Acute Study to Investigate the Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 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.
However, in addition to flavanols, other potentially bioactive compounds are present in cocoa, in particular methylxanthines. Little is known about the vascular effects of cocoa methylxanthines, i.e. mainly theobromine, in particular when consumed together with flavanols in cocoa products. The aim of the study is to characterize the nutrient-nutrient interaction between cocoa flavanols and cocoa methylxanthines.
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
- 18 Years 至 60 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male subjects
- •>18 years
排除标准
- •acute inflammation
- •cardiac arrhythmia
- •renal failure
- •heart failure (NYHA II-IV)
- •diabetes mellitus
- •CRP > 1 mg/dl
- •malignant disease
研究组 & 干预措施
flavanol rich drink intervention
flavanol rich drink
干预措施: flavanol (Dietary Supplement)
methylxanthine rich drink intervention
methylxanthine rich drink
干预措施: methylxanthine (Dietary Supplement)
flavanol + methylxanthine rich drink intervention
flavanol + methylxanthine rich drink
干预措施: flavanol + methylxanthine (Dietary Supplement)
结局指标
主要结局
Endothelial function
时间窗: 2 hours
Flow mediated dilatation (FMD)
Plasma flavanol metabolites
时间窗: 2 hours
Measured by HPLC
次要结局
- Ambulatory blood pressure(2 hours)
- Circulation angiogenetic cells(2 hours)
- Pulse wave velocity(2 hours)
研究者
Klinik für Kardiologie, Pneumologie und Angiologie
Klinik für Kardiologie, Pneumologie und Angiologie
Heinrich-Heine University, Duesseldorf
