NCT01521156已完成不适用
Cholesterol Lowering Effects of a Drinkable Low Fat Dairy Product Enriched With Plant Sterols
Danone Research2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2009年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
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 sterols after 3 weeks of daily consumption in midly hypercholesterolemic people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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/female subject, aged from 18 to 75,with BMI between 18,5 and 30 kg/m², with LDL-cholesterol blood level between 130 mg/dL to 190 mg/dL without statin therapy.
- •Subject accepting to follow the dietary recommendations advisable for hypercholesterolemic subject.
- •Subject used to consume dairy products.
- •For female subjects: effective contraceptive methods used.
- •Subject having given written consent to take part in the study.
排除标准
- •Subject with blood triglycerides levels above 350 mg/dL.
- •Subject having experienced any cardiovascular event in the last 6 months.
- •Subject having sitosterolemia.
- •Subject taking any hypocholesterolemic treatment drugs.
- •Intake of blood lipid-regulating supplementation of blood lipid-regulating dietary supplements or functional food during the last 2 weeks before study start.
- •Diabetic subject (type I and type II).
- •Subject smoking strictly more than 10 cigarettes / day.
- •Subject with heavy alcohol intake (> 40 g / day for men ; > 30 g / day for women).
- •Subject presenting known allergy or hypersensitivity to milk proteins.Subject with known soy allergy.
- •Subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product).
- •Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters.
- •Subject receiving a transplant and under immunosuppressor treatment.
- •Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial.
- •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.
- •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.
- •For female subject: subject likely to change her contraceptive method during the study.
研究者
研究点 (2)
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