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临床试验/NCT00764426
NCT00764426已完成不适用

Clinical Study of the Effect of Different Alcoholic and Non-Alcoholic Beverages on Markers of Inflammation

European Research Advisory Board1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2004年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Concentration of inflammatory markers including C-reactive protein

研究概览

简要总结

Effect of moderate alcohol consumption in form of red wine, beer and ethanol solution and corresponding de-alcoholised beverages on immune measures.

  • In healthy middle aged men and women
  • In a randomized controlled cross-over trial
  • Two intervention periods over 3 weeks

详细描述

Alcohol consumption and mortality from all causes are associated in a U-shaped manner. That means that individuals who regularly consume moderate amounts of alcohol (~1 to 2 drinks/day at maximum) on average live longer than abstainers or heavy drinkers. This is primarily through a reduced risk for fatal or non-fatal coronary heart disease events (CHD) such as myocardial infarction. In the last 10 to 15 years compelling evidence has bolstered the hypothesis that atherosclerosis is at least in part an inflammatory disease. It is also known, that alcohol influences the immune system. These facts make an impact of alcohol on the various stages of atherosclerosis via anti-inflammatory effects a reasonable assumption.

To test the effect of moderate amounts of different types of alcoholic beverages on markers of inflammation with high predictive potential for atherothrombotic complications of atherosclerosis will be examined in a cross-over short-term interventional trial. Six groups, each comprising 12 healthy individuals aged 22-56 will be included. After two weeks of abstinence from alcoholic beverages two cross-over interventional phases (each lasting 3 weeks) with red wine, beer, de-alcoholised red wine and beer of the same brand, ethanol, or water will follow. The interventions will be followed by a wash-out period of 2 weeks. Several inflammatory markers and in-vitro migration of freshly isolated monocytes will be determined before and after intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • 20-60 years
  • non-smoker

排除标准

  • personal or family history of dependency
  • any chronic disease
  • acute and chronic inflammatory processes

研究组 & 干预措施

non-alcoholic beverages

Active Comparator

dealcoholised red wine, de-alcoholised beer, water

干预措施: de-alcoholised red wine, de-alcoholised beer, water (Drug)

alcoholic beverages

Active Comparator

red wine, beer, ethanol

干预措施: red wine, beer, ethanol (Drug)

结局指标

主要结局

Concentration of inflammatory markers including C-reactive protein

时间窗: 12 weeks

次要结局

  • Ex vivo migration of monocytes(6 weeks)

研究者

发起方
European Research Advisory Board
申办方类型
Other

研究点 (1)

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