Alcohol, Inflammation and Atherosclerosis

Not Applicable

Completed

• Conditions: Arteriosclerosis; Myocardial Infarction
• Interventions: Drug: de-alcoholised red wine, de-alcoholised beer, water; Drug: red wine, beer, ethanol

• Registration Number: NCT00764426
• Lead Sponsor: European Research Advisory Board

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2008-09-30
• Status Verified: 2008-10
• Study First Submitted QC: 2008-10-01
• Last Update Submitted: 2008-10-01
• Study First Posted: 2008-10-02
• Last Update Posted: 2008-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• 20-60 years
• non-smoker
• healthy

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
non-alcoholic beverages	de-alcoholised red wine, de-alcoholised beer, water	dealcoholised red wine, de-alcoholised beer, water
alcoholic beverages	red wine, beer, ethanol	red wine, beer, ethanol

Primary Outcome Measures

Name	Time	Method
Concentration of inflammatory markers including C-reactive protein	12 weeks

Secondary Outcome Measures

Name	Time	Method
Ex vivo migration of monocytes	6 weeks

Trial Locations

Locations (1)

University of Ulm, Medical Center; 🇩🇪 Ulm, Germany