The aim of the present study was to investigate the effects of 12-week consumption of saw palmetto fruit extract (320 mg per day) on urination issues. A total of 44 Japanese men aged 40-69 years who experienced urination issues and awaken ≥2 times at night to urinate participated in a randomized, double-blind, placebo-controlled study between June and December 2017. All subjects were randomly allocated into a saw palmetto fruit extract group (SP group, = 22) or a placebo group (P group, = 22) using a computerized random number generator. Each group took their assigned one capsule every day for 12 weeks. Subjective symptoms and impact on daily life were assessed using the international prostate symptom score (IPSS) as a primary outcome, King's health questionnaire (KHQ), and overactive bladder symptom score. A safety evaluation was also performed. A total of 20 subjects in each group were analyzed. There was a significant group-time interaction for total IPSS. The SP group also showed a significant decrease in IPSS at 8 weeks compared with the P group, suggesting reduced subjective symptoms related to urination issues. We observed no adverse effects. The consumption of saw palmetto fruit extract capsule for 12 weeks relieved subjective symptoms related to urination, which suggests improvement of the issue in healthy Japanese men.
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