Sekikawa 2020.

Methods	Double‐blind randomized controlled trial
Participants	Key inclusion criteria: Healthy Japanese men 40 or more years old Those who have nocturia at least twice Those who are considered as appropriate for the study by the principal investigator Those whose high‐sensitivity PSA level is less than 3.0 ng/mL (40 to 64 years old); less than 3.5 ng/mL (65 to 70 years old); or less than 4.0 ng/mL (more than 70 years old) at screening (before consumption) Those who have 8 to 19 points on the IPSS at screening (before consumption) and do not need the treatment Select those who have relatively high score on the IPSS Key exclusion criteria: At least 1 previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction Men who have a pacemaker or an implantable cardioverter defibrillator Currently under treatment for cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases Those who need treatment for diseases related to urination, e.g. benign prostatic hypertrophy, overactive bladder, and urolithiasis Those who use or take "Foods for Specified Health Uses" and "Foods with Function Claims" daily Currently taking medications (including herbal medicines) and dietary supplements Those who are allergic to medications and/or the test food related products Those enrolled in other clinical trials within the last 3 months before agreement to participate in this trial or who plan to participate another trial during this trial Considered to be ineligible to participate in the study based on the evaluation of the principal physician
Interventions	Intervention: capsule containing saw palmetto extract with 200 mL of water daily for 8 weeks Control: placebo, same posology
Outcomes	Primary outcomes IPSS: change after 8 weeks Key secondary outcomes* IPSS Overactive Bladder Symptom Score (OABSS) Original questionnaires (Likert scale) Ultrasonography of postvoid residual volume of urine *1,2,3 Assess these at screening (before consumption) and 4 and 8 weeks after consuming. *4 Assess at screening (before consumption) and 8 weeks after consuming.
Notes