NCT01566188已完成不适用
Cardiovascular Impact of Omega-3 Dietary Supplement From Vegetal Origin in Hypertension Associated With Metabolic Syndrome
University Hospital, Rouen8 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2011年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 8
- 主要终点
- Brachial artery flow-mediated dilatation
研究概览
简要总结
The overall aims of the present project are to investigate the impact of a nutritional approach based on omega-3 from vegetal origin on vascular function in hypertension associated with metabolic syndrome.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients with treated essential hypertension (blood pressure values<140/90 mmHg under antihypertensive treatment).
- •Presence of at least two of the following criteria of the metabolic syndrome: abdominal girth >102 cm in men or >88 cm in women, HDL-C<0.4 g/L in men or <0.5 g/L in women, fasting triglyceride >1.5 g/L (or specific treatment for these lipid abnormalities), fasting glucose >1.10 g/L.
排除标准
- •Secondary hypertension, myocardial infarction, coronary artery disease, cerebrovascular disease, stroke or transient ischemia, cardiac failure, diabetes (or fasting glucose>1.26 g/L) or renal failure (MDRD < 50 ml/min)
- •Severe hypercholesterolemia (total cholesterol > 2.5 g/l), alcohol or drug abuse, toxicomania, or clinically significant abnormalities in other current biological parameters.
研究组 & 干预措施
omega-3 from vegetal origin
Experimental
干预措施: omega-3 from vegetal origin (Dietary Supplement)
Placebo
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Brachial artery flow-mediated dilatation
时间窗: 6 months after omega-3 supplementation
次要结局
- Aortic stiffness(6 months after omega-3 supplementation)
研究者
研究点 (8)
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