Safety evaluation study of excessive consumption of dietary fiber-containing green tea beverage
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000027809
- 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 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 green tea beverages. (7)Subjects who don't like caffeine (8)Subjects who have experienced allergic reactions to foods containing green tea ingredients (9)Subjects judged as unsuitable for the study by principal investigator for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety evaluation items: Examination by a physician in charge, Physical examination findings, Clinical laboratory findings (Hematological test, Biochemical test, Urine analysis), Subjective symptoms
- Secondary Outcome Measures
Name Time Method