Pharmaceutical or cosmetic composition for reducing sebum production on scalp

Abstract

Composition (C) comprising, for 100% by mass: 20% to 80% by mass of at least one sphingolipid (a1), 10% to 50% by mass of a digalactosyl diglyceride (a2), and 1% to 30% by mass of at least one phospholipid (a3), for use in a therapeutic treatment method for preventing or limiting sebum production on the scalp. A pharmaceutical composition (Cp) and a food supplement (Ca) comprising said composition (C). A non-therapeutic use of the food supplement (Ca) and a non-therapeutic implementation method.

Description

[0001] This invention belongs to the fields of cosmetics and pharmaceuticals. This invention relates to the treatment of scalp conditions and, more particularly, to the production of sebum on the scalp.

[0002] The scalp comprises all the tissues covering the skull. It covers an area of ​​approximately 600 cm² with a thickness of 6 mm. It differs from the skin on the rest of the body in that it contains a large number of sebaceous gland hair follicles—ranging from 100,000 to 200,000 depending on the individual—for hair growth.

[0003] Hair fibers consist of a visible stem, a hair bulb located beneath the scalp, and a dermal papilla at the base of the bulb. The stem comprises three concentric layers: the medulla, the cortex, and the keratin. The medulla is the central part, while the cortex is the middle layer and forms the main body of the hair. The cortex is composed of long keratin chains, which give hair its elasticity, flexibility, and strength. Hair fibers are protected by keratin, which is formed from keratin scales sealed together by an intercellular matrix rich in lipids and, in particular, ceramides. These lipids ensure the hair's barrier function by providing a degree of impermeability.

[0004] At its base, the hair shaft is surrounded by two sheaths: an outer epithelial sheath, with a composition similar to the epidermis; and an inner epithelial sheath, rich in glycoproteins that form the nutritional basis for hair growth. 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 home to the proliferation of cells essential for hair growth. It is composed of fibroblasts and ensures the hair's nutrition, irrigation, oxygenation, and removal of cellular waste.

[0005] Due to the high density of hair follicles, the scalp is highly vascularized and also contains a large number of nerve endings. Like the skin, the scalp consists of three continuous layers: the epidermis (upper layer), the dermis, and the subcutaneous tissue.

[0006] The constantly renewing epidermis consists of several layers of keratinocytes. These cells divide, differentiate, and migrate from the deepest layer (basal layer) to the superficial layer (stratum corneum), where they die and are eliminated. The stratum corneum is produced by the stacking of 15 to 20 layers of completely keratinized dead cells: keratinocytes. These cells are integrated into an intercellular lipid structure called "intercellular glial," which is composed of ceramides, fatty acids, triglycerides, and cholesterol, ensuring the skin's barrier function in maintaining moisture.

[0007] During natural exfoliation, keratinocytes shed from one or more layers of the stratum corneum, while a layer of cells in the basal layer divides to maintain the structure of the stratum corneum.

[0008] Sebaceous glands are present on almost the entire surface of the human body, but at a higher concentration on facial skin (300 to 900 / cm²) and scalp (approximately 200 / cm²). Under normal conditions, sebaceous glands produce and secrete sebum (0.7 to 1 gram per 24 hours), a complex fatty substance composed of fatty acids, triglycerides, wax esters, squalene, and cholesterol.

[0009] Sebum participates in the formation of the lipid film covering the scalp, associated with sweat and cellular debris from keratinization and exfoliation. This film spreads at the base of the hair and forms a protective barrier against dehydration and infections caused by bacteria and fungi. Therefore, sebum lubricates the skin to protect it from friction and makes it more waterproof. Sebum also promotes the survival of symbiotic flora. Furthermore, sebum transports and retains lipid-soluble antioxidants on the skin surface, thus producing protective activity against natural light. Finally, sebum has antibacterial and anti-inflammatory activities and actively participates in the healing process.

[0010] Excessive sebum production is called hyperspermia. This condition is associated in humans with a variety of factors such as: imbalances in thyroid and pituitary hormones, metabolic disorders related to saturated fat intake, intestinal or liver problems that alter the composition of sebum, or poor skin and scalp hygiene.

[0011] In addition, the proliferation of certain microorganisms (bacteria or fungi) can cause inflammation of the skin and scalp, thereby promoting sebum production. Specifically, the proliferation of the parasitic Demodex folliculorum—a type of Demodex mite that lives in hair follicles—can also trigger excessive sebum secretion. Excess sebum buildup on the scalp, combined with sweat, dead skin cells, and other debris, can lead to keratosis, itching, and oily hair. If left untreated, excessive sebum production on the scalp can lead to dandruff or acne, localized skin infections (eczema, psoriasis, seborrheic dermatitis), and even hair loss.

[0012] Scalp sebum content can be measured using Sebumeter®. Technically, sebum is collected using a cartridge equipped with a transparent membrane sensitive to sebum secretions. The cartridge's measuring head is inserted into the instrument's main unit, where a photocell measures transparency. Transmittance represents the sebum content at the surface of the measurement area, expressed in µg sebum / cm² scalp.

[0013] U.S. patent application number US 2009 / 286871 A1 discloses the cosmetic, pharmaceutical, or dermatological use of plant oil-based products as agents for increasing skin lipid synthesis.

[0014] US Patent No. 5,683,684 A discloses the use of sphingolipids or sphingolipid analogues as active ingredients in the preparation of cosmetic or dermatological pharmaceutical compositions intended to protect skin and / or hair from the harmful effects of heavy metal pollution in the atmosphere.

[0015] International application published under WO 99 / 65459 A1 discloses cereal extracts containing sphingolipids, glyceroglycolipids (including digalactosyl diglyceride or DGDG), triglycerides and phospholipids, and their use in the manufacture of dermatological, cosmetic or pharmaceutical compositions for anti-aging treatment purposes or for skin hydration or as an anti-inflammatory agent.

[0016] In the context of their research aimed at developing the use of natural compounds in therapeutic and cosmetic applications, the inventors have demonstrated that the use of orally administered compositions derived from wheat gluten extract can regulate sebum production on the scalp, especially in individuals with excessive sebum secretion.

[0017] Therefore, according to a first aspect, the subject of the present invention is a composition (C), characterized in that the composition (C) comprises a wheat gluten extract, the wheat gluten extract comprising, per 100% by weight:

[0018] - At least one sphingolipid (a1) produced by the amidation of fatty acids and sphingosine, comprising 20% ​​to 80% by weight,

[0019] -10% to 50% by weight of digalactosyl diglyceride (a2), and

[0020] - At least one phospholipid (a3) ​​comprising 1% to 30% by mass, wherein the sum of the mass contents of the at least one sphingolipid (a1), the digalactosyl diglyceride (a2), and the at least one phospholipid (a3) ​​produced by amidation of fatty acids and sphingosine is equal to 100% by mass.

[0021] The composition (C) is administered orally for use in a method of therapeutically treating the scalp to limit its sebum production.

[0022] For the purposes of this invention, "sphingolipid" is a lipid complex formed by the amidation of fatty acids and sphingosine. Sphingosine is an amide-diol with an olefinic double bond, specifically 2-aminooctadec-4-ene-1,3-diol, and has the formula (I):

[0023] (I).

[0024] For the purposes of this invention, "phospholipid" refers to lipids containing phosphate groups in the form of monoesters or diesters, and more particularly phosphoethanolamine, phosphatidylinositol, lysophosphatidylethanolamine, phosphatidic acid, phosphatidylcholine and lysophosphatidylcholine.

[0025] According to the first specific aspect, the composition (C) as defined above comprises at least one sphingolipid (a1) in amounts of 20% to 60% by weight per 100% by weight.

[0026] According to the second specific aspect, the composition (C) as defined above comprises 19% to 50% by weight of digalactosylglycerol (a2) per 100% by weight.

[0027] According to the third specific aspect, the composition (C) as defined above comprises at least one phospholipid (a3) ​​per 100% by mass from 1% to 10% by mass.

[0028] The subject of this invention is more particularly a composition (C) comprising 100% by weight:

[0029] - At least one sphingolipid (a1) produced by the amidation of fatty acids and sphingosine, comprising 20% ​​to 60% by weight,

[0030] -19% to 50% by weight of digalactosyl diglyceride (a2), and

[0031] - At least one phospholipid (a3) ​​comprising 1% to 10% by weight,

[0032] This composition (C) is used in a therapeutic treatment for preventing or limiting sebum production on the scalp.

[0033] According to another specific aspect of the invention, the composition (C) as defined above is in an oily form or in powder form.

[0034] The composition (C) as defined above is prepared by methods known to those skilled in the art, and more particularly by methods described on pages 8 to 11 of International Patent Application published in WO 99 / 65459. The composition (C) is prepared, more particularly, by a method comprising the following sequential steps:

[0035] -At least one step a): providing wheat gluten flour,

[0036] - At least one step b): Add the wheat gluten powder to ethanol (minimum 97%) under mechanical stirring and at a temperature of 60°C for at least two hours.

[0037] - At least one step c): discharge, followed by a sub-step of settling the mixture obtained in step b) in order to recover the homogeneous liquid phase.

[0038] - At least one step d): Vacuum distillation of the liquid obtained in step c) at a temperature of 35°C or lower to remove ethanol in order to obtain a concentrated composition.

[0039] - At least one step e): The product obtained at the end of step d) is added to ethanol under mechanical stirring and at a temperature of 4°C to precipitate the medium and recover the liquid fraction.

[0040] - At least one step f): Distilling the liquid obtained at the end of step e) to remove ethanol and obtain an oily composition.

[0041] -At least one step g): adding composition (C) to acetone to obtain a precipitate,

[0042] -At least one step h): Filtering the medium obtained at the end of step g) to recover the powdered solids.

[0043] -Drying step g) The solid cake obtained at the end of the drying step is used to obtain a composition in powder form.

[0044] Another subject of the present invention is an edible pharmaceutical composition (Cp) comprising, per 100% by mass:

[0045] - Composition (C) comprising 10% to 30% by weight, wherein composition (C) contains 100% by weight:

[0046] - At least one sphingolipid (a1) produced by the amidation of fatty acids and sphingosine, comprising 20% ​​to 80% by weight, and more particularly 20% to 60% by weight, by weight.

[0047] - Digalactosyl diglyceride (a2) at 10% to 50% by weight, and more particularly 19% to 50% by weight, and

[0048] - At least one phospholipid (a3) ​​comprising, by weight, 1% to 30% by weight, more particularly 1% to 10% by weight, wherein the sum of the mass contents of said at least one sphingolipid (a1), said digalactosyl diglyceride (a2), and said at least one phospholipid (a3) ​​produced by amidation of fatty acids and sphingosine is equal to 100% by weight, and said composition (C) is a wheat gluten extract.

[0049] as well as

[0050] - At least one pharmaceutically acceptable edible technical additive, comprising 70% to 90% by weight.

[0051] This edible pharmaceutical composition (Cp) is administered orally for use in methods of therapeutically treating the scalp to limit its sebum production.

[0052] Based on a specific aspect, the above-defined therapeutic treatment methods are applied to people suffering from excessive sebum secretion.

[0053] "Technical additive" means any chemical substance or chemical composition whose technical function is to enable and / or promote the mixing of various components of the edible composition, promote and / or optimize the physical properties of the edible composition, such as promoting and / or optimizing its flowability, its stability and its incorporation into subsequent pharmaceutical and / or nutritional formulations, and which can meet the conditions required by current regulations for the sale of pharmaceutical and / or nutritional formulations.

[0054] The term “pharmaceuticalally acceptable technical additive” refers to technical additives whose use meets the requirements of the current pharmaceutical regulations of the country of interest.

[0055] According to one specific aspect of the invention, the edible technical additive is pharmaceutically acceptable and selected from diluents, flow agents, binders or disintegrants.

[0056] Diluents are, for example, lactose, sucrose, saccharose, glucose, maltodextrin, mannitol, sorbitol, xylitol, isomaltitol, dicalcium phosphate, microcrystalline cellulose, starch (such as corn starch, wheat starch, or potato starch), dicalcium phosphate, sodium carbonate, calcium carbonate, or magnesium carbonate, or monoglycerides and / or diglycerides of fatty acids containing 8 to 24 carbon atoms.

[0057] Flow agents are, for example, magnesium stearate, talc, sodium stearoyl fumarate, hydrogenated vegetable oil, anhydrous colloidal silica, sodium benzoate, or silica.

[0058] The binder is, for example, starch in the form of starch paste, pregelatinized starch, hydroxypropyl methylcellulose (HPMC), methylcellulose, sucrose syrup, or gum arabic.

[0059] Disintegrants are, for example, starch, sodium starch glycolate, alginate, sodium alginate, croscarmellose sodium, crospovidone and / or polyvinylpyrrolidone.

[0060] According to one specific aspect of the invention, the edible pharmaceutical composition (Cp) as defined above further comprises at least one active ingredient selected from: bioactive lipids, water-soluble or water-dispersible trace element salts, water-soluble or fat-soluble vitamins, prebiotics, probiotics, milk proteins and / or milk protein concentrates, plant or animal enzymes, amino acids, peptides, sugars, flavor enhancers and flavorings.

[0061] The bioactive lipids optionally present in the edible pharmaceutical composition (Cp) as defined above 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 brassosterol; phytostanols; carotenoids belonging to the terpene family, extracted from algae, green plants, fungi, or bacteria; ω-3 polyunsaturated fatty acids, such as α-linoleic acid, eicosapentaenoic acid, or docosahexaenoic acid; ω-6 polyunsaturated fatty acids, such as linoleic acid, γ-linoleic acid, eicosadienoic acid, dihomo-γ-linoleic acid, arachidonic acid, docosadienoic acid, docosatraenoic acid, or docosapentaenoic acid.

[0062] Optionally, the water-soluble or water-dispersible trace element salts present in the edible pharmaceutical composition (Cp) as defined above 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 chelates of amino acid hydrates, glycine ferric chelates; 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; copper acetate monohydrate, copper nitrate ... Basic copper carbonate, copper chloride dihydrate, copper methionine, copper sulfate pentahydrate, copper chelates of amino acid hydrates, copper chelates of glycine hydrates, copper chelates of methionine hydroxy analogs; manganese carbonate, manganese chloride tetrahydrate, manganese hydrogen phosphate trihydrate, manganese sulfate tetrahydrate, manganese sulfate monohydrate, manganese chelates of amino acid hydrates, manganese chelates of glycine hydrates, manganese chelates of methionine hydroxy analogs; ammonium molybdate, sodium molybdate, sodium selenite, sodium selenate; selenium in organic form produced by Saccharomyces cerevisiae; selenomethionine (inactivated selenium yeast); and selenomethionine produced by Saccharomyces cerevisiae (inactivated selenium yeast).

[0063] Optionally present in the edible pharmaceutical composition (Cp) as defined above, the water-soluble or fat-soluble vitamins are, for example, vitamin A, more particularly in the form of retinol, retinyl acetate, retinyl palmitate, or β-carotene; vitamin D2, more particularly in the form of ergocalciferol or 25-hydroxycalciferol; vitamin D3, more particularly in the form of cholecalciferol; vitamin K, more particularly in the form of phylloquinone (levamisole hydrochloride) or methylnaphthoquinone; vitamin B1, more particularly in the form of thiamine hydrochloride, thiamine mononitrate, thiamine monophosphate, or thiamine pyrophosphate; and vitamin B2, more particularly in the form of riboflavin, riboflavin 5' - Sodium phosphate; Vitamin B6, more particularly in the form of pyridoxine hydrochloride, pyridoxine 5'-phosphate, or pyridoxal 5'-phosphate; Vitamin B12, more particularly in the form of cyanocobalamin, hydroxycobalamin, 5'-deoxyadenosylcobalamin, or methylcobalamin; Vitamin C, more particularly in the form of L-ascorbic acid, sodium L-ascorbate, calcium L-ascorbate, potassium L-ascorbate, calcium salt of palmityl-6-L-ascorbic acid, or sodium ascorbate monophosphate; Pantothenic acid, more particularly in the form of calcium D-pantothenate, sodium D-pantothenate, dextropanthenol, or pantothenic acid; Vitamin PP, more particularly in the form of nicotinic acid. In the form of nicotinic acid, nicotinamide, or inositol hexanicotinate; vitamin B9, more particularly in the form of its folic acid, folic acid salt, more particularly in the form of its pteroylmonoglutamic acid, L-methylfolate calcium, or (6S)-5-methyltetrahydrofolate in the form of glucosamine salt; vitamin H2, B7, or BW, more particularly in the form of its biotin; choline, more particularly in the form of its choline chloride, citrate dihydrocholine, or bitartrate choline; inositol; carnitine, more particularly in the form of its L-carnitine, L-carnitine-L-tartrate salt; taurine.

[0064] Prebiotics optionally present in the edible pharmaceutical composition (Cp) as defined above are, for example, inulin, trans-galacto-oligosaccharides, fructans, and mannan oligosaccharides.

[0065] The probiotics optionally present in the edible pharmaceutical composition (Cp) as defined above are various strains of the following: Saccharomyces cerevisiae, Bacillus cereus var. toyoi, Bacillus subtilis alone or in combination with Bacillus licheniformis, or other strains of Enterococcus faecium. These microbial strains are typically combined with a solid carrier (e.g., calcium carbonate, dextrose, or sorbitol).

[0066] Optionally, the proteins and / or protein concentrates present in the edible pharmaceutical composition (Cp) as defined above are, for example, milk proteins obtained from milk, such as colostrum in the form of lyophilized or atomized powder; whey in the form of powdered and purified fractions or fractions rich in IgG, lactoferrin or lactoperoxidase.

[0067] The plant or animal enzymes optionally present in the edible pharmaceutical composition (Cp) as defined above are, for example, promutase, superoxide dismutase (SOD), 3-phytase, 6-phytase, endo-1,4-β-glucanase, endo-1,4-β-xylanase, or other enzymes that improve or promote digestion.

[0068] The peptides optionally present in the edible pharmaceutical composition (Cp) as defined above are, for example, avocado peptides, lupin peptides, quinoa peptides, maca peptides, fermented or unfermented soybean peptides, rice peptides, peptides present in Acacia macrocarpa seed extract, or peptides present in passion fruit seed extract.

[0069] The amino acids optionally present in the edible pharmaceutical composition (Cp) as defined above are, for example, alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, hydroxyproline, pyrrolidone, selenocysteine, serine, threonine, tryptophan, tyrosine, valine, sarcosine, or ornithine.

[0070] Optionally, the sugars present in the edible pharmaceutical composition (Cp) as defined above are, for example, water-soluble polysaccharides or low molecular weight sugars, such as oligosaccharides, monosaccharides, or disaccharides, like glucose, lactose, or dextrose.

[0071] Flavor enhancers optionally present in the edible pharmaceutical composition (Cp) as defined above are, for example, glutamates such as glutamic acid, monosodium glutamate, potassium glutamate, calcium diglutamate, ammonium glutamate, or magnesium diglutamate; guanylate salts such as guanylic acid (guanylate monophosphate), disodium guanylate, dipotassium guanylate, or calcium guanylate; inosinate salts such as inosinate, disodium inosinate, dipotassium inosinate, or calcium inosinate; or other strong sweeteners such as stevia extract or rebaudioside.

[0072] The edible pharmaceutical composition (Cp) may be in solid or liquid form.

[0073] According to one specific aspect of the invention, the edible pharmaceutical composition (Cp) is in solid form, and more particularly in the form of tablets, hard capsules, soft capsules, powders, film-coated tablets, gummies, or granules.

[0074] When the edible pharmaceutical composition (Cp) as defined above is in tablet form, it preferably contains 50 mg to 150 mg of the composition (C) as defined above per 500 mg tablet; when it is in soft capsule form, it preferably contains 120 mg to 360 mg of the composition (C) per 1200 mg soft capsule; when it is in hard capsule form, it preferably contains 10 mg to 30 mg of the composition (C) per 100 mg capsule; and when it is in powder form, it preferably contains 200 mg to 600 mg of the composition (C) per 2000 mg powder.

[0075] When an edible pharmaceutical composition (Cp) is in powder form, it is obtained by introducing its various components into a mixer equipped with at least one mechanical stirring system (e.g., flat or impeller-type stirring blades), which is optionally a drum mixer and optionally equipped with a lumpy crushing system. This mixing operation is typically carried out at ambient temperature, particularly between 15°C and 30°C.

[0076] When the edible pharmaceutical composition (Cp) is in the form of candy gum, it preferably contains 150 mg to 450 mg of composition (C) per 1.5 g of candy gum.

[0077] When the edible pharmaceutical composition (Cp) is in liquid form, it preferably contains per 1 cm 3 Compositions of 100 mg to 300 mg ampoules (C).

[0078] Another subject of the invention is the non-therapeutic use of an effective amount of composition (C) administered orally for the prevention or reduction of unsightly signs associated with the presence of excessive sebum on the scalp, the composition (C) comprising 100% by weight:

[0079] - At least one sphingolipid (a1) produced by the amidation of fatty acids and sphingosine, comprising 20% ​​to 80% by weight, and more particularly 20% to 60% by weight, by weight.

[0080] - Digalactosyl diglyceride (a2) at 10% to 50% by weight, and more particularly 19% to 50% by weight, and

[0081] - At least one phospholipid (a3) ​​comprising 1% to 30% by mass, more particularly 1% to 10% by mass, wherein the sum of the mass contents of the at least one sphingolipid (a1), the digalactosyl diglyceride (a2), and the at least one phospholipid (a3) ​​produced by amidation of fatty acids and sphingosine is equal to 100% by mass, and the composition (C) is a wheat gluten extract.

[0082] Another subject of the present invention is a method for a cosmetic treatment to prevent or reduce the appearance of unsightly signs associated with the presence of excessive sebum on the scalp, characterized by oral administration of an effective amount of composition (C), which comprises 100% by weight:

[0083] - At least one sphingolipid (a1) produced by the amidation of fatty acids and sphingosine, comprising 20% ​​to 80% by weight, and more particularly 20% to 60% by weight, by weight.

[0084] - Digalactosyl diglyceride (a2) at 10% to 50% by weight, and more particularly 19% to 50% by weight, and

[0085] - At least one phospholipid (a3) ​​comprising 1% to 30% by mass, more particularly 1% to 10% by mass, wherein the sum of the mass contents of the at least one sphingolipid (a1), the digalactosyl diglyceride (a2), and the at least one phospholipid (a3) ​​produced by amidation of fatty acids and sphingosine is equal to 100% by mass, and the composition (C) is a wheat gluten extract.

[0086] Within the meaning of this invention, the term "unsightly signs associated with the presence of sebum on the scalp" should be understood to mean any alteration to the appearance of the scalp caused by excessive sebum on the scalp, such as an oily appearance, greasy appearance, stickiness, or film-like appearance of the scalp. Furthermore, excessive sebum present on the scalp can spread across the roots of the hair and result in an oily appearance of the hair.

[0087] Within the meaning of this invention, the term "effective amount" means an amount that enables a consumer to visually perceive the claimed aesthetic appearance effect under normal attention, namely, the lack or reduction of a shiny and / or greasy appearance and / or stickiness and / or film on the scalp.

[0088] Experimental studies presented in an additional section of this specification reveal that the composition in daily intakes 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 can be considered effective amounts.

[0089] Another subject of the present invention is a food supplement (Ca) comprising, per 100% by weight:

[0090] - Greater than 0% to 30% by weight of the composition (C) as defined above and

[0091] - At least one nutritionally acceptable technical additive, comprising 70% to less than 100% by weight.

[0092] Preferably, the food supplement (Ca) comprises 100% by weight:

[0093] - Greater than 0% and less than 10% by weight of the composition (C) as defined above and

[0094] - At least one nutritionally acceptable technical additive, comprising more than 90% and less than 100% by weight.

[0095] The term "food supplement" should be understood to mean an edible composition intended to supplement a normal diet and which constitutes a concentrated source of nutrients or other substances having nutritional or physiological effects, either alone or in combination. Such a food supplement enables the prevention of certain deficiencies or a response to specific needs in an individual's diet, particularly during physical activity. This definition of "food supplement" is given in Article 2 of French Decree No. 2006-352 of 26 March 2006 and in Directive 2002 / 46 / CE of the European Parliament and the Council of 10 June 2002.

[0096] The term "nutritionalally acceptable technical additive" means a technical additive as defined above that, when used, meets the requirements of the current regulations concerning food supplements in the country under consideration.

[0097] According to one specific aspect of the invention, the nutritionally acceptable technical additive is selected from diluents, flow agents, binders, or disintegrants.

[0098] Diluents are, for example, lactose, sucrose, saccharose, glucose, maltodextrin, mannitol, sorbitol, xylitol, isomaltitol, dicalcium phosphate, microcrystalline cellulose, starch (such as corn starch, wheat starch, or potato starch), dicalcium phosphate, sodium carbonate, calcium carbonate, or magnesium carbonate, or monoglycerides and / or diglycerides of fatty acids containing 8 to 24 carbon atoms.

[0099] Flow agents are, for example, magnesium stearate, talc, sodium stearoyl fumarate, hydrogenated vegetable oil, anhydrous colloidal silica, sodium benzoate, or silica.

[0100] The binder is, for example, starch in the form of starch paste, pregelatinized starch, hydroxypropyl methylcellulose (HPMC), methylcellulose, sucrose syrup, or gum arabic.

[0101] Disintegrants are, for example, starch, sodium starch glycolate, alginate, sodium alginate, croscarmellose sodium, crospovidone and / or polyvinylpyrrolidone.

[0102] According to one specific aspect of the invention, the food supplement (Ca) as defined above further comprises at least one active ingredient selected from: bioactive lipids, water-soluble or water-dispersible trace element salts, water-soluble or fat-soluble vitamins, prebiotics, probiotics, milk proteins and / or milk protein concentrates, plant or animal enzymes, amino acids, peptides, sugars, flavor enhancers, and flavorings.

[0103] Bioactive lipids optionally present in the food supplements (Ca) as defined above 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 phytosterols composed of campesterol, stigmasterol, and brassosterol; phytosterols; carotenoids belonging to the terpenoid family, extracted from algae, green plants, fungi, or bacteria; ω-3 polyunsaturated fatty acids, such as α-linoleic acid, eicosapentaenoic acid, or docosahexaenoic acid; ω-6 polyunsaturated fatty acids, such as linoleic acid, γ-linoleic acid, eicosadienoic acid, dihomo-γ-linoleic acid, arachidonic acid, docosadienoic acid, docosatraenoic acid, or docosapentaenoic acid.

[0104] Optionally present in the food supplements (Ca) as defined above, the water-soluble or water-dispersible trace element salts 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 chelates of amino acid hydrates, glycine ferric chelates; 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; copper acetate monohydrate, basic copper carbonate monohydrate, copper chloride dihydrate, methionine Copper, copper sulfate pentahydrate, cuprous chelates of amino acid hydrates, cuprous chelates of glycine hydrates, copper chelates of methionine hydroxy analogs; manganese carbonate, manganese chloride tetrahydrate, manganese hydrogen phosphate trihydrate, manganese sulfate tetrahydrate, manganese sulfate monohydrate, manganese chelates of amino acid hydrates, manganese chelates of glycine hydrates, manganese chelates of methionine hydroxy analogs; ammonium molybdate, sodium molybdate, sodium selenite, sodium selenate; selenium in organic form produced by Saccharomyces cerevisiae; selenomethionine (inactivated selenium yeast); and selenomethionine produced by Saccharomyces cerevisiae (inactivated selenium yeast).

[0105] Optionally present in the food supplements (Ca) as defined above, the water-soluble or fat-soluble vitamins are, for example, vitamin A, more particularly in the form of retinol, retinyl acetate, retinyl palmitate, or beta-carotene; vitamin D2, more particularly in the form of ergocalciferol or 25-hydroxycalciferol; vitamin D3, more particularly in the form of cholecalciferol; vitamin K, more particularly in the form of phylloquinone (levamisole hydrochloride) or methylnaphthoquinone; vitamin B1, more particularly in the form of thiamine hydrochloride, thiamine mononitrate, thiamine monophosphate, or thiamine pyrophosphate; vitamin B2, more particularly in the form of riboflavin or riboflavin 5'-phosphate sodium; vitamin B6, more Specifically, it is in the form of pyridoxine hydrochloride, pyridoxine 5'-phosphate, or pyridoxal 5'-phosphate; vitamin B12, more particularly in the form of cyanocobalamin, hydroxocobalamin, 5'-deoxyadenosylcobalamin, or methylcobalamin; vitamin C, more particularly in the form of L-ascorbic acid, sodium L-ascorbate, calcium L-ascorbate, potassium L-ascorbate, calcium salt of palmityl-6-L-ascorbic acid, or sodium ascorbate monophosphate; pantothenic acid, more particularly in the form of calcium D-pantothenate, sodium D-pantothenate, dextropanthenol, or pantothenic acid; vitamin PP, more particularly in the form of nicotinic acid, niacin, nicotinamide, or inositol hexanicotinate. In the form of inositol hexanicotinate; vitamin B9, more particularly in the form of folic acid, folate, more particularly in the form of pteroylmonoglutamic acid, L-methylfolate calcium, (6S)-5-methyltetrahydrofolate in the form of glucosamine salt; vitamin H2, B7 or BW, more particularly in the form of biotin; choline, more particularly in the form of choline chloride, citrate dihydrocholine, tartrate choline; inositol; carnitine, more particularly in the form of L-carnitine, L-carnitine-L-tartrate; taurine.

[0106] Prebiotics that may be present in the food supplements (Ca) as defined above are, for example, inulin, trans-galacto-oligosaccharides, fructans, and mannan oligosaccharides.

[0107] The probiotics optionally present in the food supplements (Ca) as defined above are various strains of the following: Saccharomyces cerevisiae, Bacillus cereus variant, Bacillus subtilis alone or in combination with Bacillus licheniformis, or other strains of Enterococcus faecalis. These microbial strains are usually combined with a solid carrier (e.g., calcium carbonate, dextrose, or sorbitol).

[0108] The proteins and / or protein concentrates present in the food supplements (Ca) as defined above are, for example, milk proteins obtained from milk, such as colostrum in the form of freeze-dried or atomized powder; whey in the form of powdered and purified fractions or fractions rich in IgG, lactoferrin or lactoperoxidase.

[0109] The plant or animal enzymes optionally present in the food supplements (Ca) as defined above are, for example, proteosomes, superoxide dismutase (SOD), 3-phytase, 6-phytase, endo-1,4-β-glucanase, endo-1,4-β-xylanase, or other enzymes that improve or promote digestion.

[0110] Peptides that may optionally be present in the food supplements (Ca) as defined above are, for example, avocado peptides, lupin peptides, quinoa peptides, maca peptides, fermented or unfermented soybean peptides, rice peptides, peptides present in Acacia dahurica seed extract, or peptides present in passion fruit seed extract.

[0111] The amino acids optionally present in the food supplements (Ca) as defined above are, for example, alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, hydroxyproline, pyrrolidone, selenocysteine, serine, threonine, tryptophan, tyrosine, valine, sarcosine, or ornithine.

[0112] Optionally, the sugars present in the food supplements (Ca) as defined above are, for example, water-soluble polysaccharides or low molecular weight sugars, such as oligosaccharides, monosaccharides, or disaccharides, like glucose, lactose, or dextrose.

[0113] Flavor enhancers optionally present in the food supplements (Ca) as defined above are, for example, glutamates such as glutamic acid, monosodium glutamate, monopotassium glutamate, calcium diglutamate, ammonium glutamate, or magnesium diglutamate; guanylate salts such as guanylic acid (guanylate monophosphate), disodium guanylate, dipotassium guanylate, or calcium guanylate; inosinate salts such as inosinate, disodium inosinate, dipotassium inosinate, or calcium inosinate; or other strong sweeteners such as stevia extract or rebaudioside.

[0114] The food supplement (Ca) may be in solid or liquid form.

[0115] The food supplement (Ca) may be in any form of food product known to those skilled in the art, such as beverages, and more particularly aqueous beverages, solutions, juices, flavored beverages, energy drinks, alcoholic beverages, coffee-based beverages, chocolate-based beverages, tea-based beverages, dairy products (and more particularly milk, yogurt, dairy desserts, drinkable yogurt, cheese, ice cream, chocolate bars), cereal products (and more particularly cereal bars, biscuits, breakfast cereals, flour products, bread products), specialized nutritional products (more particularly infant nutritional products, nutritional products for physical activity, clinical nutritional products), meal replacements, and confectionery (more particularly chewing gum, candy, caramel, sugar-coated pills, mints, marshmallows, Turkish delight, nougat, jelly, licorice).

[0116] The food supplement (Ca) according to the invention may also be in any form known to those skilled in the art, such as tablets, hard capsules, soft capsules, syrups, powders (e.g., immediate-release powders, delayed-release powders or powders for reconstituted beverages), liquids, sticks or gels.

[0117] According to one specific aspect of the invention, the food supplement (Ca) as defined above takes the form of a solid, and more particularly in the form of tablets, hard capsules, soft capsules, powders, film-coated tablets, gummies or granules.

[0118] When the food supplement (Ca) as defined above is in tablet form, it preferably contains less than 50 mg of the composition (C) as defined above per 500 mg tablet; when it is in soft capsule form, it preferably contains less than 120 mg of the composition (C) per 1200 mg soft capsule; when it is in hard capsule form, it preferably contains less than 10 mg of the composition (C) as defined above per 100 mg capsule; and when it is in powder form, it preferably contains less than 200 mg of the composition (C) as defined above per 2000 mg powder.

[0119] When the food supplement (Ca) is in powder form, it is obtained by introducing its various components into a mixer equipped with at least one mechanical stirring system (e.g., flat or impeller-type stirring blades), which is optionally a drum mixer and optionally equipped with a lumpy crushing system. This mixing operation is typically carried out at ambient temperature, particularly between 15°C and 30°C.

[0120] When the food supplement (Ca) is in the form of candy gum, it preferably contains less than 150 mg of the composition (C) as defined above per 1.5 g of candy gum.

[0121] When the food supplement (Ca) is in liquid form, it preferably contains 1 cm of 3 Composition (C) as defined above, with ampoules containing less than 100 mg.

[0122] Another subject of the invention is the use of the above-defined food supplement (Ca) by oral administration for the prevention and / or reduction of unsightly signs associated with the presence of excessive sebum on the scalp.

[0123] Another subject of the present invention is a method for preventing or mitigating unsightly signs associated with the presence of excessive sebum on the scalp, characterized by oral administration of an effective amount of a food supplement (Ca) as defined above.

[0124] According to one specific aspect of the invention, the food supplement (Ca) as defined above is administered orally at a ratio of at least 15 mg, more particularly at least 30 mg of the composition (C) daily for at least 4 weeks, more particularly at least 8 weeks, or even more particularly for 12 weeks.

[0125] The following examples illustrate the present invention, but do not limit it.

[0126] Comparative preparations

[0127] Commercial wheat gluten extract is used in the form of a powder composition (C) which contains, per 100% by weight: 52.5% by weight of sphingolipids, 41.5% by weight of digalactosylglycerol, and 6% by weight of phospholipids.

[0128] Two formulations were prepared: a food supplement (Ca) (containing composition (C)) and a food supplement (C'a) (not containing composition (C)), which contain the ingredients indicated in Table 1:

[0129] [Table 1]

[0130]

[0131] Principles of Evaluation Methods

[0132] Skin-purifying activity was evaluated by measuring sebum content on the volunteers' scalp at a baseline level greater than 140 µg / cm² using sebumetry® and also by self-assessment performed by the study subjects.

[0133] The sebum content of the scalp was measured using Sebumeter®.

[0134] Technically, sebum is collected using a cartridge equipped with a transparent membrane sensitive to sebum secretions. The cartridge's measuring head is inserted into the instrument's main unit, where a photocell measures the transparency. Transmittance represents the sebum content at the surface of the measurement area, expressed in µg sebum / cm² scalp.

[0135] program

[0136] The technical efficacy of composition (C) was demonstrated in an experimental, randomized, double-blind, parallel-group clinical study. This allowed for testing the effects of daily consumption of 30 mg (C) relative to placebo over an 84-day (12-week) period.

[0137] Caucasian women aged 18 to 65 years who presented with telogen effluvium (>15% of their hair was in the telogen phase) and complained of fine, brittle hair with a sebum level greater than or equal to 140 µg / cm² were included in this study. They consumed either two Ca (Ca) or two Ca'a (C'a) supplement capsules daily for 84 days (from D0 to D84). Measurements were taken on day 0 (D0), day 56 (D56), and day 84 (D84).

[0138] result

[0139] The results are listed in the table below.

[0140] [Table 2]

[0141]

[0142] SDM: Standard deviation of the mean

[0143] Observations and comments

[0144] After 84 days of consumption, a significant reduction in sebum mass was observed in the dietary supplement (Ca) group, from 196.0 ± 12.1 µg / cm² at D0 to 185.1 ± 9.9 µg / cm² at D56 and 171.7 ± 11.4 µg / cm² at D84 (p = 0.013), while no significant change was observed in the dietary supplement (C'a) group, from 166.4 ± 7.5 µg / cm² at D0 to 168.0 ± 7.0 µg / cm² at D56 and 168.5 ± 7.4 µg / cm² at D84.

[0145] Furthermore, at D84, there was a significant difference between the food supplement (Ca) group and the food supplement (C'a) group (-11.9% vs. +2.8%; p = 0.044).

[0146] Furthermore, responses on self-assessment questionnaires completed by the study participants showed that 88% of the participants in the dietary supplement (Ca) group reported “less oily hair”, compared to 63% of the participants in the dietary supplement (C'a) group.

[0147] Through clinical studies, composition (C) has demonstrated its activity in limiting sebum production on the scalp.

[0148] Illustrative examples of formulations

[0149] [Table 3] Capsule Formulations in Clinical Studies

[0150]

[0151] [Table 4] Capsule Formulation

[0152]

[0153] [Table 5] Soft Capsule Formulation

[0154]

[0155] Bibliography

[0156] (1) Lin et al. Morphogenesis, Growth Cycle and Molecular Regulation. Frontiers in Cell and Developmental Biology 2022, 10:899095. doi: 10.3389 / fcell.2022.899095.

[0157] (2) Patent application FR3069160A1: Cosmetic or pharmaceutical composition for promoting hair growth, comprising a lyophilisate of dedifferentiated seafennel cells.

[0158] (3) Nikfar and Jaberidoost. Hair in Encyclopedia of Toxicology (3rd edition), Academic Press, 2014, 813-815. https: / / doi.org / 10.1016 / B978-0-12-386454-3.00610-2.

[0159] (4) Patent application EP2821052A1: Combination of miliacin and polar lipids, particularly sphingolipids and / or phospholipids, for hair and scalp care.

[0160] (5) https: / / www.liperol.fr / le-cuir-chevelu /

[0161] (6) Makrantonaki et al. An update on the role of the sebaceous gland in the pathogenesis of acne. Dermato-Endocrinology 2011, 3:1, 41-49, doi: 10.4161 / derm.3.1.13900.

Claims

1. A composition (C) characterized in that, The composition (C) contains wheat gluten extract, which contains 100% by weight: - At least one sphingolipid (a1) produced by the amidation of fatty acids and sphingosine, comprising 20% ​​to 80% by weight, -10% to 50% by weight of digalactosyl diglyceride (a2), and - At least one phospholipid (a3) ​​comprising 1% to 30% by weight, and The sum of the mass contents of the at least one sphingolipid (a1), the digalactosyl diglyceride (a2), and the at least one phospholipid (a3) ​​produced by the amidation of fatty acids and sphingosine is equal to 100% by mass. The composition (C) is administered orally for use in a method of therapeutically treating the scalp to limit its sebum production.

2. The composition (C) of claim 1, comprising 100% by weight: - At least one sphingolipid (a1) produced by the amidation of fatty acids and sphingosine, comprising 20% ​​to 60% by weight, -19% to 50% by weight of digalactosyl diglyceride (a2), and - At least one phospholipid (a3) ​​at 1% to 10% by weight.

3. An edible pharmaceutical composition (Cp) comprising, per 100% by weight: - Composition (C) comprising 10% to 30% by weight, wherein composition (C) contains 100% by weight: - At least one sphingolipid (a1) produced by the amidation of fatty acids and sphingosine, comprising 20% ​​to 80% by weight, and more particularly 20% to 60% by weight, by weight. - Digalactosyl diglyceride (a2) at 10% to 50% by weight, and more particularly 19% to 50% by weight, and - At least one phospholipid (a3) ​​comprising 1% to 30% by weight, and more particularly 1% to 10% by weight, by weight. The sum of the mass contents of the at least one sphingolipid (a1), the digalactosyl diglyceride (a2), and the at least one phospholipid (a3) ​​produced by the amidation of fatty acids and sphingosine is equal to 100% by mass, and the composition (C) is a wheat gluten extract. as well as - At least one pharmaceutically acceptable edible technical additive, comprising 70% to 90% by weight. This edible pharmaceutical composition (Cp) is administered orally for use in methods of therapeutically treating the scalp to limit its sebum production.

4. The edible pharmaceutical composition (Cp) of claim 3 further comprises at least one active ingredient selected from: bioactive lipids, water-soluble or water-dispersible trace element salts, water-soluble or fat-soluble vitamins, prebiotics, probiotics, milk proteins and / or milk protein concentrates, plant or animal enzymes, amino acids, peptides, sugars, flavor enhancers and flavorings.

5. For non-therapeutic use by oral administration of an effective amount of composition (C) for the prevention or reduction of unsightly signs associated with the presence of excessive sebum on the scalp, wherein composition (C) comprises 100% by weight: - At least one sphingolipid (a1) produced by the amidation of fatty acids and sphingosine, comprising 20% ​​to 80% by weight, and more particularly 20% to 60% by weight, by weight. - Digalactosyl diglyceride (a2) at 10% to 50% by weight, and more particularly 19% to 50% by weight, and - At least one phospholipid (a3) ​​comprising 1% to 30% by mass, more particularly 1% to 10% by mass, wherein the sum of the mass contents of the at least one sphingolipid (a1), the digalactosyl diglyceride (a2), and the at least one phospholipid (a3) ​​produced by amidation of fatty acids and sphingosine is equal to 100% by mass, and the composition (C) is a wheat gluten extract.

6. A method of cosmetic treatment for preventing or slowing the appearance of unsightly signs associated with the presence of excess sebum on the scalp, characterized in that, An orally administered effective amount of composition (C), comprising, by weight 100%: - At least one sphingolipid (a1) produced by the amidation of fatty acids and sphingosine, comprising 20% ​​to 80% by weight, and more particularly 20% to 60% by weight, by weight. - Digalactosyl diglyceride (a2) at 10% to 50% by weight, and more particularly 19% to 50% by weight, and - At least one phospholipid (a3) ​​comprising 1% to 30% by weight, and more particularly 1% to 10% by weight, by weight. The composition (C) comprises, by mass, at least one sphingolipid (a1) produced by amidation of fatty acids and sphingosine, at least one digalactosylglycerol (a2) and at least one phospholipid (a3), the sum of which is 100% by mass, and the composition (C) is a wheat gluten extract.

7. A food supplement (Ca) comprising, per 100% by weight: - Composition (C) comprising more than 0% and less than 10% by weight of the following composition (C): - At least one sphingolipid (a1) produced by the amidation of fatty acids and sphingosine, comprising 20% ​​to 80% by weight, and more particularly 20% to 60% by weight, by weight. - Digalactosyl diglyceride (a2) at 10% to 50% by weight, and more particularly 19% to 50% by weight, and - At least one phospholipid (a3) ​​comprising 1% to 30% by weight, and more particularly 1% to 10% by weight, by weight. The sum of the mass contents of the at least one sphingolipid (a1), the digalactosyl diglyceride (a2), and the at least one phospholipid (a3) ​​produced by the amidation of fatty acids and sphingosine is equal to 100% by mass, and the composition (C) is a wheat gluten extract, and - At least one nutritionally acceptable technical additive, comprising more than 90% and less than 100% by weight.

8. The food supplement (Ca) of claim 7, further comprising at least one active ingredient selected from: bioactive lipids, water-soluble or water-dispersible trace element salts, water-soluble or fat-soluble vitamins, prebiotics, probiotics, milk proteins and / or milk protein concentrates, plant or animal enzymes, amino acids, peptides, sugars, flavor enhancers and flavorings.

9. Food supplement (Ca) according to any one of claims 7 and 8, characterized in that, This food supplement (Ca) is available in tablet, hard capsule, soft capsule, powder, film-coated tablet, gum, or granule form.

10. Use by oral administration of the food supplement (Ca) as described in any one of claims 7 to 9 for the prevention and / or reduction of unsightly signs associated with the presence of excessive sebum on the scalp.

11. A method for a cosmetic treatment to prevent or mitigate unsightly signs associated with the presence of excessive sebum on the scalp, characterized in that, An effective amount of the food supplement (Ca) as described in any one of claims 7 to 9, administered orally.

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