Dry food composition for treating chronic constipation in feline

Abstract

The present disclosure relates to a dry food composition for use in a method for treating chronic constipation in a feline in need thereof, wherein the said dry food composition includes: - from about 50g / Mcal to about 100g / Mcal of protein; - from about 25g / Mcal to about 55g / Mcal of fat; - from about 10g / Mcal to about 25g / Mcal of Ash; and - from about 15g / Mcal to about 35g / Mcal of Total Dietary Fibers (TDF), wherein the dry food composition comprises, on a dry matter basis, from about 5% to about 12% by weight of psyllium.

Description

Attorney Docket No. : 00307-0208-00304Mars Ref.: MARS / P / 393385 / WO / SEC / 1DRY FOOD COMPOSITION FOR TREATING CHRONIC CONSTIPATION IN FELINECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority to European Application No. EP 24209586.7, filed on October 29, 2024, the entirety of which is incorporated herein by reference.FIELD OF THE DISCLOSURE

[0002] The present disclosure relates to the field of food composition. Specifically, the present disclosure relates to dry food compositions for feline for treating chronic constipation.BACKGROUND OF THE DISCLOSURE

[0003] Constipation is usually defined as infrequent or difficult emission of hard, dry feaces and is a common clinical complaint in felines. The clinical signs can result from a number of different disorders including dietary (e.g., ingestion of indigestible material), environmental disturbances (e.g., hospitalisation, change in routine, inactivity), colonic obstruction (e.g., strictures, neoplasia, foreign body, pelvic trauma), electrolyte imbalances (e.g., dehydration, chronic kidney disease, hypokalaemia), iatrogenic (e.g., drug therapy) and neuromuscular disease (e.g., spinal cord disease, idiopathic megacolon). Nevertheless, it comes sometimes that chronic constipation occurs without an identifiable underlying cause. This type of constipation is referred to as idiopathic chronic constipation. Treatment of constipation involves identifying and eliminating the cause, if possible, together with medical or, in some cases, surgical management.

[0004] Dietary modification is preferentially recommended for the management of feline constipation, and recommendations generally involve the incorporation of dietary fiber, either insoluble, soluble or a mix thereof.

[0005] Among the existing soluble fiber, it can be cited psyllium. Psyllium can exhibit a low fermentability and have a husk containing both polysaccharide and nonpolysaccharide components that, once ingested, release a hydrophilic mucilaginous gel thereby increasing the bulk of the feces of the subject. In humans, preparations containing psyllium can increase the frequency and consistency of feces in humans suffering of idiopathic constipation.Attorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 1

[0006] Given the suggested benefits in humans, addition of insoluble and soluble dietary fiber, such as psyllium, has been recommended in the management of feline constipation.

[0007] However, while it has been demonstrated that dry food compositions comprising psyllium can provide a benefit for the management of constipation during less than one month in healthy cats (Keller E, Laxalde J, Tranier N, Belmar von Kretschmann P, Jackson A, van Hoek I. Psyllium husk powder increases defecation frequency and faecal score, bulk and moisture in healthy cats. J Feline Med Surg. 2024 Apr;26(4): 1098612X241234151. doi: 10.1177 / 1098612X241234151. PMID: 38635357; PMCID: PMC11103317), it has not been yet reported the use of psyllium for treating felines suffering from chronic constipation, specifically during a long treatment period. Keller et al. (2024) indicate that in human patients, those whose constipation is associated with slow transit or dyssynergia defecation are less likely to respond to an increase in dietary fiber compared to patients without pathological findings. This suggests that depending on the cause of constipation, psyllium may not be as effective.

[0008] US 2021 / 307363 discloses pet food compositions that includes a low amount of psyllium or a derivative thereof. It also discloses methods for treating, preventing or inhibiting diarrhea / constipation, improving stool characteristics, and / or improving stooling behavior. However, the food composition is not suitable to specifically treat chronic constipation.

[0009] Therefore, there is a need for developing a novel solution for treating chronic constipation in felines in need thereof.

[0010] There is therefore a need for developing a novel dry food composition for treating chronic constipation in felines in need thereof while still maintaining a suitable palatability and accepted by the feline.

[0011] The present disclosure has for purpose to satisfy all or part of the above- mentioned needs.SUMMARY

[0012] A first aspect of the present disclosure relates to a dry food composition for use in a method for treating chronic constipation in a feline in need thereof, wherein the said dry food composition includes:- from about 50g / Mcal to about 100g / Mcal of protein;- from about 25g / Mcal to about 55g / Mcal of fat;Attorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 1- from about 10g / Mcal to about 25g / Mcal of ash; and- from about 15g / Mcal to about 35g / Mcal of Total Dietary Fibers (TDF), wherein the dry food composition comprises, on a dry matter basis, from about 5% to about 12% by weight of psyllium.

[0013] An other aspect of the present disclosure relates to methods for treating chronic constipation in a feline in need thereof, including at least a step of administering to the feline a dry food composition comprising:- from about 50g / Mcal to about 100g / Mcal of protein;- from about 25g / Mcal to about 55g / Mcal of fat;- from about 10g / Mcal to about 25g / Mcal of Ash; and- from about 15g / Mcal to about 35g / Mcal of Total Dietary Fibers (TDF), wherein the dry food composition comprises, on a dry matter basis, from about 5% to about 12% by weight of psyllium.

[0014] In some embodiments, the dry food composition as described herein can comprise, on a dry matter basis, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11 % or about 12% by weight of psyllium.

[0015] In some embodiments, the dry food composition as described herein can include, on a dry matter basis, at least about 6% by weight of psyllium.

[0016] In some embodiments, the chronic constipation in a feline can consist of a constipation episode lasting at least 24 hours for at least two times in a week within a period of at least six consecutive months (in a row).

[0017] In some embodiments, a constipation episode can be characterized by less than one bowel movement per day, optionally involving hard or dry stools, difficulty or / and pain during defecation, vomiting and / or tenesmus of the feline.

[0018] In some embodiments, the chronic constipation consists of a chronic idiopathic constipation.

[0019] In some embodiments, the feline can be treated for a period of 2 months or more, 3 months or more, 4 months or more, 5 months or more, 6 months or more, 7 months or more, 8 months or more, 9 months or more, 10 months or more, 11 months or more, or 12 month or more.

[0020] In some embodiments, the feline can be treated for a period of 6 months or more.Attorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 1

[0021] In some embodiments, the dry food composition as described herein can have a Metabolizable Energy (ME) of about 3,900 kcal / kg, as measured according to the NRC 2006.

[0022] In some embodiments, the dry food composition as described herein wherein the weight ratio of total soluble fiber to total insoluble fiber can be from about 1.2:1 to about 1.5:1.

[0023] In some embodiments, the dry food composition as described herein does not include fiber sources comprising about 80% or more by weight of insoluble fibers based on the total fiber content of the fiber source.

[0024] In some embodiments, the dry food composition as described herein does not include pure cellulose.

[0025] In some embodiments, the dry food composition as described herein does not include pure hemicellulose, and / or pure lignin.

[0026] In some embodiments, a source of fiber can be selected from beet pulp, guar gum, chicory pulp, psyllium, pectin, blueberry, cranberry, squash, apples, oats, beans, citrus, barley, peas, inulin, com, rice, fructo-oligo-saccharides, mannooligosaccharides and / or combinations thereof.

[0027] In some embodiments, the dry food composition can be nutritionally complete and balanced.

[0028] In some embodiments, the dry food composition can be a kibble.

[0029] In some embodiments, the feline can be a cat.

[0030] According to a further aspect, the present disclosure relates to a method for treating chronic constipation in a feline in need thereof comprising a step of administering a dry food composition as described herein to the feline.BRIEF DESCRIPTION OF THE FIGURES

[0031] Figure 1 is a table presenting the observed parameters for determining the constipation score in felines. The feline’s owner must assign a score between 0 and 3 for each behavioral / physical parameters regarding the feline, which includes: Attitude / activity (overall attitude of the feline at home), Appetite, vomiting, stool consistency, stool frequency, and difficulty and / or pain during defecation. The scores for each parameter are summed to calculate a constipation score. A constipation score of 5 or higher indicates that the feline is constipated, while a constipation score below 5 indicates that the feline is not constipated. Optional features can be considered to refine the total score, such as the state of the mucous membranes and skin elasticityAttorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 1 assessed by the veterinarian, as well as the feline's water consumption reported by the owner.DETAILED DESCRIPTION

[0032] A dry food composition has been developed to be used to treat chronic constipation in felines. The dry food composition of the disclosure includes ingredients that are advantageously formulated to maintain the organoleptic properties of the dry food composition while having been enriched in psyllium.

[0033] The present disclosure provides a dry food composition that addresses chronic constipation in felines by promoting regular bowel movements and reducing the formation of hard, dry stools. The balanced nutritional profile and specific fiber content work together to maintain optimal digestive health, offering a practical solution for pet owners and veterinarians.

[0034] It is demonstrated in the examples that this fiber content with a high amount of psyllium is crucial for promoting regular bowel movements and preventing the formation of hard, dry stools in felines over a long period of 6 months, thus treating chronic constipation.Definitions

[0035] 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. Certain terms are discussed below, or elsewhere in the specification, to provide additional guidance in describing the compositions and methods of the disclosure and how to make and use them.

[0036] Exemplary methods and materials are described below, although methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present disclosure. Further, unless otherwise required by context, singular terms shall include pluralities, and plural terms shall include the singular.

[0037] Units, prefixes, and symbols are denoted in their International System of Units (SI) accepted form. Numeric ranges are inclusive of the numbers defining the range. The headings provided herein are not limitations of the various aspects of the disclosure. Accordingly, the terms defined immediately below are more fully defined by reference to the specification in its entirety.Attorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 1

[0038] All publications and other references mentioned herein are incorporated by reference in their entirety.

[0039] 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 a mixture of at least two compounds.

[0040] 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. In general, the term “about” can modify a numerical value above and below the stated value by a variance of, for instance, 10 percent, up or down (higher or lower). In some embodiments, the term indicates deviation from the indicated numerical value by ±10%.

[0041] As used herein, the terms “comprise”, “comprising”, “include”, “including” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a food composition, a process or a method that comprises a list of elements or ingredients which does not include only those elements or ingredients but can include other elements or ingredients not expressly listed or inherent to such food composition, process or method. The term “consisting of’ implies the inclusion of the stated element(s), to the exclusion of any additional elements. 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 “comprising” or equivalent cover the embodiments where this term is replaced with “consisting of’ or “consisting essentially of”.

[0042] In the detailed description herein, references to “embodiment,” “an embodiment,” “one embodiment,” “in some embodiments,” or any other variation thereof, indicate that the described embodiment(s) can include a particular feature, ingredient, structure, or characteristic, but every embodiment might not necessarily include the particular feature, ingredient, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, ingredient, 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, ingredient, structure, or characteristic in connection withAttorney Docket No. : 00307-0208-00304Mars Ref.: MARS / P / 393385 / WO / SEC / 1 other embodiments whether or not explicitly described. After reading the description, it will be apparent to one skilled in the relevant art(s) how to implement the disclosure in alternative embodiments.

[0043] As used herein, the term “feline” refers to any animal of the taxonomic family Felidae, characterized by shared physical traits including a compact body, retractable claws, sharp carnivorous teeth, keen senses (particularly vision and hearing), and a flexible muscular structure that enables agility and swift movements. Felines can encompass a diverse range of species, such as cats, like wild cats and domestic cats, lions, tigers, leopards, jaguars, and other big wild cats. In some embodiments, a feline can be a cat, in particular a domestic cat.

[0044] As used herein, the term “food composition”, or “diet” covers all of foodstuff; diet; food; or a material containing at least proteins, carbohydrates and / or fats; which is used in the body of an organism to sustain growth, repair and vital processes; and / or to furnish energy for a feline. A food composition as described herein can also contain supplementary substances or additives, for example, minerals, vitamins, and condiments (See Merriam -Webster’s Collegiate Dictionary, 10thEdition, 1993). A food composition according to the present disclosure can consist of a nutritionally complete and balanced food composition.

[0045] As used herein, “nutritionally complete and balanced” or “complete and balanced” in the context of a food composition means that the food composition includes all the essential nutrients in appropriate proportions to meet a feline’s dietary requirements for maintaining overall health and well-being. A nutritionally complete and balanced food composition can maintain the body weight of the cat without significant change with the Body Condition Score (BCS). A nutritionally complete and balanced cat food composition ensures that the cat receives all the necessary nutrients for optimal health, minimizing the risk of nutritional deficiencies or imbalances that could lead to health issues over time. Specifically, a nutritionally complete and balanced food composition contains all known required nutrients for the intended recipient of the food composition, in all appropriate amounts and proportions based, for example, on recommendations of recognized and competent authorities in the field of animal 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 food composition is a feed with which a feline can be fed as the sole ration and is capable of sustaining life withoutAttorney Docket No. : 00307-0208-00304Mars Ref.: MARS / P / 393385 / WO / SEC / 1 additional food (except water). Illustratively, a nutritionally complete and balanced food composition as described herein can include, but is not limited to, protein, crude fat, ash, crude fiber, starch, calcium, phosphorus, sodium, chloride, potassium, magnesium, iron, water, copper, manganese, zinc, selenium, vitamin A, vitamin D3, vitamin B1 , vitamin B2, vitamin B6, vitamin B12, vitamin B7, vitamin B9, cholin chloride, arachidonic acid, W3 fatty acid and W6 fatty acid.

[0046] As used herein, “ash” refers to any inorganic material present in food. Ash can include minerals, such as calcium, phosphorus, sodium, chloride, potassium, magnesium, or combinations thereof. Ash can also include Sodium Tripolyphosphate (STPP) and / or an equivalent ingredient. The ash content, if specified as a result of an analytical measure of a food composition which 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).

[0047] As used herein, the term “dry,” for a dry food composition, refers to a food composition having a moisture content of about 12% by weight or less, such as a moisture content ranging from about 5% to about 12% by weight, relative to the total weight of the food composition. Dry food compositions can be formed by an extrusion process. A dry food composition is formed of a core and most of the time a coating layer. A dry food composition can be a kibble.

[0048] 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 chronic constipation, the symptoms of chronic constipation, or the likelihood of chronic constipation. More particularly, “treating” or “treatment” encompasses any approach for obtaining beneficial or desired results in a feline afflicted with chronic constipation. 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 chronic constipation; diminishment or reduction of the severity of a chronic constipation or symptoms related to the chronic constipation; maintaining the stability (preventing deterioration) of a chronic constipation; delaying the progression or slowing down the progression of a chronic constipation; minimizing the recurrence of a chronic constipation; and remission, whether partial or total and whether detectable or undetectable. For example, the treatment of chronic constipation in aAttorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 1 feline can mean treating at least one criteria usually used to define constipation for a pet: (i) straining to defecate; (ii) dry / hard stool consistency (score of 2 or less on a 5- point scale based on the constipation score); iii) improve the frequency the bowel movement by more than one, or twice, or three times over 24 hours for at least two times in a week.

[0049] As used herein, the term “constipation” refers to a condition which can occur when the passage of the stools is difficult through the large intestine and the bowel movements are infrequent, typically less than once a day, and, eventually, difficult and painful for the feline. Constipation is chronic when the constipation lasting at least 24 hours for at least two times in a week within a period of at least six consecutive months. Constipation can be seen as a primary gastrointestinal disease (such as intestinal dysmotility), or as a secondary symptom of a different primary underlying disease. Constipation can also be idiopathic. Idiopathic means that constipation does not have an identifiable medical cause.

[0050] As used herein, the terms “palatability” or “palatable” refer to being desirable to the palate or taste. Further, the terms “palatability” or “palatable” as used herein means a relative preference of a feline for one food composition compared to another food composition which are proposed to the feline at the same time. It can advantageously be determined by a standard testing protocol in which the feline has equal access to both food compositions such as a test called "two-bowl test" or "versus test".

[0051] As used herein the term “providing” includes selling, supplying, administering, or feeding a feline.

[0052] 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. The specified amount of ingredients or components comprised in a food composition as described herein consists of the amount of ingredients or components that is contained in the total amount of the raw materials which are provided for producing the said food composition.

[0053] The expression “dry matter (DM) basis” must be interpreted as a method of expressing the concentration of a nutrient or a component / ingredient in a food composition by expressing its concentration relative to its dry matter content (the concentration remaining once the moisture has been taken out). On the other hand,Attorney Docket No. : 00307-0208-00304Mars Ref.: MARS / P / 393385 / WO / SEC / 1 the expression “as fed” must be interpreted as a method of expressing the concentration of a nutrient or a component / ingredient in a food composition by expressing its concentration in the state it is fed, which includes moisture. It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate embodiments, can also be provided in combination in a single embodiment. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single embodiment, can also be provided separately or in any suitable sub-combination.

[0054] It should be understood that every maximum numerical limitation given throughout this specification includes every lower numerical limitation, as if such lower numerical limitations were expressly written herein. Every minimum numerical limitation given throughout this specification will include every higher numerical limitation, as if such higher numerical limitations were expressly written herein. Every numerical range given throughout this specification will include every narrower numerical range that falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[0055] All lists of items, such as, for example, lists of ingredients, are intended to and should be interpreted as Markush groups. Thus, all lists can be read and interpreted as items “selected from the group consisting of’ the list of items “and combinations and mixtures thereof.”Units

[0056] As used herein, an amount of a nutrient or ingredient as expressed as grams per megacalorie (g / Mcal) consists of the weight amount of the said component by unit of Metabolizable Energy (ME) of the total dry food composition.

[0057] 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.

[0058] Illustratively, the ME value can be measured using a feeding trial. In practice, the gross energy (GE) of the food composition is determined in the laboratory, and the amounts of food eaten by the animals are recorded. The feces and urine from the animals are collected, and the energy in each is determined and called fecal energy (FE) and urinary energy (UE), respectively. The ME is then calculated as:Attorney Docket No. : 00307-0208-00304Mars Ref.: MARS / P / 393385 / WO / SEC / 1ME (kcal / kg) = [GE - (FE + UE)] / Kg of food consumed.

[0059] Alternatively, the ME value can be measured by standard mathematical methods, taking into account, depending on the method, the percentage of crude fat (CF), of crude protein (CP), of NFE (carbohydrates) and / or of Total Dietary Fibers (TDF) in the food composition. In practice each percentage is multiplied by its respective Atwater Factors. The resulting sum is then multiplied by 10. The mathematical method can be represented by the following formula:ME (kcal / kg) = 10 x [(3.5 x CP) + (8.5 x CF) + (3.5 x NFE)].

[0060] In some embodiments, the ME can be determined according to the predictive equation proposed by the National Research Council (NRC) in 2006.

[0061] In an embodiment of the disclosure, especially for feline, the ME, in kcal / 100g, can be calculated as:ME = GE x [95.6 - (0.89 x TDF x 100 / DM)] / 100) - (0.77 x CP) orME = GE x [87.9 - (0.88 x CF x 100 / DM)] / 100) - (0.77 x CP) with GE = (5.7 x CP) + (9.4 x CF) + [4.1 x (NFE + CF)]

[0062] 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.

[0063] In some embodiments, a food composition as described herein can be a dry food composition, typically having a moisture content ranging from about 5% to about 12% by weight.

[0064] In some embodiments, a dry food composition as described herein can have a Metabolizable Energy (ME) ranging from about 3,500 kcal / kg to 4,500 kcal / kg, or from about 3,600 kcal / kg to about 4,400 kcal / kg, or from about 3,700 kcal / kg to about 4,300 kcal / kg or from about 3,800 kcal / kg to about 4,200 kcal / kg, as measured according to the NRC 2006.

[0065] In some embodiments, a dry food composition as disclosed herein can have a Metabolizable Energy (ME) of about 3,700 kcal / kg, or about 3,750 kcal / kg, or about 3,800 kcal / kg, or about 3,850 kcal / kg, or about 3,900 kcal / kg, or about 3,950 kcal / kg, or about 4,000 kcal / kg, or about 4,050 kcal / kg, or about 4, 100 kcal / kg, or about 4,150 kcal / kg, or about 4,200 kcal / kg, or about 4,250 kcal / kg, or about 4,300 kcal / kg, as measured according to the NRC 2006.Attorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 1

[0066] As illustrated in the present disclosure, a dry food composition as disclosed herein can have a Metabolizable Energy (ME) of about 3,900 kcal / kg, as measured according to the NRC 2006.

[0067] 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.

[0068] 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.Dry food compositions

[0069] The present disclosure relates to a dry food composition for use in a method for treating chronic constipation in a feline in need thereof.

[0070] The dry 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.

[0071] The dry food composition as described herein is formulated to treat chronic constipation in felines by providing a balanced nutritional profile.

[0072] The dry food composition as described herein includes:- from about 50g / Mcal to about 100g / Mcal of protein;- from about 25g / Mcal to about 55g / Mcal of fat;- from about 10g / Mcal to about 25g / Mcal of Ash; and- from about 15g / Mcal to about 35g / Mcal of Total Dietary Fibers (TDF), wherein the dry food composition includes, on a dry matter basis, from about 5% to about 12% by weight of psyllium.

[0073] In some embodiments, the dry food composition can be nutritionally complete and balanced.

[0074] In some embodiments, the dry food composition can have a moisture content of about 5% to about 12% by weight.

[0075] In some embodiments, the dry food composition can have a moisture content of about 5%, or about 5.5%, or about 6%, or about 6.5% or about 7%, or aboutAttorney Docket No. : 00307-0208-00304Mars Ref.: MARS / P / 393385 / WO / SEC / 17.5%, or about 8%, or about 8.5%, or about 9%, or about 9.5%, or about 10%, or about10.5%, or about 11 %, or about 11.5%, or about 12% by weight.

[0076] For example, and not by the way of limitation, the examples provided herein illustrate a dry food composition having a moisture content of about 5.5% by weight.

[0077] The moisture content of a food composition can be determined by a Loss on Drying Method.

[0078] For instance, a Loss on Drying Method can include the steps of:(a) Weighing a sample of a food composition;(b) Heating, such as 135 ± 2 °C for 240 minutes, the sample of step a) in an oven until the moisture is all driven off;(c) Weighing the dry sample obtained at step (b);(d) Calculating the difference between the total weight obtained at step (a) and the dry weight obtained at step (c), thereby obtaining the moisture weight, such as: Moisture weight = (total weight) - (dry weight).

[0079] In some embodiments, the dry food composition can consist of a kibble.

[0080] In some embodiments, a feline can encompass a cheetah, a puma, a jaguar, a leopard, a lion, a lynx, a liger, a tiger, a panther, a bobcat, an ocelot, a smilodon, a caracal, a serval, and / or a cat. In some embodiments, a feline can be a cat. A cat can encompass a wild cat and a domestic cat.

[0081] A specificity of the dry food composition of the disclosure is its high amount of psyllium, as a source of Total Dietary Fibers (TDF), combined with an adapted content of protein, fat, carbohydrates, vitamins, minerals, and food additives.

[0082] In general, a dry food composition as disclosed herein includes protein, fat, fiber, and optionally one or more further ingredients such as carbohydrates, starches, additives, vitamins, and / or minerals. The sum of the weight of each of the constituents comprised therein amounting, on a dry matter basis, to 100% by weight.Total Dietary Fibers (TDF)

[0083] The dry food composition as described herein includes a source of fibers.

[0084] The dry food composition as described herein is a highly digestible diet formulated to minimize residue and thereby reduce fecal output of a feline. The dry food composition as described herein is not high in total fiber to maintain optimal digestibility of the food composition.Attorney Docket No. : 00307-0208-00304Mars Ref.: MARS / P / 393385 / WO / SEC / 1

[0085] As used herein, the term “fiber," or “dietary fiber," or “total dietary fiber" or “TDF" (for “Total Dietary Fibers"), designates both soluble fibers and insoluble fibers.

[0086] Soluble fibers can be defined as dietary fibers that are resistant to digestion and absorption in the small intestine but are fermentable in the large intestine. They can be partially or completely fermented by gut bacteria, producing short-chain fatty acids (SCFAs) that serve as an energy source for colonocytes. Soluble fibers are considered to have a prebiotic effect, promoting the growth of beneficial gut bacteria. In contrast, insoluble fibers are non-starch polysaccharides that are also resistant to digestion and absorption in the small intestine; however, they are generally resistant to fermentation in the large intestine. Insoluble fibers aid in promoting bowel regularity and overall digestive health.

[0087] In some embodiments, a source of fiber can be selected from beet pulp, guar gum, chicory pulp, psyllium, pectin, blueberry, cranberry, squash, apples, oats, beans, citrus, barley, peas, inulin, corn, rice, fructo-oligo-saccharides (FOS), mannooligosaccharides (MOS) and / or a combination thereof.

[0088] In some embodiments, a source of fiber can be psyllium (psyllium husks and seeds), beet pulp, chicory pulp, FOS, and / or MOS.

[0089] In some embodiments, the dry food composition as described herein can include from about 15g / Mcal to about 35g / Mcal of fiber.

[0090] In some embodiments, the dry food composition as described herein can include about 15g / Mcal, or about 15.5 g / Mcal, or about 16 g / Mcal, or about 16.5 g / Mcal, or about 17 g / Mcal, or about 17.5 g / Mcal, or about 18 g / Mcal, or about 18.5 g / Mcal, or about 19 g / Mcal, or about 19.5 g / Mcal, or about 20 g / Mcal, or about 20.5 g / Mcal, or about 21 g / Mcal, or about 21 .5 g / Mcal, or about 22 g / Mcal, or about 22.5 g / Mcal, or about 23 g / Mcal, or about 23.5 g / Mcal, or about 24 g / Mcal, or about 24.5 g / Mcal, or about 25 g / Mcal, or about 25.5 g / Mcal, or about 26 g / Mcal, or about 26.5 g / Mcal, or about 27 g / Mcal, or about 27.5 g / Mcal, or about 28 g / Mcal, or about 28.5 g / Mcal, or about 29 g / Mcal, or about 29.5 g / Mcal, or about 30 g / Mcal, or about 30.5 g / Mcal, or about 31 g / Mcal, or about 31 .5 g / Mcal, or about 32 g / Mcal, or about 32.5 g / Mcal, or about 33 g / Mcal, or about 33.5 g / Mcal, or about 34 g / Mcal, or about 34.5 g / Mcal, or about 35g / Mcal of fiber.

[0091] In some embodiments, the dry food composition as described herein can include from about 27g / Mcal to about 32g / Mcal of fiber.Attorney Docket No. : 00307-0208-00304Mars Ref.: MARS / P / 393385 / WO / SEC / 1

[0092] The dry food composition as described herein is high in soluble fibers.

[0093] In some embodiments, at least about 75% by weight of the total amount of TDF consists of soluble fibers. In some embodiments, at least about 75%, about 76%, about 77%, about 78%, about 79%, about 80%, about 81 %, about 82%, about 83%, about 84%, about 85%, about 86%, about 87%, about 88%, about 89% or about 90% by weight of the total amount of TDF can consist of soluble fibers, on a dry matter basis.

[0094] In some embodiments, at least about 75% by weight of the total amount of TDF comes from two distinct fiber sources wherein one of these two fiber sources is psyllium. Generally, the other fiber source is characterized by comprising about 20% by weight or less of insoluble fibers based on the total fiber content of the fiber source.

[0095] The remaining 25% by weight or less of the total amount of TDF of the dry food composition is provided from components wherein the content of fibers does not exceed 20% by weight based on the total weight of the component.

[0096] In some embodiments, the total amount of TDF comes from two distinct fiber sources wherein one of these two fiber sources is psyllium, and the other fiber source can be beet pulp, guar gum, chicory pulp, pectin, blueberry, cranberry, squash, apples, oats, beans, citrus, barley, peas, inulin, com, rice, fructo-oligo-saccharides, manno-oligosaccharides and / or a combination thereof.

[0097] In some embodiments, at least 50%, preferably at least 60% and more preferably at least 70% by weight, of said two distinct fiber sources comes from psyllium.

[0098] The dry food composition as described herein is supplemented with high levels of psyllium to provide a specific effect in the colon of the feline.

[0099] Psyllium is a small seed surrounded by a husk produced by plants of the genus Plantago, principally Plantago ovata and Plantago afra. Psyllium comprises a blend of soluble and insoluble fibers. Generally, psyllium predominantly comprises soluble fiber, accounting for about 70% to about 80% of the total fiber content and of about 20% to about 30% of insoluble fiber on the total fiber content. The soluble fiber part comprises a significant part of mucilage, and hemicellulose. The insoluble fiber comprises cellulose and lignin. Psyllium also contains a small amount (less than 10% by weight of the total content) of proteins, lipids, carbohydrates, and minerals.

[0100] In some embodiments, psyllium can include psyllium seeds, psyllium husks and / or psyllium seeds and husks.Attorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 1

[0101] In some embodiments, psyllium can consist of psyllium husks and seeds.

[0102] In some embodiments, the dry food composition can include, on a dry matter basis, from about 5% to about 12% by weight of psyllium.

[0103] In some embodiments, the dry food composition can include, on a dry matter basis, about 5%, or about 5.5%, or about 6%, or about 6.5%, or about 7%, or about 7.5%, or about 8%, or about 8.5%, or about 9%, or about 9.5%, or about 10%, or about 10.5%, or about 11 %, or about 11.5%, or about 12% by weight of psyllium.

[0104] In some embodiments, the dry food composition can include, on a dry matter basis, about 6% by weight of psyllium.

[0105] The present disclosure demonstrates that a relatively high amount of at least about 6% by weight of psyllium, on a dry matter basis, optionally in combination with another soluble fiber source, can result in an increased fecal moisture, which represents a real benefit and advantage to promote resolution of the chronic constipation.

[0106] In some embodiments, the dry food composition as described herein does not include fiber sources comprising about 70% or more, or preferably about 80% or more, by weight of insoluble fibers based on the total fiber content of the fiber source.

[0107] In some embodiments, the dry food composition as described herein can include, from about 3 g / Mcal to 10 g / Mcal, or about 3.5 g / Mcal to 10 g / Mcal, or about 3.5 g / Mcal to 9.5 g / Mcal, or about 4 g / Mcal to 9 g / Mcal, or about 4.5 g / Mcal to 8.5 g / Mcal, or about 5 g / Mcal to 8.5 g / Mcal of crude fiber.

[0108] Crude fibers can refer to the insoluble fraction of plant-based materials that primarily consist of cellulose, hemicellulose, and lignin. Crude fibers are a portion of a composition that remains after the digestion of the composition with dilute acid and dilute alkali. Crude fiber consists essentially of insoluble fibers.

[0109] In some embodiments, the dry food composition as described herein can include about 3 g / Mcal, or about 3.5 g / Mcal, or about 4 g / Mcal, or about 4.5 g / Mcal, or about 5 g / Mcal, or about 5.5 g / Mcal, or about 6 g / Mcal, or about 6.5 g / Mcal, or about 7 g / Mcal, or about 7.5 g / Mcal, or about 8 g / Mcal, or about 8.5 g / Mcal, or about 9 g / Mcal, or about 9.5 g / Mcal or about 10 g / Mcal of crude fiber.

[0110] In some embodiments, the dry food composition as described herein does not include pure cellulose. Insoluble fibers, like cellulose, are commonly used in dietary approaches to alleviate constipation due to their ability to add bulk to the stoolAttorney Docket No. : 00307-0208-00304Mars Ref.: MARS / P / 393385 / WO / SEC / 1 and promote regular bowel movements. However, there are some inconveniences and potential drawbacks associated with their consumption, such as gastrointestinal discomfort and poor tolerance by the feline. Thus, to avoid potential inconveniences and ensure overall digestive health, the dry food composition of the present disclosure demonstrates that a diet with no added pure cellulose by with very high psyllium quantity allow to treat chronic constipation and help lubricate stools thank to mucilage from psyllium. However, the composition may include traces of insoluble fiber, such as cellulose, which is naturally found in small amounts in all fiber sources. While psyllium can contain some cellulose, the amount of insoluble fiber is not greater than that of soluble fiber in the dry food composition as described herein. Typically, the dry food composition as described herein can include no more than about 10 g / Mcal of insoluble fiber.

[0111] In some embodiments, the dry food composition as described herein does not include pure hemicellulose, and / or pure lignin.

[0112] In some embodiments, the dry food composition as described herein does not include pure cellulose, pure hemicellulose, and pure lignin.

[0113] In some embodiments, the weight ratio of the total soluble fiber to the total insoluble fiber can be from about 1 .2:1 to about 1 .5:1 . In some embodiments, the weight ratio of the total soluble fiber to the total insoluble fiber can be from about 1 .3: 1 to about 1.5:1. In some embodiments, the weight ratio of the total soluble fiber to the total insoluble fiber can be from about 1 .4:1 to about 1 .5:1 .Other ingredients

[0114] A dry food composition of the present disclosure can further include other ingredients / components which may contribute to the nutritional properties and / or the organoleptic properties of the dry food composition.

[0115] In some embodiments, the dry food composition as described herein can include an amount of protein.

[0116] Accordingly, the protein level shall be high enough to ensure maintenance of lean body mass while maintaining the right texture and palatability of a dry food composition for the feline.

[0117] In some embodiments, a dry food composition can include from about 50g / Mcal to about 100g / Mcal, or about 60g / Mcal to about 100g / Mcal, or aboutAttorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 170g / Mcal to about 10Og / Mcal, or about 70g / Mcal to about 95g / Mcal, or about 75g / Mcal to about 90g / Mcal of protein.

[0118] In some embodiments, a dry food composition can include about 50 g / Mcal, or about 52 g / Mcal, or about 55 g / Mcal, or about 57 g / Mcal, or about 60 g / Mcal, or about 62 g / Mcal, or about 65 g / Mcal, or about 67 g / Mcal, or about 70 g / Mcal, or about 72 g / Mcal, or about 75 g / Mcal, or about 77 g / Mcal, or about 80 g / Mcal, or about 82 g / Mcal, or about 85 g / Mcal, or about 87 g / Mcal, or about 90 g / Mcal, or about 92 g / Mcal, or about 95 g / Mcal, or about 97 g / Mcal, or about 100 g / Mcal of protein.

[0119] In some embodiments, the dry food composition can include a plurality of proteins that are contained in a protein source which is used in the manufacture process of the dry food composition.

[0120] In some embodiments, the proteins can be non-hydrolyzed and / or hydrolyzed.

[0121] Hydrolyzed protein can be at least partially hydrolyzed, or even wholly (or fully) hydrolyzed to give a hydrolyzed protein having a molecular weight of about 100 dalton to about 50,000 dalton (Da).

[0122] In some embodiments, the wholly hydrolysed proteins can contain free amino acids and peptides. In some embodiments, the wholly hydrolyzed proteins can include at least about 95% of hydrolyzed proteins, by weight, based on the total weight of proteins. In some embodiments, the wholly hydrolyzed proteins can include at least about 95%, 96%, 97%, 98%, 99% or 100% of hydrolyzed proteins, by weight, based on the total weight of proteins, and have a molecular weight of about 11 ,000 dalton or less. In some embodiments, the wholly hydrolysed proteins can have a molecular weight ranging from about 100 Da to about 11 ,000 Da. In some embodiments, the wholly hydrolysed proteins can have a molecular weight ranging from about 100 Da to about 5,000 Da or from about 100 Da to about 1 ,000 Da.

[0123] A component / ingredient that can provide a protein source to the dry food composition can originate from an animal source and / or a vegetal source. In some embodiments, a protein source can be a mixture of one or more animal protein source.

[0124] In some embodiments, a protein source can be a mixture of at least one or more animal protein source and at least one or more vegetable protein source.

[0125] A source of protein in a non-transformed form can also provide to the dry food composition a source of water, a source of fat, a source of minerals, a source ofAttorney Docket No. : 00307-0208-00304Mars Ref.: MARS / P / 393385 / WO / SEC / 1 fibers, and / or a source of vitamins. The nutritional composition of the source of protein depends on the quality and the specificity of the source of protein. For instance, an animal source of protein can also provide an amount of fat. A vegetable source of protein can also provide an amount of fiber.

[0126] An animal source can be selected, without limitation, from chicken meals, chicken, chicken by-product, lamb, lamb meals, pork, turkey, turkey meals, beef, beef by-products, white fish, venison, or a combination thereof.

[0127] A vegetable source can be selected, without limitation, from soybean meal, soy protein isolate, soy protein concentrate, maize gluten, milk proteins, gluten, tofu, green lentils, carrot, potato, beets, com gluten meal, com protein concentrate or a combination thereof.

[0128] The protein content of a dry food composition can be determined by any methods known by those of skill in the art.

[0129] In some embodiments, the dry food composition as described herein includes fat.

[0130] Accordingly, the fat level shall be enough to ensure maintenance of lean body mass while maintaining the right texture and palatability of the dry food composition for the feline.

[0131] The expression “fat” or “crude fat” as used herein can include any food- acceptable crude fat(s) and / or oil(s) irrespective of their consistency at room temperature.

[0132] The fat in a dry food composition as described herein can encompass the total amount of digestible, partially digestible, and nondigestible fats or oils that are present in the embodiments of the present disclosure.

[0133] Fat can be present in essentially fluid form or in essentially solid form.

[0134] In some embodiments, the dry food composition can include fat from an animal source and / or a vegetable source.

[0135] In some embodiments, a vegetable source providing fat can include, without limitation, wheat, sunflower, safflower, rapeseed, olive, borage, flaxseed, peanuts, blackcurrant seed, cottonseed, wheat, germ, com germ as well as oils derived from these and combinations thereof.

[0136] In some embodiments, an animal source providing fat can include, without limitation, chicken crude fat, turkey crude fat, beef crude fat, duck crude fat,Attorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 1 pork crude fat, lamb crude fat, fish oil or any meat, meat by-products, seafood, fish byproducts, dairy, eggs or a combination thereof.

[0137] Fat can be supplied by any sources known by the person skilled in the art.

[0138] In some embodiments, a dry food composition includes from about 25g / Mcal to about 55g / Mcal of fat.

[0139] In some embodiments, a dry food composition can include about 25 g / Mcal, or about 26 g / Mcal, or about 27 g / Mcal, or about 28 g / Mcal, or about 29 g / Mcal, or about 30 g / Mcal, or about 31 g / Mcal, or about 32 g / Mcal, or about 33 g / Mcal, or about 34 g / Mcal, or about 35 g / Mcal, or about 36 g / Mcal, or about 37 g / Mcal, or about 38 g / Mcal, or about 39 g / Mcal, or about 40 g / Mcal, or about 41 g / Mcal, or about 42 g / Mcal, or about 43 g / Mcal, or about 44 g / Mcal, or about 45 g / Mcal, or about 46 g / Mcal, or about 47 g / Mcal, or about 48 g / Mcal, or about 49 g / Mcal, or about 50 g / Mcal, or about 51 g / Mcal, or about 52 g / Mcal, or about 53 g / Mcal, or about 54 g / Mcal, or about 55 g / Mcal of fat.

[0140] The fat content of a dry food composition can be determined by any methods known by the person of skill in the art.

[0141] In some embodiments, a dry food composition as described herein can include com starch, carbohydrates, flavors, preservatives, additives, minerals, trace elements, amino acids, and / or coloring.

[0142] In some embodiments, the dry food composition can include from about 10g / Mcal to about 25g / Mcal, or about 12g / Mcal to about 24g / Mcal, or about 13g / Mcal to about 23g / Mcal, or about 14g / Mcal to about 22g / Mcal of Ash.

[0143] In some embodiments, the dry food composition can include about 10 g / Mcal, or about 11 g / Mcal, or about 12 g / Mcal, or about 13 g / Mcal, or about 14 g / Mcal, or about 15 g / Mcal, or about 16 g / Mcal, or about 17 g / Mcal, or about 18 g / Mcal, or about 19 g / Mcal, or about 20 g / Mcal, or about 21 g / Mcal, or about 22 g / Mcal, or about 23 g / Mcal, or about 24 g / Mcal, or about 25 g / Mcal of ash.

[0144] In some embodiments, starch can include modified starch, pregelatinized starch, wheat starch, potatoes starch, rice starch, cassava starch, com starch and / or a combination thereof.

[0145] In some embodiments, starch can include com starch.Attorney Docket No. : 00307-0208-00304Mars Ref.: MARS / P / 393385 / WO / SEC / 1Method of manufacturing

[0146] The present disclosure also relates to a method for manufacturing a dry food composition as described herein.

[0147] A person of ordinary skill in the art will appreciate a wide variety of methods of manufacturing a dry food composition which is suitable for use with the present disclosure.

[0148] Illustratively, a method for manufacturing a dry food composition as described herein can include at least the steps of: mixing the ingredients; conditioning the mixture by applying heat (typically between 60-90°C); extruding the conditioned mixture into the extruder wherein the mixture is cooked under pressure and forced through a die, obtaining a kibble; drying the kibble to reduce the moisture content to 12% or less by weight; optionally coating the kibble before packaging.Uses and methods

[0149] The dry food composition as described is used for treating chronic constipation in a feline in need thereof.

[0150] The present disclosure also relates to a method for treating chronic constipation in a feline in need thereof including at least a step of administering a dry food composition as described herein to the feline.

[0151] The present disclosure also relates to the use of a dry food composition in the manufacture of a medicament for treating chronic constipation in a feline in need thereof, wherein the said dry food composition comprises: from about 50g / Mcal to about 100g / Mcal of protein; from about 25g / Mcal to about 55g / Mcal of fat; from about 10g / Mcal to about 25g / Mcal of Ash; and from about 15g / Mcal to about 35g / Mcal of Total Dietary Fibers (TDF), wherein the dry food composition comprises, on a dry matter basis, from about 5% to about 12% by weight of psyllium.

[0152] The present disclosure also relates to the use of from about 50g / Mcal to about 100g / Mcal of protein; from about 25g / Mcal to about 55g / Mcal of fat; from about 10g / Mcal to about 25g / Mcal of Ash; from about 15g / Mcal to about 35g / Mcal of Total Dietary Fibers (TDF) and from about 5% to about 12% by weight of psyllium, on a dry matter basis, in the manufacture of a dry food composition or a medicament for treating chronic constipation in a feline in need thereof.Attorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 1

[0153] A chronic constipation in a feline can consist of a constipation episode lasting at least 24 hours for at least two times within a period of at least six consecutive months.

[0154] In particular, a constipation episode is characterized by less than one bowel movement per day, optionally involving hard or dry stools, difficulty or / and pain during defecation, vomiting and / or tenesmus of the feline.

[0155] In some embodiments, a chronic constipation in a feline can be diagnosed when the feline presents less than one bowel movement over at least 24 hours for at least two times in a week within a period of at least six consecutive months.

[0156] Illustratively, a feline can be diagnosed as constipated based on a constipation score (Figure 1 ). A constipation score of 5 or higher indicates that the feline is constipated, while a constipation score below 5 indicates that the feline is not constipated. The constipation score can be determined as follows: the feline’s owner can assign a score between 0 and 3 for each behavioral parameters regarding the feline, which includes: Attitude / activity, Appetite, vomiting, stool consistency, stool frequency, and difficulty and / or pain during defecation. The scores for each parameter are summed to calculate the constipation score.

[0157] In some embodiments, a dry food composition as described herein can be provided to a feline in need thereof on a daily basis.

[0158] In some embodiments, a dry food composition as disclosed herein can be provided to the feline in need thereof as the sole food composition during the period of treatment.

[0159] In some embodiments, a dry food composition as described herein can be provided to the feline in need thereof in alternation with an additional food composition.

[0160] Without wishing to be bound by any particular theory, an efficient treatment of chronic constipation, can require that the feline is provided with a dry food composition as described herein at least one time, two times, or three times on a daily basis.

[0161] The period of feeding with a dry food composition as described herein can range from several months to several years, depending notably on the seventy of the chronic constipation.

[0162] In some embodiments, the dry food composition can be provided to the feline in need thereof during a longer period of time, such as during a period of 3Attorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 1 months or more, or 6 months of more, or 9 months or more, or 12 months or more, or 15 months or more, or 18 months or more, or20 months or more, or 24 months or more, or 30 months or more.

[0163] In some embodiments, the feline can be provided with a dry food composition as described herein for a longer period, such as three years or more.

[0164] In some embodiments, the feline can be provided with a dry food composition described herein for the whole lifetime of the said feline.

[0165] The uses and methods of the present disclosure do not affect the appetite of the feline in need thereof.

[0166] The uses and methods of the present disclosure do not affect the body weight of the feline in need thereof.

[0167] The methods of the present disclosure can further include a step of making a feeding recommendation that includes a dry food composition as described herein.

[0168] Without wishing to be bound by any particular theory, an efficient treatment of a chronic constipation can occur when an amelioration of the frequency of the stool has occurred. In particular, an amelioration of the condition of the feline can occur when the bowel movement is more than one, or twice, or three times over 24 hours for at least two times in a week, in particular for period of two, or three, or four, or five, or six or more months in a row.

[0169] Without wishing to be bound by any particular theory, an efficient treatment of a chronic constipation can occur when the constipation score of the feline is less than 5, based on the constipation score (Figure 1 ).

[0170] Without wishing to be bound by any particular theory, an efficient management of an intestinal disorder can occur when an amelioration of the effort of the feline to defecate is seen or the effort to defecate returns to normal.

[0171] In some embodiments, the dry food composition is not suitable to treat diarrhea.EXAMPLES

[0172] This disclosure can be further illustrated by the following examples of particular embodiments thereof, although it will be understood that these examples are included merely for purposes of illustration.Attorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 1

[0173] The study protocol was designed to evaluate the effectiveness and the long-term control of clinical signs of a new dry diet enriched with psyllium in cats with chronic gastrointestinal disorders by comparing it to a positive control diet with only 0.5% by weight of psyllium. The study was conducted in 22 investigational centers across Europe, with cat follow-up from inclusion (V0) to the final visit (V4), approximately 6 months.A. Materials and methods a. Studied Cat Population:

[0174] The study includes 48 adult cats showing signs of chronic constipation with at least two episodes of constipation (less than one bowel movement per day) in the last 6 months, each lasting at least 24h). Inclusion criteria involved cats of any breed or gender, aged at least 12 months (24 months for Maine Coons), dewormed at least 3 days before inclusion, and experiencing recurrent constipation with a seventy score > 5 (hard dry faeces - Figure 1 ).

[0175] Exclusion Criteria of the cats: Lactating / gestating females, concurrent diseases, certain medications, need for a veterinary therapeutic diet for another condition.

[0176] - Post-Inclusion Removal Criteria: Worsening clinical signs, refusal of diet, intolerance to diet, development of systemic disease. b. Tested Dietary Compositions:

[0177] Cats received either the PAR01 diet (18 cats) or the PAR02 diet (30 cats) at inclusion (V0) during 6 months and could also switch diet (from PAR01 to PAR02 or vice versa) and restart the study if their constipation score did not improve after one week of diet.

[0178] Test Diet (PAR01): Composed of dehydrated poultry proteins, rice, maize gluten, psyllium, etc. Additives include vitamins A, D3, C, taurine, and various minerals.Table 1 : Test Diet fPARODAttorney Docket No. : 00307-0208-00304Mars Ref.: MARS / P / 393385 / WO / SEC / 1

[0179] Control Diet (PAR02): Similar to the test diet but with vegetable fibers instead of a high amount of psyllium.Table 2: Control Diet (PAR02)

[0180] The study diet (PAR01 ), psyllium-enriched, is formulated to improve the frequency of clinical signs, and the severity index of constipation in felines. PAR01 contains 6% by weight of psyllium as fed as an additional source of highly soluble fiber. The control diet (PAR02), in contrast, contains 0.5% by weight of psyllium as fed as a positive control as some amount of psyllium is considered for a baseline treatment forAttorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 1 cats with chronic constipation. Psyllium inclusion in PAR02 diet is part of a larger fiber bundle that provides a balance of insoluble and soluble fiber sources. In contrast, the soluble to insoluble ratio is higher due to the increased psyllium in PAR01 . It has been hypothesis that this high amount of psyllium would benefit to treat chronically constipated cats.

[0181] PAR02 corresponds to a highly digestible «low-residue» diet which is often recommended to constipated cats with the intention to lower the amount of stools and ease defecation. Fiber-balance is one of the keys to ensure stool quality, avoiding generation of too hard stools. The addition of psyllium at 6% in PAR01 provides a source of soluble and mucilaginous fiber, which achieves a ‘soft laxative’ / stool lubrication effect to ease the passage of stools. c. Study Visits and Tests:

[0182] Visits: The study was conducted during 6 months and included at least five visits (V0 (DO), V1 (D7), V2 (D30), V3 (D60), V4 (D180).

[0183] The following parameters were assessed:- Physical Examination: Conducted at each visit to assess any gastrointestinal abnormalities.- Weighing and Body condition Score (BCS): Cats were weighed, and their body condition scores were assessed at each visit.- Constipation Score: Evaluated at each visit and during a phone call with the owner. Constipation score is determined according to the parameters in Figure 1.- Blood Analysis: Performed at inclusion (V0) and if necessary, during other visits, analyzing parameters like hematocrit, RBC, WBC, and more.- Feces Aspect: Owners monitored stool frequency and consistency, reporting any abnormalities. Stool consistency is assessed using the following scoring system:- 0: Normal- 1 : Hard and dry, slightly smaller- 2: Very hard and small I separate small hard lumps- 3: No stool, passes fecal fluid, liquid stools- Quality of life: The quality of life of the cats is analyzed through several questions asked to the owners during each visit. The questions include the cat's enthusiasm for eating the study food, the appearance of the stools, the quality of the stools compared to before the study, the overall quality of life of the cat, the interactionAttorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 1 and playfulness of the cat, as well as the discomfort felt by the owner due to the gastrointestinal disorders of their pet. Pain during defecation is assessed based on the pet owner's perception using the following scoring system: 0: Never; 1 : Slightly increased; 2: Moderately increased; 3: Always.

[0184] A statistical analysis is conducted at CEBIPHAR with the STATA® software (statistical analysis software from StataCorp., College Station, TX, USA, version 18).B. Results

[0185] In the PAR01 group, 72% of cats completed the entire study compared with only 37% in the PAR02 group (p<0.05). The reasons for withdrawal in the PAR01 group were digestive tolerance problems (1 cat), concomitant disease (2 cats) and death (1 cat), whereas the main reason for withdrawal in the PAR02 group was discomfort related to gastrointestinal disorders not compatible with the continuation of the study and / or requiring treatment (6 cats), then palatability problems (1 cat), digestive tolerance problem (1 cat), owner’s decision (1 cat), death (1cat) and other reason (1 cat).

[0186] In PAR01 , 2 (11 %) cats dropped out / switched due to diet related issues while 17 (56%) cats in PAR02 dropped out / switched due to diet related issues. PAR02 has a statistically significant higher drop-out rate (8%) due to diet related issues compared to PAR01 (p=0,0048). .0018). In assessing the time to dropping out or switching (due to diet related issues), the PAR02 group had a median time to event of 53 days (the duration till the survival probability is 50%), while the lowest probability of survival (not dropping out or switching) in PAR01 was 88%.

[0187] Six percent of cats in the PAR01 group switched to the PAR02 diet compared to 30% in the PAR02 group who switched to the PAR01 diet. The majority of cases (78%) who switched to PAR01 subsequently completed the entire study follow-up.

[0188] These findings suggest that the PAR01 diet prevented relapse of symptoms in more cats than the PAR02 diet after an initial adjustment period. For cats with chronic constipation, the prevention of relapse of signs is a main goal of treatment.

[0189] All the parameters of the constipation score improved during the study in both groups for cats that completed the entire study.Attorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 1

[0190] In the PAR01 group, the percentage of cats with an attitude / activity score of 0 ranged from 50% at V0 to 85% at V4; the percentage of cats with an appetite score of 0 ranged from 67% to 92%; the percentage of cats with a vomiting score of 0 ranged from 44% to 62%; the percentage of cats with a stool consistency score of 0 ranged from 0% to 62%; the percentage of cats with a stool frequency score of 0 ranged from 11 % to 54%; the percentage of cats with a difficulty and / or pain during defecation score of 0 ranged from 6% to 64% and the percentage of cats with a hydration status score of 0 ranged from 72% to 77%. Finally, 77% of the cats presented a total constipation score <5 at the end of follow-up.

[0191] In the PAR02 group, the percentage of cats with an attitude / activity score of 0 ranged from 43% at V0 to 73% at V4; the percentage of cats with an appetite score of 0 ranged from 33% to 91 %; the percentage of cats with a vomiting score of 0 ranged from 60% to 100%; the percentage of cats with a stool consistency score of 0 ranged from 3% to 18%; the percentage of cats with a stool frequency score of 0 ranged from 33% to 82%; the percentage of cats with a difficulty and / or pain during defecation score of 0 ranged from 13% to 91 % and the percentage of cats with a hydration status score of 0 ranged from 63% to 82%. Finally, 91 % of the cats presented a total constipation score <5 at the end of follow-up.

[0192] For the clinically important parameters of stool consistency and pain at defecation the PAR01 group presented with consistently larger changes (reductions) from baseline compared to PAR02. The change from baseline in stool consistency score, for each visit, was larger in the PAR01 group, ranging from -1 to -1.44, compared to the PAR02 group ranging from -0.40 to -0.91. The difference in the change from baseline between the two groups was statistically significant at the Phone call (p=0.0173), Day 60 (p=0.0044) and Day 180 (p=0.0112), indicating that the decrease from baseline was significantly larger for PAR01 compared to PAR02. Similarly, for pain at defecation the change from baseline in pain score was larger in the PAR01 group, for each visit, ranging from -1 to -1.42, compared to the PAR02 group ranging from -0.6 to -1 .26. The difference in the change from baseline between the two groups was statistically significant at Day 30 (p=0.0270), indicating that the decrease from baseline was significantly larger for PAR01 compared to PAR02.

[0193] According to owners, stool consistency improved as 93% of PAR01 owners and 100% of PAR02 owners observed better stool quality at the end of the study compared to before the beginning of the study. The Quality of life scoreAttorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 1 increased slightly or sharply for 64% of cats in the PAR01 group and for 75% of cats in the PAR02 group. Owner discomfort score was slightly or greatly decreased at the end of follow-up in both groups for 77% of owners in the PAR01 group and for 74% of owners in the PAR02 group.

[0194] In the PAR01 group, 92% of the owners were rather or very satisfied by the diet versus 91 % in the PAR02 group.

[0195] In the switch population, the only case that switched on the PAR02 diet was withdrawn after one week. Two cases that switched on the PAR01 diet were withdrawn after switch. A huge decrease in the total constipation score was observed in this population with a mean score of 8.9 ± 3.1 at V0 and 1 .4 ± 1 .6 at the end of the study, with no cat presenting a score of 5 or more (>5) at V4. No major difference in the owner’s perception was observed.C. Conclusion

[0196] The study aimed to evaluate the effectiveness of two dry diets, PAR01 and PAR02, in treating chronic constipation.

[0197] The test diet contains 6% by weight of psyllium as fed as an additional source of highly soluble fiber. The control diet, in contrast contains 0.5% by weight of psyllium as fed as a positive control as some amount of psyllium is considered a baseline treatment for cats with chronic constipation.

[0198] The study demonstrates that the psyllium-enriched dry diet (PAR01 - 6% psyllium) was effective in managing recurrent constipation in cats and that the PAR01 diet had several advantages over the control positive diet PAR02. The psyllium- enriched dry diet (PAR01 ) demonstrated significant improvements in constipation scores and was well-received by both owners and investigators, with high satisfaction rates. While both nutritional approaches (Gastrointestinal diet [PAR02] vs psyllium- enriched dry diet [PAR01 ]) showed efficacy in improving clinical signs of cats with chronic constipation, the lower drop-out rates over the life of the study, as well as the lower diet failure rate, and the positive results obtained in cats switched to the psyllium- enriched diet (PAR01 ) suggest the psyllium-enriched dry diet (PAR01 ) is the best option for long-term nutritional management of feline chronic constipation, improving stool consistency / clinical signs and pain at defecation in cats with chronic constipation and limiting recurrence / relapse.Attorney Docket No. : 00307-0208-00304Mars Ref.: MARS / P / 393385 / WO / SEC / 1

[0199] The present examples demonstrate that the use of a psyllium-enriched diet, in particular with the inclusion of at least about 6% by weight of psyllium, is effective to treat chronic constipation in cats during a long period of treatment.

Claims

Attorney Docket No. : 00307-0208-00304Mars Ref.: MARS / P / 393385 / WO / SEC / 1CLAIMS1 . A dry food composition for use in a method for treating chronic constipation in a feline in need thereof, wherein the said dry food composition comprises:- from about 50g / Mcal to about 100g / Mcal of protein;- from about 25g / Mcal to about 55g / Mcal of fat;- from about 10g / Mcal to about 25g / Mcal of Ash; and- from about 15g / Mcal to about 35g / Mcal of Total Dietary Fibers (TDF), wherein the dry food composition comprises, on a dry matter basis, from about 5% to about 12% by weight of psyllium.

2. The dry food composition for use according to claim 1 , wherein the food composition comprises, on a dry matter basis, about 6% by weight of psyllium.

3. The dry food composition for its use according to claim 1 or 2, wherein chronic constipation in a feline consists of a constipation episode lasting at least 24 hours for at least two times in a week within a period of at least six consecutive months.

4. The dry food composition for its use according to any one of claims 1 to 3, wherein the constipation episode is characterized by less than one bowel movement per day, optionally wherein the constipation episode involves hard or dry stools, difficulty and / or pain during defecation, vomiting and / or tenesmus of the feline.

5. The dry food composition for its use according to any one of the preceding claims, wherein the chronic constipation consists of a chronic idiopathic constipation.

6. The dry food composition for its use according to any one of the preceding claims, wherein the feline is treated for a period of 6 months or more.

7. The dry food composition for its use according to any one of the preceding claims, wherein the weight ratio of total soluble fiber to total insoluble fiber is from about 1.2:1 to about 1.5:1.Attorney Docket No. : 00307-0208-00304Mars Ref.: MARS / P / 393385 / WO / SEC / 18. The dry food composition for use according to any one of the preceding claims, wherein the food composition does not include fiber sources comprising about 80% or more by weight of insoluble fibers based on the total fiber content of the fiber source.

9. The dry food composition for use according to claim 8, wherein the food composition does not include pure cellulose.

10. The dry food composition for use according to claim 8 or 9, wherein the food composition does not include pure hemicellulose, and / or pure lignin.11 . The dry food composition for its use according to any one of the preceding claims, wherein a source of fiber is selected from beet pulp, guar gum, chicory pulp, psyllium, pectin, blueberry, cranberry, squash, apples, oats, beans, citrus, barley, peas, inulin, corn, rice, fructo-oligo-saccharides, manno-oligosaccharides and / or combinations thereof.

12. The dry food composition for its use according to any one of the preceding claims, wherein said dry food composition is nutritionally complete and balanced.

13. The dry food composition for its use according to any one of the preceding claims, wherein said dry food composition is a kibble.

14. The dry food composition for its use according to any one of the preceding claims, wherein said feline is a cat.

15. The dry food composition for its use according to any one of the preceding claims, wherein the food composition is not suitable to treat diarrhea.

16. A method for treating chronic constipation in a feline in need thereof including at least a step of administering to the feline a dry food composition comprising:- from about 50g / Mcal to about 100g / Mcal of protein;- from about 25g / Mcal to about 55g / Mcal of fat;- from about 10g / Mcal to about 25g / Mcal of Ash; andAttorney Docket No. : 00307-0208-00304Mars Ref.: MARS / P / 393385 / WO / SEC / 1- from about 15g / Mcal to about 35g / Mcal of Total Dietary Fibers (TDF), wherein the dry food composition comprises, on a dry matter basis, from about 5% to about 12% by weight of psyllium.

17. The method of claim 16, wherein the food composition comprises, on a dry matter basis, about 6% by weight of psyllium.

18. The method of claim 16, wherein the chronic constipation consists of a constipation episode lasting at least 24 hours for at least two times in a week within a period of at least six consecutive months.

19. The method of claim 18, wherein the constipation episode is characterized by less than one bowel movement per day.

20. The method of claim 19, wherein the constipation episode involves hard or dry stools, difficulty and / or pain during defecation, vomiting and / or tenesmus of the feline.21 . The method of claim 16, wherein the chronic constipation consists of a chronic idiopathic constipation.

22. The method of claim 16, wherein the feline is treated for a period of 6 months or more.

23. The method of claim 16, wherein the weight ratio of total soluble fiber to total insoluble fiber is from about 1 .2: 1 to about 1.5:1.

24. The method of claim 16, wherein the food composition does not include fiber sources comprising about 80% or more by weight of insoluble fibers based on the total fiber content of the fiber source.

25. The method of claim 16, wherein the food composition does not include pure cellulose.Attorney Docket No. : 00307-0208-00304 Mars Ref.: MARS / P / 393385 / WO / SEC / 126. The method of claim 16, wherein the food composition does not include pure hemicellulose, and / or pure lignin.

27. The method of claim 16, wherein a source of fiber is selected from beet pulp, guar gum, chicory pulp, psyllium, pectin, blueberry, cranberry, squash, apples, oats, beans, citrus, barley, peas, inulin, com, rice, fructo-oligo-saccharides, mannooligosaccharides and / or combinations thereof.

28. The method of claim 16, wherein said dry food composition is nutritionally complete and balanced.

29. The method of claim 16, wherein the dry food composition is in a kibble format.

30. The method of claim 16, wherein the feline is a cat.

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