A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Daily Ingestion of Green Tea Containing Polyphenol to Improve Lipid Metabolism
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000021452
- Lead Sponsor
- Hokkaido Information University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Not provided
1. Subjects who are under physician's advice, treatment and/or medication for 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 with familial hypercholesterolemia. 4. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy,enterectomy, etc. 5. Subjects with unusually high and/or low blood pressure or abnormal hematological data. 6. Subjects with serious anemia. 7. Pre- or post-menopausal women having obvious changes in physicalcondition. 8. Subjects who are at risk of having allergic reactions to drugs or foods (especially tea). 9.Subjects who regularly take drugs, functional foods and/or supplements (EPA, DHA, MCT, phytosterol, sesamin, turmeric, polyphenols and dietary fiber such as indigestible dextrin, etc.) which would affect the blood lipid levels. 10.Subjects who regularly take drugs, functional foods and/or supplements (containing dietary fiber such as indigestible dextrin, polyphenol, etc.) which would affect blood glucose. 11. Heavy smokers, alcohol addicts or subjects with irregular lifestyle. 12. Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study. 13. Pregnant or lactating women or women expect to be pregnant during the clinical trial. 14. Subjects who participate in other clinical trials within the last one month prior to this study. 15. Any other medical reasons judged by the principal investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method evel of LDL-C at 4 weeks, 8 weeks and 12 weeks after the beginning of ingestion of test meals and at 4 weeks after the end of ingestion of test meals.
- Secondary Outcome Measures
Name Time Method TC, HDL-C, TG, NEFA, phospholipid, ApoB, ApoAI, ApoB/ApoAI ratio, fasting blood glucose, HbA1c, body composition (BW, BFR, BMI)