Pharmaceutical or cosmetic composition for promoting hair strength

Abstract

Composition (C) comprising, for 100% by mass: 20% by mass to 80% by mass of at least one sphingolipid (a1), 10% by mass to 50% by mass of digalactosyldiacylglycerol (a2), and 1% by mass to 30% by mass of at least one phospholipid (a3), for use in a therapeutic treatment method for promoting hair strength. Pharmaceutical composition (Cp) and food supplement (Ca) comprising said composition (C). Non-therapeutic use of said food supplement (Ca) and non-therapeutic method of implementation.

Description

[0001] PHARMACEUTICAL OR COSMETIC COMPOSITION PROMOTING HAIR STRENGTH

[0002] The invention relates to the field of cosmetics and pharmacy. It concerns a treatment for promoting, stimulating or improving the strength of hair, in particular for strengthening or increasing its resistance to breakage and traction, as well as the volume of the hair.

[0003] The hair fiber consists of a visible shaft, a hair bulb, located under the surface of the scalp, and a dermal papilla located at the base of the bulb. The shaft is made up of three concentric layers: the medulla, the cortex, and the cuticle. The medulla is the central part, while the cortex is the middle layer and constitutes the body of the hair. The cortex is composed of long chains of keratin that give the hair its elasticity, flexibility, and strength. The hair fiber is protected by the cuticle, formed by keratin scales sealed together by an intercellular cement rich in lipids, particularly ceramides. These lipid substances provide the hair's barrier function by giving it a certain impermeability.

[0004] At its base, the shaft is surrounded by two sheaths: the outer epithelial sheath, which has a composition similar to the epidermis, and the inner epithelial sheath, rich in glycoproteins, constituting the nourishing base of the developing hair. The hair bulb is composed of keratinocytes whose active division is responsible for the formation of the hair shaft, as well as the inner and outer epithelial sheaths. The dermal papilla is a highly vascularized area and constitutes the site of cell multiplication necessary for hair growth. It is composed of fibroblasts and ensures nutrition, irrigation, oxygenation and the elimination of cellular waste from the hair.

[0005] Hair grows according to a growth cycle composed of three successive phases: the anagen phase (growth phase), the catagen phase (regression phase) and the telogen phase (resting phase).

[0006] The anagen phase is a growth phase, lasting on average 2 to 4 years in men and up to 6 years in women. This phase is characterized by rapid proliferation and differentiation of keratinocytes to form the hair and epithelial sheaths. Intense metabolic activity in the bulb leads to the formation of keratin, a protein essential to the composition of hair. Under normal conditions, approximately 85% of the hair is in the anagen phase.

[0007] The catagen phase is a regression phase, lasting two to three weeks, constituting the transition phase between the growth phase and the resting phase. This phase is characterized by the involution of the hair follicle by a phenomenon of programmed death. Cell differentiation decreases until it stops. The volume of the bulb decreases, the latter rises towards the surface of the epidermis until causing the rupture of the physical link with the dermal papilla. This phase concerns approximately 1% of the hair.

[0008] The telogen phase is a resting phase preceding hair loss, lasting an average of two to three months. This phase is characterized by a lack of cell proliferation. The dead hair remains attached to the hair follicle and falls out when it is displaced by a new hair, for which a new anagen phase begins. This phase affects approximately 10 to 15% of the hair.

[0009] Under the influence of various factors, this hair cycle can be altered. In particular, stress, fatigue, pollution, hormonal imbalance, or drug treatment can lead to abundant and non-localized hair loss, called telogen effluvium. In this case, the proportion of hair in the telogen phase increases, sometimes exceeding 20%. This is called telogen effluvium. This disruption generally lasts between two and four months and is accompanied by a weakening of the hair structure.

[0010] As part of their research aimed at developing the use of natural compounds in therapy and cosmetics, the inventors have demonstrated that the use of a composition derived from wheat gluten extracts, administered orally, is capable of promoting, stimulating or improving the strength of hair or restoring strength to the hair, in particular to strengthen or increase its resistance to breakage and traction, as well as the volume of the hair.

[0011] According to a first aspect, the invention thus relates to a composition (C) characterized in that it is a wheat gluten extract, comprising for 100% by mass: from 20% by mass to 80% by mass of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, from 10% by mass to 50% by mass of digalactosyldiacylglycerol (a2), and from 1% by mass to 30% by mass of at least one phospholipid (a3), and in that the sum of the mass contents of said at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, of said digalactosyldiacylglycerol (a2) and of said at least one phospholipid (a3), is equal to 100% by mass, for its use by oral route, in a method therapeutic treatment to increase the elasticity and tensile strength of hair. For the purposes of the present invention, the term "sphingolipids" means complex lipids resulting from the amidation of a fatty acid on sphingosine.Sphingosine is an amido-diol with an ethylenic double bond; called 2-amino-octadec-4-ene-1,3-diol and of formula (I):.

[0012] For the purposes of the present invention, the term "phospholipid" means a lipid comprising a phosphoric acid group in the form of a monoester or diester, and more particularly phosphoethanolamines, phosphatidylinositol, lysophosphatidylethanolamines, phosphatidic acids, phosphatidylcholine and lysophosphatidylcholines.

[0013] According to a first particular aspect, the composition (C) as defined above comprises, for 100% by mass, from 20% by mass to 60% by mass, at least one sphingolipid (a1). According to a second particular aspect, the composition (C) as defined above comprises, for 100% by mass, from 19% by mass to 50% by mass, digalactosyldiacylglycerol (a2). According to a third particular aspect, the composition (C) as defined above comprises, for 100% by mass, from 1% by mass to 10% by mass, at least one phospholipid (a3). The invention more particularly relates to a composition (C) as defined above comprising for 100% by mass: from 20% by mass to 60% by mass of at least one sphingolipid (a1) resulting from the amidation of a fatty acid on sphingosine, from 19% by mass to 50% by mass of digalactosyldiacylglycerol (a2), and from 1% by mass to 10% by mass of at least one phospholipid (a3).for its use in a therapeutic treatment method intended to promote hair strength.

[0014] According to another particular aspect of the invention, the composition (C) as defined above is in oily form or in powder form.

[0015] Said composition (C) as defined above, is prepared by methods known to those skilled in the art and more particularly that described in the international application published under number WO 99 / 65459, on pages 8 to 11. It is more particularly prepared according to a process comprising the following successive steps:

[0016] - At least one step a) of providing wheat gluten flour, - At least one step b) of adding the wheat gluten flour to ethanol (97% minimum) with mechanical stirring for a period of at least two hours and at a temperature of 60°C,

[0017] - At least one step c) of spinning followed by a sub-step of decantation of the mixture obtained in step b) so as to recover a homogeneous liquid phase,

[0018] - At least one step d) of vacuum distillation of the liquid obtained during step c), at a temperature less than or equal to 35°C to remove the ethanol so as to obtain a concentrated composition,

[0019] - At least one step e) of adding the product obtained at the end of step d) to ethanol, with mechanical stirring and at a temperature of 4°C, so as to precipitate the medium and recover the liquid part,

[0020] - At least one step f) of distillation of the liquid obtained at the end of step e) to remove the ethanol and obtain an oily composition,

[0021] - At least one step g) of adding composition (C) to acetone so as to obtain a precipitate,

[0022] - At least one step h) of filtration of the medium obtained at the end of step g) making it possible to recover a powdery solid, of drying the solid cake obtained at the end of step g) to obtain a composition in powder form.

[0023] The present invention also relates to an edible pharmaceutical composition (Cp) comprising for 100% by mass:

[0024] - more than 0% by mass to 30% by mass of said composition (C) as defined above and from 70% by mass to less than 100% by mass of at least one pharmaceutically acceptable edible technological additive, for its oral use, in a therapeutic treatment method for increasing the elasticity and tensile strength of hair.

[0025] Preferably, said edible pharmaceutical composition (Cp) comprises for 100% by mass:

[0026] - from 10% by mass to 30% by mass of a composition (C) comprising for 100% by mass:

[0027] - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine,

[0028] - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and

[0029] - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine, of said digalactosyldiacylglycerol (a2) and of said at least one phospholipid (a3), being equal to 100% by mass, and said composition (C) being a wheat gluten extract, and

[0030] - from 70% by mass to 90% by mass of at least one pharmaceutically acceptable edible technological additive, for oral use, in a therapeutic treatment method for increasing the elasticity and tensile strength of hair.

[0031] By "technological additive" is meant any chemical substance or chemical composition whose technical function is to enable and / or facilitate the mixing of the different constituents of said edible composition, to facilitate and / or optimize the physical properties of said edible composition, as well as to facilitate and / or optimize its flow, its stability, and its incorporation into a subsequent pharmaceutical and / or nutritional formulation, and which are likely to comply with the conditions required by the regulations in force for the placing on the market of a pharmaceutical formulation and / or a nutritional formulation.

[0032] A pharmaceutically acceptable technological additive means a technological additive whose use meets the requirements of the pharmaceutical regulations in force in a country concerned.

[0033] According to a particular aspect of the invention, said pharmaceutically acceptable edible technological additive is chosen from a diluting agent, a flow agent, a binding agent or a disintegrating agent.

[0034] Examples of diluting agents are lactose, sucrose, saccharose, glucose, maltodextrin, mannitol, sorbitol, xylitol, isomalt, calcium hydrogen phosphate, microcrystalline cellulose, starches such as corn, wheat or potato starch, dicalcium phosphate, sodium, calcium or magnesium carbonates, monoglycerides and / or diglycerides of fatty acids with 8 to 24 carbon atoms. Examples of free-flowing agents are magnesium stearate, talc, sodium stearyl fumarate, hydrogenated vegetable oils, colloidal anhydrous silica, sodium benzoate or silicon dioxide.

[0035] Binding agents include, for example, starches in the form of starch, pregelatinized starches, hydroxypropylmethyl cellulose (HPMC), methylcellulose, sucrose syrups or acacia gum.

[0036] Examples of disintegrating agents are starches, sodium starch glycolate, alginic acid, sodium alginate, croscarmellose sodium, crospovidone, and polyvinylpyrrolidone.

[0037] According to a particular aspect of the invention, said edible pharmaceutical composition (Cp) as defined above, further comprises at least one active ingredient chosen from bioactive lipids, salts of water-soluble or water-dispersible trace elements, water-soluble or fat-soluble vitamins, prebiotics, probiotics, proteins and / or milk protein concentrates, plant or animal enzymes, amino acids, peptides, sugars, flavor enhancers and flavoring agents.

[0038] As bioactive lipids possibly present in said edible pharmaceutical composition (Cp) as defined above, there are for example phytosterols, such as those extracted from vegetable oils, and more particularly extracts of sea buckthorn oil, corn oil or soybean oil; phytosterol complexes isolated from vegetable oils, such as cholestatin composed of campesterol, stigmasterol and brassicasterol; phytostanols; carotenoids, which belong to the family of terpenoids extracted from algae, green plants, fungi, bacteria; polyunsaturated fatty acids of the omega-3 group, such as alpha-linoleic acid, eicosapentaenoic acid, docosahexaenoic acid;polyunsaturated fatty acids of the omega-6 group, such as linoleic acid, g-linoleic acid, eicosadienoic acid, dihomo-y-linoleic acid, arachidonic acid, docosadienoic acid, docosatetraenoic acid, docosapentaenoic acid.;

[0039] As salts of water-soluble or water-dispersible trace elements possibly present in said edible pharmaceutical composition (Cp) as defined above, there are for example ferrous carbonate, ferrous chloride tetrahydrate, ferric chloride hexahydrate, ferrous citrate hexahydrate, ferrous fumarate, ferrous lactate tetrahydrate, ferrous sulfate monohydrate, ferrous sulfate heptahydrate, ferrous chelate of amino acids hydrates, iron chelate of glycine; calcium iodate hexahydrate, anhydrous calcium iodate; sodium iodide, potassium iodide; cobalt acetate tetrahydrate, basic cobalt carbonate monohydrate, cobalt carbonate hexahydrate, cobalt sulfate heptahydrate, cobalt sulfate monohydrate, cobalt nitrate hexahydrate;cupric acetate monohydrate, basic copper carbonate monohydrate, cupric chloride dihydrate, copper methionate, cupric sulfate pentahydrate, cuprous chelate of amino acids hydrates, cuprous chelate of glycine hydrate, copper chelate of hydroxy analogue of methionine; manganous carbonate, manganous chloride tetrahydrate, manganese acid phosphate trihydrate, manganous sulfate tetrahydrate, manganese sulfate monohydrate, manganese chelate of amino acids hydrate, manganese chelate of glycine hydrate, manganese chelate of hydroxy analogue of methionine; ammonium molybdate, sodium molybdate, sodium selenite, sodium selenate; the organic form of selenium produced by Saccharomyces cerevisiae, selenomethionine (inactivated selenium yeast), and seleno methionine produced by Saccharomyces cerevisiae (inactivated selenium yeast).;

[0040] As water-soluble or fat-soluble vitamins possibly present in said edible pharmaceutical composition (Cp) as defined above, there is for example vitamin A, more particularly in its form of retinol, retinyl acetate, retinyl palmitate or β-carotene; vitamin D2, more particularly in its form of ergocalciferol, or 25-hydroxy calciferol; vitamin D3, more particularly in its form of cholecalciferol; vitamin K, more particularly in its form of phylloquinone (phytomenadione) or Menaquinone; vitamin B1, more particularly in its form of thiamine hydrochloride, thiamine mononitrate, thiamine chloride monophosphate, or thiamine chloride pyrophosphate, vitamin B2, more particularly in its form of riboflavin, riboflavin 5'-phosphate sodium, vitamin B6, more particularly in its form of pyridoxine hydrochloride, pyridoxine 5'-phosphate,or pyridoxal 5'-phosphate, vitamin B 12, more particularly in its form of cyanocobalamin, hydroxocobalamin, 5'-deoxyadenosylcobalamin, or methylcobalamin, vitamin C, more particularly in its form of L-ascorbic acid, sodium L-ascorbate, calcium L-ascorbate, potassium L-ascorbate, calcium salts of palmityl-6-L-ascorbic acid, sodium ascorbyl monophosphate, pantothenic acid, more particularly in its form of calcium D-pantothenate, sodium D-pantothenate, Dexpanthenol, or Pantethine, vitamin PP, more particularly in its form of nicotinic acid, niacin, nicotinamide, or inositol hexanicotinate (hexaniacinate inositol), vitamin B9, more particularly in its folic acid form, folates, more particularly in their steroylmonoglutamic acid form, calcium L-methylfolate, (6S)-5-methyltetrahydrofolic acid in the form of glucosamine salt,vitamin H2, B7 or BW, more particularly in its biotin form, choline, more particularly in its choline chloride form, choline dihydrogen citrate, choline bitartrate, inositol, carnitine, more particularly in its L-carnitine form, L-carnitine-L-tartrate, taurine. As prebiotics possibly present in said edible pharmaceutical composition (Cp) as defined above, there are for example inulin, trans-galacto-oligosaccharides, fructans and manno-oligosaccharides.,

[0041] As probiotics possibly present in said edible pharmaceutical composition (Cp) as defined above, there are different strains of Saccharomyces cerevisiae, Bacillus cereus var toyoi, Bacillus subtilis alone or in combination with Bacillus licheniformis, or strains of Enterococcus faecium. These strains of microorganisms are generally associated with a solid support, for example calcium carbonate, dextrose or sorbitol.

[0042] As proteins and / or protein concentrates possibly present in said edible pharmaceutical composition (Cp) as defined above, there are for example milk proteins derived from milk, such as colostrum in the form of lyophilized or atomized powder or whey in the form of powder, purified fractions or enriched with IgG, lactoferrin, lactoperoxidase.

[0043] As plant or animal enzymes possibly present in the edible pharmaceutical composition (Cp) as defined above, there are for example promutase, superoxide dismutase (SOD), 3-phytase, 6-phytase, endo-l,4-betaglucanases, endo-l,4-betaxylanases, or other enzymes improving or promoting digestion. As peptides possibly present in said edible pharmaceutical composition (Cp) as defined above, there are for example avocado peptides, lupin peptides, quinoa peptides, maca peptides, fermented or non-fermented soybean peptides, rice peptides, peptides present in Acacia macrostachya seed extract, peptides present in passionflower seed extracts.

[0044] As amino acids possibly present in said edible pharmaceutical composition (Cp) as defined above, there are for example alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, hydroxy-proline, pyrrolysine, selmeno-cysteine, serine, threonine, tryptophan, tyrosine, valine, sarcosine, omithine. As sugars possibly present in said edible pharmaceutical composition (Cp) as defined above, there are for example water-soluble polysaccharides, sugars of lower molecular weight, such as oligosaccharides, mono- or disaccharides, such as for example glucose, lactose, dextrose.

[0045] As flavor enhancers possibly present in the edible pharmaceutical composition (Cp) as defined above, there are for example glutamates, such as glutamic acid, monosodium glutamate, monopotassium glutamate, calcium diglutamate, ammonium glutamate, magnesium diglutamate; guanylates, such as for example guanylic acid (guanosine monophosphate), disodium guanylate, dipotassium guanylate, calcium guanylate, inosinates, such as for example inosinic acid, disodium inosinate, dipotassium inosinate, calcium inosinate, or intense sweeteners such as Stevia extracts, Rebiaudosides.

[0046] Said edible pharmaceutical composition (Cp) may be in solid or liquid form.

[0047] According to a particular aspect of the invention, said edible pharmaceutical composition (Cp) is in the form of a solid, and more particularly the form of a tablet, a capsule, a soft capsule, a powder, a dragee, a confectionery gum or a granule.

[0048] When the edible pharmaceutical composition (Cp) as defined above is in the form of a tablet, it preferably comprises from 50 mg to 150 mg of said composition (C) as defined above, for a 500 mg tablet; when it is in the form of a soft capsule, it preferably comprises from 120 mg to 360 mg of said composition (C) for a 1200 mg soft capsule; when it is in the form of a capsule, it preferably comprises from 10 mg to 30 mg of composition (C) for a 100 mg capsule; when it is in the form of a powder, it preferably comprises from 200 mg to 600 mg of composition (C) for a 2000 mg powder.

[0049] When the edible pharmaceutical composition (Cp) is in the form of a powder, it is obtained by introducing its various constituents into a mixer equipped with at least one mechanical stirring system, such as for example flat or propeller-type stirring blades, and the mixer is optionally a turning mixer, and the mixer is optionally equipped with an emitter-type system. This mixing operation is generally carried out at room temperature, in particular between 15°C and 30°C. When the edible pharmaceutical composition (Cp) is in the form of a confectionery gum, it preferably comprises from 150 mg to 450 mg of composition (C) for a 1.5 g confectionery gum.

[0050] When the edible pharmaceutical composition (Cp) is in the form of a liquid, it preferably comprises from 100 mg to 300 mg of composition (C) for a 1 cm ampoule 3 .

[0051] The invention also relates to the cosmetic use in oral administration of an effective amount of a composition (C) comprising for 100% by mass:

[0052] - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine,

[0053] - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and

[0054] - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine, of said digalactosyldiacylglycerol (a2) and of said at least one phospholipid (a3), being equal to 100% by mass and said composition (C) being a wheat gluten extract, for increasing the elasticity and tensile strength of the hair as well as a cosmetic treatment method intended to increase the elasticity and tensile strength of the hair, characterized in that an effective amount of the composition (C) as defined above is administered orally.

[0055] For the purposes of the present invention, "effective amount" means a sufficient amount which allows a consumer of average attention to visually observe the reality of the aesthetic aspect invoked with regard to the strength of their own hair, in particular the increase in the resistance to breakage of the hair, the tensile strength of the hair and the increase in the volume of the hair.

[0056] The experimental study set out in the remainder of this description shows that an amount of between 1 mg and 250 mg, more particularly between 10 mg and 150 mg, even more particularly between 15 mg and 100 mg, and even more particularly between 30 mg and 70 mg of said composition, ingested per day, can be considered as an effective amount. The present invention also relates to a food supplement (Ca) comprising for 100% by mass:

[0057] - More than 0% by mass to 30% by mass of said composition (C) as defined above and from 70% by mass to less than 100% by mass of at least one nutritionally acceptable technological additive.

[0058] Preferably, said food supplement (Ca) comprises for 100% by mass:

[0059] - more than 0% by mass and less than 10% by mass of a composition (C) comprising for 100% by mass:

[0060] - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine,

[0061] - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and

[0062] - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine, of said digalactosyldiacylglycerol (a2) and of said at least one phospholipid (a3), being equal to 100% by mass and said composition (C) being a wheat gluten extract, and

[0063] - more than 90% by mass and less than 100% by mass of at least one nutritionally acceptable technological additive.

[0064] A food supplement is an edible composition intended 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. A food supplement helps to avoid certain deficiencies or to meet specific needs in an individual's diet, particularly during physical exertion. This definition of "food supplement" is given in Article 2 of Decree No. 2006-352 of March 26, 2006 of the French Republic relating to food supplements and in Directive 2002 / 46 / EC of the European Parliament and of the Council of June 10, 2002.

[0065] By "nutritionally acceptable technological additive" is meant a technological additive as defined above, the use of which meets the requirements of the regulations relating to food supplements in force in a country in question. According to a particular aspect of the invention, said nutritionally acceptable technological additive is chosen from a diluting agent, a flow agent, a binding agent or a disintegrating agent.

[0066] Examples of diluting agents are lactose, sucrose, saccharose, glucose, maltodextrin, mannitol, sorbitol, xylitol, isomalt, calcium hydrogen phosphate, microcrystalline cellulose, starches such as corn, wheat or potato starch, dicalcium phosphate, sodium, calcium or magnesium carbonates, monoglycerides and / or diglycerides of fatty acids with 8 to 24 carbon atoms. Examples of free-flowing agents are magnesium stearate, talc, sodium stearyl fumarate, hydrogenated vegetable oils, colloidal anhydrous silica, sodium benzoate or silicon dioxide.

[0067] Binding agents include, for example, starches in the form of starch, pregelatinized starches, hydroxypropylmethyl cellulose (HPMC), methylcellulose, sucrose syrups or acacia gum.

[0068] Examples of disintegrating agents are starches, sodium starch glycolate, alginic acid, sodium alginate, croscarmellose sodium, crospovidone, and polyvinylpyrrolidone.

[0069] According to a particular aspect of the invention, said food supplement (Ca) as defined above, further comprises at least one active ingredient chosen from bioactive lipids, water-soluble or water-dispersible trace element salts, water-soluble or fat-soluble vitamins, prebiotics, probiotics, proteins and / or milk protein concentrates, plant or animal enzymes, amino acids, peptides, sugars, flavor enhancers and flavoring agents.

[0070] As bioactive lipids possibly present in said food supplement (Ca) as defined above, there are for example phytosterols, such as those extracted from vegetable oils, and more particularly extracts of sea buckthorn oil, corn oil, or soybean oil; phytosterol complexes isolated from vegetable oils, such as cholestatin composed of campesterol, stigmasterol and brassicasterol; phytostanols; carotenoids, which belong to the family of terpenoids extracted from algae, green plants, fungi, bacteria; polyunsaturated fatty acids of the omega-3 group, such as alpha-linoleic acid, eicosapentaenoic acid, docosahexaenoic acid;polyunsaturated fatty acids of the omega-6 group, such as linoleic acid, g-linoleic acid, eicosadienoic acid, dihomo-y-linoleic acid, arachidonic acid, docosadienoic acid, docosatetraenoic acid, docosapentaenoic acid. As salts of water-soluble or water-dispersible trace elements possibly present in said food supplement (Ca) as defined above, there are for example ferrous carbonate, ferrous chloride tetrahydrate, ferric chloride hexahydrate, ferrous citrate hexahydrate, ferrous fumarate, ferrous lactate tetrahydrate, ferrous sulfate monohydrate, ferrous sulfate heptahydrate, ferrous chelate of amino acids hydrates, iron chelate of glycine; calcium iodate hexahydrate, calcium iodate anhydrous; sodium iodide, potassium iodide;cobalt acetate tetrahydrate, basic cobalt carbonate monohydrate, cobalt carbonate hexahydrate, cobalt sulfate heptahydrate, cobalt sulfate monohydrate, cobalt nitrate hexahydrate; cupric acetate monohydrate, basic copper carbonate monohydrate, cupric chloride dihydrate, copper methionate, cupric sulfate pentahydrate, cuprous chelate of amino acids hydrates, cuprous chelate of glycine hydrate, copper chelate of hydroxy analogue of methionine; manganous carbonate, manganous chloride tetrahydrate, manganese acid phosphate trihydrate, manganous sulfate tetrahydrate, manganous sulfate monohydrate, manganese chelate of amino acids hydrate, manganese chelate of glycine hydrate, manganese chelate of hydroxy analogue of methionine; ammonium molybdate, sodium molybdate, sodium selenite, sodium selenate;the organic form of selenium produced by Saccharomyces cerevisiae, selenomethionine (inactivated selenium yeast), and seleno methionine produced by Saccharomyces cerevisiae (inactivated selenium yeast).;

[0071] As water-soluble or fat-soluble vitamins possibly present in said food supplement (Ca) as defined above, there is for example vitamin A, more particularly in its form of retinol, retinyl acetate, retinyl palmitate or P-carotene; vitamin D2, more particularly in its form of ergocalciferol, or 25-hydroxy calciferol; vitamin D3, more particularly in its form of cholecalciferol; vitamin K, more particularly in its form of phylloquinone (phytomenadione) or Menaquinone; vitamin B1, more particularly in its form of thiamine hydrochloride, thiamine mononitrate, thiamine chloride monophosphate, or thiamine chloride pyrophosphate, vitamin B2, more particularly in its form of riboflavin, riboflavin 5'-sodium phosphate, vitamin B6, more particularly in its form of pyridoxine hydrochloride, pyridoxine 5'-phosphate,or pyridoxal 5'-phosphate, vitamin B 12, more particularly in its form of cyanocobalamin, hydroxocobalamin, 5'-deoxyadenosylcobalamin, or methylcobalamin, vitamin C, more particularly in its form of L-ascorbic acid, sodium L-ascorbate, calcium L-ascorbate, potassium L-ascorbate, calcium salts of palmityl-6-L-ascorbic acid, sodium ascorbyl monophosphate, pantothenic acid, more particularly in its form of calcium D-pantothenate, sodium D-pantothenate, Dexpanthenol, or Pantethine, vitamin PP, more particularly in its form of nicotinic acid, niacin, nicotinamide, or inositol hexanicotinate (hexaniacinate inositol), vitamin B9, more particularly in its folic acid form, folates, more particularly in their pteroylmonoglutamic acid form, calcium L-methylfolate, (6S)-5-methyltetrahydrofolic acid in the form of glucosamine salt,vitamin H2, B7 or BW, more particularly in its biotin form, choline, more particularly in its choline chloride, choline dihydrogen citrate, choline bitartrate form, inositol, carnitine, more particularly in its L-carnitine, L-carnitine-L-tartrate form, taurine.,

[0072] As prebiotics possibly present in said food supplement (Ca) as defined above, there are for example inulin, trans-galacto-oligosaccharides, fructans and manno-oligosaccharides.

[0073] As probiotics possibly present in said food supplement (Ca) as defined above, there are different strains of Saccharomyces cerevisiae, Bacillus cereus var toyoi, Bacillus subtilis alone or in combination with Bacillus licheniformis, or strains of Enterococcus faecium. These strains of microorganisms are generally associated with a solid support, for example calcium carbonate, dextrose or sorbitol.

[0074] As proteins and / or protein concentrates possibly present in said food supplement (Ca) as defined above, there are for example milk proteins derived from milk, such as colostrum in the form of freeze-dried or atomized powder or whey in the form of powder, purified fractions or enriched with IgG, lactoferrin, lactoperoxidase.

[0075] As plant or animal enzymes possibly present in said food supplement (Ca) as defined above, there are for example promutase, superoxide dismutase (SOD), 3-phytase, 6-phytase, endo-1,4-betaglucanases, endo-1,4-betaxylanases, or other enzymes improving or promoting digestion.

[0076] As peptides possibly present in said food supplement (Ca) as defined above, there are for example avocado peptides, lupin peptides, quinoa peptides, maca peptides, fermented or non-fermented soy peptides, rice peptides, peptides present in Acacia macrostachya seed extract, peptides present in passionflower seed extracts.

[0077] As amino acids possibly present in said food supplement (Ca) as defined above, there are for example alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, hydroxy-proline, pyrrolysine, selmeno-cysteine, serine, threonine, tryptophan, tyrosine, valine, sarcosine, omithine.

[0078] As sugars possibly present in said food supplement (Ca) as defined above, there are for example water-soluble polysaccharides, sugars of lower molecular weight, such as oligosaccharides, mono- or disaccharides, such as for example glucose, lactose, dextrose.

[0079] As flavor enhancers possibly present in said food supplement (Ca) as defined above, there are for example glutamates, such as glutamic acid, monosodium glutamate, monopotassium glutamate, calcium diglutamate, ammonium glutamate, magnesium diglutamate; guanylates, such as for example guanylic acid (guanosine monophosphate), disodium guanylate, dipotassium guanylate, calcium guanylate, inosinates, such as for example inosinic acid, disodium inosinate, dipotassium inosinate, calcium inosinate, or intense sweeteners such as Stevia extracts, Rebiaudosides.

[0080] The said food supplement (Ca) can be in solid or liquid form.

[0081] Said food supplement (Ca) may be in any form of food product known to those skilled in the art, such as a drink, and more particularly an aqueous drink, a solution, a fruit juice, a flavored drink, an energy drink, an alcoholic drink, a coffee-based drink, a chocolate-based drink, a tea-based drink, a dairy product, and more particularly milk, yogurt, a dairy dessert, drinking yogurt, cheese, ice cream, a chocolate bar, a cereal product, and more particularly a cereal bar, a biscuit, breakfast cereals, flours, bakery products, a specialized nutrition product, more particularly an infant nutrition product, a nutrition product to prepare for physical exertion, a clinical nutrition product, a meal replacement, confectionery, more particularly chewing gum, candies, caramels, sugared almonds,berlingots, marshmallows, lokoums, nougats, fruit pastes, liquorice. The food supplement (Ca) according to the invention may also be presented in any galenic form known to those skilled in the art, such as for example in the form of a tablet, a capsule, a soft capsule, a syrup, a powder, such as for example an immediate-release powder, a delayed-release powder or a powder for reconstituted drinks, a liquid, a stick, a gel.,

[0082] According to a particular aspect of the invention, said food supplement (Ca) as defined above, is in the form of a solid, and more particularly the form of a tablet, a capsule, a soft capsule, a powder, a dragee, a confectionery gum or a granule.

[0083] When said food supplement (Ca) as defined above is in the form of a tablet, it preferably comprises less than 50 mg of said composition (C) as defined above, for a 500 mg tablet; when it is in the form of a soft capsule, it preferably comprises less than 120 mg of said composition (C) for a 1200 mg soft capsule; when it is in the form of a capsule, it preferably comprises less than 10 mg of said composition (C) as defined above for a 100 mg capsule; when it is in the form of a powder, it preferably comprises less than 200 mg of said composition (C) as defined above for a 2000 mg powder.

[0084] When said food supplement (Ca) is in the form of a powder, it is obtained by introducing its various constituents into a mixer equipped with at least one mechanical stirring system, such as for example flat or propeller-type stirring blades, and the mixer is optionally a turning mixer, and the mixer is optionally equipped with an emitter-type system. This mixing operation is generally carried out at room temperature, in particular between 15°C and 30°C.

[0085] When said food supplement (Ca) is in the form of a confectionery gum, it preferably comprises less than 150 mg of said composition (C) as defined previously for a 1.5 g confectionery gum.

[0086] When the food supplement (Ca) is in the form of a liquid, it preferably comprises less than 100 mg of said composition (C) as defined above for a 1 cm ampoule. 3 .

[0087] The invention also relates to the use in oral administration of the food supplement (Ca) as defined above, to increase the elasticity and tensile strength of the hair as well as a cosmetic treatment method intended to increase the elasticity and tensile strength of the hair, characterized in that an effective quantity of the food supplement (Ca) as defined above is administered orally.

[0088] According to a particular aspect of the invention, said food supplement (Ca) as defined above is administered orally at a rate of at least 15 mg, in particular at least 30 mg, of said composition (C) per day for at least 4 weeks, in particular for at least 8 weeks, even more particularly for 12 weeks.

[0089] The following examples illustrate the invention, without however limiting it.

[0090] Comparative formulations

[0091] A commercial wheat gluten extract is used in the form of a powdered composition (C) which comprises, for 100% of its mass: 52.5% by mass of sphingolipids, 41.5% by mass of DigalactosylDiacylGlycerol and 6% by mass of phospholipids.

[0092] Two formulations were prepared, respectively a food supplement (Ca) (comprising composition (C)) and a food supplement (C'a) (not comprising composition (C)), which comprise the ingredients as shown in Table 1: [Table 1] Operating mode

[0093] The technical effect of composition (C) was demonstrated in a pilot, randomized, double-blind, parallel-group clinical study. It tested the effect of daily consumption of 30 mg of (C) versus placebo over a period of 84 days (12 weeks).

[0094] Caucasian women aged 18 to 65 years, with telogen effluvium (proportion of hair in the telogen phase > 15%) and complaining of thin, brittle hair, and a sebum level greater than or equal to 140 pg / cm 2, were included in the study. They consumed for 84 days (from JO to D84) either 2 capsules per day of the food supplement (Ca) or 2 capsules per day of the food supplement (C'a). The measurements were carried out on day 0 (JO) and 56 (D56) and 84 days (D84).

[0095] A- Hair strength:

[0096] Hair strength is characterized by its resistance to breakage, tensile strength, and hair volume. It was also analyzed through a self-assessment questionnaire completed by the study subjects.

[0097] A, 1- Resistance to breakage:

[0098] Principle of the evaluation method

[0099] Resistance to breakage was assessed by measuring hair elasticity using a dynamometer (Tensolab 2512A, Mesdan Lab) in accordance with the UNI EN ISO 5079:1998 standard procedure. The reading was taken hair by hair by setting the instruments as follows: elongation speed: 50 mm / min; pre-tension: 5 cN. Fifteen hairs were collected and measured. Hair elasticity corresponds to their maximum elongation (% of the initial hair length) before breakage.

[0100] Results

[0101] The results obtained are presented in Table 2.

[0102] [Table 2]

[0103] ETM: standard error of measurement Observations - Comments

[0104] A significant increase in hair elasticity was observed in the composition (Ca) group after 84 days of consumption: from 44.1 ± 0.7% at D0 to 45.2 ± 0.6% at D84 (p=0.008), while there was no significant change in the composition (C'a) group: 45.5 ± 0.6% at D0 to 45.2 ± 0.5% at D84.

[0105] Furthermore, there was a significant difference between the composition (Ca) group and the composition (C'a) group at D84 (+2.8% vs -0.3%; p=0.013).

[0106] This increase was also highlighted by the use of the questionnaire completed by the study subjects, which shows that 85% of subjects in the composition (Ca) group reported that their “hair was less susceptible to breakage”, compared to 78% of subjects in the composition (C'a) group, and 91% of subjects in the composition (Ca) group reported that their “hair had fewer split ends”, compared to 72% of subjects in the composition (C'a) group.

[0107] A, 2- Tensile strength:

[0108] Principle of the evaluation method

[0109] Hair tensile strength was assessed using the “pull test,” which involves gently pulling a strand of hair (approximately 60) in three areas of the scalp (frontal, temporal, and occipital) and then counting the number of hairs extracted. In this test, hairs in the anagen phase remain rooted, while hairs in the telogen phase are easily extracted. If the number of extracted hairs is greater than 9, the pull test is positive and indicates telogen effluvium. Results

[0110] The results obtained are presented in Table 3.

[0111] [Table 3]

[0112] ETM: standard error of measurement

[0113] Observations - Comments

[0114] A significant increase in tensile strength was observed in the composition (Ca) group after 56 days of consumption: from 14.9 ± 0.6 hairs extracted at D0 to 12.5 ± 0.6 hairs extracted at D56 (p=0.028) and 7.6 ± 0.3 hairs extracted at D84 (p<0.0001), whereas a significant decrease was observed in the composition (C'a) group only after 84 days of consumption: from 14.3 ± 0.7 hairs extracted at D0 to 13.5 ± 0.8 hairs extracted at D56 and 8.5 ± 0.3 hairs extracted at D84 (p<0.0001).

[0115] In addition, there was a significant difference between the composition (Ca) group and the composition (C'a) group at D56 (-14.7% vs -4.7%; p=0.046) and borderline significant at D84 (-47.9% vs -38.2%; p=0.052).

[0116] A, 3- The volume of the hair:

[0117] Principle of the evaluation method

[0118] Hair volume was also analyzed through a clinical assessment performed by a dermatologist as well as using a self-assessment form completed by the study subjects.

[0119] Observations - Comments An increase in hair volume was noted by clinical assessment (performed by a dermatologist) in 58% of subjects in the composition (Ca) group at D56 (vs. 47% of subjects in the composition (C'a) group), and in 64% of subjects in the composition (Ca) group at D84 (vs. 59% of subjects in the composition (C'a) group). This increase was also highlighted by the study subjects, with 85% of subjects in the composition (Ca) group reporting that their “hair was fuller,” compared to 66% of subjects in the composition (C'a) group, and 76% of subjects in the composition (Ca) group reporting that their “hair was thicker,” compared to 63% of subjects in the composition (C'a) group. A, 4 Conclusions

[0120] Through the clinical study, composition (C) has demonstrated its activity in increasing hair strength, thanks to its effect on hair breakage resistance, hair tensile strength, and its effect on increasing hair volume.

[0121] Examples of illustrative formulations [Table 4] Clinical study capsule formula

[0122] [Table 5] Formula for capsules [Table 6] Formula for soft capsules Bibliography

[0123] (1) Lin et al. Morphogenesis, Growth Cycle and Molecular Regulation. Frontiers in Cell and Developmental Biology 2022, 10:899095.

[0124] (2) Patent application FR3069160A1: Cosmetic or pharmaceutical composition promoting hair growth comprising a lyophilisate of dedifferentiated sea fennel cells.

[0125] (3) Nikfar & Jaberidoost. Hair In Encyclopedia of Toxicology (Third Edition), Academic Press, 2014, 813-815.

[0126] (4) Patent application EP2821052A1: Association of miliacin and polar lipids, in particular sphingolipids and / or phospholipids, for hair and scalp care. (5) Yin et al. Telogen Effluvium - a review of the science and current obstacles. Journal of

[0127] Dermatological Science 2021, 101, 156-163.

Claims

CLAIMS 1. Composition (C) characterized in that it is a wheat gluten extract, comprising for 100% by mass: - from 20% by mass to 80% by mass of at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass of at least one phospholipid (a3), and in that the sum of the mass contents of said at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine, of said digalactosyldiacylglycerol (a2) and of said at least one phospholipid (a3), is equal to 100% by mass, for its oral use, in a therapeutic treatment method for increasing the elasticity and tensile strength of hair.

2. Composition (C) according to claim 1, comprising for 100% by mass: - from 20% by mass to 60% by mass of at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine, - from 19% by mass to 50% by mass of digalactosyldiacylglycerol (a2), and - from 1% by mass to 10% by mass of at least one phospholipid (a3).

3. Edible pharmaceutical composition (Cp) comprising 100% by mass: - from 10% by mass to 30% by mass of a composition (C) comprising for 100% by mass: - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine, of said digalactosyldiacylglycerol (a2) and of said at least one phospholipid (a3), being equal to 100% by mass, and said composition (C) being an extract of wheat gluten, and - from 70% by mass to 90% by mass of at least one pharmaceutically acceptable edible technological additive, for oral use, in a therapeutic treatment method for increasing the elasticity and tensile strength of hair.

4. Edible pharmaceutical composition (Cp) according to claim 3, further comprising at least one active ingredient chosen from bioactive lipids, water-soluble or water-dispersible trace element salts, water-soluble or fat-soluble vitamins, prebiotics, probiotics, proteins and / or milk protein concentrates, plant or animal enzymes, amino acids, peptides, sugars, flavor enhancers and flavoring agents.

5. Cosmetic use in oral administration of an effective quantity of a composition (C) comprising for 100% by mass: - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine, of said digalactosyldiacylglycerol (a2) and of said at least one phospholipid (a3), being equal to 100% by mass and said composition (C) being a wheat gluten extract, to increase the elasticity and tensile strength of the hair.

6. Cosmetic treatment method intended to increase the elasticity and tensile strength of hair, characterized in that an effective amount of a composition (C) comprising, for 100% by mass: - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine, of said digalactosyldiacylglycerol (a2) and of said at least one phospholipid (a3), being equal to 100% by mass and said composition (C) being a wheat gluten extract.

7. Food supplement (Ca) comprising 100% by mass: - more than 0% by mass and less than 10% by mass of a composition (C) comprising for 100% by mass: - from 20% by mass to 80% by mass, more particularly from 20% by mass to 60% by mass, of at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine, - from 10% by mass to 50% by mass, more particularly from 19% by mass to 50% by mass, of digalactosyldiacylglycerol (a2), and - from 1% by mass to 30% by mass, more particularly from 1% by mass to 10% by mass, of at least one phospholipid (a3), the sum of the mass contents of said at least one sphingolipid (al) resulting from the amidation of a fatty acid on sphingosine, of said digalactosyldiacylglycerol (a2) and of said at least one phospholipid (a3), being equal to 100% by mass and said composition (C) being a wheat gluten extract, and - more than 90% by mass and less than 100% by mass of at least one nutritionally acceptable technological additive.

8. Food supplement (Ca) according to claim 7, further comprising at least one active ingredient chosen from bioactive lipids, water-soluble or water-dispersible trace element salts, water-soluble or fat-soluble vitamins, prebiotics, probiotics, proteins and / or milk protein concentrates, plant or animal enzymes, amino acids, peptides, sugars, flavor enhancers and flavoring agents.

9. Food supplement (Ca) according to any one of claims 7 or 8, characterized in that it is in the form of a tablet, a capsule, a soft capsule, a Tl powder, a dragée, a confectionery gum or a granule.

10. Use in oral administration of the food supplement (Ca) according to any one of claims 7 to 9, to increase the elasticity and tensile strength of the hair.

11. Cosmetic treatment method intended to increase the elasticity and tensile strength of the hair, characterized in that an effective amount of the food supplement (Ca) according to any one of claims 7 to 9 is administered orally.

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