USE OF WHEAT EXTRACT TO REDUCE SEBUM SECRETION IN THE SKIN

Abstract

The invention relates to the non-therapeutic nutricosmetic use of a composition in a form suitable for oral administration, comprising, in a physiologically acceptable medium, a wheat extract. The invention is characterized in that the wheat extract, containing 35-40% triglycerides and diglycerides, 20-30% glycolipids, 7-10% phospholipids, and 2-4% ceramides and glycosylceramides, by weight of the total extract, is used to reduce excessive sebum secretion on the facial skin. Figure 2

Description

Title of the invention: USE OF A WHEAT EXTRACT TO REDUCE SEBUM SECRETION IN THE SKIN technical field

[0001] The present invention relates to the field of nutricosmetics, that is to say the field of food supplements used to obtain a benefit for the skin.

[0002] More particularly, the invention relates to a composition in a form suitable for oral administration comprising a wheat extract to reduce excessive sebum secretion in the skin.

[0003] The skin is an organ that covers the surface of the body and constitutes the interface between the organism and the external environment. Its purpose, among others, is to protect the organism against external aggressions.

[0004] For the purposes of the invention, the skin is not a single element in that its composition differs according to the different areas of an individual's body, namely generally dry areas such as the forearms, wet areas such as under the armpits, oily areas such as the face, or thicker areas such as the soles of the feet.

[0005] If the scalp is considered as an extension of the skin, it is characterized in particular by the greater presence of sebaceous glands and hair follicles compared to other areas of the skin on the rest of the body, contributing to a particular environment.

[0006] Sebum is a complex mixture of lipids (composed, for example, of 30-50% triacylglycerols / diacylglycerols, 15-30% fatty acids, 12-20% squalene, 26-30% wax esters, 3-6% cholesterol esters, and 1.5-2.5% cholesterol) produced by the sebaceous glands in the dermis. It forms an impermeable film, which contributes in particular to skin hydration and the skin barrier function, and delivers lipophilic antioxidants to the skin surface.

[0007] Sebum is therefore very important in the skin environment, provided that it is in good quantity and of good quality.

[0008] Excessive sebum production leads to oily skin and certain factors greatly influence its production: hormonal influence, age, sex, ethnic origin, body area, time of day, seasons and climate.

[0009] Areas of pimples generally appear where sebum is abundant: the face, shoulders, and chest area, on the upper back and the front of the chest. On the face, sebum production is maximum in the T zone (area with high sebum production, namely the forehead, nose and chin); it is less intense in the cheeks, upper eyelids and neck (U zone).

[0010] Among the clinical characteristics of oily skin are a shiny appearance, increased skin thickness, enlarged or even clogged pores leading to comedones, a predisposition to acne, and a dull or uneven complexion. Problems associated with oily skin can impact self-esteem and quality of life.

[0011] The difference in sebum production between the T-zone (area with high sebum production, namely the forehead, nose, and chin) and the U-zone (area with low sebum production, namely the cheeks) characterizes combination skin. In other words, it is oily in the T-zone (forehead, nose, chin) and dry or normal on the rest of the face. Previous technique

[0012] Considering the composition of the skin, ceramides are known in particular to be used in topical application to improve the integrity and barrier function of the skin, particularly in atopic dermatitis or sensitive skin (Wu et al., “Compromised Skin Barrier and Sensitive Skin in Diverse Populations”, J. Drugs Dermatol. 2021, 20(4 Suppl): 17-22; Draelos ZD, “The effect of ceramide-containing skin care products on eczema resolution duration”, Cutis. 2008, 81(1): 87-91; and Lynde et al., “A cohort study on a ceramide-containing cleanser and moisturizer used for atopic dermatitis”, Cutis. 2008, 2014, 93(4): 207-213).

[0013] It also appears that ceramides (for example, ceramides and / or glycosylceramides contained in an (oily) wheat extract) are particularly known for oral use (e.g., as a food supplement) for:

[0014] - to combat hair loss or the loss of animal fur and / or to promote their growth and / or regrowth and / or improving their beauty (shine, softness, strength) and / or improving scalp comfort (EP2821052);

[0015] - to be included in compositions for dietary use (hydrating properties) and food use (anti-radical, antioxidant, emulsifying and lubricating properties) (FR2785806).

[0016] - improve skin hydration (scaling, roughness and redness) to to prevent and limit age-related skin damage and its potential use in skin healing processes or to reduce dryness, itching, and red patches in atopic dermatitis and during skin inflammation (Boisnic et al., "Polar lipids from wheat extract oil improve"). skin damages induced by aging: Evidence from a randomized, placebo controlled clinical trial in women and an ex vivo study on human skin expiant”, 2019).

[0017] It is also known from the publication by Léo et al. (“Effect of Rice (Oryza sativa L.) Ceramides Supplementation on Improving Skin Barrier Functions and Depigmentation: An Open-Label Prospective Study,” Nutrients 2022, 14, 2737) that daily (oral) supplementation with rice ceramides for three months significantly improved skin hydration, sebum production, firmness and elasticity, and wrinkle severity in the areas evaluated. In particular, sebum production was significantly improved in the cheek, neck, and arm, respectively.

[0018] While the underlying mechanism of sebum production induced by ceramide (rice) supplementation remains unclear, it is thought to be associated with increased ceramide production following ceramide consumption. Ceramides are known to enhance lipid synthesis in sebocyte culture models. Interestingly, sebum production in the three areas examined improved considerably from the normal healthy range, by 70 to 180 (arbitrary units, AU) for the cheek, 55 to 130 AU for the neck, and >6 AU for the arm. The older participants in the study showed more significant changes in sebum production in the cheeks and neck than those in the younger age groups. It is most likely their extremely low baseline sebum secretion rate that makes them more sensitive to the effects of ceramide supplementation.

[0019] Technical problem

[0020] Considering the above, one problem that the invention proposes to solve is to implement a natural product based on a wheat extract, known for its use in particular in the hydration of the skin and the growth of hair, in a new targeted and effective cosmetic application.

[0021] The invention further aims to provide such a composition which does not cause troublesome side effects and does not alter the hormonal balance of the person concerned.

[0022] Surprisingly and unexpectedly compared to ceramide (rice) supplementation, the wheat extract used according to the invention actually reduces sebum secretion, particularly of facial skin.

[0023] Technical solution

[0024] The invention therefore relates to the non-therapeutic nutricosmetic use of a composition in a form suitable for oral administration comprising, in a physiologically acceptable medium, a wheat extract containing 35-40% triglycerides and diglycerides, 20-30% glycolipids, 7-10% of Phospholipids and 2-4% ceramides and glycosylceramides, by weight of the total extract, to reduce excessive sebum secretion on the facial skin. Brief description of the drawings

[0025] In this description, unless otherwise specified, it is understood that, when an interval is given, it includes the upper and lower bounds of said interval.

[0026] The invention and its advantages will be better understood upon reading the following description and non-limiting embodiments, with reference to the accompanying figures in which:

[0027] Fig. 1 represents the variation in the amount of sebum on the face in healthy female volunteers with combination to oily skin after daily supplementation for 90 days with a food supplement based on a composition according to the invention (see example 4).

[0028] Fig. 2 represents the rate of change in the amount of sebum between J0 and J90 versus placebo. Description of the implementation methods

[0029] The invention relates to the non-therapeutic nutricosmetic use of a composition in a form suitable for oral administration comprising, in a physiologically acceptable medium, a wheat extract containing 35-40% triglycerides and diglycerides, 20-30% glycolipids and in particular digalactosyldiacylglycerol (DGDG), 7-10% phospholipids and 2-4% ceramides and glycosylceramides, by weight of the total weight of the extract, to reduce excessive sebum secretion on the skin of the face.

[0030] A physiologically acceptable medium means a medium suitable for use in contact with human and animal cells, without toxicity, irritation, undue allergic response and the like, and proportionate to a reasonable benefit / risk ratio.

[0031] The wheat extract preferably used according to the invention contains 55-65% linoleic acid, 15-20% palmitic acid, 10-15% oleic acid, and 3-4% linolenic acid, by weight of the total weight of triglycerides and diglycerides. The wheat extract contains 20-30% glycolipids, essentially digalactosyldiacylglycerol (DGDG) as glycolipids, and 25-30% phosphatidylethanolamine, 30-35% phosphatidylcholine, and 30-35% phosphatidylinositol, by weight of the total weight of phospholipids.

[0032] The wheat extract thus used is an oily extract or a powder of wheat grain endosperm, preferably an oily extract.

[0033] In particular, the wheat extract may consist of that which is used in the product LIPOWHEAT®, marketed by the applicant of this application.

[0034] By way of example, the process for preparing the wheat extract used according to the invention may include the step of harvesting the wheat grains of Triticum aestivum / vulgare, followed by the removal of the bran and germ of the grain. Leaching then allows the separation of the starch and gluten, and then, by ethanolic extraction of the wheat gluten, the extract is obtained in the form of an oily extract and optionally after a second extraction using acetone, the extract is obtained in the form of a powder with the removal of the acetone by drying.

[0035] The dosage forms used for oral administration may be solid or liquid. Solid oral forms are generally tablets, hard capsules (capsules), soft capsules, sachets containing powder or granules, gums, powders, food supplements, or foods presented, for example, in the form of biscuits. Liquid oral forms are generally oral solutions, syrups, elixirs, oral emulsions, oral suspensions, oral drops, beverages, or instant drinks.

[0036] The composition used according to the invention is preferably administered in the form of a powder, capsule, caplet or emulsion.

[0037] The composition according to the invention can also be incorporated into food supplement formulas where it can be associated with compounds known to those skilled in the art and thus include sulfur amino acids, vitamins, in particular B group vitamins, and / or a plant extract, taken alone or in combination.

[0038] Advantageously, the composition used according to the invention further comprises a rosemary extract, preferably an extract of rosemary leaves (Rosmarinus officinalis), comprising in particular carnosic acid and carnosol.

[0039] The composition preferably used according to the invention comprises rosemary extract at a concentration of between 0.01 and 2% by weight of the total weight of the composition, preferably 0.2%.

[0040] The composition used according to the invention is preferably administered daily as a food supplement for a period of at least 30 days (d), preferably 60d or 90d.

[0041] Advantageously, according to a preferred embodiment, the composition used according to the invention is administered at a dose of 350 mg / day, in one or more doses, preferably in a single dose, for example a single dose in the morning with a large glass of water.

[0042] The composition according to the invention is used to reduce excessive sebum secretion on the skin of the face, preferably in the T-zone, more preferably on the forehead, chin and / or nose.

[0043] By excessive secretion, we mean a natural phenomenon which can be designated as hyperseborrhea or seborrhea, linked to an excess production of sebum which can occur at any age and result from several factors (fatigue, stress, diet, hormones, heat, pollution, ...), which gives a shiny appearance to the skin characteristic of combination to oily skin.

[0044] The composition according to the invention is used to have an effect on the T-zone of the face, in areas where sebum production is at its maximum, while it is less intense, for example, on the cheeks, upper eyelids and neck.

[0045] Particularly advantageously, the skin on which the composition according to the invention is used is combination or oily skin.

[0046] As indicated above, oily skin is characterized by a shiny appearance, increased skin thickness, enlarged or even clogged pores leading to blackheads, a predisposition to acne, and a dull or uneven complexion. Problems associated with oily skin can have a negative impact on self-esteem and quality of life.

[0047] Combination skin is characterized by a difference in the amount of sebum between the T-zone (area with high sebum production, namely the forehead, nose, and chin) and the U-zone (area with low sebum production, namely the cheeks). In other words, it is oily in the T-zone (forehead, nose, chin) and dry or normal on the rest of the face.

[0048] The composition according to the invention can also be used to limit excessive sebum secretion in sensitive skin.

[0049] Sensitive skin (or reactive, hyper-reactive, intolerant, or irritable skin) is defined by the appearance of unpleasant sensations such as tightness, tingling, burning (possibly pain or itching) in response to stimuli that would not normally cause such sensations. The contributing factors may be physical, chemical, psychological, or hormonal. These unpleasant sensations cannot be explained by lesions attributable to any skin disease. Thus, although often transient and, in many cases, not accompanied by visible dermatological responses, sensitive skin affects quality of life, and erythema may occasionally occur.

[0050] The invention, and the advantages it presents, will be more easily understood through the examples of embodiment set out below. Examples

[0051] Example 1: Composition according to the invention in the form of a soft capsule (= LIPOWHEAT®) Ingredients per capsule Quantity (mg) % Wheat extract according to the invention 349.3 99.8 Rosemary extract 0.7 0.2 Total 350 100.00

[0052] The soft capsule shell is composed of gelatin, glycerol, sorbitol, water and caramel E150 D.

[0053] Said capsule is advantageously taken as a food supplement, preferably at a dosage of 1 capsule per day.

[0054] Example 2: Composition according to the invention in the form of a soft capsule (containing the LIPOWHEAT® product) Ingredients per capsule Quantity (mg) % Wheat extract according to the invention 349.3 64.68 Rosemary extract 0.7 0.13 Borage oil 150 27.78 Beeswax 33 6.11 Sunflower lecithin 7 1.30 Total 540 100.00

[0055] The soft capsule shell is composed of gelatin, glycerol, sorbitol and water.

[0056] Said capsule is advantageously to be taken as a food supplement, preferably at a dosage of 1 capsule per day.

[0057] Example 3: Composition according to the invention in the form of a capsule (containing the (LIPOWHEAT® product) Ingredients per capsule Quantity (mg) % Wheat extract according to the invention 87.325 32.95 Rosemary extract 0.175 0.07 Dicalcium phosphate 162.5 61.32 Rice flour 15 5.66 Total 265 100.00

[0058] The capsule shell is composed of HPMC, coconut powder and calcium carbonate.

[0059] Said capsule is advantageously taken as a food supplement, preferably at a dosage of 2 capsules per day.

[0060] Example 4: Evaluation of the effect of a composition according to the invention (example 1 = LIPOWHEAT®) on the modulation of sebum secretion in the skin of the face

[0061] The objective of this study was to evaluate the effect on facial skin of a food supplement based on a composition according to the invention (example 1), versus placebo) on the modulation of sebum secretion, after 90 days of daily administration at a dose of 350mg (at day 90 compared to day 0 and placebo).

[0062] The study was carried out on 60 healthy female volunteers (58 of Caucasian type and 2 of Asian type), aged 20-50 years, with combination to oily skin.

[0063] Three volunteers withdrew from the study.

[0064] The average age of the remaining 57 volunteers is 42.2 ± 8.6 years.

[0065] 77% of the subjects had combination skin and 23% had oily skin.

[0066] Table 1: Study chronology Day 0 Day 30 Day 60 Day 90 Verification of inclusion / non-inclusion criteria X Informed consent X Inclusion questionnaire X 2D photographs (LifeViz Mini) XX Sebum level measurement by Sebumeter XX Dermatological tolerance check XXXX

[0067] Sebum levels were measured on days 0 and 90 using the Monaderm Skin Diagnostic® SM 815 sebumeter (Courage & Khazaka, Cologne, Germany). Measurements were taken on the forehead, chin, and nostril, and summed for each volunteer, thus allowing for a more precise quantification of sebum levels in the T-zone.

[0068] The quantity of sebum measured is expressed in qg / cm2.

[0069] 2D photographs taken with the LifeViz Mini camera were taken at J0 and J90.

[0070] Results

[0071] The variation in the amount of sebum is illustrated by [Fig. 1].

[0072] Figure 2 highlights in particular the rate of change in the quantity of sebum between the quantity at J0 (T0) and the quantity at J90 (T90).

[0073] Table 2: Parameter 1 Parameter 2 Statistical Test P-value Significance Lipowheat T0 Lipowheat T9 0 Wilcoxon <0.0001 **** Placebo T0 Placebo T90 Wilcoxon 0.0764 NS rate of change Lipowheat rate of change Placebo Mann-Whitney 0.0004 *** ***p<0.001, ****p<0.0001, NS: Not Significant

[0074] Conclusion

[0075] A significant decrease in the amount of sebum of 23.4% was observed after 90 days of use of the Lipowheat food supplement in 29 subjects, while the placebo did not significantly change the amount of sebum.

[0076] Comparative analysis of the variations J0 versus J90 in the Lipowheat and placebo groups by the Mann-Whitney test highlights a statistically greater decrease in the amount of sebum in the Lipowheat group compared to the placebo group.

Claims

Demands

1. Non-therapeutic nutricosmetic use of a composition in a form suitable for oral administration comprising, in a physiologically acceptable medium, a wheat extract containing 35-40% triglycerides and diglycerides, 20-30% glycolipids, 7-10% phospholipids and 2-4% ceramides and glycosylceramides, by weight of the total weight of the extract, to reduce excessive sebum secretion on the skin of the face.

2. Use according to claim 1, characterized in that the wheat extract contains 55-65% linoleic acid, 15-20% palmitic acid, 10-15% oleic acid, and 3-4% linolenic acid, by weight of the total weight of triglycerides and diglycerides, essentially digalactosyl-diglycerol (DGDG) as glycolipids and 25-30% phosphatidyl-ethanolamine, 30-35% phosphatidyl-choline and 30-35% phosphatidylinositol, by weight of the total weight of phospholipids.

3. Use according to claim 1 or 2, characterized in that the wheat extract is an oily extract.

4. Use according to any one of the preceding claims, characterized in that sebum secretion is reduced in the T-zone, preferably on the forehead, chin and / or nose.

5. Use according to any one of the preceding claims, characterized in that the skin is combination or oily skin.

6. Use according to any one of the preceding claims, characterized in that the composition further comprises a rosemary extract, preferably a rosemary leaf extract (Rosmarinus officinalis).

7. Use according to claim 6, characterized in that the composition comprises rosemary extract at a concentration of between 0.01 and 2% by weight of the total weight of the composition, preferably 0.2%.

8. Use according to any one of the preceding claims, characterized in that the composition is administered in the form of a powder, capsule, softgel, or emulsion.

9. Use according to any one of the preceding claims, characterized in that the composition is administered daily as 11 food supplement for a period of at least 30 days (d), preferably 60d or 90d.

10. Use according to any one of the preceding claims, characterized in that the composition is administered at a dose of 350 mg / day, in one or more doses.

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