NCT01521169已完成不适用
Clinical Study for Evaluating the Plasma Cholesterol-reducing Activity of a Plant Sterol-enriched Yoghurt Drink - Effectiveness and Long-term Safety Study
Danone Japan2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to investigate the effect of consumption of a drinkable low fat fermented milk enriched with 0,8g or 1,6g of plant sterols on reducing plasma cholesterol (LDL-cholesterol) concentration during 12 weeks of product consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject with total cholesterol plasma level between 200 mg/dL to 240 mg/dL; and LDL-cholesterol between 120 mg/dL to 160 mg/dL.
- •Subject aged from 20 to 65 years (bounds included)
- •Subject with BMI between 19 - 30 kg/m² (bounds included)
- •Subject with triglycerides under 400 mg/dL (4.6 mmol/L)
- •Non diabetic subjects (BS≤125 mg/dL)
- •Non hypertensive subjects (SBP<140mmHg and DBP<90 mmHg)
- •Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic
- •Subject agreeing not to consume any other plant sterol supplements or excess plant sterol during the study period
- •Subject, upon briefing of the content of the present study, fully understanding and agreeing to its objective; and being able to personally sign a written informed consent and subject having signed the written consent to take part in the study
排除标准
- •Subject currently involved in a clinical trial.
- •Subject taking any dislipademia treatment (statins,ezetimibe, niacin, omega-3 FA, fibrates)
- •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.
- •For female subject: pregnancy or intention to be pregnant during the study.
- •For female subject: breast feeding.
- •Subject presenting known allergy or history of hypersensitivity to plant sterols or dairy products.
- •Subject having lactose intolerance.
- •Subjects having sitosterolemia
- •Diabetic subject (Type I and type II)
- •Subject with heavy alcohol intake (>60g/day)
- •Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
- •Subject receiving a transplant or under immunosuppressor treatment
- •Subject receiving treatment for serious liver, renal, cardio-vascular, respiratory, endocrine, or metabolic disorders.
- •Subject having cardiovascular history or cardiovascular events (e.g.myocardial infarction, angina pectoris, surgical or endocoronary intervention, stroke, inferior member arteriopathy, etc.) during the last 6 months
- •Subject deemed unsuitable by the investigator.
研究者
研究点 (2)
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