JPRN-UMIN000003449已完成未知
A CLINICAL STUDY FOR EVALUATING THE SAFETY OF EXCESS IVE CONSUMPTION OF A PLANT STEROL-ENRICHED YOGHURT DRINK - A CLINICAL STUDY FOR EVALUATING THE SAFETY OF EXCESS IVE CONSUMPTION OF A PLANT STEROL-ENRICHED YOGHURT DRINK
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- Soiken Inc.
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 65years-old(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •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.
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