A CLINICAL STUDY FOR EVALUATING THE SAFETY OF EXCESS IVE CONSUMPTION OF A PLANT STEROL-ENRICHED YOGHURT DRINK
- Conditions
- hypercholestemia
- Registration Number
- JPRN-UMIN000003449
- Lead Sponsor
- Soiken Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1)Subject currently involved in a clinical trial. 2)Subject taking any hypocholesterolemic treatment drugs (statins,ezetimibe, niacin, omega-3 fatty acids, 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 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 to plant sterols or dairy products. 7)Subjects having lactose intorelance 8) Subjects having sitosterolemia 9)Diabetic subject (Type I and type II) 10)Subject having lactose intolerance. 11)Subject with heavy alcohol intake (> 60g/day) 12)Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters 13)Subject receiving a transplant or under immunosuppressor treatment 14)Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders. 15)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 after 2-week and 4-week consumption
- Secondary Outcome Measures
Name Time Method