Clinical trial NCT00764426: Alcohol, Inflammation and Atherosclerosis
Official title: Clinical Study of the Effect of Different Alcoholic and Non-Alcoholic Beverages on Markers of Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arteriosclerosis
Myocardial Infarction
Keywords: alcoholic beverages
non-alcoholic beverages
inflammation
Serum concentration of inflammatory markers before and after intervention
Lead sponsor: European Research Advisory Board
Sponsor class: OTHER
First posted: 2008-10-02
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 20-60 years
* non-smoker
* healthy

Exclusion Criteria:

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

Primary outcomes:
measure: Concentration of inflammatory markers including C-reactive protein
timeFrame: 12 weeks
Secondary outcomes:
measure: Ex vivo migration of monocytes
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University of Ulm, Medical Center
Study officials:
affiliation: University of Ulm, Medical Center, Ulm, Germany
name: Armin P Imhof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Imhof A, Blagieva R, Marx N, Koenig W. Drinking modulates monocyte migration in healthy subjects: a randomised intervention study of water, ethanol, red wine and beer with or without alcohol. Diab Vasc Dis Res. 2008 Mar;5(1):48-53. doi: 10.3132/dvdr.2008.009.