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Endocrine and safety assessment pre‐ and post‐ingestion of Natural S‐equol for 12 weeks in healthy Japanese adult males

S‐equol is an intestinal bacterial metabolite of daidzein. S‐equol is produced by 50% of Japanese but only 30% of North Americans and Western Europeans. SE5‐OH is an S‐equol containing ingredient made via fermentation of soy germ by Lactococcus garvieae 20–92. Serum hormone measures were conducted in equol and non‐equol producing adult Japanese men given a daily supplement of SE5‐OH containing Natural S‐equol. In this randomized, double blind placebo controlled parallel study 46 males ages 22–64 yr on a regular diet were divided into 3 groups and given either a placebo, S‐equol 10 mg/d or S‐equol 30 mg/d for 12 weeks followed by a 4 week period without the supplement. Measures of serum total and free testosterone, estradiol, TSH, free T3, free T4 and PSA were assessed at weeks 0, 4, 8, 12 and 16. All serum hormone measures and PSA were within normal limits, and the treated groups did not differ significantly from placebo or each other. In the 30 mg group, a non‐significant trend for an increase in serum total testosterone was noted: 6.2±1.6 ng/mL at week 12 versus 5.49 ng/mL at week 0. No adverse events were observed. The data showed that SE5‐OH with Natural S‐equol given at doses of 10 mg and 30 mg for 12 weeks would be safe for endocrine function in Japanese adult males. There is potential for assessment for use of SE5‐OH for benefits for prostate health. Support for this study was provided by Otsuka Pharmaceutical Co, Ltd.