NCT01353820已完成不适用
Proof of Concept -Effects of Lactobacillus Delbruckii Lactis DN111244 Fermented Milk Consumption on Plasma Lipids Levels in Hypercholesterolaemic Adults.
Danone Research2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年9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
- 100
- 试验地点
- 2
研究概览
简要总结
The objective of this study is to investigate the effect of Lactobacillus Delbruckii lactis (DN111244) fermented milk consumption on relative change of plasma LDL-cholesterol concentration in hypercholesterolaemic adults after 8 weeks of product consumption versus control product.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male and female aged 18-75 years;
- •BMI between 19 and 30 kg/m2,
- •LDL-cholesterol plasma level between 130 mg/dL to 190 mg/dL (bounds included) with or without statin monotherapy,
- •stabilized hypercholesterolemia (since more than 3 months),
- •accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines),
- •used to consume dairy products,
- •for female: effective contraceptive methods used,
- •agreeing to a written informed consent
排除标准
- •plasma triglycerides (TG) levels > 350 mg/dL (4 mmol//L),
- •any cardiovascular event (infarction, angina, surgical or endocoronary intervention, stroke, peripheral arteriosclerosis, etc) in the last 6 months,
- •known allergy or hypersensitivity to milk proteins,
- •systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
- •subject currently involved in a clinical trial or in an exclusion period following participation in another clinical tria,
- •subject 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,
- •diabetic subjects (type I and type II),
- •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 become pregnant during the study,
- •for female subject: subject likely to change her contraceptive method during the study,
- •active heavy cigarette smokers (reported more than 20 cigarettes / day),
- •subjects who are actively participating in a weight loss program or have participated in a weight loss program in the three months prior to screening for the study
研究者
研究点 (2)
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