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临床试验/NCT02149238
NCT02149238已完成不适用

Acute Study to Investigate the Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects

Heinrich-Heine University, Duesseldorf2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

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

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

Active Comparator

flavanol rich drink

干预措施: flavanol (Dietary Supplement)

methylxanthine rich drink intervention

Active Comparator

methylxanthine rich drink

干预措施: methylxanthine (Dietary Supplement)

flavanol + methylxanthine rich drink intervention

Active Comparator

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

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
Other
责任方
Principal Investigator
主要研究者

Klinik für Kardiologie, Pneumologie und Angiologie

Klinik für Kardiologie, Pneumologie und Angiologie

Heinrich-Heine University, Duesseldorf

研究点 (2)

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