NCT01781559已完成不适用
Effect of Phenolic Acids on the Human Vasculature
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2012年10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
- 14
- 试验地点
- 2
- 主要终点
- Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment
研究概览
简要总结
The objective is to demonstrate the effect of phenolic acids on endothelial function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, Men and women
- •Subjects with endothelial dysfunction defined as a basal brachial artery flow-mediated dilatation (FMD) measurement between 3% and 8% at screening
排除标准
- •Any food allergy
- •Abnormal blood pressure defined as follow: systolic <100 or >160 mmHg and diastolic <50 or >100mmHg
- •Pregnancy or lactating women
- •Regular consumption of cholesterol-lowering or antihypertensive medication
- •Inability to restrain from caffeine/tea and alcohol for 12hrs prior to study visits (intake1 day before screening measurements (and 1 day before each visit)
- •Not restrain the intake of multivitamin-tablets and other supplemental compounds 10 days before the study start and throughout the study.
- •Excessive alcohol intake defined as > 280 g per week for men and >210g per week for women
结局指标
主要结局
Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment
时间窗: After 1 hour
次要结局
- Change from predose in blood pressure at 0.5h(After 30 min)
研究者
研究点 (2)
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