MX2008007843A - Food supplement based on group b vitamins, trace elements and w-3 and/or w-6 fatty acids and use of this food supplement in the simultaneous treatment of localized cellulite and slackening of the skin - Google Patents

Abstract

The present invention relates to the use of a combination of group B vitamins, trace element(s), at least one oil comprising essential fatty acids (-3 and/or -6) and an excipient suitable for oral administration, for the manufacture of a food supplement for use in the simultaneous treatment of excess weight and slackening of the skin localized in the same area. The invention also relates to a food supplement consisting of a mixture of group B vitamins, at least one trace element, chosen from the group consisting of zinc, magnesium, copper, selenium, chromium, iron, manganese and mixtures thereof, of at least one oil comprising at least one essential fatty acid (-3 and/or -6) and at least one excipient suitable for oral administration. The invention also relates to the associated cosmetic treatment method.

Description

FOOD SUPPLEMENT BASED ON THE GROUP OF VITAMINS B.

OLIGOELEMENTS AND FATTY ACIDS W-3 AND / OR W-6, AND USE OF THIS FOOD SUPPLEMENT IN THE SIMULTANEOUS TREATMENT OF THE LOCALIZED SKIN CELLULITE AND FLACIDEZ DESCRIPTIVE MEMORY The invention relates to the use of a mixture of trace elements and vitamins of group B, administered orally, for the simultaneous treatment of localized cellulitis and flaccidity of the skin. The invention also relates to a method of cosmetic treatment, administered orally, for excess weight located in a surface area and simultaneously for the flaccidity of the skin located in the same area. The invention also relates to a food supplement, which can be administered within the competence of that use or that method of cosmetic treatment. The localized excess weight is materialized in the form of fat, whose quantity and distribution differ according to gender. In this way, adipose tissue represents 20 to 30% of body weight in women and 10 to 15% in men. Subcutaneous fat is twice as thick in women as in men. In men, fat accumulates around and above the waist (android distribution, metabolic risk factor) and below the waist, in the femoral gluteal region in women (gynoid distribution, not correlated with a vascular risk) .

One of the characteristics of this accumulated fat in the lower part of the body is that it is difficult to mobilize. It tends to provide reproductive energy needs (pregnancy and, above all, stfeeding) and therefore represents the body's largest energy reserve. At a cellular level, adipocytes are spherical cells in which the intercellular space is filled by a large vacuole filled with triglycerides. Adipocytes can change volume rapidly. In fact, these cells can reach, depending on the circumstances, from 40 μm to 120 μm in diameter, which corresponds to a volume increase of 27 times. In some extreme cases, this increase can be up to 0 times. In this way, the adipocyte has the main role of energy in the body, as it is capable of storing (absorption or lipogenesis) or, conversely, of mobilizing (lipolysis) triglycerides, the body's main source of energy, quickly . Lipogenesis involves the synthesis of t acylglycerols which is the result of esterification of glycero-3-phosphate by activated fatty acids; conversely, lipolysis corresponds to the hydrolysis of stored triacylglycerols, in glycerol and fatty acids. Different mechanisms controlling lipolysis and lipogenesis have been demonstrated, involving, for example, receptors such as alpha-2 and / or beta-1 and -2 receptors, adenosine A1, prostaglandin E2, Y2 type YY and NPY neuropeptide receptors, and also sex hormones.

Two main types of slimming active substances are known: lipolytic substances (which act in the elimination of excess fat) and liporreductive substances (which combat the formation of fat). a) Lipolytic substances -Caffeine (found in a large number of plants: green tea, guarana beans): inhibits phosphodiesterase, thus ensuring an optimal level of intracellular cAMP, stimulates the ß receptors and inhibits lipoprotein lipase; - Rodisterol (red algae extract): activates the a receptors and promotes the penetration of caffeine; - Palmitoyl-carnitine: accelerates the combustion of fatty acids, improving the absorption of them by the mitochondria; - Alpha and gamma bioactive substances (obtained from a marine bacterium and a fungus, respectively): block the a2 and NPY receptors; - Escina and gingko biloba: blockers of a2; - Sphingosine: limits the penetration of glucose. b) Liporreductive substances - Andiroba (triterpenes) and Carcin Cambogia: block the conversion of pre-adipocytes to adipocytes - Rutin (Ruta graveolens extract): isolates glucose and avoids the combination thereof with free fatty acids. To these specific active substances, it is possible to add anti-infiltration and venotonic substances, which are often combined with active slimming substances.

Anti-infiltration substances: - Viburnum (drained, decongestant, activates caffeine, antiradical, firming effect) - Ivy (anti-inflammatory, anti-swelling, analgesic) - Arnica (anti-swelling, sedative) - Pisolo (anti-radical, accelerates the drained) - Wild thinking (important role in the balance of hydration) - Vesicular sargassum (anti-swelling, sedative) Venotonic substances: - Ruscus (action of vitamin P, vascular stimulant) - Gingko biloba (combat vascular and capillary stasis) - Escin (improves venous tonicity, modifies capillary permeability).

Finally, the formulations comprising these active slimming substances can be supplemented by active ingredients that remodel and softeners that make it possible to combat sagging skin. Active slimming substances according to the prior art are generally administered topically. Food supplements comprising a combination of vitamins, trace elements and essential fatty acids are already known in the prior art. For example, the international application WO 91/11117 describes a formulation, designed to be administered orally, that contains vitamins (B1, B2, B3, B5, B6, B9, B12, C, D3, K1) and minerals (boron, calcium , chromium, copper, iodine, iron, magnesium, manganese, molybdenum, potassium, selenium, silica, vanadium and zinc) in combination with antioxidants and fish oils. This oral formulation is designed to prevent cancer and cardiovascular disease. US Patent 6,071, 544 describes the use of O-3 and O-6 fatty acids, to promote weight loss in cats, in an oral formulation comprising in combination vitamins (A, B1, B2, B3, B5, B6) , B7, B8, B9, B12, C, D3 and E) and minerals (calcium, cobalt, copper, iron, magnesium, manganese, phosphorus, potassium, selenium and zinc). No effect is observed on the flaccidity of the skin. Although knowledge of the mechanisms of control of lipolysis and adipocyte lipogenesis has improved markedly, they require satisfactory slimming active substances. In addition, it is not easy to determine a satisfactory combination of active slimming ingredients and active softening ingredients. Therefore, currently, there is a genuine demand for the preparation of oral formulations, particularly food supplements, which make it possible to effectively promote weight loss and, at the same time, combat sagging skin. The invention relates firstly to the use of a combination, comprising: a mixture of a group of vitamins B and derivatives thereof; - at least one trace element, in the form of a salt or complex, chosen from the group consisting of zinc, magnesium, copper, selenium, chromium, iron, manganese and mixtures thereof; - at least one vegetable and / or animal oil comprising at least one essential fatty acid selected from fatty acids O-3 and fatty acids O-6; - and at least one excipient suitable for oral administration, for the manufacture of a food supplement, administered orally, for the treatment of excess weight located in a surface area and simultaneously of the flaccidity of the skin located in the same area. The invention also relates to a method of cosmetic treatment of excess weight located in a surface area and simultaneously of the flaccidity of the skin located in the same area, comprising the oral administration of a combination comprising: a mixture of group B vitamins and derivatives thereof; - at least one trace element, in the form of salt or complex, selected from the group consisting of: zinc, magnesium, copper, selenium, chromium, iron, manganese and mixtures thereof; - at least one vegetable and / or animal oil comprising at least one essential fatty acid selected from fatty acids O-3 and fatty acids O-6; - and at least one excipient suitable for oral administration. Finally, the invention relates to a food supplement designed for oral administration, consisting of a combination consisting of: a) a mixture of group B vitamins and derivatives thereof; b) at least one trace element, in the form of a salt or complex, chosen from the group consisting of zinc, magnesium, copper, selenium, chromium, iron, manganese and mixtures thereof; c) at least one vegetable and / or animal oil comprising at least one essential fatty acid selected from fatty acids O-3 and / or fatty acids O-6; d) if applicable, a plant enzyme advantageously selected from the group comprising papain, bromelain and ficin; e) and at least one excipient suitable for oral administration. The vitamins that are found in the food supplement according to the invention are exclusively group B vitamins. Within the competence of the present description, the mass ratios are determined, unless otherwise specified, on the basis of Weight per mass of the compounds (fatty acids, vitamins, trace elements) alone. Thus, for trace elements, the weight of the trace element is only used as a base, and not the weight of the salt or its complex (for example, the weight of zinc in zinc sulfate). Similarly, for vitamins, the weight of the vitamin contained in the derivative is used as a base (for example, the weight of vitamin B3 contained in commercial nicotinamide). For the essential fatty acids O-3 and O-6, the content thereof in vegetable and / or animal oils is used as a base. The combination of the food supplement advantageously comprises the said vitamins, trace elements and essential fatty acids in a ratio of between 3 and 6, advantageously between 3.5 and 5 (essential fatty acids O-3 and / or O-6) :( group of vitamins B + trace element (s)). This mass ratio is preferably about 4.

In the combination or in the food supplement, these essential fatty acids O-3 and O-6 are advantageously present in a mass ratio O-3: O-6 of between 1 and 5, advantageously between 1 and 4, more advantageously between 1 and 3, even more advantageously between 1.4 and 2.1. This ratio is advantageously of approximately 2. The combination of the food supplement advantageously comprises the vitamins and the trace elements in a mass ratio (group of vitamins B) :( trace elements) between 0.2 and 1, advantageously between 0.4 and 0.6. This mass ratio is preferably about 0.5. The essential fatty acids O-3 present in the combination or in the food supplement are advantageously eicosapentaenoic acid (EPA) and / or docosahexaenoic acid (DHA). The food supplement combination advantageously comprises more EPA than DHA, more advantageously at least 2 times or more, preferably at least 3 times more, more preferably at least 4 times more, or at least 5 times more EPA than DHA. The essential fatty acids O-6 present in the combination or in the food supplement are advantageously linoleic acid and / or gamma-linoleic acid (GLA). The food combination or supplement advantageously comprises more linoleic acid than gamma-linoleic acid, more advantageously the mass ratio linoleic acid: gamma-linoleic acid is between 1.2 and 2, more advantageously between 1.6 and 1.9.

The group of vitamins B are advantageously chosen from the group consisting of vitamins B2, B3, B5, B6, B8, B9, B12 and mixtures thereof. The sources of these vitamins are, advantageously: - vitamin B12: riboflavin, boflavin-sodium phosphate - vitamin B3 (niacin): nicotinic acid, nicotinamide - vitamin B5 (pantothenic acid): calcium D-pantothenate, D- sodium pantothenate, dexpantotenol - vitamin B6: piroxidine hydrochloride, piroxidine-d-phosphate - vitamin B8 (biotin): D-biotin - vitamin B9 (folic acid): pteroylmonoglutamic acid, folic acid vitamin B12 (cobalamines): cyanocobalamin, hydroxocobalamin. The group of vitamins B and derivatives thereof advantageously choose from the group consisting of riboflavin, nicotinamide, calcium pantothenate, pyridoxine hydrochloride, biotin, folic acid, cobalamin, and mixtures thereof. Zinc advantageously comes in the form of a zinc salt or in the form of a complex, in particular in the form of zinc acetate, zinc chloride, zinc citrate, zinc gluconate, zinc lactate, zinc oxide, carbonate. of zinc or zinc sulfate. In an advantageously alternative embodiment of the invention, zinc is introduced in the form of zinc sulfate.

In this case, the food supplement according to the invention advantageously comprises from 15 to 25 mg, per dose, of zinc sulfate. Magnesium is used to convert the group of vitamins B to the active form. Advantageously, it is introduced into the combination or the food supplement in the form of magnesium acetate, magnesium carbonate, magnesium chloride, magnesium salts of citric acid, magnesium gluconate, magnesium glycerophosphate, magnesium salts of orthophosphoric acid, lactate of magnesium, magnesium hydroxide, magnesium oxide or magnesium sulfate, magnesium is preferably introduced in the form of magnesium oxide. In this case, the food supplement according to the invention advantageously comprises from 30 to 35 mg, per dose, of magnesium oxide. Copper is advantageously introduced into the combination or the food supplement in the form of copper carbonate, copper citrate, copper gluconate, copper sulfate or copper-lysine complex. Selenium is advantageously introduced into the food combination or supplement in the form of yeast extracts nourished with selenium, sodium selenate, hydrogenated sodium selenite or sodium selenite. Chromium is advantageously introduced into the food combination or supplement in the form of chromium (III) chloride or chromium (III) sulfate. Iron is advantageously introduced into the combination or food supplement in the form of iron carbonate, iron citrate, ammonium citrate iron, iron gluconate, iron fumarate, sodium diphosphate iron, iron lactate, iron sulphate, iron diphosphate (iron pyrophosphate) or iron saccharate. Manganese is advantageously introduced into the combination in the form of manganese carbonate, manganese chloride, manganese gluconate, manganese glycerophosphate or manganese sulfate. The food combination or supplement preferably comprises at least zinc and magnesium, as trace elements; In accordance with an advantageous alternative embodiment of the invention, the only trace elements present in the food supplement combination are zinc and magnesium. The oils used in the food combination or supplement are oils rich in omega-3 (nut oils, rape seed, wheat germ, soybeans, canola, flaxseed, fish, krill) and / or omega-6 (seed oils of grape, black currant, sunflower, walnut, corn, borage, evening primrose, saffron, wheat gum, soy, sesame, rapeseed, peanut, hazelnut, olive). The oils that are advantageously used within the competence of the invention are borage and / or fish oils. According to an advantageous alternative embodiment of the invention, the food combination or supplement also comprises a plant enzyme, particularly a plant enzyme chosen from the group consisting of papain, bromelain and ficin.

The food supplement according to the invention advantageously consists of a mixture of 365 mg consisting of: a) 15 to 30 mg of a mixture of group B vitamins and mixtures thereof, chosen from the group consisting of riboflavin, nicotinamide , calcium pantothenate, pyridoxine hydrochloride, biotin, folic acid and cobalamins; b) 38 to 61 mg of a mixture of magnesium oxide and zinc sulfate; c) 200 to 245 mg of a mixture of borage oil and fish oil; d) 20 to 30 mg of a concentrated pineapple extract with bromelain; and e) q.s. suitable excipient (s) for oral administration. The excipients that can be used in a conventional manner are glyceryl monostearate, rapeseed or soybean lecithin, vegetable oils (soybean, sunflower), hydrogenated or partially hydrogenated vegetable oils, waxes such as beeswax. The method of cosmetic treatment according to the invention can prove to be particularly advantageous for pregnant women or women who have given birth less than 6 months before, who may be lactating. In this way, the present invention also relates to a method of cosmetic treatment to combat excess weight located in the surface area and simultaneously to combat sagging skin located in the same area in pregnant women or women who have given birth less than 6 months before (who may be lactating). In fact, one of the advantages of the combination according to the invention is the absence of active ingredients contraindicated for women who have given birth, particularly for lactating women. In addition, the combination or food supplement makes it possible to provide women who have recently given birth to the B vitamins, while lactating or pregnant women are considered a risk group for the deficiency of B vitamins, particularly those of the B group. vitamins B2, B5, B6 and B9. The term "slimming" or "combating localized excess weight" according to the invention refers to an action that makes it possible to avoid or at least reduce the formation of subcutaneous fat as described above. In this way, the storage of fat (lipogenesis) is significantly limited and / or the release of fat (lipolysis) is significantly stimulated. This action promotes a reduction in adipose tissue and is particularly driven by a reduction in excess weight or unsightly reserves, by thinning the figure, by an acceleration in the excess removal, by an improved definition of the body delineation or a remodeled figure. The term "combat localized flaccidity of the skin", in accordance with the invention, refers to an action that makes it possible: - strengthen the epidermal ridge and remodel the epidermis, particularly by activating the keratinocyte metabolism (proliferation / differentiation); and / or - redensifying the skin (the elasticity of the skin is restored), particularly by activating the metabolism of fibroblasts (proliferation / total protein synthesis) and / or stimulating the synthesis of the key molecules of the extracellular matrix (collagen I, elastin, fibronectin); and / or - reinforcing the dermal-epidermal junction, particularly by stimulating the synthesis of collagen VII. The term "cosmetic treatment method for combating localized excess weight and localized flaccidity of the skin", according to the present invention, refers to the application of a cosmetic treatment that makes it possible to visibly measure the action described above. In this way, the food combination or supplement according to the invention can be used to treat areas of the skin tending to form that localized excess weight, i.e., the areas in which that excess weight has already formed or is in training process. The various compounds in the combination can be administered simultaneously (for example, in the same capsule) or as combination products for separate use or extended use over time. The various compounds of the combination are advantageously administered simultaneously (in the same capsule, for example).

The food supplement or combination is formulated to be administered orally. In this way, it can be presented in the form of a capsule, soft capsule, tablet, granule, advantageously in the form of a capsule. If the food supplement or combination is in the form of a soft capsule, the coating of those soft capsules may particularly contain animal gelatin such as fish gelatin, glycerin, or a material of plant origin such as cellulose or starch derivatives, or a plant protein. If the food supplement or combination is in the form of a soft capsule, tablet or granule, the mixture of active substances can be fixed in a powder substrate such as silica, cellulose and maltodextrin. The recommendations for use are 2 doses per day. The food supplement according to the present invention can advantageously comprise any suitable carrier or excipient, acceptable from a nutraceutical point of view, together with conventional additives known to those skilled in the art. The food supplement and the combination can be used simultaneously in combination with other active substances with slimming action, such as lipolytic and liporreductive substances, separately or distributed over time. The lipolytic type slimming active substance can be chosen from: caffeine, risterxol, palmitoyl-carnitine, alpha and gamma bioactive substances, escin, gingko biloba and sphingosine. The slimming active substance liporreductora type can be chosen from andiroba, garcinia cambodia, routine. It is also possible to use one or two anti-infiltration or venotonic active substances simultaneously, separately or spread over time, in addition to the food combination or supplement according to the invention. The anti-infiltration or venotonic active substances can be selected from viburnum, ivy, arnica, pisóla, wild thought, vesicular sargassum, ruscus, gingko biloba and escin. The following examples illustrate the invention.

EXAMPLE 1 Food supplement The food supplement according to Example 1 complies with the following composition by weight: TABLE 1 Composition of the food supplement The food supplement is in the form of a soft capsule. For this specific soft capsule, the recommended dose is two capsules per day, preferably one in the morning and one in the afternoon.

EXAMPLE 2 In vitro study The purpose of this test is to demonstrate the effect of the combination as described in Example 1 in a synthesis of type I collagen in a fibroblast model in culture.

Materials and methods Human normal dermal fibroblasts were inoculated, in step P10, in 96-well trays, in DMEM medium (Dulbeco's Modified Eagle Medium) with GlutaMAX ™ I, 1000 mg / L D-Glucose, sodium pyruvate, supplemented with 10% fetal calf serum + antibiotics. After 24 h of incubation at 37 ° C, 5% C02 in a humidified atmosphere, the cells were rinsed twice with PBS and incubated for 48 hours with or without the combination according to Example 1. At the end of the treatment , the total intracellular protein concentration is determined using the Lowry method and, in parallel, the collagen Type I released by the cells is tested in the culture floats using the ELISA technique.

For each treatment condition, the concentration of Type I collagen refers to the amount of total protein, and the results are they express in ng of collagen type I per μg of proteins.

The increase in type I collagen release induced by the combination treatment according to Example 1, with with respect to the control cells (untreated), it was calculated as follows: 0,. Collagen I treatment - collagen I control% increase = 100 x collagen I control The significance of the results is analyzed by means of a Student's t test. Four tests were performed. The mean of the tests and the standard deviation are given in Table 2 below: TABLE 2 The combination according to Example 1 makes it possible, under our experimental conditions, to increase the synthesis of type I collagen by dermal fibroblasts in culture, by 481% (p < 0.001).

EXAMPLE 3 Clinical study The purpose of the test will be to evaluate the benefit of supplementation with the food supplement according to Example 1, in postpartum body remodeling. It will be analyzed in post-parturient women comparing a treated group with an untreated control group. This test is performed by dermatologists or midwives.

Treatment Ingestion or not of a capsule in the mornings and afternoons of the food supplement as described in Example 1, for 3 months.

Subjects Women, lactating or not, who have given birth at least two months, and no more than 3 months, before. These women did not follow in parallel any other slimming treatment and / or treatment designed to reshape the skin. In addition, they did not follow that treatment after giving birth or before conducting the test. Tables 3 and 4 below report the variants (in%) of the measurements of waist circumference (Table 3) and thigh circumference (Table 4) for treated and untreated groups.

TABLE 3 Variation of the circumference of the waist TABLE 4 Variation of the circumference of the thigh These parameters progress more favorably for the treated group than for the untreated group. These results demonstrate the efficacy of twice-daily administration of the capsules according to Example 1, to reduce waist circumference and thigh measurements.

Table 5 below summarizes the results of the subjects' self-evaluations. There is a statistically significant difference between the treated group and the untreated group, in favor of the treated group. In other words, these results demonstrate the efficacy of a twice daily dose of the food supplement according to Example 1 TABLE 5 The twice daily administration of a food supplement according to Example 1: - makes it possible to significantly reduce the circumference of the waist and the circumference of the thigh; - induces a significant improvement in the elasticity, flexibility and tonicity of the skin, and reduces skin flaccidity, in parallel; - correlates with a general reaffirmation of the skin, combined with a thinner figure and reduced curves; - makes it possible to reduce the size of stretch marks due to pregnancy; - makes it possible to improve the appearance of the skin.

Claims (15)

NOVELTY OF THE INVENTION CLAIMS

1. - The use of a combination comprising: a mixture of group B vitamins and derivatives thereof; at least one trace element, in the form of a salt or complex, selected from the group consisting of zinc, magnesium, copper, selenium, chromium, iron, manganese and mixtures thereof; at least one vegetable and / or animal oil comprising at least one essential fatty acid selected from fatty acids O-3 and fatty acids O-6; and at least one excipient suitable for oral administration, for the manufacture of a food supplement, orally administrable, useful for the treatment of excess weight located in a surface area and simultaneously skin flaccidity located in the same area.

2. The use as claimed in claim 1, wherein the combination comprises said vitamins, said trace elements and said essential fatty acids in a mass ratio (essential fatty acids O-3 and / or O-6) :( group of vitamins B + trace element (s)) between 3 and 6.

3. The use as claimed in claim 1 or 2, wherein the combination comprises the essential fatty acids O-3 and O-6 in a ratio of mass of O-3: O-6 between 1 and 5.

4. The use as claimed in any of the preceding claims, wherein the combination comprises the vitamins and trace elements in a mass ratio of (B vitamins) :( trace elements) between 0.2 and 1.

5. The use as claimed in any of the preceding claims, wherein the group of vitamins B and the derivatives of the They are selected from the group consisting of riboflavin, nicotinamide, calcium pantothenate, piroxidine hydrochloride, biotin, folic acid, cobalamin, and mixtures thereof.

6. The use as claimed in any of the preceding claims, wherein the combination comprises, as trace elements, zinc and magnesium.

7 '.- The use as claimed in any of the preceding claims, wherein the oil used in the combination is borage oil and / or fish oil.

8. The use as claimed in any of the preceding claims, wherein the combination also comprises a plant enzyme, particularly a plant enzyme selected from the group consisting of papain, bromelain and ficin.

9. A food supplement, designed for oral administration, consisting of a combination consisting of: a) a mixture of group B vitamins and derivatives thereof; b) at least one salt or complex of trace element, said trace element being selected from the group consisting of zinc, magnesium, copper, selenium, chromium, iron, manganese and mixtures thereof; c) at least one vegetable oil and / or animal comprising at least one essential fatty acid selected from fatty acids O-3 and / or fatty acids O-6; d) if applicable, a plant enzyme advantageously selected from the group comprising papain, bromelain and ficin; e) and at least one excipient suitable for oral administration.

10. The food supplement according to claim 9, further characterized in that vitamins, trace elements and essential fatty acids are introduced in a mass ratio of (O3 and / or O-6 essential fatty acids): group B + trace element (s)) between 3 and 6.

11. The food supplement according to claim 9 or 10, further characterized in that the essential fatty acids O-3 and the essential fatty acids O-6 are introduced in a mass ratio of O-3: O-6 between 1 and 5.

12. The food supplement according to any of claims 9 to 11, further characterized in that the vitamins and trace elements are introduced in a mass ratio. of (group of vitamins B) :( trace elements) between 0.2 and 1.

13. The food supplement according to any of claims 9 to 12, further characterized in that the group of vitamins B and the derivatives thereof are selected. from the group consisting of riboflavin, nicotinamide, calcium pantothenate, piroxidine hydrochloride, biotin, folic acid, cobalamin and mixtures thereof.

14. - The food supplement according to any of claims 9 to 13, further characterized in that the combination comprises, as trace elements, zinc and magnesium.

15. The food supplement according to any of claims 9 to 14, further characterized in that it consists of a mixture of 365 mg, consisting of: a) 15 to 30 mg of a mixture of vitamins of group B and mixtures thereof , chosen from the group consisting of riboflavin, nicotinamide, calcium pantothenate, pyridoxine hydrochloride, biotin, folic acid and cobalamins; b) 38 to 61 mg of a mixture of magnesium oxide and zinc sulfate; c) 200 to 245 mg of a mixture of borage oil and fish oil; d) 20 to 30 mg of a concentrated pineapple extract with bromelain; and e) q.s. suitable excipient (s) for oral administration.