Alcohol, Inflammation and Atherosclerosis

European Research Advisory Board

Status: Completed

Conditions: Myocardial Infarction; Arteriosclerosis

Treatments: Drug: red wine, beer, ethanol; Drug: de-alcoholised red wine, de-alcoholised beer, water

Study type: Interventional

Funder types: Other

Identifiers

NCT00764426

EA 03 06

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 20-60 years
• non-smoker
• healthy

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

non-alcoholic beverages

Active Comparator group

Description:

dealcoholised red wine, de-alcoholised beer, water

Treatment:

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

alcoholic beverages

Active Comparator group

Description:

red wine, beer, ethanol

Treatment:

Drug: red wine, beer, ethanol