A CLINICAL STUDY FOR EVALUATING THE SERUM CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHD CHOCOLATE
- Conditions
- hypercholestemia
- Registration Number
- JPRN-UMIN000005622
- Lead Sponsor
- Soiken Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
1) Subject taking any hypocholesterolemic treatment 2) Subfect currently involved in other clinical trial 3) Subject having blood sample of 200 ml or more taken (e.g., donated blood) within 1 month, or 400 ml or more within 3 months prior to the start of the present study 4) For female subject: pregnancy or possibility of pregnancy, or intention to be pregnant during the study 5) For female subject: breast feeding 6) Subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products 7) Subject having sitosterolemia 8) Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders 9) Subject deemed unsuitable by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bloodchemisty, hematology and physical examination at 4-week, 8-week, 12-week consumption and 4-week after consumption period
- Secondary Outcome Measures
Name Time Method