Safety evaluation study of excessive consumption of dietary fiber in carbonated water
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000031272
- Lead Sponsor
- Medical Corporation Hokubukai Utsukushigaoka Hospital
- Brief Summary
Safety was confirmed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 16
Not provided
(1)Subjects with history of serious diseases or subjects with hepatic, renal, cardiac or organ disorders, diabetes, or other serious diseases. (2)Subjects with a surgical history of digestive system (except appendicectomy). (3)Subjects with chronic diseases under treatment. (4)Subjects who are pregnant or lactating, or intend to become pregnant during the study. (5)Subjects who consume excessive alcohol (equivalent to more than 540 mL/day of sake or 1,500 mL/day of 5% beer or such) for 5 days or more per week. (6)Subjects who are aware of having weak stomach or difficulties of taking blended tea beverages. (7)Subjects judged as unsuitable for the study by principal investigator with other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method