A CLINICAL STUDY FOR EVALUATING THE PLASMA CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED YOGHURT DRINK - Effectiveness and Long-term Safety Study - - A CLINICAL STUDY FOR EVALUATING THE PLASMA CHOLESTEROL-REDUCING ACTIVITY OF A PLANT STEROL-ENRICHED YOGHURT DRINK - Effectiveness and Long-term Safety Study

Soiken Inc.0 个研究点目标入组 117 人开始时间: 2010年6月18日最近更新: 2023年10月17日

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•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.

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