None (Healthy adults)
Conditions
Interventions
Intake period: 53 weeks Test food: Hard capsules containing 800 mg vegetable sterol formulation (phytosterols content 400 mg/6 capsules) Twice a day (6 capsules/day)
Intake period: 53 weeks Tes
Sponsors
Riken Vitamin Co., Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Japanese. 2. Healthy adult males. 3. Participants who are judged as eligible to participate in the study by the principal investigator. 4. PSA-HS is less than 4 ng/mL. 5. OABSS-urgency score is less than 2 or OABSS total score is less than 3. 6. Prostate volume is less than 30 mL. 7. Maximum urinary flow rate is 15 mL/s or more and postvoid residual urine volume is less than 50 mL. 8. Daytime urinary average frequency is 8 or more and less than 15. 9. Participants who have been fully informed of the purpose and content of this study and who have signed a consent form prior to the start of this study.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IPSS: baseline and 26, 53 weeks after the start of intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy IPSS(QOL): baseline and 26, 53 weeks after the start of intake 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 | — |
Countries
Japan
Contacts
Public ContactRyuto TAKAHASHI
Riken Vitamin Co., Ltd Healthcare Unit
Outcome results
None listed