A verification study on improvement of problems with urination due to ingestion of the food containing saw palm extracts: a randomized double-blind, parallel-group, placebo-controlled study

INTERVENTION: Duration: 12 weeks Test material: Saw palmetto extracts containing capsule B Dose: Take a capsule once a day Administration: Swallow a capsule after breakfast with water or warm water (approximately 200 mL) without chewing *If you forget ingestion the test food, take it as soon as you remember within the day Duration: 12 weeks Test material: Placebo Dose: Take a capsule once a day Administration: Swallow a capsule after breakfast with water or warm water (approximately 200 mL) without chewing *If you forget ingestion the test food, take it as soon as you remember within the day CONDITION: Healthy human PRIMARY OUTCOME: International Prostate Symptom Score (IPSS); *Assess at 0, 4, 8 and 12 weeks after consuming SECONDARY OUTCOME: 1. King' s Health Questionnaire (KHQ); ; 2. Overactive Bladder Symptom Score (OABSS); ; 3. Subjective symptoms; 3‐1. Visual Analogue Scale (VAS); Pleasantness of waking, Sleep quality; 3‐2. Diary; A frequency of urination per day, A frequency of urination at night; 3‐3. Interview sheet; Time required for urination; ; *1,2 Assess at 0, 4, 8 and 12 weeks after consuming; *3‐2 Keep it from a week before consuming to 12 weeks after consuming; *3‐1,3‐3 Assess at 0 and 12 weeks after consuming INCLUSION CRITERIA: 1. Japanese men who are 40 or more to less than 70 years old 2. Those who wake up for urination at least twice during nocturnal sleep 3. Those who have problems with urination, e.g. urinary urgency, frequent urination, and urinary incontinence 4. Those who are considered as appropriate for the study by the principal investigator 5. Those whose high‐sensitivity PSA level is less than 3.0 ng/mL (40‐65 years old) or less than 3.5 ng/ml (65‐70 years old) at screening and examination before ingestion 6. Those who get less than 20 in score of IPSS at screening and examination before ingestion and do not need the treatment 7. If number of people who passed 6. exceed the sample size, select those who have relatively high score in IPSS