A CLINICAL STUDY FOR EVALUATING THE PLASMA CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED YOGHURT DRINK - Effectiveness and Long-term Safety Study
- Conditions
- hypercholestemia
- Registration Number
- JPRN-UMIN000003779
- Lead Sponsor
- Soiken Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 117
Not provided
1) Subject currently involved in other clinical trial. 2) Subject taking any hypocholesterolemic treatment (statins, ezetimibe, niacin, omega-3 FA, fibrates) 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 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 lactose intolerance. 8) Subject having sitosterolemia 9) Diabetic subject (Type I and type II) 10) Subject with heavy alcohol intake (>60 g/day) 11) Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters 12) Subject receiving a transplant or under immunosuppressor treatment 13) Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders. 14) Subject having cardiovascular history or cardiovascular events (e.g.myocardial infarction, angor pectoris, surgical or endocoronary intervention, stroke, inferior member arteriopathy, etc.) during the last 6 months 15) 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 after 4-week, 8-week and 12-week consumption
- Secondary Outcome Measures
Name Time Method