A CLINICAL STUDY FOR EVALUATING THE SAFETY OF EXCESSIVE CONSUMPTION OF A PLANT STEROL-ENRICHED CHOCOLATE
Not Applicable
- Conditions
- hypercholestemia
- Registration Number
- JPRN-UMIN000005485
- Lead Sponsor
- Soiken Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1) Subject taking any hypocholesterolemic treatment drugs 2) Subject currently involved in a 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 of 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 7) Subject having sitosterolemia 8) Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, of metabolic disorders 9) Subject deemed unsuitable by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bloodchemistry, hematology and physical examination at 2-week, 4-week consumption and 2-week after consumption period
- Secondary Outcome Measures
Name Time Method