Sex-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Absolute change of Flow-mediated Vasodilation (FMD)
研究概览
简要总结
Epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. Dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. Endothelial dysfunction is the key event in the development and progression of cardiovascular disease. The aim of the study is to assess sex specific effects of cocoa flavanols on endothelial and vascular function in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy post-menopausal femal subjects (>50 years)
- •healthy male subjects (>50 years)
排除标准
- •acute inflammation
- •cardiac arrhythmia
- •renal failure
- •heart failure (NYHA II-IV)
- •diabetes mellitus
- •CRP > 1 mg/dl
- •malignant disease
结局指标
主要结局
Absolute change of Flow-mediated Vasodilation (FMD)
时间窗: 2 hours
次要结局
- Pulse wave velocity(2 hours)
- Augmentation index(2 hours)
- Ambulatory blood pressure(2 hours)
- Plasma flavanol metabolites(2 hours)
- laboratory safety parameters(2 hours)
研究者
Klinik für Kardiologie, Pneumologie und Angiologie
Klinik für Kardiologie, Pneumologie und Angiologie
Heinrich-Heine University, Duesseldorf