Alcohol, Inflammation and Atherosclerosis

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764426
• Other study ID #: EA 03 06
• Status: Completed
• Phase: N/A
• First received: September 30, 2008
• Last updated: October 1, 2008
• Start date: June 2004

Study information

• Verified date: October 2008
• Source: European Research Advisory Board
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arteriosclerosis
• Inflammation
• Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Germany	University of Ulm, Medical Center	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
European Research Advisory Board

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of inflammatory markers including C-reactive protein		12 weeks	No
Secondary	Ex vivo migration of monocytes		6 weeks	No