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临床试验/NCT01639781
NCT01639781已完成1 期

Age-dependent Effects of Flavanol Metabolism and Absorption on Vascular Status After Acute and Chronic Application.

Heinrich-Heine University, Duesseldorf2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2011年11月1日最近更新:
适应症

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

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

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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