Age-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status After Acute and Chronic Application.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Endothelial function
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. Aging is the major non-modifiable cardiovascular risk factor associated with progressive decline in endothelial function, vascular stiffening and increase in blood pressure. We hypothesize that flavanols can counteract age-dependent vascular changes by interacting with key mechanisms, most prominently endothelial function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male participants between 18-35 years
- •healthy male participants between 50-80 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
Endothelial function
时间窗: change in flow mediated dilatation between first treatment at day 0 and after last treatment at day 14
Flow mediated dilatation (FMD)
次要结局
- Ambulatory blood pressure(blood pressure at day 0 and at day 14)
- Pulse wave velocity(14 days)
- Heart rate(14 days)
- Plasma flavanol metabolites(analysis of metabolites between first treatment at day 0 and after last treatment at day 14)
- Erythrocyte deformability(14 days)
- NO bioavailability(14 days)
- Microvascular function(14 days)
- Augmentation index(14 days)
研究者
Klinik für Kardiologie, Pneumologie und Angiologie
Klinik für Kardiologie, Pneumologie und Angiologie
Heinrich-Heine University, Duesseldorf
