NCT00720720撤回不适用
Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque
French Cardiology Society6 个研究点 分布在 1 个国家开始时间: 2009年12月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 6
- 主要终点
- Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque
研究概览
简要总结
The objective of this exploratory study is to analyse in humans any qualitative changes of carotid artery atherosclerotic plaque under the influence of plant sterols consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient, men and women, aged between 40 to 75 ans (limits included) willing to participate to the study and have signed informed consent for its participation in the study
- •Displaying a non serious chirurgical indication of clinical asymptomatic carotid stenosis defined by:
- •atherosclerotic stenosis of 60 to 75% on one on the two carotid junction (external carotid excluded) according to criteria from NASCET
- •without constituted or transitory recent cerebral vascular accident. The discovery of an ischaemic after-effect on a systematic scanner is not a criterion of exclusion
- •Subject with normal body weight or in over weight (Body Mass Index ranged between 19 and 30 kg/m2, [limits included])
- •Subject willing to follow dietary recommendations advised during hypercholesterolemia (according to AFSSAPS' recommendations)
- •Subject with social insurance or equivalent.
排除标准
- •Subject who, according to AFSSAPS' recommendations, should received a hypocholesterolemic therapy before the end of the study.
- •Subject with a history of diabetes
- •Subject with cardiac disease such as unstable angina, myocardial infarction, coronary angioplasty, coronary artery bypass graft surgery, or moderate or severe congestive heart failure within the last 6 months.
- •Subject with plasma triglyceride levels higher than 2,5 g/l [limit included],
- •Subject taking any drugs known to affect the evaluation of studied parameters
- •Subject with severe or acute disease that could affect the results of the study or subject safety
- •Subject with regular consumption of phytosterol enriched foods products during the study.
- •Subject with any other medical condition or laboratory abnormality prior to recruitment that in the opinion of the principal investigator could affect subject safety or render unlikely trial to be conducted to the end.
- •For women: pregnancy or breast feeding or subject likely to be pregnant during the study.
- •For women: subject likely to modify their hormonal therapy during the study
- •Subject in exclusion period after its participation in an other clinical trial
结局指标
主要结局
Effect of Phytosterols Enriched Products Consumption on Carotid Artery Artherosclerotic Plaque
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (6)
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