Effect of the Test Food Intake on Urination.
- Conditions
- o
- Registration Number
- JPRN-UMIN000052848
- Lead Sponsor
- Medical Corporation Seishukai Hasegawa Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 80
Not provided
1)Individuals who are currently suffering from some kind of disease and undergoing drug treatment. And individuals who regularly use pharmaceuticals or quasi-drugs for purposes other than disease treatment. 2)Individuals who are suffering from, are undergoing treatment for, or have a history of serious diseases such as diabetes, kidney disease, heart disease, thyroid disease, adrenal gland disease, or other metabolic diseases. 3)Individuals who have a history of heart failure, kidney failure, hepatitis B or hepatitis C. 4)Individuals who have a history of digestive system disease. 5)Individuals whose PSA level is over 4.0 ng/m. 6)Individuals with nocturia, benign prostatic hyperplasia, or overactive bladder. 7)Individuals who meet the following criteria on the Overactive Bladder Symptom Questionnaire: I.Diagnostic criteria for overactive bladder Individuals who have a urinary urgency score of 2 points or more, and an OABSS total score of 3 points or more and who may have overactive bladder. II.Determination of severity of overactive bladder Individuals with OABSS total score of 6 points or more. 8)Individuals who used a drug to treat a disease in the past 1 month. 9)Individuals whose BMI is over 30. 10)Individuals who are sensitive to a test product or other foods, and medical products. 11)Individuals who have a habit of continuously taking functional foods, health foods, or supplements that claim urinary-related indicators in the past month, or who plan to take them during the study period. 12)Individuals whose life style will change during the test period. 13)Individuals who are pregnant, nursing or possibly pregnant. 14)Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. 15)Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company. 16)Individuals judged inappropriate for the study by the principal.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Indexes for urination
- Secondary Outcome Measures
Name Time Method * Secondary outcomes 1) Overactive Bladder-questionnaire (1) 2) King's Health Questionnaire (1) * Safety 1) Blood pressure, pulsation (1) 2) Weight, body fat percentage, BMI (1) 3) Hematologic test (1) 4) Blood biochemical test (1) 5) Urine analysis (1) 6) Doctor's questions (1) 7) Subject's diary (2) (1): Week 0, Week 8 (2): Recording all days from the designated day to the end of the test.