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OpenTrials
Completed

NCT Number: NCT00764426

Alcohol, Inflammation and Atherosclerosis

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

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ulm, Medical Center

Ulm, 89081, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 20-60 years
  • non-smoker
  • healthy

Exclusion criteria

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

Treatment and study plan

red wine, beer, ethanol

Drug

Alcoholic beverages equivalent to 30g of alcohol per day for men and 20g/d for women for 3 weeks

de-alcoholised red wine, de-alcoholised beer, water

Drug

de-alcoholised red wine, de-alcoholised beer, water

Primary outcomes

  1. Concentration of inflammatory markers including C-reactive protein

    Time frame: 12 weeks

Secondary outcomes

  1. Ex vivo migration of monocytes

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

European Research Advisory Board

Other

Registry information

Official study title

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

Important dates

Study start
2004
First posted
Oct 2, 2008
Registry last updated
Oct 2, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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