Evaluation of the efficacy of phytosterols intake on changes in urinary symptoms in healthy middle-aged and elderly me
- Conditions
- one (Healthy adults)
- Registration Number
- JPRN-UMIN000052269
- Lead Sponsor
- Riken Vitamin Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Male
- Target Recruitment
- 200
Not provided
1. Undergoing treatment for or having history of malignancy, heart failure, or myocardial infarction. 2. With implanted pacemaker or implantable cardioverter defibrillator. 3. Undergoing treatment for arrhythmia, liver disease, kidney injury, cerebrovascular disease, rheumatism, diabetes, or other chronic disease. 4. Those who scheduled to undergo surgery during or within 2 weeks after the intake period. 5. Undergoing treatment or had been treated within 2 months for benign prostatic hyperplasia, prostatitis, prostate cancer, overactive bladder, underactive bladder, cystitis, interstitial cystitis, bladder cancer, bladder stones, urethritis, urethral stenosis, neuropathy, polyuria, or nycturia. 6. Sitosterolemia. 7. Those who wake up more than twice at bedtime to urinate. 8. Overactive bladder symptom. 9. IPSS total score is 8 or more. 10. Those who constantly consume alcohol exceeding the appropriate amount. 11. Those who regularly consume foods or beverages that is possible to affect urination. 12. Those who regularly consume medicine, Chinese herbal medicines, or supplements that is possible to affect urination. 13. Those who have been taking medicine or supplements to lower cholesterol levels. 14. Participants with allergies to drugs or foods associated with the test food. 15. Those who have participated in other studies within a month prior to the consent, or planned participation during this study. 16. Those who are judged as unsuitable to participate in the study by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method IPSS: baseline and 26, 53 weeks after the start of intake
- Secondary Outcome Measures
Name Time Method Efficacy urinary frequency: baseline and 26, 53 weeks after the start of intake OABSS: baseline and 26, 53 weeks after the start of intake postvoid residual urine volume: baseline and 26, 53 weeks after the start of intake maximum urinary flow rate: baseline and 53 weeks after the start of intake Safety expression rate of side effects and adverse events: 53 weeks after the start of intake physical examination, hematological examination, blood biochemistry test, urinalysis: baseline and 26, 53 weeks after the start of intake