Composition for whitening skin
By using skin care supplement compositions of melon concentrate powder, pomegranate fruit extract and olive fruit extract, the problem of difficulty in achieving whitening, antioxidant and skin protection at the same time is solved, achieving a significant improvement in skin health and appearance.
Patent Information
- Application Number
- CN202480002339.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-09-01
- Filing Date
- 2024-08-30
- Publication Date
- 2025-05-06
AI Technical Summary
Existing skin care products are difficult to achieve both whitening, antioxidant and protect the skin from UV light and free radical damage.
Provided is a skin care supplement composition comprising melon concentrate powder, pomegranate fruit extract and olive fruit extract that protects and improves skin health through its antioxidant, anti-UV light and whitening effects.
The composition significantly improves the skin's antioxidant ability, improves skin whiteness and brightness, reduces skin spots and wrinkles, and provides effective protection against UV light and free radicals.
Smart Images

Figure BDA0005104718410000151 
Figure BDA0005104718410000181 
Figure BDA0005104718410000182
Abstract
Description
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS
[0002] This application claims the priority benefit of PCT application No. PCT / CN2023 / 116586 filed on September 1, 2023, the contents of which are incorporated herein by reference. Technical Field
[0003] The present invention relates to the field of skin care supplements. For example, the present invention relates to compositions useful for whitening a subject's skin and / or for protecting the skin from free radicals and / or ultraviolet light. Background Art
[0004] Skin whitening is a very popular treatment in Asian populations. In these cultures, for many consumers, skin whitening can be a symbol of beauty and affluence. Except for Asian populations, cosmetic consumers in Western countries now recognize that skin whitening (or as Western consumers call it skin brightening / brightening (skin brightening / lightening)) is highly desirable for treating skin problems such as uneven pigmentation caused by excessive sun exposure, age spots and freckles. In addition, recent studies have shown that a sign of young skin is that it glows. What contributes to the glowing skin of teenagers is uniform pigmentation, healthy oxygenated skin and flawless skin surface. In addition, skin problems can be caused by ultraviolet exposure and free radicals. Summary of the invention
[0005] The present application provides skin care supplement compositions. For example, the present application provides skin care supplement compositions useful for human or animal consumption. The skin care supplement compositions provided herein can whiten the skin, protect the skin from ultraviolet light and skin antioxidants. Typically, the supplement compositions provided herein include melon concentrate powder or yeast, pomegranate fruit extract, and olive fruit extract.
[0006] Generally, the skin care supplement compositions described herein can improve the skin health of the subject to which the composition is applied. As provided herein, the skin health supplement compositions can include more than one benefit described herein. The combination of ingredients in the composition including melon concentrate powder, pomegranate fruit extract, and olive fruit extract provides different and complementary mechanisms of action for general skin health and skin whitening of the subject.
[0007] For example, the supplement compositions provided herein can be used to provide skin benefits. In some cases, the skin care supplement compositions provided herein can also be used to prevent or protect the skin from damage by ultraviolet light and free radicals or from overexposure to ultraviolet light and free radicals, thereby providing skin benefits. In addition, the skin care supplement compositions provided herein can have an antioxidant effect, thereby giving skin protection benefits. In some cases, the combination of the melon concentrate powder, pomegranate fruit extract and olive fruit extract in the composition can provide a synergistic effect (e.g., to the percentage of reducing melanin content), resulting in skin health benefits being at a level statistically significantly higher than the following levels: the level obtained by using melon concentrate powder, pomegranate fruit extract or olive fruit extract alone, or the level obtained by using any two of the three ingredients without using the third.
[0008] In one aspect, a composition is provided comprising: melon concentrate powder or yeast comprising at least 1000 IU / g to 100000 IU / g of superoxide dismutase; pomegranate fruit extract comprising at least 5 wt% polyphenols based on the total weight of the pomegranate fruit extract; and olive fruit extract comprising at least 1 wt% hydroxytyrosol based on the total weight of the olive fruit extract.
[0009] In some embodiments, based on the total weight of the composition, the composition includes about 0.2wt% to about 84wt% of melon concentrate powder, about 0.01wt% to about 99.6wt% of pomegranate fruit extract, and about 0.01wt% to about 99.6wt% of olive fruit extract. In some embodiments, based on the total weight of the composition, the composition includes about 1.6wt% to about 20wt% of melon concentrate powder, about 10wt% to about 55.6wt% of pomegranate fruit extract, and about 37.5wt% to about 87wt% of olive fruit extract. In some embodiments, based on the total weight of the pomegranate fruit extract, the pomegranate fruit extract includes at least 10wt%, at least 20wt%, at least 30wt% or at least 40wt% of polyphenols.
[0010] In some embodiments, the pomegranate fruit extract further comprises punicalagins. In some embodiments, the pomegranate fruit extract comprises at least 10 wt%, at least 15 wt%, or at least 20 wt% punicalagins based on the total weight of the pomegranate fruit extract. In some embodiments, the melon concentrate comprises at least 12,000 IU / g of superoxide dismutase or at least 14,000 IU / g of superoxide dismutase. In some embodiments, the olive fruit extract comprises at least 5 wt%, at least 8 wt%, or at least 10% hydroxytyrosol based on the total weight of the olive fruit extract.
[0011] In some embodiments, at least one tablet, capsule, candy, gummy, jelly, freeze-dried block or soft gel comprises a full serving of composition. In some embodiments, two tablets, capsules, candies, gummy, jelly, freeze-dried block or soft gel combinations comprise a full serving of composition. In some embodiments, three tablets, capsules, candies, gummy, jelly, freeze-dried block or soft gel combinations comprise a full serving of composition. In some embodiments, tablets, capsules, candies, gummy, jelly, freeze-dried block or soft gel further comprise one or more of sugar alcohol, starch, resistant dextrin, sweetener, xanthan gum, gelatin, guar gum, carrageenan, fructose syrup, maltose syrup, pectin, lactose, magnesium stearate, maltodextrin, fruit powder, coating material, microcrystalline cellulose, sucralose, silicon dioxide, citric acid, flavoring agent and stearic acid.
[0012] In some embodiments, the composition is a powder or granules. In some embodiments, the powder further comprises one or more of sugar alcohol, fructose, maltodextrin, fruit powder, sucralose, steviol glycosides, citric acid and malic acid.
[0013] In some embodiments, the composition is a liquid product. In some embodiments, the liquid product further comprises one or more of sugar, syrup, juice, sucralose, citric acid, and flavoring.
[0014] In some embodiments, a full serving of the composition includes about 2 mg to about 100 mg of melon concentrate powder, about 20 mg to about 500 mg of pomegranate fruit extract, and about 20 mg to about 500 mg of olive fruit extract. In some embodiments, a full serving of the composition includes about 10 mg to about 50 mg of melon concentrate powder, about 50 mg to about 200 mg of pomegranate fruit extract, and about 150 mg to about 400 mg of olive fruit extract. In some embodiments, a full serving of the composition includes about 20 mg to about 30 mg of melon concentrate powder, about 60 mg to about 150 mg of pomegranate fruit extract, and about 160 mg to about 400 mg of olive fruit extract.
[0015] In some embodiments, the composition may further include one or more additional active ingredients. In some embodiments, the additional active ingredients include sodium hyaluronate, beta-carotene, white tomato extract, grape seed extract, collagen peptides, Rosa roxburghii powder, acerola cherry powder, red rose powder, green tea powder, fruit powder, vitamins, minerals, Haematococcus pluvialis extract, buckthorn seed, black chokeberry, blue anthocyanin, Phyllanthus fructus, and red juice orange powder.
[0016] In another aspect, methods of treating, reducing or preventing free radical damage to a subject's skin are provided. Such methods generally include administering to the subject an effective amount of a composition as described herein.
[0017] In some embodiments, an effective amount of the composition includes about 2 mg to about 100 mg of melon concentrate powder, about 20 mg to about 500 mg of pomegranate fruit extract, and about 20 mg to about 500 mg of olive fruit extract. In some embodiments, an effective amount of the composition includes about 10 mg to about 50 mg of melon concentrate powder, about 50 mg to about 200 mg of pomegranate fruit extract, and about 150 mg to about 400 mg of olive fruit extract. In some embodiments, an effective amount of the composition includes about 20 mg to about 30 mg of melon concentrate powder, about 60 mg to about 150 mg of pomegranate fruit extract, and about 160 mg to about 400 mg of olive fruit extract.
[0018] In some embodiments, the composition is administered orally. In some embodiments, the composition further comprises a pharmaceutical excipient. In some embodiments, the subject is a human.
[0019] In yet another aspect, methods of whitening the skin of a subject are provided. Such methods generally comprise administering to the subject an effective amount of a composition as described herein.
[0020] In some embodiments, an effective amount of the composition includes about 2 mg to about 100 mg of melon concentrate powder, about 20 mg to about 500 mg of pomegranate fruit extract, and about 20 mg to about 500 mg of olive fruit extract. In some embodiments, an effective amount of the composition includes about 10 mg to about 50 mg of melon concentrate powder, about 50 mg to about 200 mg of pomegranate fruit extract, and about 150 mg to about 400 mg of olive fruit extract. In some embodiments, an effective amount of the composition includes about 20 mg to about 30 mg of melon concentrate powder, about 60 mg to about 150 mg of pomegranate fruit extract, and about 160 mg to about 400 mg of olive fruit extract.
[0021] In some embodiments, the composition is administered orally. In some embodiments, the composition further comprises a pharmaceutical excipient. In some embodiments, the subject is a human.
[0022] In yet another aspect, a method of reducing UV damage on a subject's skin is provided. Such methods generally include administering to the subject an effective amount of a composition as described herein.
[0023] In some embodiments, an effective amount of the composition includes about 2 mg to about 100 mg of melon concentrate powder, about 20 mg to about 500 mg of pomegranate fruit extract, and about 20 mg to about 500 mg of olive fruit extract. In some embodiments, an effective amount of the composition includes about 10 mg to about 50 mg of melon concentrate powder, about 50 mg to about 200 mg of pomegranate fruit extract, and about 150 mg to about 400 mg of olive fruit extract. In some embodiments, an effective amount of the composition includes about 20 mg to about 30 mg of melon concentrate powder, about 60 mg to about 150 mg of pomegranate fruit extract, and about 160 mg to about 400 mg of olive fruit extract.
[0024] In some embodiments, the composition is administered orally. In some embodiments, the composition further comprises a pharmaceutical excipient. In some embodiments, the subject is a human.
[0025] Unless otherwise limited, all technical and scientific terms used herein have the same meanings as those of ordinary skill in the art to which the invention belongs. Although methods and materials similar or equivalent to those described herein can be used to practice the present invention, suitable methods and materials are described below. All publications, patent applications, patents and other references mentioned herein are incorporated herein by reference in their entirety. In the event of a conflict, the present specification including definitions will prevail. In addition, materials, methods and examples are illustrative only and are not intended to be limiting.
[0026] The details of one or more embodiments of the present invention are set forth in the drawings and description below. Other features, objects, and advantages of the present invention will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS
[0027] Figure 1 is a flow chart showing the steps of a clinical trial.
[0028] Figure 2 is a diagram showing classification of skin color.
[0029] Figures 3A-3C is a graph plotting the effects of the compositions provided herein on antioxidant markers in the blood. Figure 3A :TEAC; Figure 3B :SOD; Figure 3C : GPx. Compared with week 0: *, p<0.05; **, p<0.01; ***, p<0.001. Compared with placebo: #, p<0.05; ##, p<0.01; ###, p<0.001.
[0030] Figures 4A-4E Included are graphs plotting the results of a skin metrics test, as well as representative images showing test group subjects before and after 12 weeks of ingestion of the composition. Figure 4A is a graph that plots L* values. Figure 4B Included are a graph plotting ITA° values (top), and a pair of representative images showing overall skin brightness of test subjects from the treatment group (TG) at week 0 and week 12 (bottom). Figure 4C Includes graphs plotting the number of spots (top), and showing the differences in the number of subjects in the TG at week 0 and week 12. A representative pair of images comparing skin pigmentation Image (bottom). Figure 4D Includes a graph plotting a* values (top), and a representative graph showing a comparison of skin redness at week 0 and week 12 for subjects in the TG Image (bottom). Figure 4E Included is a graph plotting the number of wrinkles (top), and a pair of representative images showing a comparison of skin wrinkles at week 0 and week 12 in subjects in the TG Images (bottom). Compared with week 0: *, p<0.05; **, p<0.01; ***, p<0.001. Compared with placebo: #, p<0.05; ##, p<0.01; ###, p<0.001. DETAILED DESCRIPTION
[0031] The present application provides a skin care supplement composition containing melon concentrate powder, pomegranate fruit extract and olive fruit extract. For example, the skin care supplement composition provided herein may include: melon concentrate powder or yeast, which contains at least 1000IU / g to 100000IU / g of superoxide dismutase; pomegranate fruit extract, which contains at least 5wt% of polyphenols based on the total weight of pomegranate fruit extract; and olive fruit extract, which contains at least 1wt% of hydroxytyrosol based on the total weight of olive fruit extract. Based on the total weight of the composition, the skin care supplement composition provided herein may include about 0.2wt% to about 84wt% of melon concentrate powder, about 0.01wt% to about 99.6wt% of pomegranate fruit extract and about 0.01wt% to about 99.6wt% of olive fruit extract. In some embodiments, pomegranate fruit extract is optional (i.e., based on the total weight of the composition, the skin care supplement composition provided herein can include about 0.2 wt% to about 84 wt% of melon concentrate powder and about 0.01 wt% to about 99.6 wt% of olive fruit extract). In some embodiments, olive fruit powder is optional (i.e., based on the total weight of the composition, the skin care supplement composition provided herein can include about 0.2 wt% to about 84 wt% of melon concentrate powder and about 0.01 wt% to about 99.6 wt% of pomegranate fruit extract). The skin care supplement composition can be in the form of a liquid, a solution, a suspension, a tablet, a powder, a cream, a mist, a mist, an aerosol, a soft gelatin capsule, a hard gelatin capsule, a gel, a confectionary, a milkshake, a stick, a candy, a soft candy, a jelly, a freeze-dried block, and a supplementary food. For example, the skin care supplement composition can be formulated as a tablet, a capsule, a candy, a soft candy, a jelly, a freeze-dried block, or a soft gel.
[0032] As described herein, the skin care supplement compositions provided herein can contain melon concentrate powder or yeast. Melon concentrate powder or yeast can be obtained using any suitable process and can be from any suitable source. In some embodiments, the skin care supplement composition includes melon concentrate powder. In some embodiments, the skin care supplement composition includes yeast. In some cases, melon concentrate powder or yeast can be obtained commercially. For example, melon concentrate powder or yeast can be obtained from Robertet (Grasse, France). The skin care supplement composition provided herein can include at least 0.2wt% of melon concentrate powder or yeast. For example, at least 0.2 weight percent (e.g., at least 0.55, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 15 weight percent) of the skin care supplement composition provided herein can be melon concentrate powder or yeast. In some cases, the skin care supplement composition can include from about 0.2wt% to about 84wt% of melon concentrate powder or yeast. For example, the skin care supplement composition may include from about 1 wt % to about 50 wt %, from about 1 wt % to about 25 wt %, from about 1.6 wt % to about 20 wt %, or from about 2 wt % to about 15 wt % of melon concentrate or yeast.
[0033] In some cases, the skin care supplement compositions provided herein can include a daily dosage of about 2 mg to about 100 mg (e.g., about 5 mg to about 90 mg, about 5 mg to about 80 mg, about 5 mg to about 70 mg, about 5 mg to about 60 mg, about 10 mg to about 50 mg) of melon concentrate powder or yeast. In some cases, the skin care supplement compositions provided herein can be formulated to include an amount of melon concentrate powder or yeast such that a daily dosage of about 2 mg to about 100 mg (e.g., about 5 mg to about 90 mg, about 5 mg to about 80 mg, about 5 mg to about 70 mg, about 5 mg to about 60 mg, about 10 mg to about 50 mg) of melon concentrate powder or yeast can be conveniently administered. In some cases, the skin care supplement compositions provided herein can be formulated to include an amount of melon concentrate powder or yeast such that a daily dosage is about 2 mg to about 100 mg (e.g., about 10 mg to about 50 mg, about 5 mg to about 20 mg, about 20 mg to about 30 mg, or about 30 mg to about 100 mg).
[0034] The melon concentrate powder or yeast of the skin care supplement composition can include superoxide dismutase. In some cases, the melon concentrate powder or yeast provided herein can include at least 1000 IU / g of superoxide dismutase (e.g., at least about 5000 IU / g, 10000 IU / g, 12000 IU / g, 14000 IU / g, 20000 IU / g, 30000 IU / g, 40000 IU / g, 50000 IU / g, 75000 IU / g, or 90000 IU / g) of superoxide dismutase. For example, the melon concentrate powder or yeast of the skin care supplement composition can include about 1000 IU / g to about 100000 IU / g (e.g., about 10000 IU / g to about 90000 IU / g, about 10000 IU / g to about 75000 IU / g, about 10000 IU / g to about 50000 IU / g, or about 10000 IU / g to about 25000 IU / g) of superoxide dismutase. In some embodiments, the melon concentrate powder or yeast of the skin care supplement composition includes about 14000 IU / g.
[0035] The skin care supplement composition provided herein also includes pomegranate fruit extract. Pomegranate fruit extract can be obtained using any suitable process. In some cases, pomegranate fruit extract can be obtained commercially. For example, pomegranate fruit extract can be obtained from eUROMED (Barcelona, Spain). The skin care supplement composition provided herein can include at least about 0.01wt% of pomegranate fruit extract. For example, at least 1 weight percent (for example, at least 5, 10, 15, 20, 25, 30, 40, 50, 60 or 75 weight percent) of the skin care supplement composition provided herein can be pomegranate fruit extract. In some cases, the skin care supplement composition can include about 0.01wt% to about 99.6wt% of pomegranate fruit extract. For example, the skin care supplement composition can include about 10wt% to about 75wt%, about 10wt% to about 55.6wt%, about 10wt% to about 40wt%, about 20wt% to about 50wt%, about 10wt% to about 20wt% or about 40wt% to about 60wt% of pomegranate fruit extract.
[0036] In some cases, the skin care supplement compositions provided herein can include about 20 mg to about 500 mg (e.g., about 30 mg to about 450 mg, about 40 mg to about 400 mg, about 50 mg to about 350 mg, about 50 mg to about 300 mg, about 50 mg to about 250 mg, about 50 mg to about 200 mg, about 20 mg to about 60 mg, about 60 mg to about 150 mg, or about 150 mg to about 500 mg) of pomegranate fruit extract. In some cases, the skin care supplement compositions provided herein can be formulated to include an amount of pomegranate fruit extract that allows for convenient administration of a daily dose of pomegranate fruit extract from about 20 mg to about 500 mg (e.g., about 20 mg to about 60 mg, about 60 mg to about 150 mg, or about 150 mg to about 500 mg).
[0037] In some cases, based on the total amount of pomegranate fruit extract, pomegranate fruit extract can include at least 5wt% (e.g., 10, 20, 30, 35, 40, 45, 50, 55, 60 or 70 weight percent) of polyphenols. In some cases, based on the total weight of pomegranate fruit extract, pomegranate fruit extract contains at least 10wt%, at least 20wt%, at least 30wt% or at least 40wt% of polyphenols. In some cases, pomegranate fruit extract contains about 10wt% to about 80wt%, about 20wt% to about 70wt%, about 30wt% to about 60wt% or about 40wt% to about 60wt% of polyphenols. In some embodiments, pomegranate fruit extract contains about 40wt% polyphenols.
[0038] In some cases, the pomegranate fruit extract may include at least 1 wt% (e.g., 10, 20, 30, 35, 40, 45, or 50 weight percent) of punicalagins based on the total amount of the pomegranate fruit extract. In some cases, the pomegranate fruit extract comprises at least 1 wt%, at least 5 wt%, at least 10 wt%, or at least 15 wt% of punicalagins based on the total weight of the pomegranate fruit extract. In some cases, the pomegranate fruit extract comprises about 0 wt% to about 50 wt%, about 5 wt% to about 30 wt%, about 10 wt% to about 30 wt%, or about 15 wt% to about 25 wt% of punicalagins. In some embodiments, the pomegranate fruit extract comprises about 20 wt% punicalagins.
[0039] The skin care supplement composition provided herein also includes olive fruit extract. The olive fruit extract can be obtained using any suitable process and can be from any suitable olive fruit source. In some cases, the olive fruit extract can be obtained commercially. For example, the olive fruit extract can be obtained from Jiaherb, Inc. (Xi'an, China). The skin care supplement composition provided herein can include at least about 0.01wt% of the olive fruit extract. For example, at least 1 weight percent (e.g., at least 5, 10, 15, 20, 25, 30, 40, 50, 60 or 75wt%) of the skin care supplement composition provided herein can be olive fruit extract. In some cases, the skin care supplement composition can include about 0.01wt% to about 99.6wt% of the olive fruit extract. For example, the skin care supplement composition can include about 10 wt % to about 95 wt %, about 20 wt % to about 95 wt %, about 30 wt % to about 90 wt %, about 37.5 wt % to about 87 wt %, about 40 wt % to about 80 wt %, or about 40 wt % to about 60 wt % of olive fruit extract.
[0040] In some cases, the skin care supplement compositions provided herein can include from about 20 mg to about 500 mg (e.g., from about 30 mg to about 450 mg, from about 40 mg to about 400 mg, from about 50 mg to about 350 mg, from about 50 mg to about 300 mg, from about 50 mg to about 250 mg, from about 50 mg to about 200 mg, from about 20 mg to about 60 mg, from about 60 mg to about 150 mg, or from about 150 mg to about 500 mg) of olive fruit extract. In some cases, the skin care supplement compositions provided herein can be formulated to include an amount of olive fruit extract that allows for convenient administration of a daily dose of olive fruit extract from about 20 mg to about 500 mg (e.g., from about 20 mg to about 160 mg, from about 160 mg to about 4000 mg, or from about 400 mg to about 500 mg).
[0041] In some cases, based on the total amount of olive fruit extract, the olive fruit extract can include at least 1wt% (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20 or 30 weight percent) of hydroxytyrosol. In some cases, based on the total weight of the olive fruit extract, the olive fruit extract comprises at least 1wt%, at least 5wt%, at least 7.5wt% or at least 9wt% of hydroxytyrosol. In some cases, the olive fruit extract comprises about 1wt% to about 20wt%, about 5wt% to about 15wt%, about 7.5wt% to about 12wt% or about 9wt% to about 11wt% of hydroxytyrosol. In some embodiments, the olive fruit extract comprises about 10wt% of hydroxytyrosol.
[0042] In some cases, the skin care supplement provided herein may include melon concentrate powder, pomegranate fruit extract and olive fruit extract as disclosed herein, wherein the composition is formulated as tablets, capsules, candies, soft candies, jellies, freeze-dried blocks or soft gels. In some cases, based on the gross weight of the composition, the skin care supplement provided herein may include about 0.2wt% to about 84wt% of melon concentrate powder, about 0.01wt% to about 99.6wt% of pomegranate fruit extract and about 0.01wt% to about 99.6wt% of olive fruit extract. In some cases, based on the gross weight of the composition, the skin care supplement provided herein may include about 1.6wt% to about 20wt% of melon concentrate powder, about 10wt% to about 55.6wt% of pomegranate fruit extract and about 37.5wt% to about 87wt% of olive fruit extract. In some cases, the skin care supplement provided herein can include about 7.6 wt % melon concentrate powder, about 31.6 wt % pomegranate fruit extract, and about 60.8 wt % olive fruit extract, based on the total weight of the composition.
[0043] The skin care supplement compositions provided herein can be formulated so that a daily dose includes about 2 mg to about 100 mg of melon concentrate powder, about 20 mg to about 500 mg of pomegranate fruit extract, and about 20 mg to about 500 mg of olive fruit extract. For example, the skin care supplement compositions provided herein can be formulated so that a daily dose includes about 10 mg to about 50 mg of melon concentrate powder, about 50 mg to about 200 mg of pomegranate fruit extract, and about 150 mg to about 400 mg of olive fruit extract, or about 20 mg to about 30 mg of melon concentrate powder, about 60 mg to about 150 mg of pomegranate fruit extract, and about 160 mg to about 400 mg of olive fruit extract.
[0044] The skin care supplement compositions provided herein can be formulated to include one or more additional active ingredients. For example, the skin care supplement compositions can include melon concentrate powder, pomegranate fruit extract and olive fruit extract, and one or more additional active ingredients, such as sodium hyaluronate, beta-carotene, white tomato extract, grape seed extract, collagen peptides, prickly pear powder, acerola powder, red rose powder, green tea powder, fruit powder, vitamins, minerals, Haematococcus pluvialis extract, sea buckthorn seeds, Aronia nigra, blue anthocyanins, emblica and red juice orange powder.
[0045] In some cases, the skin care supplement compositions provided herein can include one or more of the following additional active ingredients: carotenoids (e.g., alpha-carotene, beta-carotene, lycopene, lutein, zeaxanthin and / or cryptoxanthin), and / or phenolic compounds (e.g., flavonoids, flavonols, flavanones, catechins, anthocyanins, isoflavones, dihydroflavonols and / or chalcones).
[0046] In some cases, the skin care supplement compositions provided herein can further include one or more of vitamin E, tocopherol, tocotrienol, vitamin A, carotene, lutein, astaxanthin, CoQ10, vitamin C, folate, uric acid, vitamin B12, and folic acid.
[0047] The skin care supplement compositions provided herein can be formulated for oral administration and can include one or more suitable excipients, flavoring agents, coloring agents and / or other ingredients. When intended for oral use, for example, tablets, lozenges, lozenges, aqueous or oil suspensions, non-aqueous solutions, dispersible powders or particles (including micronized particles or nanoparticles), emulsions, hard or soft capsules, syrups or elixirs can be prepared. Compositions intended for oral use can be prepared according to any suitable method including the standard method for making pharmaceutical compositions. Such compositions can contain one or more reagents, such as, but not limited to, sweeteners, flavoring agents, coloring agents and preservatives, so as to provide a palatable preparation. For oral administration, tablets, capsules, candies, soft candies, jellies, lyophilized blocks or soft gels can be prepared with one or more pharmaceutically acceptable excipients such as adhesives, fillers, lubricants, disintegrants and / or wetting agents. In some cases, tablets can have coatings (e.g., coatings based on polymers or polysaccharides with or without plasticizers and / or pigments). In some embodiments, the tablet, capsule, candy, gummies, jellies, lyophilized blocks, or soft gels further comprise one or more of sugar alcohols, starches, resistant dextrins, sweeteners, xanthan gum, gelatin, guar gum, carrageenan, fructose syrup, maltose syrup, pectin, lactose, magnesium stearate, maltodextrin, fruit powder, coating materials, microcrystalline cellulose, sucralose, silicon dioxide, citric acid, flavorings, and stearic acid.
[0048] The skin care supplement compositions provided herein can be powders or granules. In some embodiments, the skin care supplement compositions provided herein formulated as powders or granules further comprise one or more of sugar alcohols, fructose, maltodextrin, fruit powder, sucralose, steviol glycosides, citric acid, and malic acid.
[0049] Liquid products for oral administration can take the form of, for example, solutions, syrups or suspensions, or they can be presented as dry products reconstituted with saline or other suitable liquid vehicles before use. In some cases, as required, liquid preparations can contain pharmaceutically acceptable additives such as suspending agents, emulsifiers, non-aqueous solvents, preservatives, buffer salts, flavoring agents, coloring agents and sweeteners. Preparations for oral administration can be appropriately formulated to give controlled release of more than one compound. In some cases, tablets, capsules or soft gels can be prepared with methacrylic copolymers (e.g., L100-55 or S100) coating for release outside the stomach (e.g., in the intestine, colon, or both). In some embodiments, the skin care supplement composition provided herein formulated as a liquid product further comprises one or more of sugar, syrup, fruit juice, sucralose, citric acid, and flavoring agents.
[0050] In some cases, the skin care supplement compositions provided herein may contain a pharmaceutically acceptable carrier for administration to a mammal. Suitable carriers include, but are not limited to, sterile aqueous or non-aqueous solutions, suspensions, and emulsions. Examples of non-aqueous solvents include, but are not limited to, propylene glycol, polyethylene glycol, vegetable oils, and organic esters. Suitable aqueous carriers include, for example, water, ethanol, saline, and buffered solutions. Pharmaceutically acceptable carriers may also include physiologically acceptable aqueous vehicles (e.g., physiological saline) or other carriers suitable for oral administration.
[0051] In some cases, by way of example only, the skin care supplement compositions provided herein can be in the form of capsules, tablets, or soft gels configured to have a unit dose equal to the daily desired dose for a particular mammal. For example, if a mammal desires 100 mg of a particular medicament, each tablet can include about 100 mg of the medicament by weight. As used herein, mammals generally refer to humans, but can also include domesticated mammals (e.g., dogs, cats, and livestock such as cattle, horses, pigs, or sheep). The dosage of a particular skin care supplement composition provided herein will depend on many factors, including the general health of the mammal. In some cases, the total daily dose (e.g., a complete serving) can be prepared and administered in the form of more than one dosage unit (e.g., one tablet, capsule, candy, soft candy, jelly, lyophilized block or soft gel, two tablets, capsules, candy, soft candy, jelly, lyophilized block or soft gel, three tablets, capsules or soft gel, four tablets, capsules, candy, soft candy, jelly, lyophilized block or soft gel, five tablets, capsules, candy, soft candy, jelly, lyophilized block or soft gel, or six tablets, capsules or soft gel). For example, in some cases, one tablet, one capsule, candy, soft candy, jelly, lyophilized block or one soft gel can include a complete serving (e.g., a daily dose) of the composition. In some cases, a combination of two tablets, two capsules, candy, soft candy, jelly, lyophilized block or two soft gels can include a complete serving (e.g., a daily dose) of the composition. In some cases, a combination of three tablets, three capsules, candy, soft candy, jelly, lyophilized block or three soft gels can include a complete serving (e.g., a daily dose) of the composition.
[0052] In some cases, when the skin care supplement composition provided herein is in the form of a capsule, tablet or soft gel, the composition may further include one or more pharmaceutically acceptable excipients, such as calcium powder (e.g., calcium carbonate powder), microcrystalline cellulose (MCC) (e.g., MCC101), cross-linked sodium carboxymethylcellulose, stearic acid, silicon dioxide (e.g., Silicon dioxide) and magnesium stearate. In some cases, the skin care supplement composition in the form of a capsule, tablet or soft gel provided herein further includes MCC (e.g., MCC 101), magnesium stearate and c-moisture barrier coating.
[0053] In some cases, the skin care supplement composition in the form of a tablet, capsule, or soft gel can be formulated to release the active ingredient (e.g., melon concentrate powder, pomegranate fruit extract, and olive fruit extract) in water at a temperature of about 37° C. in less than 60 minutes (e.g., an immediate release formulation). The skin care supplement composition provided herein can release the active ingredient in water at a temperature of about 37° C. in less than 45 minutes. In some cases, the tablet, capsule, or soft gel is formulated with a coating that will dissolve at the pH of gastric fluid. In some cases, the coating of the tablet, capsule, or soft gel exhibits an in vitro dissolution profile in simulated gastric fluid that includes at least about 95% of the absorption window active ingredient released after 1 hour.
[0054] In some cases, the skin care supplement composition in the form of a tablet, capsule or soft gel is formulated as a controlled release formulation. A controlled release formulation may include a pH-dependent coating on a tablet, capsule or soft gel, from which the release of the active ingredient depends on the pH of the surrounding environment. The pH-dependent coating material may be dispersed or dissolved in water or in a suitable organic solvent. The pH-dependent coating exhibits a pH-dependent solubility, making it insoluble in acidic media (e.g., acidic gastric juice) but soluble in intestinal fluid (e.g., small intestine or colon). In some cases, the pH-dependent coating will cause degradation of the coating and release of the active ingredient when exposed to the pH environment of the small intestine. In some cases, the pH-dependent coating will not cause significant degradation of the coating when exposed to the pH environment of the small intestine and will not release the active ingredient. In some cases, the pH-dependent coating will cause degradation of the coating and release of the active ingredient when exposed to the pH environment of the colon. In some cases, the pH-dependent coating delays the release of the absorption window of the active ingredient until the composition passes through the stomach and reaches the higher pH environment of the small intestine. In some cases, the pH dependent coating will dissolve at a pH of about 5, about 5.5, about 6, or about 6.5, or the pH dependent coating will dissolve at a pH of about 5.5, about 6.0, about 6.5, or about 7.
[0055] The pH-dependent coating may include more than one enteric coating polymer. Typical examples include one or more of the following (alone or in combination): methacrylic copolymers, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, polyvinyl acetate phthalate, cellulose acetate trimellitate, carboxymethyl ethyl cellulose, shellac, zein, or other suitable enteric coating polymer(s) in solution or dispersion. Specific enteric polymers that may be used are those that preferentially dissolve in the more alkaline pH of the intestine. L and / or S, or for example a slowly dissolving (e.g., at a predetermined rate in the digestive tract) polymer such as RL (e.g. RL 100), RS (e.g. R100), and / or such Blends of polymers.
[0056] Provided herein are methods of treating, reducing or preventing free radical damage to the skin of a subject, the methods comprising administering to the subject an effective amount of a skin care supplement composition of the present disclosure.
[0057] Also provided herein are methods of whitening (eg, lightening) the skin of a subject, the methods comprising administering to the subject an effective amount of a skin care supplement composition of the present disclosure.
[0058] Also provided herein is a method of reducing UV damage on a subject's skin, the method comprising administering to the subject an effective amount of a skin care supplement composition of the present disclosure. Whether the composition reduces UV damage on the subject's skin can be determined using, for example, a test that measures the minimum erythema dose (MED), which is defined as the lowest dose of UV light that causes reddening of non-diseased skin (e.g., an indication of sunburn). See, e.g., Heckman et al. (2013, "Minimal Erythema Dose (MED) testing," J. Vis. Exp., 75: e50175).
[0059] The present invention will be further described in the following examples, which do not limit the scope of the invention described in the claims.
[0060] Example
[0061] Example 1 - Human Studies
[0062] 1. Project Scope
[0063] An experiment was conducted to investigate the skin whitening effect of a composition containing frozen melon powder (melon, vegetable oil), pomegranate powder extract and olive fruit powder.
[0064] 2. Test samples
[0065] 2.1 Placebo group: Placebo tablets (400 mg / tablet, 2 tablets / day)
[0066] 2.2 Treatment group: received a composite tablet of frozen melon powder (melon, vegetable oil), pomegranate powder extract and olive fruit powder (400 mg / tablet, 2 tablets / day)
[0067]
[0068] 3. Subject recruitment
[0069] 3.1 Inclusion criteria:
[0070] 3.1.1 Healthy adults aged 25-55 years (female:male = 4:1).
[0071] 3.1.2ITA° value is between 20° and 41°.
[0072] 3.2 Exclusion criteria:
[0073] 3.2.1 Women who are pregnant, breastfeeding or planning to become pregnant during the course of the study.
[0074] 3.2.2 Those subjects with a history of skin diseases such as psoriasis, eczema, atopic dermatitis, severe acne; or those subjects with other chronic systemic diseases.
[0075] 3.2.3 Those subjects who have taken anti-inflammatory drugs such as corticosteroids orally or topically within the past month.
[0076] 3.2.4 Those subjects who have used any product or medication that affects skin color (such as hydroquinone preparations) such as alpha hydroxy acids, salicylic acid, etc. in the past 2 months.
[0077] 3.2.5 Those subjects who have used retinoic acid preparations or have undergone chemical peels, laser, pulsed light and other medical and cosmetic procedures on the test site within the past 3 months.
[0078] 3.2.6 Those subjects who cannot avoid excessive UV exposure.
[0079] 4. Number of subjects
[0080] A total of 60 subjects participated in the study. There were two groups with 30 subjects in each group.
[0081] 5. Trial Period
[0082] 12 weeks.
[0083] 6. Study Design
[0084] A double-blind, placebo-controlled study was conducted. Subjects were instructed to take 2 tablets of Melaleuca whitening tablets or placebo tablets every day after breakfast for 12 weeks. Information on skin condition (test site was face), fasting blood samples and questionnaires were collected at weeks 0, 8 and 12.
[0085] 7. Test items / equipment
[0086] 7.1 Skin melanin index / MX18. Expressed as a numerical value.
[0087] 7.2 Skin erythema index / MX18. Expressed as a numerical value.
[0088] 7.3 Skin brightness (L* value) / CR-10 tristimulus colorimeter. Expressed as numerical value.
[0089] 7.4 Yellow hue of skin (b* value) / CR-10 tristimulus colorimeter. Expressed as numerical value.
[0090] 7.5 Skin tone (ITA° value) / CR-10 tristimulus colorimeter. Expressed in numerical value.
[0091] 7.6 Visible spots on the skin / VISIA complexion analysis system. Expressed in numerical values and photos.
[0092] 7.7 Skin texture, wrinkles / VISIA complexion analysis system. Expressed in numerical values and photos.
[0093] 7.8 Blood antioxidant markers - total antioxidant capacity (TEAC), SOD content, glutathione peroxidase (GPx) are expressed in numbers.
[0094] 7.9 Self-Assessment Questionnaire.
[0095] 8. Experimental Schedule
[0096] month 3 4 5 6 7 8 9 10 11 12 IRB Application X X X Subject recruitment X Testing period X X X X Data analysis and report writing X X
[0097] Melaleuca Whitening Tablets Questionnaire (Week 0)
[0098] Name: Gender: Male / Female Date: Basic information survey (please answer based on the situation in the past two weeks)
[0099] 1. Age: □25-35 years old □36-45 years old □46-55 years old
[0100] 2. What is your skin type?
[0101] □Dry skin□Combination skin□Normal skin□Oily skin□Sensitive skin
[0102] 3. Do you usually have the habit of taking care of your skin?
[0103] □Never □Occasionally □Often □Every day
[0104] 4. Do you usually have the habit of sun protection?
[0105] □Never □Occasionally □Often □Every day
[0106] 5. Do you often eat fried foods or sweets?
[0107] □Never □Occasionally □Often □Every day
[0108] 6. Do you have the habit of staying up late?
[0109] □Never □Occasionally □Often □Every day
[0110] 7. Please fill in your average daily sunshine hours in the past two weeks. hours.
[0111] On the day with the most sunshine hours in the last 2 weeks, you received hours of sunshine.
[0112] The sunshine intensity on that day is:
[0113] □Weak □Medium □Strong □Extremely strong
[0114] Did you wear sunscreen on that day?
[0115] □None □Use sunscreen □Physical sun protection (hold a parasol and wear a hat) Skin condition assessment (Please answer based on the situation in the past two weeks)
[0116]
[0117] Assessment of hair and scalp condition (Please answer based on the last two weeks)
[0118]
[0119] Melaleuca Whitening Tablets-Questionnaire (Week 4)
[0120] Name: Gender: Male / Female Date: Basic information survey (please answer based on the situation in the past two weeks)
[0121] 1. Age: □25-35 years old □36-45 years old □46-55 years old
[0122] 2. What is your skin type?
[0123] □Dry skin□Combination skin□Normal skin□Oily skin□Sensitive skin
[0124] 3. Do you usually have the habit of taking care of your skin?
[0125] □Never □Occasionally □Often □Every day
[0126] 4. Do you usually have the habit of sun protection?
[0127] □Never □Occasionally □Often □Every day
[0128] 5. Do you often eat fried foods or sweets?
[0129] □Never □Occasionally □Often □Every day
[0130] 6. Do you have the habit of staying up late?
[0131] □Never □Occasionally □Often □Every day
[0132] 7. Please fill in your average daily sunshine hours in the past two weeks. hours.
[0133] On the day with the most sunshine hours in the last 4 weeks, you received hours of sunshine.
[0134] The sunshine intensity on that day is:
[0135] □Weak □Medium □Strong □Extremely strong
[0136] Did you wear sunscreen on that day?
[0137] □None □Use sunscreen □Physical sun protection (hold a parasol and wear a hat)
[0138] Skin condition assessment (Please answer based on the situation in the past two weeks)
[0139]
[0140]
[0141] Assessment of hair and scalp condition (Please answer based on the last two weeks)
[0142]
[0143] Product satisfaction survey: Please tick according to how you feel after taking the product.
[0144]
[0145]
[0146] Other feedback and suggestions:
[0147] Melaleuca Whitening Tablets-Questionnaire (Week 8)
[0148] Name: Gender: Male / Female Date:
[0149] Basic information survey (please answer based on the situation in the past two weeks)
[0150] 1. Age: □25-35 years old □36-45 years old □46-55 years old
[0151] 2. What is your skin type?
[0152] □Dry skin □Combination skin □Normal skin □Oily skin □Sensitive skin 3. Do you usually have the habit of taking care of your skin?
[0153] □Never □Occasionally □Often □Every day
[0154] 4. Do you usually have the habit of sun protection?
[0155] □Never □Occasionally □Often □Every day
[0156] 5. Do you often eat fried foods or sweets?
[0157] □Never □Occasionally □Often □Every day
[0158] 6. Do you have the habit of staying up late?
[0159] □Never □Occasionally □Often □Every day
[0160] 7. Please fill in your average daily sunshine hours in the past two weeks. hours.
[0161] On the day with the most sunshine hours in the last 4 weeks, you received hours of sunshine.
[0162] The sunshine intensity on that day is:
[0163] □Weak □Medium □Strong □Extremely strong
[0164] Did you wear sunscreen on that day?
[0165] □None □Use sunscreen □Physical sun protection (hold a parasol and wear a hat)
[0166] Skin condition assessment (Please answer based on the situation in the past two weeks)
[0167]
[0168] Assessment of hair and scalp condition (Please answer based on the last two weeks)
[0169]
[0170]
[0171] Product satisfaction survey: Please tick according to how you feel after taking the product.
[0172]
[0173] Other feedback and suggestions:
[0174] Melaleuca Whitening Tablets-Questionnaire (Week 12)
[0175] Name: Gender: Male / Female Date: Basic information survey (please answer based on the situation in the past two weeks)
[0176] 1. Age: □25-35 years old □36-45 years old □46-55 years old
[0177] 2. What is your skin type?
[0178] □Dry skin□Combination skin□Normal skin□Oily skin□Sensitive skin
[0179] 3. Do you usually have the habit of taking care of your skin?
[0180] □Never □Occasionally □Often □Every day
[0181] 4. Do you usually have the habit of sun protection?
[0182] □Never □Occasionally □Often □Every day
[0183] 5. Do you often eat fried foods or sweets?
[0184] □Never □Occasionally □Often □Every day
[0185] 6. Do you have the habit of staying up late?
[0186] □Never □Occasionally □Often □Every day
[0187] 7. Please fill in your average daily sunshine hours in the past two weeks. hours.
[0188] On the day with the most sunshine hours in the last 4 weeks, you received hours of sunshine.
[0189] The sunshine intensity on that day is:
[0190] □Weak □Medium □Strong □Extremely strong
[0191] Did you wear sunscreen on that day?
[0192] □None □Use sunscreen □Physical sun protection (hold a parasol and wear a hat)
[0193] Skin condition assessment (Please answer based on the situation in the past two weeks)
[0194]
[0195]
[0196] Assessment of hair and scalp condition (Please answer based on the last two weeks)
[0197]
[0198] Product satisfaction survey: Please tick according to how you feel after taking the product.
[0199]
[0200]
[0201] Other feedback and suggestions:
[0202] Example 2 - Skin Care Supplement Composition Skin care supplement compositions were prepared using the compositions shown in Table A below.
[0203] Table A: Skin Care Supplements
[0204] Melon Concentrate Powder (SOD 14000IU / g) 25mg Pomegranate fruit extract (40% polyphenols, 20% punicalagins) 100mg Olive Fruit Extract (10% Hydroxytyrosol) 250mg
[0205] Example 3 - Skin Care Supplement Composition Skin care supplement compositions were prepared using the compositions shown in Table B below.
[0206] Table B: Skin Care Supplements
[0207] Melon Concentrate Powder (SOD 14000IU / g) 30mg Pomegranate fruit extract (40% polyphenols, 20% punicalagins) 75mg Olive Fruit Extract (10% Hydroxytyrosol) 200mg
[0208] Example 4 - Skin Care Supplement Composition Skin care supplement compositions were prepared using the compositions shown in Table C below.
[0209] Table C: Skin Care Supplements
[0210] Melon Concentrate Powder (SOD 14000IU / g) 50mg Pomegranate fruit extract (40% polyphenols, 20% punicalagins) 150mg Olive Fruit Extract (10% Hydroxytyrosol) 100mg
[0211] Example 5 - Formulation and other potential ingredients Table D: Exemplary ingredients in tablet / capsule formulations
[0212] Sugar alcohols (e.g. maltitol, erythritol, isomalt, etc.) lactose Magnesium Stearate Maltodextrin Fruit powder Coating materials Microcrystalline Cellulose Sucralose Silicon dioxide Citric Acid spices Stearic acid
[0213] Table E: Exemplary ingredients in liquid formulations
[0214] sugar syrup juice Sucralose Citric Acid spices
[0215] Table F: Exemplary ingredients in powder formulations
[0216] Sugar alcohols (such as maltitol, erythritol, isomalt, etc.) fructose Maltodextrin Fruit powder Sucralose Steviol glycosides Citric Acid Malic Acid
[0217] Table G: Exemplary Other Ingredients
[0218] Sodium Hyaluronate Beta-carotene White Tomato Grape Seed Extract Collagen Peptides Rosa roxburghii powder Acerola Powder Red Rose Powder Green tea powder Fruit powder Vitamins and minerals Haematococcus pluvialis extract Red juice orange powder
[0219] Example 6 Composition containing multi-plant concentrated powder for skin whitening
[0220] In a double-blind, randomized, placebo-controlled clinical study, 60 healthy subjects were screened and randomly divided into two groups: a test group (TG) and a placebo group (PG). TG took two compound component tablets every day, while PG received placebo tablets without compound components. The study lasted for 12 weeks. Trolox equivalent antioxidant capacity (TEAC), superoxide dismutase (SOD) and glutathione peroxidase (GPx) were measured at week 0 (W0), week 8 (W8) and week 12 (W12). Skin L* value, individual type angle (ITA°), a* value, skin spots and wrinkles were evaluated at week 0 (W0), week 4 (W4), week 8 (W8) and week 12 (W12). The results showed that compared with PG, significant improvement (p<0.01) of all three antioxidant markers in the blood after taking compound component tablets. L* values and ITA° increased significantly at week 8 (p<0.1). Skin spots decreased significantly at W8 and W12 (p<0.1). Although a* values and skin wrinkles showed significant decreases in TG at week 12 (p<0.1), there was no significant difference compared to PG. These studies show that the administration of the compound ingredient tablet improved skin whitening, brightened skin tone, reduced skin spots, and led to improvements in wrinkles and erythema.
[0221] Methods and Materials
[0222] Test formulation: The formulations for the test formulation and placebo are shown in Table 1. In addition to melon freeze-dried concentrated powder containing not less than 14000 IU / g SOD, olive fruit powder with 10% hydroxytyrosol, and pomegranate concentrated powder with 30% punicalagins (A+B) and punicalins (Punicalins) (A+B), other excipients are used as binders. The test formulation contains three compound ingredients, and the test formulation shows a specific color due to the properties of the three compound ingredients. The placebo is colored using pigments to make it look similar to the text product after being compressed into tablets. The two formulations are coated with the same coating powder to ensure a consistent appearance.
[0223] Table 1: List of ingredients used in the test formulation and placebo formulation
[0224]
[0225]
[0226] Study Participants: Healthy volunteers aged 25-65 years with ITA° values between 20° and 41° were eligible. Exclusion criteria included pregnancy or breastfeeding, planning to become pregnant in the near future, history of psoriasis, eczema, atopic dermatitis, severe acne, or other chronic systemic diseases. Also excluded were participants who had taken corticosteroids or other anti-inflammatory medications orally or topically in the past month, had used products or medications that affect skin color such as glycolic acid, salicylic acid, or hydroquinone preparations in the past 2 months, had used retinoid preparations in the past 3 months or had undergone chemical peels, laser treatments, or intense pulsed light therapy, or had unavoidable chronic sun exposure.
[0227] Test protocol: During the initial screening, participants were selected based on a skin type test and a health questionnaire. Before each assessment, participants cleaned their facial skin with water and sat indoors for 30 minutes at ambient temperature. The test facility was equipped with air conditioning set to 25°C and humidity maintained at 55±5%. The L* value, a* value, and ITA° of the cheeks were tested, and spots and wrinkles on the entire face were evaluated. Before starting the product program, a baseline facial skin assessment (W0) and fasting blood collection after 8 hours of fasting were performed.
[0228] After enrollment, participants were instructed to take 2 placebos or 2 test tablets daily after breakfast for 12 consecutive weeks. Follow-up evaluations of facial skin were performed at weeks 4, 8, and 12, and fasting blood samples were collected at weeks 8 and 12 (see, Figure 1 ).
[0229] Test items and instruments: TEAC, SOD, and GPx levels were measured by blood tests. Skin fairness (L* value), ITA°, and skin erythema (a* value) were analyzed using a skin colorimeter (Chroma Meter MM500; Minolta, Japan). Complexion Analysis System Complexion Analysis, Canfield Scientific, Inc.; Parsippany, NJ, USA) was used to evaluate skin pigmentation spots and wrinkles.
[0230] The color of the skin is mainly determined by the amount of pigments in the skin, such as melanin and erythema (Petitl and Pirardge, Int J Cosmetic Sci., 2003, 25 (4): 169-181). The L* value represents the brightness of the skin, and a higher L* value indicates increased brightness. The a* value reflects the level of erythema, and a lower a* value indicates reduced redness of the skin. ITA° is the most common index for evaluating skin whitening effects. The definition of ITA° is as follows:
[0231]
[0232] In this study, the participants' skin tone at baseline and evaluation of whitening effect were assessed using ITA° values. The standard surface color method established by the CIE (Commission internationale de l'éclairage, or International Commission on Illumination) system was used to obtain the quantification of color (L*) values; its numerical range is 0-100. Higher ITA° values indicate lighter skin tones, while lower ITA° values indicate darker skin tones. Figure 2 Specific classification is shown (Bao et al., J Invest Derm., 2020, 140(1):3-12.e1), and Table 2 indicates the skin color classification based on ITA° values.
[0233] Table 2
[0234] ITA° Skin color classification 55 to 90 Very shallow 41 to 54 shallow 28 to 40 medium 10 to 27 Sepia -30 to 9 Brown -90 to -29 Dark
[0235] Serum biochemical parameters: Fasting blood was collected from each participant at weeks 0, 8, and 12 for subsequent analysis of physiological parameters. Blood samples were centrifuged at 2,000r for 15 minutes at 4°C. Clarified serum samples were collected and stored at -80°C until testing. Serum biochemical parameters monitored included the values of TEAC, SOD, and GPx. TEAC (TEAC assay kit; XAN-5040), SOD (superoxide dismutase assay kit; BSKH62259), and GPx (GPx assay kit; Cayman BSKH61049) were analyzed according to the instructions of the manufacturers of the corresponding kits.
[0236] Statistical analysis: The results were analyzed by Student's t-test using R programming language. Statistical significance is indicated as *, p<0.05; **, p<0.01; ***, p<0.001 relative to week 0 of the group, and #, p<0.05; ##, p<0.01; ###, p<0.001 relative to placebo at week 0.
[0237] result
[0238] TG consisted of 30 participants, female n=26 and male n=4, and the average age was 47.5±10.1 years. PG included 30 participants, female n=25 and male n=5 and the average age was 48.5±11.6 years. During the entire test process, there was no dropout among the participants, and no adverse effects related to the product were reported. There were no significant differences between the baseline data in the two groups (Table 3).
[0239] Table 3: Baseline data between PG and TG
[0240]
[0241] Antioxidant markers: Figures 3A-3C The changes in the antioxidant capacity of the blood of participants after taking either the compound ingredient tablet or the placebo tablet for 12 weeks are plotted in . The TEAC test is used to assess the antioxidant potency of the blood by testing the ability of the blood to scavenge free radicals. The higher the TEAC value, the greater the total antioxidant capacity of the blood sample, and the higher the antioxidant capacity of the subject. After taking two tablets of the test preparation daily for 8 and 12 weeks, the TEAC of TG increased significantly from 223.4 μM at week 0 to 257.0 μM at week 8 (p<0.001) and 266.3 μM at week 12 (p<0.001) ( Figure 3A ). The percentage changes were 15% and 19.2%, respectively, and the number of TG subjects showing improvement at weeks 8 and 12 was 86.7% and 93.3%, respectively. TEAC values were also significantly higher than those in PB (p<0.001) ( Figure 3A ).
[0242] The trends of SOD and GPx changes were consistent with those of TEAC. SOD is an antioxidant enzyme that can effectively remove superoxide free radicals, protect cells from oxidative damage, maintain cell health, and improve the body's metabolic capacity. The higher the SOD activity test value in the blood, the stronger the antioxidant capacity in the body. The SOD activity in the blood of TG subjects increased significantly from 6.2ng / mL at week 0 to 8.1ng / mL at week 8 (p<0.001) and 7.8ng / mL at week 12 (p<0.001) ( Figure 3B ). The percentage changes were 30.6% and 25.8%, respectively. The percentage of TG subjects showing improvement at both weeks 8 and 12 was 83.3%, and the SOD activity value was significantly higher than that in the placebo group (p<0.01) ( Figure 3B ).
[0243] GPx is a water-soluble antioxidant that mainly protects cells from the effects of free radicals. GPx can convert toxic peroxides into water and other harmless compounds, thereby protecting cell structure and function from interference and damage by peroxides. If the test value of GPx activity in the blood is higher, it means that the antioxidant capacity in the body is stronger. After taking 2 tablets of the test preparation daily for 8 and 12 weeks, the GPx activity in the blood of TG subjects increased significantly from 668.6pg / mL at week 0 to 916.0pg / mL at week 8 (p<0.001) and 941.2pg / mL at week 12 (p<0.001) ( Figure 3C ). The percentages of change were 37.0% and 40.8%, respectively, and the number of subjects showing improvement was 80.0% and 86.7%, respectively. In addition, the GPx activity values at weeks 8 and 12 were significantly higher than those of the placebo group (p<0.01 and p<0.001, respectively) ( Figure 3C ).
[0244] Skin indicators: The whitening effect of the product is evaluated by testing skin whiteness (L* value), overall skin tone (ITA° value), pigmentation and skin redness (a* value).
[0245] After taking 2 tablets of the test formulation daily for 4, 8 and 12 weeks, the skin whiteness (L* value) of the TG subjects increased from 57.2 at week 0 to 58.1 at week 4, 59.0 at week 8 (p<0.001) and 59.1 at week 12 (p<0.001), with percentage changes of 0.3%, 1.9% and 2.0%, respectively ( Figure 4A The percentages of TG subjects showing improvement at each time point were 63.3%, 86.7%, and 93.3%, respectively, and the values of skin whiteness (L* values) at weeks 8 and 12 were significantly higher than those of PG at weeks 8 and 12 (p<0.001)( Figure 4A ).
[0246] The overall skin tone brightness (ITA° value) of the TG subjects increased from 28.0 at week 0 to 28.6 at week 4, 31.2 at week 8 (p<0.001), and 31.4 at week 12 (p<0.001), with percentage changes of 2.1%, 11.4%, and 12.1%, respectively ( Figure 4B ). The percentages of TG subjects showing improvement at each time point were 53.3%, 83.3%, and 90.0%, respectively, and overall skin tone brightness (ITA° values) were significantly higher than those of the placebo group at weeks 8 and 12 (p<0.05 and p<0.01, respectively) ( Figure 4B ).
[0247] After taking the test preparation for 12 weeks, the skin spot test value of the TG subjects decreased from 153.5 at week 0 to 149.0 at week 4, 150.2 at week 8, and 141.9 at week 12 (p<0.01), with percentage changes of 2.9%, 2.1%, and 7.6%, respectively ( Figure 4C , top). The percentages of TG subjects showing improvement at each time point were 73.3%, 60.0%, and 76.7%, respectively. In addition, the skin spot values in TG were significantly higher than those in PG at weeks 8 and 12 (p<0.05). Representative of subjects from TG The image is shown in Figure 4C (Bottom) , showing that at week 12, the number of skin pigmentation spots was significantly reduced compared to week 0.
[0248] Redness of the skin can cause the skin to appear darker. The redness of the skin (a* value) of the subjects in the TG decreased from 8.7 at week 0 to 8.5 at week 4, 8.3 at week 8 (p<0.01), and 8.2 at week 12 (p<0.001), with percentage changes of 2.3%, 4.6%, and 5.7%, respectively ( Figure 4D , top). The percentage of subjects showing improvement at each time point was 66.7%, 73.3%, and 83.3%, respectively. However, there was no significant change in skin redness in the placebo group ( Figure 4D , top). Representative images of subjects from TG taken at week 0 and week 12 The image is also shown in Figure 4D (bottom).
[0249] Also use Microscopic analysis of skin imaging analyzer to detect skin wrinkles on the entire face. After taking 2 tablets of the test preparation daily for 4 weeks, 8 weeks and 12 weeks, the skin wrinkle detection value of the subjects in TG decreased from 55.5 at week 0 to 50.2 at week 4, 49.0 at week 8 (p<0.05) and 43.3 at week 12 (p<0.05), with percentage changes of 9.5%, 11.7% and 22.0% respectively ( Figure 4E , top). The percentage of subjects showing improvement at each time point was 53.3%, 60.0%, and 73.3%, respectively. In contrast, there was no significant change in the values of skin wrinkles in the placebo group ( Figure 4E , top). Representative of subjects from TG The images showed that at week 12, the number of wrinkles was significantly reduced compared to week 0 ( Figure 4E ,bottom).
[0250] Overall, these studies confirmed the effectiveness of the compound ingredients (melon freeze-dried concentrate powder, pomegranate concentrate powder, and olive fruit powder) for improving the body's antioxidant capacity and for improving skin conditions. In TG taking the compound ingredient tablet, TEAC, SOD, and GPx were significantly higher than those in PG, indicating that the compound ingredient tablet can enhance the body's endogenous antioxidant capacity. In addition, skin indicators showed that the L* value and ITA° value increased significantly at both weeks 8 and 12, with more significant effects over time. This indicates that skin whiteness and brightness are significantly improved with long-term use of the product. Compared with PG, skin spots showed a significant reduction in TG after 8 weeks, and even more significant improvements by week 12. Compared with week 0, the a* value in TG was significantly lower at weeks 8 and 12, indicating that the compound ingredient tablet had some effect on reducing skin redness, although there was no significant difference compared with PG. Skin wrinkles in TG were significantly improved by week 12, with no difference from PG. These studies show that the compound ingredients can whiten the skin, brighten the complexion, reduce skin spots and redness, and are also effective in improving wrinkles.
[0251] Subjects' sensory evaluation: A self-assessment questionnaire was used to study the subjects' skin condition, hair and scalp condition, and product satisfaction before and after taking the product. These questionnaires showed that after taking 2 test preparations a day for 4 weeks, 8 weeks, and 12 weeks, the subjects felt that many skin conditions were improved, most notably in skin sagging, pigmentation, and dullness (Table 4). In addition, 70.0% of the subjects were satisfied with the skin brightening effect of the test preparation (Table 5), and 73.3% of the subjects were satisfied with the overall skin beauty effect of the test preparation (Table 6). In addition, after taking the test preparation for 12 weeks, the subjects felt that their scalp was less red and itchy, and their fine hair and hair loss were improved (Table 7). The number of subjects who were satisfied with the overall product was 83.3% (Table 8).
[0252] Table 4: Changes in self-assessed skin conditions of the subjects
[0253]
[0254] *, p<0.05; **, p<0.01)
[0255] Table 5: Satisfaction with skin brightness
[0256]
[0257] Table 6: Overall cosmetic effect
[0258]
[0259] Table 7: Changes in Subjects' Self-Reported Hair and Scalp Condition
[0260]
[0261] *, p<0.05
[0262] Table 8: Overall product satisfaction
[0263]
[0264] Other Implementations
[0265] It should be understood that although the invention has been described in conjunction with the detailed description of the invention, the foregoing description is intended to illustrate and not to limit the scope of the invention, which is defined by the scope of the appended claims. Other aspects, advantages and modifications are within the scope of the appended claims.
Claims
1. A composition comprising: Melon concentrate powder or yeast containing at least 1000 IU / g to 100000 IU / g of superoxide dismutase; A pomegranate fruit extract comprising at least 5 wt % of polyphenols based on the total weight of the pomegranate fruit extract; and An olive fruit extract comprising at least 1 wt % hydroxytyrosol based on the total weight of the olive fruit extract.
2. The composition according to claim 1, wherein based on the total weight of the composition, the composition comprises: about 0.2 wt % to about 84 wt % of melon concentrate powder, about 0.01 wt % to about 99.6 wt % of pomegranate fruit extract, and From about 0.01 wt % to about 99.6 wt % olive fruit extract.
3. The composition according to claim 1, wherein based on the total weight of the composition, the composition comprises: about 1.6 wt % to about 20 wt % of melon concentrate powder, about 10 wt % to about 55.6 wt % of pomegranate fruit extract, and From about 37.5 wt % to about 87 wt % olive fruit extract.
4. The composition of claim 1, wherein the pomegranate fruit extract comprises at least 10 wt%, at least 20 wt%, at least 30 wt%, or at least 40 wt% of polyphenols based on the total weight of the pomegranate fruit extract.
5. The composition of claim 1, wherein the pomegranate fruit extract further comprises punicalagins.
6. The composition of claim 5, wherein the pomegranate fruit extract comprises at least 10 wt%, at least 15 wt%, or at least 20 wt% of punicalagins based on the total weight of the pomegranate fruit extract.
7. The composition of claim 1, wherein the melon concentrate powder comprises at least 12,000 IU / g of superoxide dismutase or at least 14,000 IU / g of superoxide dismutase.
8. The composition of claim 1, wherein the olive fruit extract comprises at least 5 wt%, at least 8 wt%, or at least 10% hydroxytyrosol based on the total weight of the olive fruit extract.
9. The composition of claim 1, wherein at least one tablet, capsule, candy, gummies, jellies, lyophilized blocks, or soft gels comprises a complete serving of the composition.
10. The composition of claim 1, wherein a combination of two tablets, capsules, candies, gummies, jellies, lyophilized blocks, or soft gels comprises a complete serving of the composition.
11. The composition of claim 1, wherein a combination of three tablets, capsules, candies, gummies, jellies, lyophilized blocks, or soft gels comprises a complete serving of the composition.
12. The composition according to claim 1, wherein the tablet, capsule, candy, soft candy, jelly, freeze-dried block or soft gel further comprises one or more of sugar alcohol, starch, resistant dextrin, sweetener, xanthan gum, gelatin, guar gum, carrageenan, fructose syrup, maltose syrup, pectin, lactose, magnesium stearate, maltodextrin, fruit powder, coating material, microcrystalline cellulose, sucralose, silicon dioxide, citric acid, flavoring and stearic acid.
13. The composition according to claim 1, wherein the composition is a powder or granules.
14. The composition according to claim 13, wherein the powder further comprises one or more of sugar alcohol, fructose, maltodextrin, fruit powder, sucralose, steviol glycosides, citric acid and malic acid.
15. The composition according to claim 1, wherein the composition is a liquid product.
16. The composition of claim 15, wherein the liquid product further comprises one or more of sugar, syrup, fruit juice, sucralose, citric acid and flavoring.
17. A composition according to any one of claims 9 to 11, wherein a complete serving of the composition comprises: From about 2mg to about 100mg of melon concentrate powder, From about 20 mg to about 500 mg of pomegranate fruit extract, and From about 20 mg to about 500 mg of olive fruit extract.
18. The composition of claims 9-11, wherein a complete serving of the composition comprises: about 10mg to about 50mg of melon concentrate powder, about 50 mg to about 200 mg of pomegranate fruit extract, and About 150 mg to about 400 mg of olive fruit extract.
19. The composition of claims 9-11, wherein a complete serving of the composition comprises: about 20mg to about 30mg of melon concentrate powder, about 60 mg to about 150 mg of pomegranate fruit extract, and From about 160 mg to about 400 mg of olive fruit extract.
20. The composition of claim 1, further comprising one or more additional active ingredients.
21. The composition according to claim 20, wherein the additional active ingredients comprise one or more of sodium hyaluronate, beta-carotene, white tomato extract, grape seed extract, collagen peptide, roxburghii powder, acerola powder, red rose powder, green tea powder, fruit powder, vitamins, minerals, Haematococcus pluvialis extract, sea buckthorn seeds, Aronia nigra, blue anthocyanins, emblica and red juice orange powder.
22. A method of treating, reducing or preventing free radical damage to the skin of a subject, the method comprising administering to the subject an effective amount of a composition according to any one of claims 1-19.
23. The method of claim 20, wherein an effective amount of the composition comprises: From about 2mg to about 100mg of melon concentrate powder, From about 20 mg to about 500 mg of pomegranate fruit extract, and From about 20 mg to about 500 mg of olive fruit extract.
24. The method of claim 20, wherein an effective amount of the composition comprises: about 10mg to about 50mg of melon concentrate powder, about 50 mg to about 200 mg of pomegranate fruit extract, and About 150 mg to about 400 mg of olive fruit extract.
25. The method of claim 20, wherein an effective amount of the composition comprises: about 20mg to about 30mg of melon concentrate powder, about 60 mg to about 150 mg of pomegranate fruit extract, and From about 160 mg to about 400 mg of olive fruit extract.
26. The method of any one of claims 20-23, wherein the composition is administered orally.
27. The method of any one of claims 20-24, wherein the composition further comprises a pharmaceutically acceptable excipient.
28. The method of any one of claims 20-25, wherein the subject is a human.
29. A method of whitening the skin of a subject, the method comprising administering to the subject an effective amount of a composition according to any one of claims 1-19.
30. The method of claim 27, wherein an effective amount of the composition comprises: From about 2mg to about 100mg of melon concentrate powder, From about 20 mg to about 500 mg of pomegranate fruit extract, and From about 20 mg to about 500 mg of olive fruit extract.
31. The method of claim 27, wherein an effective amount of the composition comprises: about 10mg to about 50mg of melon concentrate powder, about 50 mg to about 200 mg of pomegranate fruit extract, and About 150 mg to about 400 mg of olive fruit extract.
32. The method of claim 27, wherein an effective amount of the composition comprises: about 20mg to about 30mg of melon concentrate powder, about 60 mg to about 150 mg of pomegranate fruit extract, and From about 160 mg to about 400 mg of olive fruit extract.
33. The method of any one of claims 27-30, wherein the composition is administered orally.
34. The method of any one of claims 27-31, wherein the composition further comprises a pharmaceutically acceptable excipient.
35. The method of any one of claims 27-32, wherein the subject is a human.
36. A method of reducing ultraviolet light damage on a subject's skin, the method comprising administering to the subject an effective amount of the composition of any one of claims 1-19.
37. The method of claim 34, wherein an effective amount of the composition comprises: From about 2mg to about 100mg of melon concentrate powder, From about 20 mg to about 500 mg of pomegranate fruit extract, and From about 20 mg to about 500 mg of olive fruit extract.
38. The method of claim 34, wherein an effective amount of the composition comprises: about 10mg to about 50mg of melon concentrate powder, about 50 mg to about 200 mg of pomegranate fruit extract, and About 150 mg to about 400 mg of olive fruit extract.
39. The method of claim 34, wherein an effective amount of the composition comprises: about 20mg to about 30mg of melon concentrate powder, about 60 mg to about 150 mg of pomegranate fruit extract, and From about 160 mg to about 400 mg of olive fruit extract.
40. The method of any one of claims 34-37, wherein the composition is administered orally.
41. The method of any one of claims 34-38, wherein the composition further comprises a pharmaceutically acceptable excipient.
42. The method of any one of claims 34-39, wherein the subject is a human.