Effect of the test food intake on urinatio
- Conditions
- Overactive Bladder (OAB)
- Registration Number
- JPRN-jRCTs031210504
- Lead Sponsor
- Takara Tsuyoshi
- Brief Summary
Eight weeks of consumption of the test food was found to improve quality of life loss due to overactive bladder and the frequency of daytime urination.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 88
1. Japanese
2. Male or female
3. Subjects aged 50 or more
4. Subjects who wake up more than twice to urinate at bedtime
5. Subjects with symptoms of overactive bladder (urination frequency of 8 times or more per day and urinary urgency of 1 time or more per week)
6. Subjects who are judged as eligible to participate in the study by the physician
7. Subjects with a high-sensitivity PSA level of less than 4 ng/mL at the screening test
8. Subjects with an OABSS urinary urgency score of at least 2 and a total OABSS score of at least 3 at the screening test
9. Subjects whose average daytime urination frequency of 8 or more times in the 7 days prior to the screening test
10. Subjects whose average nocturnal voiding frequency of 2 or more times in the 7 days prior to the screening test
11. Subjects with a relatively high degree of trouble on the OAB-q at the screening test
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects who 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. Subjects who 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
5. Subjects who 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)}
6. Subjects who use or take Foods for Specified Health Uses, Foods with Functional Claims, or other functional food/beverage in daily
7. Subjects who are currently taking medications (including herbal medicines) and supplements
8. Subjects who are allergic to medicines and/or the test food related products
9. Subjects who are pregnant, breast-feeding, and planning to become pregnant
10. Subjects who 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
11. Subjects who 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 The measured values symptom bother of Overactive Bladder questionnaire (OAB-q) at 8 weeks after consumption (8w).
- Secondary Outcome Measures
Name Time Method