, about 1.0%, about 1.5%, about 2.0%, about 2.5%, about 3.0%, about 3.5%, about 4.0%, about 4.5%, about 5.0%, or about 5.5%, or about 6.0%, or about 6.5%, or about 7.0%, or about 7.5%, or about 8.0%, or about 8.5%, or about 9.0%, or about 9.5%, or about 10.0% by weight of crude fiber, on a dry matter basis.Carbohydrates

[0160] In some embodiments, the food composition described herein can include carbohydrates. In some embodiments, a food composition according to the present disclosure can further contain a carbohydrate source.

[0161] As used herein, the term “carbohydrates” designates a mixture of polysaccharides and sugars that are metabolized for energy when hydrolyzed in the body. The carbohydrate content in the food composition and / or the kit can be determined by any number of methods known by those of skilled in the art. Carbohydrates can be supplied under the form of any of a variety of carbohydrate sources known by those skilled in the art, including starch (any kinds, corn, wheat, barley, etc.) beet pulp (which contain a bit of sugars) and psyllium.Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 Starches

[0162] An important source of Nitrogen Free Extract (NFE) that is optionally included in the food composition disclosed herein can consist of starch. A person skilled in the art will appreciate a wide variety of starches are suitable for use in compositions of the present disclosure.

[0163] The term “starch” as used herein refers to a polysaccharide that is composed of amylose and amylopectin. Starch occurs in many plant tissues as granules, usually between 1 and 100 pm in diameter, depending upon the plant source. Chemically, starches are polysaccharides composed of a-D-glucopyranosyl units linked together with a-D(1-4) and / or a-D(1 -6) linkages and are comprised of two molecular types: amylose, the straight chain polyglucan comprised of approximately 1000, a-D(1-4) linked glucoses; and amylopectin, the branched glucan, comprised of approximately 4000 glucose unite with branches occurring as a-D(1-6) linkages.

[0164] As used herein, starch encompasses the various crystalline structures of A-type, B-type and C-type starches, which contain different proportions of amylopectin. A-type starches are found mainly in cereals, while B-type starches are found mainly in tubers and amylose-rich starches. C-type starch consists of a mixture of both A and B forms and is found mainly in legumes.

[0165] In general, digestible starches are broken down (hydrolyzed) by the enzymes a-amylases, glucoamylase and sucrose-iso-maltase in the small intestine to yield free glucose that is then absorbed.

[0166] Starch included in the food composition disclosed herein can consist in any starch suitable for dietary purpose.

[0167] Indeed, the native starch included in the starting materials used for preparing the food composition as described herein is susceptible to undergo changes during the manufacture process. The specified amount of starch included in the food composition of the present disclosure can consist of the amount of starch that is contained in the total amount of the raw materials which are provided for producing the said food composition. However, the amount of starch included in the food composition disclosed herein equates the total amount of starch included in the starting materials used for preparing the said food composition.

[0168] If not already known by advance, the starch content of the starting materials used for preparing the food composition described herein can be determinedAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 according to conventional techniques known in the art, and especially according to the known polarimetric method, such as according to NF EN ISO 10520.

[0169] In some embodiments, wherein the starting materials can include also modified starch or pre-gelatinized starch, the starch content can also be determined according to NF EN ISO 15914.Ash

[0170] In some embodiments, the food composition disclosed herein can include ash.

[0171] The term “ash” refers to the mineral content of a food composition. Ash is the total inorganic residue left after a food sample is burned at a high temperature (usually around 500-600°C) to remove all organic material. Sometimes, contaminants like soil, sand, or metallic residues from processing can be included. Ash can include minerals such as calcium, phosphorus, sodium, chloride, potassium, magnesium, or combinations thereof. The ash content, if specified as a result of an analytical measure of the food composition described herein, is a measure of the total amount of minerals comprised therein. The mineral content is a measure of the amount of specific inorganic components comprised therein, which includes calcium (Ca), sodium (Na), potassium (K) and chlorine (Cl).

[0172] In some embodiments, the food composition as described herein can include from about 2% to about 12% by weight of ash, on a dry matter basis.

[0173] In some embodiments, the food composition as described herein can include about 2.0%, or about 2.5%, or about 3.0%, or about 3.5%, or about 4.0%, or about 4.5%, or about 5.0%, or about 5.5%, or about 6.0%, or about 6.5%, or about 7.0%, or about 7.5%, or about 8.0%, or about 8.5%, or about 9.0%, or about 9.5%, or about 10.0%, or about 10.5%, or about 11.0%, or about 11.5%, or about 12.0% by weight of ash, on a dry matter basis.

[0174] As it shall be readily understood, every embodiment of the food composition encompassed by the present disclosure can include a variety of ingredients, each comprised in the said food composition at a given weight percentage, as compared to the total weight of dry matter of the food composition.

[0175] In some embodiments, the food composition as disclosed herein can further include, protein, fat, fibers, NFE, carbohydrates, starches, ash, additional vitamins, minerals, etc., the sum of the weight of each of the ingredients comprisedAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 therein amounting to 100% by weight, based on the total weight of dry matter of the said food composition.Methods for the preparation of a food composition

[0176] The present disclosure also provides a method for manufacturing or preparing the food composition described herein. The process for the manufacture of the food composition as described includes any methods known in the art.

[0177] The food composition described herein can be manufactured by mixing together ingredients and kneading in order to make consistent dough or meat emulsion that can be cooked. This applies also to liquids where ingredients are mixed, homogenized before a cooking step in a packaging. The process of creating an embodiment of a dry food is usually done by baking and / or extruding. The dough is typically fed into a machine called an expander and / or extruder, which uses pressurized steam or water to cook the ingredients. While inside the extruder, the dough is under extreme pressure and high temperatures. The dough is then pushed through a die (specifically sized and shaped hole) and then cut off using a knife. The puffed dough pieces are made into kibble by passing it through a dryer so that moisture is dropped down to a defined target ensuring stability of the food until consumption. The kibble can then be sprayed with fats, oils, minerals, vitamins, the natural extracts cocktail, palatants and optionally sealed into packages.

[0178] The composition can be a dry food, a wet food or a semi-moist food.

[0179] In some embodiments, the present disclosure relates to a method of manufacturing a food composition including the steps of:a) mixing at least Linoleic acid, histidine, EPA / DHA and at least one vitamin selected from vitamin B6 (Pyridoxine), vitamin C, and vitamin E, thereby providing a mixture; andb) heating the mixture, thereby obtaining a food composition.

[0180] In some embodiments, the present disclosure relates to a method of manufacturing a food composition including the steps of:a) mixing at least Linoleic acid, histidine, EPA / DHA and at least one vitamin selected from vitamin B6 (Pyridoxine), vitamin C, and vitamin E, thereby providing a mixture; andb) heating the mixture, thereby obtaining a food composition,Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 wherein from about 9.1g / Mcal to about 10.5g / Mcal of linoleic acid; from about 2.5g / Mcal to about 4g / Mcal of histidine; and from about 1.0g / Mcal to about 3.0g / Mcal of ERA and / or DHA are expected to be included in the food composition.

[0181] In some embodiments, the manufacturing method comprises at least the steps of:(a) mixing at least:- linoleic acid in an amount from about 9.1 g / Mcal to about 10.5g / Mcal,- histidine in an amount from about 2.5g / Mcal to about 4.0g / Mcal,- EPA / DHA in an amount from about 1.Og / Mcal to about 3.0g / Mcal andat least one vitamin selected from about 10.0mg / Mcal to about 20.0mg / Mcal of vitamin B6 (Pyridoxine), from about 50.0mg / Mcal to about 100.0mg / Mcal of vitamin C, and from about 200.0mg / Mcal to about 250.0mg / Mcal of vitamin E, thereby obtaining a mixture,(b) heating the mixture, thereby obtaining a food composition.

[0182] In some embodiments, the food composition manufactured by the methods described herein can be a kibble.

[0183] In some embodiments, the food composition manufactured by the methods described herein includes a source of protein, fiber and fat.

[0184] In some embodiments, the mixture in step (a) further comprises ingredients suitable to provide a nutritionally complete and balanced food composition, optionally including at least sources of protein, fiber, fat, carbohydrates, vitamins, and minerals in amounts suitable to meet the nutritional requirements of companion animals, in particular for canines.

[0185] In some embodiments, the mixture in step (a) further comprises the incorporation from about 0.20g / Mcal to about 1. Og / Mcal of alpha-linolenic acid.Therapeutic and non-therapeutic applications

[0186] The present disclosure provides therapeutic and non-therapeutic uses and methods implementing a food composition as disclosed herein.

[0187] A further aspect of the present disclosure relates to the non-therapeutic use of a food composition disclosed herein, for sustaining or improving a healthy skin condition of a canine, in particular a healthy canine.

[0188] A further aspect of the present disclosure relates to a non-therapeutic method for sustaining or improving a healthy skin condition of a canine, in particular aAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 healthy canine, comprising at least a step of administrating a food composition disclosed herein to the canine.

[0189] In some embodiments, food compositions disclosed herein can be non-therapeutically used for sustaining or improving coat shine of a canine.

[0190] In some embodiments, food compositions disclosed herein can be non-therapeutically used for sustaining or improving coat softness of a canine.

[0191] In some embodiments, food compositions disclosed herein can be non-therapeutically used for sustaining or improving skin barrier of a canine.

[0192] In some embodiments, food compositions disclosed herein can be non-therapeutically used for reducing the dandruff of a canine.

[0193] In some embodiments, food compositions disclosed herein can be non-therapeutically used for sustaining or improving overall coat and / or skin condition of a canine.

[0194] In some embodiments, the canine can be a healthy canine, in particular a healthy dog.

[0195] In some embodiments, the canine, in particular the healthy canine, can have a disrupted TEWL without manifesting any associated medical disease condition.

[0196] In some embodiments, the food composition disclosed herein sustains healthy skin condition by maintaining hydration and / or maintaining transepidermal water loss (TEWL).

[0197] In some embodiments, the food composition disclosed herein can sustain healthy skin condition during, before or after an event that causes a disrupted TEWL of the canine skin. The event can occur over a short or long period, including a week, several weeks, a month, or several months.

[0198] In some embodiments, the food composition disclosed herein can improve healthy skin condition by enhancing hydration and / or reducing transepidermal water loss (TEWL). This improvement can be measured by an increase in skin hydration of about 5% to about 50%, and / or a reduction in TEWL by about 5% to about 50%.

[0199] In some embodiments, the food composition disclosed herein can improve healthy skin condition during, before or after an event that causes a disrupted TEWL of the canine skin. The event can occur over a short or long period, including a week, several weeks, a month, or several months.Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1

[0200] In some embodiments, the food composition described herein can be provided to a canine, especially a dog, on a daily basis.

[0201] In some embodiments, the food composition described herein can be provided to a canine, especially a dog, one, two, three, or four times a day.

[0202] In some embodiments, the food composition described herein can be provided to a canine, especially a dog, in alternance with another food composition.

[0203] The period of non-therapeutically feeding the canine with the food composition as described herein can range from several weeks to several years.

[0204] A further aspect of the present disclosure relates to the food composition disclosed herein for use as a medicament.

[0205] A further aspect of the present disclosure relates to the use of the food composition disclosed herein in the manufacture of a medicament for the treatment or prevention of a disrupted Trans-Epidermal-Water-Loss (TEWL) associated disease or disorder in a canine in need thereof.

[0206] A further aspect of the present disclosure relates to the food composition disclosed herein for use in a method for treating and / or preventing a disrupted Trans-Epidermal-Water-Loss (TEWL) associated disease or disorder in a canine in need thereof. The present disclosure provides a food composition for canine including from about 9.1g / Mcal to about 10.5g / Mcal of linoleic acid; from about 2.5g / Mcal to about 4g / Mcal of histidine; from about 1g / Mcal to about 3g / Mcal of EPA and / or DHA; and at least one vitamin selected from vitamin B6, vitamin C, and vitamin E, for use in a method for treating and / or preventing a disrupted Trans-Epidermal-Water-Loss (TEWL) associated disease or disorder in a canine in need thereof.

[0207] A further aspect of the present disclosure relates to a method for treating and / or preventing a disrupted Trans-Epidermal-Water-Loss (TEWL) associated disease or disorder in a canine in need thereof, comprising at least the step of administering to said canine the food composition disclosed herein. The present disclosure provides aa method for treating and / or preventing a disrupted Trans-Epidermal-Water-Loss (TEWL) associated disease or disorder in a canine in need thereof, comprising at least the step of administering to said canine a food composition for canine including from about 9.1g / Mcal to about 10.5g / Mcal of linoleic acid; from about 2.5g / Mcal to about 4g / Mcal of histidine; from about 1g / Mcal to about 3g / Mcal of EPA and / or DHA; and at least one vitamin selected from vitamin B6, vitamin C, and vitamin E.Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1

[0208] As shown in the Examples, a food composition as described herein allows promoting recovery of the detergent compromised epidermal barrier of dog’s skin, relative to a standard adult food composition. Specifically, a food composition as described herein allows accelerating the recovery of disrupted transepidermal water loss (TEWL) to baseline. Beneficial effects can be obtained in canines fed exclusively with the food composition described herein, during, before or after a disrupted transepidermal water loss (TEWL).

[0209] In some embodiments, the food composition described herein is effective in treating and / or preventing the severity, frequency, or recurrence of a disrupted transepidermal water loss (TEWL) disease or disorder, as determined / assessed by Transepidermal water loss (TEWL) analysis, natural moisturising factor (NMF) analysis and / or sensory evaluation of dog coats.

[0210] In some embodiments, the food composition is administering in a therapeutically effective amount.

[0211] In some embodiments, the food composition described herein can be provided to a canine, especially a dog, on a daily basis.

[0212] In some embodiments, the food composition described herein can be provided to a canine, especially a dog, one, two, three, or four times a day.

[0213] In some embodiments, the food composition disclosed herein can be provided to a canine as the sole food composition during the period of treatment. According to these embodiments, the food composition is provided to the canine on a daily basis during the time period of treatment.

[0214] It shall be understood that, in the daily practice of feeding animals, especially dogs, the animal owner cannot proceed according to a systemic way of feeding the animal with an animal food composition always on daily basis.

[0215] In some embodiments, the beneficial effects of preventing and / or treating a disrupted transepidermal water loss (TEWL) disease or disorder are fully provided when the canine is fed with the food composition described herein every day for at least 2 months or more, or 3 months or more, or 4 months or more, or 5 months or more, or 6 months or more, or 7 months or more, or 8 months or more, or 9 months or more, or 10 months or more, or 11 months or more, or 12 months or more.

[0216] The period of feeding the canine with the food composition as described herein can range from several weeks to several years, depending notably on the severity of the disrupted transepidermal water loss (TEWL) disease or disorder.Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1

[0217] In some embodiments, the food composition described herein can be provided to the canine in need thereof for a period of between about one month to about 36 months.

[0218] In some embodiments, the food composition described herein can be provided to the canine in need thereof for a period about one month, or about two months, or about three months, or about four months, or about five months, or about six months, or about seven months, or about eight months, or about nine months, or about ten months, or about eleven months, or about twelve months, or about thirteen months, or about fourteen months, or about fifteen months, or about sixteen months, or about seventeen months, or about eighteen months, or about nineteen months, or about twenty months, or about twenty-one months, or about twenty-two months, or about twenty-three months, or about twenty-four months, or about twenty-five months, or about twenty-six months, or about twenty-seven months, or about twenty-eight months, or about twenty-nine months, or about thirty months, or about thirty-one months, or about thirty-two months, or about thirty-three months, or about thirty-four months, or about thirty-five months, or about thirty-six months.

[0219] In some embodiments, a disrupted TEWL associated disease or disorder can consist of a skin condition characterized by skin dehydration.

[0220] In some embodiments, a disrupted TEWL associated disease or disorder can consist of a skin condition characterized by a compromised skin barrier.

[0221] In some embodiments, a disrupted TEWL associated disease ordisorder can consist of a significant augmentation of TEWL observed in a companion animal during a period of one week, two weeks, three weeks, four weeks, one month or more, compared to baseline.

[0222] In some embodiments, a disrupted TEWL associated disease ordisorder can be selected from ichthyosis vulgaris, diaper rash, dry skin, scaly skin, seborrheic dermatitis, atopic dermatitis, eczema, flea allergic dermatitis, bacterial skin infection, fungal skin infection, reactive skin, skin inflammatory conditions, in particular psoriasis, rosacea, perioral dermatitis, perianal dermatitis, alopecia, ringworm and contact dermatitis.EXAMPLES

[0223] The presently disclosed subject matter will be better understood by reference to the following Examples, which are provided as exemplary of theAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 disclosure, and not by way of limitation. The materials and methods used in the Examples are summarized below.

[0224] The objective of the study is to demonstrate that a new combination of active micronutrients / macronutrients improves barrier skin properties of dogs compared to a control diet. Improvement can take the form of more rapid restoration of the skin barrier, ora more complete recovery of the skin barrier over the study period in the Test group versus the Control group.A. Materials and Methods

[0225] This study tests the ability of a novel set of nutrients formulation to promote recovery of the skin barrier following a mild disruption using a series of detergent washes over fourteen (14) days.

[0226] Schematic table 1 of the study.Table 1* Cross over groups means switching the groups around to verify if the results differ when a group that worked on one composition now tests a different composition.

[0227] Animals: Twenty-six (26) adult healthy dogs with normal weight are enrolled. Two groups of 13 dogs for control and test. Different breeds are included: Standard Poodle, Labrador retriever, Beagle, Brittany spaniel, Miniature Poodle, Shih Tzu.Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1

[0228] Food compositions: Two food compositions are used for the study, Control and Test. The food compositions are based on dry Royal Canin® Medium Adult formulation (Composition: dehydrated poultry proteins, wheat, corn flour, wheat flour, corn, hydrolyzed animal proteins, animal fats, dehydrated pork proteins, barley, corn gluten, beet pulp, mineral substances, soybean oil, yeast products, fish oil, yeast (source of mannan-oligosaccharides), and Schizochytrium sp. algae oil - Protein: 25.0%, TDF: 5.2% (Crude fiber: 1.4%), Fat content: 14.0%, Crude ash: 6.3% and Moisture :10%).

[0229] The test food composition includes higher levels of a complex combination of lipids as well as prebiotics and vitamins compared to the reference (control) food composition (Table 2).Table 2

[0230] The test food composition also includes Alpha-linolenic acid from flaxseed (seeds) at an estimated concentration in the food composition of 0.2g / 100g (0.94 g / Mcal).

[0231] The control food composition formula is based on the classic Royal Canin® Medium Adult formulation and does not include any additional supplements (Table 3). The test food composition is also designed to closely match the lipid,Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 micronutrient, and macronutrient profile of the classic Royal Canin® Medium Adult formulation (Table 3), but differs in specific components, specifically pyridoxine, vitamin C, vitamin E, ERA, DHA and linolenic acid.

[0232] Both food compositions met all Minimum Nutritional Standards requirement established by the European Union (MPENS).Table 3: Nutritional component of the test and control food compositionsAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1

[0233] Dogs are fed following a defined energy allowance of 95kcal / kgA0.75. The meal frequency is two meals per day with unlimited access to water. The intake can be adjusted during the study to maintain healthy bodyweight (BCS 4, 5, 6).

[0234] Parameters to be measured: Transepidermal Water Loss (TEWL -Tewameter); Hydration (Corneometer); pH (LaquaACT pH meter); Sebum production (Sebumeter); Epidermal NMF (Natural Moisturizing Factor) concentration; and, Shine / Gloss, Scale and Overall Coat Quality assessed via subjective measures. A method for NMF analysis is described in: Dapic, I., Jakasa, I., Yau, N. L. H., Kezic, S., & Kammeyer, A. (2013). Evaluation of an HPLC Method for the Determination of Natural Moisturizing Factors in the Human Stratum Corneum. Analytical Letters, 46(14), 2133-2144.

[0235] TEWL and Hydration measurements are performed on shaved areas of skin on the back of the animal, towards the base of the spine.

[0236] The schedule of sampling is presented in Figure 1.DECON (washing) protocol

[0237] All the studied dogs were examined prior to study start to ensure that they are suitable for the bathing regimen.

[0238] The ‘DECON’ bathing protocol (Phase 2) involves receiving a single bath to each dog for 14 consecutive days. All DECON bathing sessions use the same cleanser, Dawn Ultra Dishwashing Soap (dilution ratio of 60 or 120 ml of detergent per 3800ml ml of water).Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1

[0239] The bathing procedure is carried out in a controlled indoor environment by trained personnel. Each bath lasts for 10-12 minutes and follows these steps:1) Initial rinse: The dog's coat and skin are wetted for 2 minutes using a spray nozzle;2) Detergent application: A diluted solution (300 ml) of the detergent is applied with a soft brush, followed by lathering for 6 minutes; and3) Rinse to remove detergent: The dog is rinsed thoroughly for 2-4 minutes using a spray nozzle to ensure complete removal of the detergent.

[0240] The head region is not to be submerged in water. Specifically, no water should come into contact with any area of the dog’s body from behind the ears forward.

[0241] After each bath, dogs are towel-dried before returning to their normal activities. If necessary, depending on the external temperature, the dogs may be kept indoors until they are fully dry.

[0242] Statistical methods: Following the washout period the identity of all dogs is anonymized and their TEWL data is passed to AW for analysis required to balance the 2 groups for the study. The feeding diet are blinded. Un-blinding of the protocol is only done at the end of the study for data analysis.

[0243] Statistical description: Three TEWL measurements are done per timepoint per animal. They are each composed of readings from three probes (A, B and C) over 30 seconds. Only data from 20 to 30 seconds are used. However, no effect of Probe nor measurement was observed. TEWL data from this study is assessed and the final results are the average of 3 measurements from the 3 probes from 20 seconds to 30 seconds. Two-ways repeated measures Anova is used to analyse quantitative parameters (TEWL, hydration and pH) with animal as random term and the following fixed effects: Diet, Sequence, Time, Diet*Sequence and Diet*Time. If not significant, Sequence and Diet*Sequence effects will be removed for obtaining a more parsimonious model. Tukey HSD is used for p-value correction for multiple comparisons. Significance level is set at 5% after correction for two-sided test. Data will be Log or rank transformed when appropriate for meeting classical statistical assumptions of the model (normally distributed residuals and homoscedasticity).

[0244] Powering of the study: For a parallel design, sample size is estimated using a two independent means t-test whereas a two dependent means t-test is used for cross-over design. For cross-over design, an assumption of unsignificant sequence effect is taken. Sample size is estimated using an alpha risk of 0.05 and a power ofAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 80%. Alpha risk would be lowered in function of the number of pairwise comparison which will be planned.B. ResultsTransepidermal water loss (TEWL) analysis

[0245] The DECON protocol clearly demonstrated its ability to challenge the epidermis of dogs in this study. A significant increase in TEWL is observed in both groups when comparing pre- and post-DECON protocol values (Figure 2). This TEWL increase is observed when comparing Baseline (week 0) to 6 weeks (immediately post-challenge) as well as 3 weeks vs 6 weeks. In addition, the repeated detergent washing disrupted the epidermal lipid barrier, leading to sustained elevation of TEWL even after washing ceased, which was essential for the study model.

[0246] When comparing TEWL values across the two diets (combining data leg 1 and leg 2), a significant dietary effect on the recovery rate is observed. Figure 3 illustrates this by comparing mean TEWL at 3 weeks, after both groups had been on the diets for a ‘normalisation’ period, with subsequent timepoints following the DECON protocol (6, 6+4, 9 and 12 weeks). When comparing TEWL at 3-week vs 6-week, both the Test group (p=0.026) and the Control group (0.0002) exhibited a significant increase. However, when comparing the 3-week vs 6-week 4day data, no significant difference is observed in the Test group (p=0.065), while the Control group maintained a significant TEWL increase (p=0.0011). At 9 weeks, the Control group still showed a trend toward increased TEWL (3wk v 9wk; p=0.055), while no significant difference is observed for the Test group (3wk v 9wk; p=0.96). At 12 weeks, both groups have returned to pre-challenge TEWL rates. These results suggest a significantly accelerated recovery of the skin barrier in the Test vs the Control group, with barrier restoration occurring as much as 2 weeks faster in those dogs fed the Test formula.

[0247] Further evidence of this accelerated recovery effect is provided by comparing the rates of change in TEWL (ATEWL) from Baseline to subsequent timepoints. The change in TEWL between Baseline and 3 weeks versus Baseline and 6 weeks is not significant for the T est group (p=0.086), but is significant for the Control group (p=0.004), indicating a greater impact of the DECON protocol on the Control group. This is further reinforced when comparing the rates of change between baseline and 3 weeks vs baseline and 6+4 weeks, where a significant difference was found in the Control group (p=0.003), but not in the Test group (p=0.133). While thereAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 is no significant differences between Baseline and 3 weeks versus Baseline and 9 weeks for either group, a strong trend is observed in the Control group (p=0.076), while the Test group showed no change (p=0.944).Natural Moisturising Factor (NMF) Analysis

[0248] The NMF was collected from the epidermis of the dogs during the study using tape strips, and the samples were analysed following extraction from these tape strips. Tape strips were collected from all dogs at 3, 6, 6+4 and 9 weeks. In addition to measuring the total NMF concentration, four individual NMF components — histidine, cis- and trans-UCA, and PCA — were analyzed. For each measurement, concentrations were normalized to the total protein content on the tape strips, as determined by optical density at 340 nm (OD 340nm).

[0249] The results are presented in Figures 4A to 4E.

[0250] Significant reductions in the concentration of NMF and its individual components is observed between 3 weeks (pre-DECON) and 6 weeks (immediately post-DECON), indicating that the DECON protocol effectively removed a substantial portion of the NMF from the superficial epidermis. This depletion coincided with the observed increase in TEWL between these timepoints. Although the concentrations of NMF and its components is slightly higher in the Test group compared to the Control group after the 3-week time point, these differences are not statistically significant. However, it is noteworthy that the biological significance of changes in NMF concentrations and its components remains poorly understood. Therefore, while the observed increases are small, they could still represent a biologically relevant change. As such it cannot be discounted that NMF recovery was promoted sufficiently in the supplemented test group to contribute to the accelerated decline in TEWL observed in the test relative to the control group.Sensory Evaluation of dog coats

[0251] The sensory evaluation panel assessed four parameters: shine, softness, dander / dandruff, and overall coat score.

[0252] Overall coat score is based on uniformity of the coat across the body, considering colour, thickness, length (where appropriate) and shine, using a 1-4 scale (1 = best, 4 = worst), with half-point scores allowed. Four evaluators were involved at each timepoint.Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1

[0253] The outcomes for the coat assessments are presented in Figures 5A-5C.

[0254] Impact of DECON Washing protocol: The DECON washing procedure has a significant positive impact on all four parameters, as observed with TEWL and NMF concentration. Regular cleaning of the dogs' coats and skin led to improvements in softness, shine, dander (both locations), and overall coat score across both test and control groups (comparing 3-week and 6-week timepoints).

[0255] Coat softness: The test group showed overall better coat softness at all timepoints compared to the control group (Figure 5A). Also, at the 12-week timepoint, the softer coat in the test group is significantly softer than in the control group. This suggests the test diet positively influenced coat softness over the 12-week feeding period.

[0256] Shine: Similarly, coat shine improved over the 12 weeks in the test group. At 12 weeks, the test group’s coat shine was significantly better than the control group’s, indicating a positive effect of the test diet (Figure 5B).

[0257] Overall Coat Score: The test group had a better overall coat score at 3 weeks (before the washing protocol), and when all data were combined, the test group showed a consistent improvement in overall coat appearance compared to the control group. This indicates that the test diet benefited the condition of the coat as early as 3 weeks (Figure 5C).

[0258] No Significant Changes in Skin Parameters: There were no significant changes observed in skin pH, skin hydration, or sebum concentration between the test and control groups.C. Conclusions

[0259] The test food composition, containing higher levels of the combination of active nutrients outlined in Table 2, is able to promote recovery of the detergent compromised epidermal barrier of healthy dog’s skin, relative to a standard adult food composition. Specifically, the test food composition accelerates the recovery of transepidermal water loss (TEWL), likely by promoting the restoration of natural moisturizing factor (NMF) concentrations in the epidermis. Additionally, improvements are observed in various aspects of coat quality in dogs that were fed the supplemented diet.* * *Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1

[0260] Although the presently disclosed subject matter and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the disclosure as defined by the appended claims. Moreover, the scope of the present disclosure is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the presently disclosed subject matter, processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein can be utilized according to the presently disclosed subject matter. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.

[0261] For any patents, patent applications, publications, product descriptions, and protocols are cited throughout this disclosure, the disclosures of all of which are incorporated herein by reference in their entireties for all purposes.

Claims

1. Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 CLAIMS1. A canine food composition comprising:- from about 9.1 g / Mcal to about 10.5g / Mcal of linoleic acid;- from about 2.5g / Mcal to about 4g / Mcal of histidine;- from about 1 .0g / Mcal to about 3.0g / Mcal of EPA and / or DHA; and- at least one vitamin selected from vitamin B6, vitamin C or vitamin E.

2. The canine food composition according to claim 1 , wherein the at least one vitamin is selected:- from about 10.Omg / Mcal to about 20.0mg / Mcal of vitamin B6;- from about 50.0mg / Mcal to about lOO.Omg / Mcal of vitamin C; and / or- from about 200.0mg / Mcal to about 250.0mg / Mcal of vitamin E.

3. The canine food composition according to claim 1 or 2, said food composition further comprising from about 0.20g / Mcal to about 1.0g / Mcal of alpha-linolenic acid.

4. The canine food composition according to any one of claims 1 to 3, wherein said composition comprises:- from about 9.1 g / Mcal to about 10.5g / Mcal of linoleic acid;- from about 2.5g / Mcal to about 4g / Mcal of histidine;- from about 1.Og / Mcal to about 3.0g / Mcal of EPA and / or DHA;- from about 10.0mg / Mcal to about 20.0mg / Mcal of vitamin B6, and optionally, from about 50.0mg / Mcal to about 100.0mg / Mcal of vitamin C and / or from about 200.0mg / Mcal to about 250.0mg / Mcal of vitamin E.

5. The canine food composition according to any one of claims 1 to 4, further comprising a source of protein, fat, and fiber, and optionally a source of carbohydrates.

6. The canine food composition according to claim 5, wherein said food composition is a nutritionally complete and balanced food composition or a functional complement.Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 7. The canine food composition according to any one of claims 1 to 6, wherein said food composition consists of a dry food composition, preferentially a kibble.

8. The canine food composition according to any one of claims 1 to 7, said food composition does not comprise inositol.

9. A non-therapeutic use of a canine food composition according to claims 1 to 8, for sustaining or improving a healthy skin condition of a healthy canine, optionally for sustaining or improving coat shine of a healthy canine; for sustaining or improving coat softness of a healthy canine; for sustaining or improving skin barrier of a healthy canine; and / or for reducing the dandruff of a healthy canine.

10. The non-therapeutic use according to claim 9, wherein the combination of linoleic acid, histidine, EPA / DHA, the vitamin(s), and optionally alpha-linoleic acid, are the sole active agents.

11. A canine food composition according to any one of claims 1 to 8, for use as a medicament.

12. The canine food composition for use according to claim 11, wherein the combination of linoleic acid, histidine, EPA / DHA, the at least one vitamin, and optionally alpha-linoleic acid, are the sole active agents.

13. A canine food composition according to any one of claims 1 to 8, for use in a method for treating and / or preventing a disrupted Trans-Epidermal-Water-Loss (TEWL) associated disease or disorder in a canine in need thereof.

14. The canine food composition for use according to claim 13, wherein the combination of linoleic acid, histidine; EPA / DHA; the at least one vitamin, and optionally alpha-linolenic acid, are the sole active agents.

15. The food composition for use according to claim 13 or 14, wherein the said disrupted TEWL associated disease or disorder consists of a skin condition characterized by skin dehydration.Attorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 116. The food composition for use according to any one of claims 13 to 15, wherein said disrupted TEWL associated disease or disorder consists of a skin condition characterized by a compromised skin barrier.

17. The food composition for use according to any one of claims 13 to 16, wherein said disrupted TEWL associated disease or disorder is selected from ichthyosis vulgaris, diaper rash, dry skin, scaly skin, seborrheic dermatitis, atopic dermatitis, eczema, flea allergic dermatitis, bacterial skin infection, fungal skin infection, reactive skin, skin inflammatory conditions, in particular psoriasis, rosacea, perioral dermatitis, perianal dermatitis, alopecia, ringworm and contact dermatitis.

18. Use of linoleic acid, histidine, EPA / DHA and at least one vitamin selected from vitamin B6 (Pyridoxine), vitamin C, and vitamin E, in the manufacture of a medicament for the treatment or prevention of a disrupted T rans-Epidermal-Water-Loss (TEWL) associated disease or disorder in a canine in need thereof, wherein linoleic acid is provided at a level from about 9.1g / Mcal to about 10.5g / Mcal, histidine is provided at a level from about 2.5g / Mcal to about 4.0g / Mcal, and EPA / DHA is provided at a level from about 1.0g / Mcal to about 3.0g / Mcal.

19. The use according to claim 18, wherein the at least one vitamin is selected:- from about 10.Omg / Mcal to about 20.0mg / Mcal of vitamin B6;- from about 50.0mg / Mcal to about 100.0mg / Mcal of vitamin C; and / or- from about 200.0mg / Mcal to about 250.0mg / Mcal of vitamin E.

20. A method of manufacturing a canine food composition according to claims 1 to 8, comprising at least the steps of:(a) mixing at least linoleic acid, histidine, EPA / DHA and at least one vitamin selected from vitamin B6 (Pyridoxine), vitamin C, and vitamin E, and optionally alphalinoleic acid, thereby obtaining a mixture,(b) heating the mixture, thereby obtaining a food composition.

21. The manufacturing method according to claim 20, wherein the mixture in step (a) further comprises ingredients suitable to provide a nutritionally complete andAttorney Docket No.: 00307-0217-00304Mars Ref.: MARS / P / 393358 / WO / SEC / 1 balanced canine food composition, optionally including at least a source of proteins, fibers, carbohydrates, vitamins, and minerals in amounts suitable to meet the nutritional requirements of canines.

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