跳至主要内容
临床试验/NCT00553774
NCT00553774已完成1 期

Effect of Cocoa Flavanols on Vascular Function in Optimally Treated Coronary Artery Disease Patients: Interaction Between Endothelial Progenitor Cells, Reactivity of Micro- and Macrocirculation

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2007年3月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
16
试验地点
1
主要终点
An improvement of endothelial function as measured by flow-mediated dilation (FMD)

研究概览

简要总结

Endothelial dysfunction is associated with a higher incidence of adverse cardiovascular events in patients with coronary artery disease (CAD). CAD patients also show impaired function and number of endothelial progenitor cells (EPCs, adult stem cells) which circulate in adult blood and contribute to endothelial repair. Clinical studies suggest that endothelial function can be improved in CAD patients by consumption of flavanol-rich cocoa. Yet, the mechanism is not known. It is also not known whether flavanol-rich cocoa provides an additive, positive effect in patients who are already receiving the maximal recommended therapies for risk factor modification. Therefore, the researchers propose to perform an investigator-initiated, randomized controlled cross-over study administering flavanol-rich cocoa or a placebo for two months in CAD patients on optimal medical therapy. An improvement of endothelial function as measured by flow-mediated dilation (FMD) will be the primary endpoint of this study. The researchers propose to also measure determinants of FMD such as microvascular response, inflammatory markers, metabolites of nitric oxide, as well as the number and function of EPCs in the blood. Importantly, detailed food questionnaires and plasma flavanols/metabolites will help to further support a causal link between flavanol-intake and improved vascular 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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •CAD patients over 18 years of age
  • •Contact university for more details.

排除标准

  • •Contact university for more details.

研究组 & 干预措施

Placebo

Placebo Comparator

干预措施: Placebo (Other)

Flavanol

Experimental

Cocoa Flavanol

干预措施: Cocoa Flavanols (Dietary Supplement)

结局指标

主要结局

An improvement of endothelial function as measured by flow-mediated dilation (FMD)

时间窗: 1 month

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yerem Yeghiazarians

Proffessor of Clinical Medicine

University of California, San Francisco

研究点 (1)

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