Inulin particle for preventing and / or treating functional bowel disorders

Abstract

The present invention relates to an inulin particle, to a method for producing same and to the uses thereof, in particular for treating functional bowel disorders. In particular, the present invention relates to an inulin particle comprising: - a soluble core comprising native inulin having an average degree of polymerisation of between 9 and 14; and - an insoluble coating that coats said core and comprises fractionated inulin having an average degree of polymerisation of greater than or equal to 15.

Description

[0001] INULIN PARTICLE AIMED AT PREVENTING AND / OR TREATING DISORDERS

[0002] INTESTINAL FUNCTIONAL

[0003] Technical field

[0004] The present invention relates to the technical field of prevention, regulation and / or treatment of functional intestinal disorders in a human or animal individual, and in particular constipation. The invention thus relates to a particular inulin particle, its method of obtaining and its uses.

[0005] State of the art

[0006] Functional digestive disorders are among the disorders without proven lesions, but which constitute a source of troublesome dysfunction for the digestive system. Indeed, if these functional digestive disorders generally prove to be benign, they nevertheless significantly alter the quality of life of the individuals who suffer from them, especially since, in half of the cases, symptoms other than digestive symptoms are associated, such as diffuse muscular and skeletal pain, chronic fatigue, stress and anxiety.

[0007] These functional digestive disorders are very common in the population, affecting up to 40% of adults, with a female predominance.

[0008] There are several known types of functional digestive disorders, including stomach disorders (loss of appetite, nausea, heartburn, belching, bloating) and functional intestinal disorders, which correspond to clinical signs resulting in particular in disorders of the motility of the digestive tract, in particular the colon (constipation or diarrhea), but also in disorders of visceral sensitivity, without an identifiable anatomopathological lesion (equivalent: irritable bowel syndrome).

[0009] Among functional bowel disorders, constipation is particularly bothersome. Constipation is a common and persistent condition that affects a large number of people. In addition to infrequent bowel movements, constipation also includes excessive straining, a feeling of incomplete evacuation, prolonged or unsuccessful attempts at defecation, the use of digital maneuvers to evacuate stools, abdominal bloating, and hard stool consistency.

[0010] Constipation, regardless of its etiology, is treated primarily by modifying diet and lifestyle, including encouraging adequate fluid and fiber intake and regular exercise.

[0011] When the initial approach is inconclusive or the constipation is chronic in nature, standard pharmacological treatment is based on the use of osmotic laxatives, particularly macrogols.

[0012] The administration of macrogols, also known as polyethylene glycols, is one of the most common treatments for constipation, particularly chronic constipation. When administered orally, they increase the volume of intestinal fluids, facilitating the expulsion of stools through an osmotic effect.

[0013] Although having satisfactory therapeutic efficacy, macrogols can cause frequent adverse effects such as diarrhea, abdominal pain, abdominal distension and nausea.

[0014] Furthermore, macrogols are synthetic polymers that are poorly biodegradable and accumulate in the environment.

[0015] Faced with these problems, inulin has emerged as a promising candidate for improving intestinal transit by increasing stool frequency, particularly in constipated individuals.

[0016] Inulin is a natural polymer produced by many plants. Belonging to a class of fibers called fructans, inulins are used by plants as a means of energy storage.

[0017] Inulin is an indigestible dietary fiber. More precisely, inulin is not digested by the enzymes of the human digestive system but is fermented by bacteria in the intestinal microbiota (particularly in the colon), known to exert beneficial effects (prebiotic effects) on the body, such as bacteria belonging to the genera Bifidobacterium and Lactobacillus.

[0018] In addition, inulin has the advantage of being soluble or dispersible in water, which facilitates the development of aqueous liquid dosage forms such as aqueous solutions or suspensions.

[0019] According to a report by the European Food Safety Authority (EFSA), the dose of native inulin recognized as effective in normalizing stool frequency is 12g per day without this dose causing diarrhea.

[0020] This minimal daily consumption of native inulin, however, has certain drawbacks.

[0021] Firstly, the daily quantity of native inulin required to obtain the desired beneficial effect on transit is significant, which may require several doses per day and may be restrictive for certain patients / subjects.

[0022] Furthermore, the fermentation of a large amount of native inulin in the colon can be accompanied by excessive gas production and cause bloating, which can lead to digestive discomfort due to a buildup of these gases in the intestine; the buildup of these gases causes tension in the intestine and, thus, a swelling of the abdomen. As a result, bloated individuals may have a feeling of a "bloated belly," which, at the very least, generates a feeling of discomfort, which can affect their daily life and social relationships.

[0023] Furthermore, given this high dosage, from an economic point of view, the cost of daily treatment may represent a barrier to providing a competitive alternative to synthetic osmotic laxatives such as macrogols.

[0024] There is therefore a need to develop a new composition, making it possible, in an effective manner, to prevent and / or treat functional intestinal disorders, in particular constipation, while overcoming all or part of the aforementioned drawbacks, such as in particular:

[0025] - problems with compliance with treatment / cure due to the need to ingest too large a quantity or to the ingestion of a repeated number of inulin before and after each meal;

[0026] - the risks of bloating and flatulence linked to the repeated intake of large quantities of inulin.

[0027] Summary of the invention:

[0028] To meet this need, the invention proposes a new inulin-based composition intended to prevent and / or treat functional intestinal disorders, in particular constipation.

[0029] Thus, the subject of the invention is an inulin particle comprising:

[0030] - a soluble core comprising native inulin having an average degree of polymerization of between 9 and 14; and

[0031] - an insoluble coating coating said core, said coating comprising fractionated inulin having an average degree of polymerization greater than or equal to 15.

[0032] Advantageously, the insoluble coating helps to increase the digestion time of the native inulin core, thus ensuring a more prolonged action over time in the intestine while avoiding excessive gas generation during the fermentation of native inulin.

[0033] In the context of the invention, the solubility of the core and the coating is relative to the solubility in water.

[0034] Preferably, the inulin particle according to the invention has a native inulin / fractionated inulin ratio of between 100 / 1 and 1 / 100. This native inulin / fractionated inulin ratio thus makes it possible to control the digestion time of the native inulin core, making it possible to prolong the delivery of native inulin into the intestine.

[0035] According to a suitable embodiment, the inulin particle also comprises at least one additive chosen from a binder, a preservative and a flavoring.

[0036] The invention also relates to a composition comprising at least one inulin particle according to the invention.

[0037] Advantageously, such a composition is homogeneous, easily dispersible and can contain a significant amount of native inulin.

[0038] The invention also relates to a method for manufacturing an inulin particle according to the invention comprising the introduction of solid particles of native inulin into a reactor, the preparation of a fractionated inulin solution and the spraying of the fractionated inulin solution in the reactor onto the particles of native inulin.

[0039] Finally, according to a last object, the invention relates to the particle or composition according to the invention for its use in preventing and / or treating intestinal digestive disorders, preferably constipation.

[0040] Other characteristics and advantages will emerge from the detailed description of the invention and from the examples which are purely illustrative and in no way limitative of the scope of the invention.

[0041] Brief description of the Figures

[0042] [Fig. 1] Figure 1 is a graphical representation of a comparative test of the measurement of digestion time in a human colon model of a composition according to the invention and a composition outside the invention.

[0043] [Fig 2] Figure 2 is a graphical representation measuring the digestion rate in a human colon model of a composition according to the invention and a composition outside the invention.

[0044] Detailed description of the invention

[0045] Definitions

[0046] For the purposes of the invention, the term "additives" means a natural or synthetic substance, compound or composition used in a pharmaceutical or veterinary composition, a medical device or a food supplement, and which, for example, improves the presentation, use or function of said composition. Additives act, for example, to protect, maintain and / or improve the stability of the formulation, to enable unitary shaping, to improve organoleptic characteristics (taste, appearance, etc.), to facilitate compliance by the patient or subject, or to improve the action of the active ingredients.

[0047] For the purposes of the invention, the term "Food supplement" means a composition for human or animal use, the purpose of which is to supplement the normal diet and which constitutes a concentrated source of nutrients or other substances having a nutritional or physiological effect, alone or in combination, intended to be taken in measured units of small quantity.

[0048] For the purposes of the invention, the term "degree of polymerization (DP)" means the length of an oligomeric or polymer chain. The DP corresponds to the total number of monomers in said oligomeric or polymer chain. In the case of a fructan, the DP therefore corresponds to the total number of fructose monomers in a / the oligo- or poly-fructose chain of said fructan.

[0049] For the purposes of the invention, "Average degree of polymerization" (also referred to as "number-average degree of polymerization") means the average number of monomers in an oligomeric or polymeric chain. In the case of a fructan, it therefore corresponds to the average number of fructose monomers in a / the oligo- or poly-fructose chain of said fructan.

[0050] For the purposes of the invention, the term "fructan" means linear or branched homo-oligomers or homopolymers of fructose linked by 13-(2—>1) and / or 13-(2—>6) bonds. They are synthesized from a sucrose molecule. As indicated, for example, in the publication by Velàzquez-Martfnez et al. Fructans are classified according to their fructosyl bonds. Inulin and levan-type fructans have linear fructose chains linked by 13-(2—>1) and 13-(2—>6) bonds, respectively. Graminans are branched fructans that have chains with both 13(2— >1) and 13-(2— >6) linkages, whereas neoserie-type fructans have two linear 13-(2— >1) or 13-(2— >6) fructosyl chains, one attached to the fructosyl residue of sucrose and the other attached to the glucosyl residue of sucrose, generating levans and inulin neoseries.The genus Agave possesses branched fructans (graminans), and two-branched graminan neoserial structures have been identified (referred to as "agavins"): one branch is linked to the fructosyl residue of sucrose and the other to glucosyl. Agavins contain a complex mixture of fructans with different degrees of polymerization (DP) (up to 80). After starch, fructans are the most abundant non-structural polysaccharides in nature, occurring in about 15% of flowering plants.

[0051] For the purposes of the invention, “Fructooligosaccharides (FOS)” means fructose-based oligosides that can be produced by hydrolysis of inulin and are compounds of the same nature as inulin but with a lower average degree of polymerization (between 2 and 10 and typically between 2 and 8).

[0052] For the purposes of the invention, the term “Homopolymers / homo-oligomers” means a polymer or oligomer derived from a single monomer species. All repeating units of a homopolymer or homo-oligomer are of the same chemical nature.

[0053] For the purposes of the invention, the term "inulins" means fructans in which the fructose monomers are linked by beta (2— >1) sugar bonds and generally terminate in a glucose molecule (linked by an alpha (1— >2) bond, as in sucrose). The chain lengths of inulins generally range from 2 to 60 units, with an average degree of polymerization of approximately 10 (DeLéenhéer and Hoebregs 1994, Joint IUPAC-IBU Commission on Biochemical Nomenclature 1982, VanHaastrecht 1995), it being specified that inulins having a degree of polymerization between 2 and 10 (and typically between 2 and 8) are generally called "fructo-oligosaccharides (FOS)". Inulins take their name from the botanical genus Inula, to which the Elecampane (Inula helenium) belongs, which contains significant quantities of them. They are particularly abundant in chicory root, from which they are extracted industrially.They are also found in other plants such as artichokes, dandelions, Jerusalem artichokes, dahlia bulbs, burdock, echinacea, agaves, asparagus, bananas, garlic, onions, leeks, and wheat.

[0054] For the purposes of the invention, “native inulin” means inulin directly extracted from a plant. That is to say, inulin with an average degree of polymerization of between 9 and 14.

[0055] For the purposes of the invention, the term “fractionated inulin” means a selection of inulin fibers having an average degree of polymerization greater than or equal to 15. These fibers are characterized by a lower aqueous solubility than native inulin, which promotes the creation of a so-called insoluble coating. Due to its degree of polymerization, the digestion time of fractionated inulin is significantly prolonged by the intestinal microbiota. These fibers are notably characterized by a very low level of aqueous solubility allowing the preparation of an insoluble coating, and by a longer digestion time by the intestinal microbiota.On the other hand, this type of fiber promotes the phenomenon of cross-feeding, thus contributing to better microbial diversity within the microbiota as well as to the production of final metabolites of the Short Chain Fatty Acid type, which constitute nutrients for colonocytes, which also contribute to the regulation of transit.

[0056] For the purposes of the invention, the term "monomer" means a molecule of small size and low molecular mass (in the case of fructans, a fructose molecule), which, as a unit, chemically bonds to other organic molecules to form a supramolecular polymer.

[0057] For the purposes of the invention, “average particle size” means the size for which 50% of the particles have a size greater than this.

[0058] Inulin particle

[0059] The present invention therefore relates to an inulin particle comprising:

[0060] - a soluble core comprising native inulin with an average degree of polymerization between 9 and 14;

[0061] - an insoluble coating coating said core, said coating comprising fractionated inulin having an average degree of polymerization greater than or equal to 15.

[0062] Such a particle is particularly useful in the context of the invention, thus making it possible to prevent and / or treat functional intestinal disorders while overcoming the drawbacks of the prior art. Indeed, the particle according to the invention, comprising in particular an insoluble coating, makes it possible to increase the gastrointestinal residence time of the particle and thus release the native inulin over time, making it possible to prevent and / or treat functional intestinal disorders.

[0063] According to a preferred embodiment, native inulin and fractionated inulin are obtained from chicory root.

[0064] According to another embodiment, the inulin particle comprises:

[0065] - a soluble core comprising native inulin having an average degree of polymerization of between 9 and 14, preferably between 9 and 12, in particular between 9 and 11; and

[0066] - an insoluble coating coating said core, said coating comprising fractionated inulin having an average degree of polymerization greater than or equal to 15, preferably 20, in particular 25.

[0067] The degree of inulin polymerization influences the digestion time of fiber by intestinal bacteria, particularly bacteria present in the colon. In addition, it also affects the solubility of inulin, making it possible to provide a particle comprising a soluble core and an insoluble coating.

[0068] This fermentation time is explained in particular by the length of the inulin chain, which requires the intervention of a sufficient quantity of microbial diversity to digest the inulin. The higher the average degree of polymerization of the inulin, the greater the quantity of substrate to be digested, which requires the mobilization of a sufficient quantity of diversity of microorganisms to degrade it effectively. Consequently, the higher the degree of polymerization, the longer the digestion time of the inulin.

[0069] Advantageously, the two-layer structure of the inulin particle according to the invention, namely the core and the coating, makes it possible to obtain slower degradation of the native inulin core by the microbial flora.

[0070] According to one embodiment, said inulin particle has an average size of between 50 pm and 5 mm, preferably between 50 pm and 1 mm, in particular between 50 pm and 500 pm.

[0071] Particle size can be measured by sieving, which is a method well known to those skilled in the art and described in the European Pharmacopoeia. Sieving consists of using a column of sieves of decreasing size subjected to a mechanical vibration system allowing the particles to distribute themselves according to their size on the different sieves. After weighing the quantities of particles on each sieve, the results can be expressed in the form of a size histogram or the proportion of particles greater or less than a given size (sieve mesh) can be indicated.

[0072] Preferably, the inulin particles are round, oval or elliptical in shape.

[0073] Advantageously, the size and shape of the inulin particle according to the invention allows it to be easily administered orally to a human or animal being.

[0074] According to another embodiment, the inulin particle has a native inulin / fractionated inulin ratio of between 100 / 1 and 1 / 100, preferably between 25 / 1 and 1 / 25, more preferably between 10 / 1 and 1 / 10.

[0075] Advantageously, the greater the thickness of the fractionated inulin coating layer, the longer it takes for the core formed by native inulin to be digested.

[0076] According to another embodiment, the inulin particle according to the invention comprises at least one additive.

[0077] Preferably, the inulin particle according to the invention comprises at least one additive chosen from:

[0078] - diluents and / or texturizing agents to improve the consistency of the composition, such as gelling agents of natural origin,

[0079] - flow agents to facilitate the product manufacturing operations, in particular the distribution operation, - natural flavors and / or sweeteners of natural origin such as unrefined natural sugars like agave syrup or coconut flower syrup, or polyols to give the composition a more pleasant taste,

[0080] - compounds which can bind with the free water contained in the composition in order to reduce the water activity (Aw) such as sugars or polyols of natural origin, for example glycerol, sorbitol, xylitol, erythritol,

[0081] - hydrophobic agents such as fatty substances of natural origin in order to improve the conservation of the composition and, where appropriate, to contribute to a gradual release of the composition in the digestive tract;

[0082] - bacteria belonging to the genera Bifidobacterium and / or Lactobacillus, known in particular for exerting beneficial probiotic properties and for their capacity to digest fructans,

[0083] - at least one SCFA, or at least one of its precursors, preferably butyrate or at least one of its precursors so as to further accentuate the post-biotic effect due to the SCFA,

[0084] - vitamins or minerals, preferably calcium which is involved in particular in the regulation of enzymes involved in digestive function; and - their mixtures.

[0085] According to a particular embodiment of the invention, the inulin particle comprises:

[0086] - a soluble core comprising (i) native inulin having an average degree of polymerization between 9 and 14 and (ii) butyrate; and

[0087] - an insoluble coating coating said core, said coating comprising (i) fractionated inulin having an average degree of polymerization greater than or equal to 15.

[0088] The invention also relates to a composition comprising at least one inulin particle according to any of the embodiments previously described.

[0089] Preferably, the composition according to the invention comprises at least 10% of inulin particles according to the invention by weight relative to the total weight of the composition.

[0090] According to a preferred embodiment, the composition comprises at least 25% of inulin particles, preferably between 25 and 100%, more preferably between 50 and 100%.

[0091] According to one embodiment, the composition according to the invention consists of 100% of inulin particles described according to any of the embodiments previously described.

[0092] Advantageously, the composition according to the invention consisting of a single-particle system allows:

[0093] - to overcome mixing homogeneity problems. This type of problem is frequently encountered when a composition includes at least 2 types of particles, particularly if these particles are of different sizes, shapes and densities and if their proportions in the mixture are significantly different.

[0094] - to reduce the speed of digestion of the core formed by native inulin, thus reducing the risk of flatulence; and

[0095] - to reduce the total quantity of native inulin to be administered to prevent and / or treat functional intestinal disorders, in particular constipation

[0096] Advantageously, the composition can include up to 15g of native inulin.

[0097] The composition according to the invention preferably comprises a mixture of inulin particles according to the invention with different native inulin / fractionated inulin ratios.

[0098] Preferably, the composition according to the invention comprises at least two inulin particles having different native inulin / fractionated inulin ratios.

[0099] According to one embodiment, the invention relates to a composition comprising at least two different types of inulin particle, namely:

[0100] - a first type of inulin particle comprising: a) a soluble core comprising native inulin having an average degree of polymerization of between 9 and 14; and b) an insoluble coating coating said core, said coating comprising fractionated inulin having an average degree of polymerization greater than or equal to 15 in which the native inulin / fractionated inulin ratio is between 10 / 1 and 3 / 1.

[0101] - a second type of inulin particle comprising: a) a soluble core comprising native inulin having an average degree of polymerization of between 9 and 14; and b) an insoluble coating coating said core, said coating comprising fractionated inulin having an average degree of polymerization greater than or equal to 15 in which the native inulin / fractionated inulin ratio is between 1 / 10 and 1 / 3.

[0102] The composition according to the invention thus allows prolonged digestion of inulin and consequently a prolonged effect over time. The prolonged digestion over time allows in particular the composition according to the invention to be compatible with a single administration per day.

[0103] In addition to increasing and / or normalizing stool frequency, the composition according to the invention also makes it possible to improve digestive comfort by regulating the composition of the microbial flora at the level of the intestinal microbiome. Indeed, the composition according to the invention makes it possible to increase the production of metabolites and in particular short-chain fatty acids, such as butyrate. These metabolites and in particular butyrate are known for their action on the functioning of the cells of the colon wall.

[0104] The composition according to the invention advantageously leads to a modification of the proportions of certain microbial populations, in particular via the implementation of cross-feeding of intestinal and colonic bacteria. Indeed, the fermentation products resulting from the degradation of inulin by one set of bacteria can be used as a nutrient source for another set of bacteria present in the microbiota. For example, regular, in particular daily, consumption of native inulin indirectly leads to an increase in the production of butyrate by genera of bacteria such as Bifidobacterium and Lactobacillus. It is important to note that bacteria belonging to these two genera do not directly produce butyrate from native inulin, but they use this compound to generate lactates and acetates.These latter by-products are then used as substrate by other groups of bacteria that produce butyrate, such as Eubacterium, Roseburia and Faecalibacterium.

[0105] The composition according to the invention may be in solid, semi-solid or liquid form.

[0106] When the composition according to the invention is in solid form, it is preferably in the form of powder, tablet, capsule, gel cap, gummies or granules.

[0107] When the composition according to the invention is in semi-solid form, it is preferably in the form of a gel, a paste or a chewing gum.

[0108] When the composition according to the invention is in liquid form, it is preferably in the form of a suspension, packaged in a bottle, sachet or stick.

[0109] According to one embodiment, the composition according to the invention is in the form of an aqueous suspension.

[0110] Advantageously, the composition according to the invention makes it possible to obtain a homogeneous suspension which is easily dispersible in water.

[0111] Surprisingly, when the composition is in solid form, in particular in powder form, the composition can disperse in water in less than 30 seconds. Furthermore, the composition according to the invention is capable of dispersing so as to obtain a suspension comprising up to 15g of native inulin in a small volume of water, in particular a volume of water less than 250mL, preferably less than 150mL, even more preferably a volume less than 100mL.

[0112] According to a preferred embodiment, the composition according to the invention comprises up to 12g of native inulin in a volume of water of less than 250mL.

[0113] Advantageously, the composition according to the invention makes it possible to administer up to 15g of inulin in a single dose in an easily administrable form, in particular in the form of an aqueous suspension having a water volume of less than 250mL.

[0114] Advantageously, the slow fermentation of native inulin makes it possible to reduce the dose necessary to obtain an effect in humans or animals.

[0115] The composition according to the invention is preferably stored in single-dose containers. They are preferably stored at room temperature and / or under conditions allowing their preservation until use.

[0116] Advantageously, the ready-to-use single-dose packaging, such as a sachet, a stick or a bottle, makes it possible to avoid any problem of controlling the dose administered to the patient / subject.

[0117] Process:

[0118] According to another aspect, the invention also relates to a method for manufacturing an inulin particle according to the invention comprising at least the implementation of the following steps: a) Introduction of native inulin particle into a suitable reactor b) Preparation of an aqueous dispersion of fractionated inulin c) Spraying of the aqueous dispersion prepared during step b) into the reactor of step a) comprising the native inulin, forming the inulin particle according to the invention.

[0119] Preferably, the reactor of step a) is equipped with a spraying system.

[0120] According to a particularly suitable embodiment, the reactor for implementing the method according to the invention is a fluidized air bed reactor.

[0121] Preferably, step b) is carried out in the presence of a sufficient quantity of water to allow the dispersion of the fractionated inulin. Preferably, step b) can be carried out at a temperature between 60 and 90°C, preferably 80°C.

[0122] Advantageously, the method according to the invention makes it possible to produce a large quantity of homogeneous inulin particles.

[0123] Uses

[0124] According to a final aspect, the invention relates to the inulin particle and / or the composition according to the invention for its use as a medicament or medical device.

[0125] Preferably, the inulin particle and / or the composition according to the invention can also be used as a food supplement.

[0126] According to a preferred embodiment, the inulin particle and / or the composition according to the invention can be used to prevent and / or treat intestinal digestive disorders.

[0127] Intestinal digestive disorders being preferentially chosen from constipation, dysbiosis, normalization of intestinal transit and frequency and / or consistency of stools

[0128] According to a particular embodiment of the invention, the inulin particle and / or the composition according to the invention can be used as a prebiotic.

[0129] Through its action on the intestinal microbiota, the composition according to the invention can also be used to increase the concentration of short-chain fatty acids such as butyrate which are produced by digestion by microorganisms of the intestinal microbiota.

[0130] According to one embodiment, the inulin particle and / or the composition according to the invention can be used to increase the production of short-chain fatty acids such as butyrate in the intestine.

[0131] According to one variant, the inulin particle and / or the composition according to the invention can be used to increase the quantity of intestinal bacteria belonging to at least one genus chosen from Eubacterium, Roseburia and Faecalibacterium.

[0132] Preferably, the inulin particle and / or the composition according to the invention is administered in a single dose per day.

[0133] According to a particular embodiment, the inulin particle and / or the composition according to the invention can be administered, preferably in a single dose per day, at a content of less than 12g of native inulin to prevent and / or treat intestinal digestive disorders. Advantageously, the particular structure of the inulin particle according to the invention makes it possible to reduce the dose necessary to obtain the desired biological effect, namely to prevent and / or treat intestinal digestive disorders such as constipation.

[0134] Advantageously, the size, shape and structure of the inulin particles allow for easy administration and a prolonged effect throughout the day.

[0135] Thus, against all expectations, the inventor discovered that the composition according to the invention was not only effective in preventing / regulating and / or treating functional intestinal disorders such as constipation in a human or animal individual but also in improving, in the broad sense, digestive comfort in a human or animal individual.

[0136] Examples

[0137] Example 1: Measurement of the particle size of a composition according to the invention

[0138] The composition used in this example is in the form of a powder comprising 100% inulin particles. The inulin particles in said composition have a native inulin / fractionated inulin ratio of 4 / 1.

[0139] Once the composition obtained from the process according to the invention was obtained, the particle size was measured by laser diffraction. Laser diffraction measures particle size distributions by measuring the angular variation of the scattered light intensity when a laser beam passes through a sample of dispersed particles. Large particles scatter light at small angles to the laser beam and small particles scatter light at larger angles. The data relating to the scattered intensity as a function of angle is analyzed to calculate the size of the particles that created the diffraction pattern using Mie theory. The particle size represents the diameter of the equivalent sphere having the same volume as the particle.

[0140] [Table 1 The residual humidity (RH) of the inulin particles is less than 5% to avoid microbial contamination problems. The density was also measured by successive tamping. D10 corresponds to the density measurement after 10 tampings. The average size of the inulin particles in the composition according to Example 1 is 118 pm.

[0141] Example 2: Comparative test of the digestion time of a composition according to the invention vs. a composition outside the invention

[0142] This example aims to compare the digestion rates of two inulin-based compositions.

[0143] This study was conducted in a colon digestion model published under the name COMINIGUT. In this study using this colon model, 3 human microbiotas from 3 different donors were used to better consider the biological variability of the microbiota between individuals.

[0144] The compositions used in this example are described below:

[0145] *Composition A: Composition A consists solely of native inulin (Outside the invention);

[0146] *Composition B: Composition B consists of 100% inulin particles comprising a core comprising 85% native inulin by weight of the total weight of the particle and a coating comprising 15% fractionated inulin by weight of the total weight of the particle (Composition according to the invention).

[0147] The digestion of the different compositions was carried out in the mini-digester. The pH of the medium was continuously stabilized by injecting a standardized sodium hydroxide solution. The injection of the standardized sodium hydroxide solution neutralizes the amount of short-chain fatty acids formed in the mini-digester throughout the study. Thus, the amount of sodium hydroxide introduced into the mini-digester is directly correlated with the formation of short-chain fatty acids that are produced by certain strains of bacteria throughout the study. It is therefore possible to follow the digestion kinetics of compositions A and B indirectly, by calculating the amount of sodium hydroxide solution introduced into the mini-digester to neutralize the short-chain fatty acids formed during digestion.

[0148] The digestion experiment was carried out over a period of 30 hours. It is important to note that approximately 70% of the digestion was complete after 12 hours from the start of the experiment (Figure 1).

[0149] The results presented in Figure 1 show that the fastest digestion period occurs from 4 hours to 9 hours after the start of digestion.

[0150] This period corresponds to the most active phase of digestion and is therefore likely to cause significant release of gas in the colon, causing undesirable effects such as bloating.

[0151] During this period, it is important to note that the digestion rate was reduced by approximately 18% with composition B compared to composition A (Figure 2). These results indicate that a fractionated inulin coating contributes to significantly reducing the digestion rate of native inulin, thus helping to limit the risks of side effects such as bloating resulting from overly rapid digestion by the intestinal microbiota, particularly in sensitive subjects.

[0152] In addition, these results allow us to consider a simplified dosage (one dose per day) and a possible reduction in the doses of native inulin administered, allowing better economic competitiveness compared to macrogols.

Claims

CLAIMS

1. Inulin particle comprising: - a water-soluble core comprising native inulin having an average degree of polymerization of between 9 and 14, preferably between 9 and 12; and - a water-insoluble coating coating said core, said coating comprising fractionated inulin having an average degree of polymerization greater than or equal to 15, preferably greater than or equal to 20.

2. Inulin particle according to the preceding claim, characterized in that it has a native inulin / fractionated inulin ratio of between 100 / 1 and 1 / 100, preferably between 25 / 1 and 1 / 25.

3. Inulin particle according to one of the preceding claims, characterized in that the particle has an average size of between 50 pm and 5 mm.

4. Inulin particle according to one of the preceding claims, characterized in that the particle also comprises at least one additive chosen from diluents, texturizing agents, flow agents, natural flavors, sweeteners of natural origin, compounds allowing binding with free water, hydrophobic agents, bacteria belonging to the genera Bifidobacterium and / or Lactobacillus, at least one short-chain fatty acid and / or at least one of its precursors, vitamins or minerals and mixtures thereof.

5. Composition comprising at least one inulin particle according to one of claims 1 to 4.

6. Composition according to the preceding claim, characterized in that the composition is in a solid, semi-solid or liquid form.

7. Composition according to one of claims 5 or 6, characterized in that the composition is in a form chosen from a powder, a tablet, a capsule, a gel capsule, gummies, a granule, a suspension, a gel, a paste or chewing gum.

8. A method of manufacturing an inulin particle according to one of claims 1 to 4, comprising the implementation of the following steps: a) Introduction of the native inulin particles having an average degree of polymerization of between 9 and 14 into a suitable reactor; b) Preparation of an aqueous dispersion of fractionated inulin having an average degree of polymerization greater than or equal to 15; c) Spraying the aqueous dispersion of fractionated inulin from step b) into the reactor of step a) comprising the native inulin.

9. Inulin particle according to one of claims 1 to 4 or composition according to one of claims 5 to 7 for its use as a medicament, medical device or food supplement.

10. Inulin particle or composition for its use according to the preceding claim, for preventing and / or treating intestinal digestive disorders.

11. Inulin particle or composition for its use according to the preceding claim, characterized in that the intestinal digestive disorders are chosen from constipation and dysbiosis.

12. Composition according to one of claims 5 to 7 for its use according to one of claims 9 to 11, characterized in that the composition is administered in a single dose per day, preferably at a content of less than 12g of native inulin.

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