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. 2023 Feb 7;12(4):1326.
doi: 10.3390/jcm12041326.

Efficacy and Safety of the Genistein Nutraceutical Product Containing Vitamin E, Vitamin B3, and Ceramide on Skin Health in Postmenopausal Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Mingkwan Na Takuathung  1   2   3 , Preeyaporn Klinjan  1   2 , Wannachai Sakuludomkan  1   2 , Nahathai Dukaew  1   2 , Ratchanon Inpan  1 , Rattana Kongta  1 , Wantida Chaiyana  3   4 , Supanimit Teekachunhatean  1   2 , Nut Koonrungsesomboon  1   2   5
Affiliations

Efficacy and Safety of the Genistein Nutraceutical Product Containing Vitamin E, Vitamin B3, and Ceramide on Skin Health in Postmenopausal Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Mingkwan Na Takuathung et al. J Clin Med. .

Abstract

Skin aging is one of the most concerning issues that occur after menopause. The Genistein Nutraceutical (GEN) product, containing genistein, vitamin E, vitamin B3, and ceramide, has been formulated as a topical anti-aging product for improving the health of postmenopausal women's facial skin. This study aimed to investigate the efficacy and safety of the GEN product on postmenopausal women's facial skin. This randomized, double-blind, placebo-controlled trial randomly assigned 50 postmenopausal women to receive either the GEN product (n = 25) or the placebo (PLA) product (n = 25), topically applied twice daily for 6 weeks. The outcome assessments included multiple skin parameters related to skin wrinkling, color, hydration, and facial skin quality at baseline and week 6. The percentage mean changes or absolute mean changes, where appropriate, in skin parameters were compared between the two groups. The mean age of the participants was 55.8 ± 3.4 years. For skin wrinkling and skin color parameters, only skin redness was significantly higher in the GEN group when compared to the PLA group. Following the application of the GEN product, skin hydration increased while fine pores and their area decreased. Subgroup analysis of older women (age ≥ 56 years) with adequate compliance found significant differences between the two groups in the percentage mean changes of most skin wrinkle parameters. The GEN product has benefits for the facial skin of postmenopausal women, particularly those who are older. It can moisturize facial skin, lessen wrinkles, and enhance redness.

Keywords: genistein; menopause; nutraceuticals; postmenopausal women; randomized-controlled trial; skin aging.

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Conflict of interest statement

N.K., P.K., W.S., N.D., R.I., R.K. and W.C. declare no conflict of interest. Chiang Mai University, a public university, has submitted the petty patent application for the Genistein Nutraceutical product, with S.T. and M.N.T. listed as the inventors. S.T. is a shareholder of the company that distributes the Genistein Nutraceutical product in the market. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

Figures

Figure 1
Figure 1
Consort flow diagram.
Figure 2
Figure 2
Percentage mean changes of skin wrinkling parameters in older women (age ≥ 56 years). An orange triangle represents the GEN group, while a grey circle represents the PLA group. Abbreviation: MD, mean difference; CI, confidence interval.
Figure 3
Figure 3
Replica image of the topography of the skin surface at baseline and week 6. Abbreviation: GEN, the Genistein Nutraceutical product; PLA, placebo.
See this image and copyright information in PMC

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