Effects of consumption of the test food on urination in healthy Japanese subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000045334
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 68
Not provided
Subjects who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. plan to have surgery from first consumption to two weeks after last consumption 5. are undergoing treatment, have had treatment within two months, or need the treatment for diseases related to urination, e.g. benign prostatic hypertrophy, prostatitis, prostate cancer, overactive bladder, hypoactive bladder, cystitis, interstitial cystitis, bladder cancer, bladder stones, urethritis, urethral stricture, neurological disease, polyuria, and nocturnal polyuria 6. wake up twice or more to urinate at bedtime 7. have overactive bladder symptom (subjects who urinate eight times or more per day, and have urinary urgency at least once a week) 8. drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 9. use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily 10. are currently taking medications (including herbal medicines) and supplements 11. are allergic to medicines and/or the test food related products 12. are pregnant, breast-feeding, and planning to become pregnant 13. have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 14. are judged as ineligible to participate in the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The measured values of "frequent urination during the daytime hours" of "symptom bother" of Overactive Bladder questionnaire (OAB-q) at 12 weeks after consumption (12w)
- Secondary Outcome Measures
Name Time Method