NCT01571869已完成不适用
Influence of a Meal on the Efficacy of Plant Sterol Given at Different Times of the Day in Management of Hypercholesterolemia
Danone Research2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2005年4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
- 30
- 试验地点
- 2
研究概览
简要总结
The objective of this study is to compare efficacy of a plant sterol enriched yogurt given at different moments of the day in lowering blood cholesterol of hypercholesterolemic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male and post-menopausal female aged 40-80 years;
- •BMI between 22 and 32 kg/m2,
- •Non-smoker, Stabilized LDL-c over 3.0 mmol/L,
- •Not taking any medication known to affect lipid metabolism for at least the previous 3 month period,
- •Agree to follow the dietary recommendations in the context of their hypercholesterolemia,
- •Have to give written consent to take part in the study
排除标准
- •Thyroid disease, diabetes mellitus, kidney disease or liver disease, Hypertension (95<SBP>140 mmHg and/or 45<DBP>90 mmHg),
- •Previous history of symptomatic vascular disease, TG level > 2,8 g/l,
- •History of metabolic or gastrointestinal disease with the exception of appendicectomy,
- •Consumption of large amounts of alcohol,
- •Having undergone general anesthesia in the month prior to pre-selection,
- •Receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
- •Having serious or acute disease likely to influence study results or involved in life time,
- •Presenting allergy or hypersensitivity to milk proteins, or refusing to consume them,
- •Refusing to stop his/her consumption of enriched plant sterol trade products during the study,
- •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,
- •For female subjects: likely to change her hormonal substitutive treatment,
- •Currently in an exclusion period following participation in another clinical trial.
研究者
研究点 (2)
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