An Open-label, Uncontrolled Study on Safety of Excessive Intake of Green Tea Containing Polyphenol
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000022244
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1.Subjects who are under physician's advice, treatment and/or medication for obesity, hyperlipidemia and diabetes. 2.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, disorder of endocrine and metabolism or affected with infectious diseases which are required to report to the authorities. 3.Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 4. Subjects with unusually high and/or low blood pressure or abnormal hematological data. 5. Subjects with serious anemia. 6. Pre- or post-menopausal women having obvious changes in physical condition. 7. Subjects who are at risk of having allergic reactions to drugs or foods (especially tea). 8. Subjects who have largely changed their dietary habits, physical activity habits and/or BW within the last 6 months. 9. Subjects with familial hypercholesterolemia. 10. Subjects who regularly take drugs, functional foods and/or supplements which would affect BW and BFP. 11. Subjects who regularly take drugs, functional foods and/or supplements which would affect the blood lipid levels. 12. Subjects who regularly take drugs, functional foods and/or supplements which would affect blood glucose. 13. Heavy smokers, alcohol addicts or subjects with irregular lifestyle. 14.Subjects who donated either 400ml whole blood within 12 weeks (men) /16 weeks (women) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study. 15. Pregnant or lactating women or women expect to be pregnant during the clinical trial. 16. Subjects who participated in other clinical trials within the last one month prior to this study. 17. Subjects who have participated in previous clinical trials of ingestion of the same active test food. 18. Any other medical reasons judged by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method