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临床试验/NCT00933218
NCT00933218已完成不适用

Effects of Polyphenols on Changes of Inflammatory and Cardiovascular Status After a Marathon Run

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2009年6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
250
试验地点
1
主要终点
Inflammatory marker: Interleukin 6 and Interleukin 10

研究概览

简要总结

The purpose of the study is to determine the myocardial function and vascular adaptation after strenuous exercise in association with consumption of polyphenols. The investigators aim to investigate the effects of extreme endurance exercise on the inflammatory system. Furthermore, the role of the cardiovascular response and adaptive mechanisms of the vasculature are examined. Subclinical injuries to the myocardium and vascular wall are being investigated.

详细描述

Regular exercise leads to an improvement of cardiovascular risk factors in patients with coronary heart disease, atherosclerosis and metabolic disorders.

Aerobic exercise has anti-inflammatory effects. In contrast, the exertional exercise of marathon running causes an acute pro-inflammatory impulse. This may lead to myocardial injury and, in case of preexisting plaques, may result in plaque rupture and acute myocardial infarction.

We aim to define the critical role of inflammatory markers and cardiovascular risc factors as a predictor of an increased risk for myocardial and endothelial dysfunction in marathon runners.

Diagnostic tools include measurements of microvasculature, the large vessels and echocardiography. Inflammatory markers include high sensitive c-reactive protein (CRP) and interleukins.

All variations are analysed on the basis of consumption of polyphenols as they are found in in hops (Humulus lupus L.) and beer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •men aged 20-60 years

排除标准

  • •manifested heart disease
  • •insulin dependent diabetes mellitus
  • •multi drug therapy
  • •GFR < 60 ml/min
  • •neoplasia
  • •(former) alcoholism
  • •known malabsorption
  • •known chronic inflammatory disease

研究组 & 干预措施

polyphenols (non-alcoholic beer)

Active Comparator

干预措施: polyphenols (non-alcoholic beer) (Dietary Supplement)

beverage without polyphenols

Placebo Comparator

干预措施: beverage without polyphenols (Dietary Supplement)

结局指标

主要结局

Inflammatory marker: Interleukin 6 and Interleukin 10

时间窗: pre-, post-, one & three day follow-up

次要结局

  • E/E' ratio(pre-, post-, one & three day follow-up)
  • AV-ratio(pre-, post-, one & three day follow-up)

研究者

发起方
Technical University of Munich
申办方类型
Other

研究点 (1)

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