Effects of green tea catechins on cholesterol synthesis/absorption markers in Japanese adults: a single-arm, open-label trial.
- Conditions
- Borderline hyper LDL cholesterolemia
- Registration Number
- JPRN-UMIN000029130
- Lead Sponsor
- Central Research Institute, ITO EN, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1) A history of malignant tumor, heart failure, or myocardial infarct 2) Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia or hypertension 3) Subjects use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 4) Currently taking medicines and/or herbal medicine 5) Those who are allergic to medicines and/or the test food related products 6) Pregnant, subjects with lactation period, or subjects having the mind to become pregnant in the test period 7) Subjects who participated in other clinical tests in 3 months before writing informed consent of this study was obtained 8) Subjects who are inadequate for enrollment judged by the responsible physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cholesterol synthesis and absorption markers(0, 4, and 8 wk)
- Secondary Outcome Measures
Name Time Method 1) Synthesis/absorption(0, 4, and 8 wk) 2) LDL-cholesterol(0, 4, and 8 wk) 3) HDL-cholesterol(0, 4, and 8 wk) 4) Total cholesterol(0, 4, and 8 wk) 5) LDL/HDL(0, 4, and 8 wk) 6) Correlation between changing rate of LDL-cholesterol and changing rate of each of cholesterol absorption and synthesis markers from baseline to 8 weeks