NCT01340287已完成不适用
Effects of the Consumption of a Plant Sterols-enriched Dairy Fermented Product on Hypercholesterolemia Management in Hypercholesterolemic Adults
Danone Research1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2008年7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
- 168
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in midly hypercholesterolemic people not treated by statins.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male/female subject,
- •aged from 21 to 75 years,
- •BMI between 19 and 30 kg/m2,
- •LDL-cholesterol plasma level between 130 and 190 mg/dL without statin monotherapy,
- •stabilized hypercholesterolemia,
- •accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines),
- •used to consume dairy products,
- •effective contraceptive methods used for female subjects,
- •having given written consent to take part in the study
排除标准
- •subject with plasma triglycerides (TG) levels ≥ 350 mg/dL,
- •having experienced any cardiovascular event in the last 6 months,
- •taking any hypocholesterolemic treatment,
- •diabetic subject (type I and type II),
- •smoking strictly more than 10 cigarettes / day,
- •heavy alcohol intake (> 40 g / day for men ; > 30 g / day for women),
- •presenting known allergy or hypersensitivity to milk proteins,
- •known soy allergy,
- •refusing to stop the consumption of plant sterols-enriched products (other than the studied product),
- •receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
- •receiving a transplant and under immunosuppressor treatment,
- •currently involved in a clinical trial or in an exclusion period following participation in another clinical trial,
- •in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject,
- •with any kind of disease likely to interfere with the evaluation of efficiency or safety of the product,
- •for female subject: pregnancy, breast feeding or intention to be pregnant during the study or subject likely to change her contraceptive method during the study
研究者
研究点 (1)
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