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Alcohol, Inflammation and Atherosclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00764426
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : October 2, 2008
Information provided by:
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

Condition or disease Intervention/treatment Phase
Arteriosclerosis Myocardial Infarction Drug: red wine, beer, ethanol Drug: de-alcoholised red wine, de-alcoholised beer, water Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Clinical Study of the Effect of Different Alcoholic and Non-Alcoholic Beverages on Markers of Inflammation
Study Start Date : June 2004

Arm Intervention/treatment
Active Comparator: non-alcoholic beverages
dealcoholised red wine, de-alcoholised beer, water
Drug: de-alcoholised red wine, de-alcoholised beer, water
de-alcoholised red wine, de-alcoholised beer, water

Active Comparator: alcoholic beverages
red wine, beer, ethanol
Drug: red wine, beer, ethanol
Alcoholic beverages equivalent to 30g of alcohol per day for men and 20g/d for women for 3 weeks

Primary Outcome Measures :
  1. Concentration of inflammatory markers including C-reactive protein [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Ex vivo migration of monocytes [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 20-60 years
  • non-smoker
  • healthy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00764426

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University of Ulm, Medical Center
Ulm, Germany, 89081
Sponsors and Collaborators
European Research Advisory Board
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Principal Investigator: Armin P Imhof, MD University of Ulm, Medical Center, Ulm, Germany

Publications of Results:
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Responsible Party: ERAB Identifier: NCT00764426     History of Changes
Other Study ID Numbers: EA 03 06
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: October 2, 2008
Last Verified: October 2008

Keywords provided by European Research Advisory Board:
alcoholic beverages
non-alcoholic beverages
Serum concentration of inflammatory markers before and after intervention

Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs