Clinical Effect of Oral Administration of Maca (Lepidium meyenii) Extract on Japanese Peri-Menopausal Women Subjects: A Randomized, Double-Blind, Placebo-Controlled Study

Abstract

Background: Roots of Lepidium meyenii (Maca) is traditionally used as a food supplement for its rich nutritional property in Andes of Peru for thousands of years. Native Peruvian have further expanded Maca usage in medicine to enhance fertility and aphrodisiac in both human and live stocks and to treat menopausal disorders. Objective: We examined the effect of Maca extract containing at least 1.2% of benzylglucosinolate (Maca-BG1.2TM) on the serum level of hormones and menopausal disorder of Japanese peri-menopausal women. Methods: a randomized, double-blind, placebo controlled, parallel clinical study was carried out in a period of 8 weeks, levels of estradiol (E2), follicle stimulating hormone (FSH), luteinizing hormone (LH) and progesterone (PGS) in sera of baseline (week 0) and week 8 were compared. As for menopausal disorder, we compared the simplified menopausal index (SMI) of all the cohorts. 42 healthy peri-menopausal Japanese women (aged 40 to 58 years) were randomly allocated to two groups, one receiving Maca-BG1.2TM for 8 weeks and the other receiving placebo. All participants signed informed consent forms. Two hard gel capsules with 150 mg Maca-BG1.2TM or 180 mg placebo were self-administered by participants once daily after breakfast. Results: after 8 weeks administration of Maca-BG1.2TM, the E2 level was significantly increased in the sera of peri-menopausal women with periodical menstruation. insomnia, one key SMI, was also elevated and mild menopausal disorder peri-in menopausal women was alleviated by Maca-BG1.2TM. Conclusion: These results showed that Maca-BG1.2TM may be a useful non-hormonal plant material for Japanese peri-menopausal women.