Text Size

Alcohol, Inflammation and Atherosclerosis

This study has been completed.
Sponsor:
Information provided by:
European Research Advisory Board
ClinicalTrials.gov Identifier:
NCT00764426
First received: September 30, 2008
Last updated: October 1, 2008
Last verified: October 2008
History of Changes
  Purpose

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 Intervention
Arteriosclerosis
Myocardial Infarction
 Drug: red wine, beer, ethanol
Drug: de-alcoholised red wine, de-alcoholised beer, water

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Clinical Study of the Effect of Different Alcoholic and Non-Alcoholic Beverages on Markers of Inflammation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by European Research Advisory Board:

Primary Outcome Measures:
  • Concentration of inflammatory markers including C-reactive protein [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ex vivo migration of monocytes [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: June 2004
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764426

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

Publications:

Responsible Party: ERAB
ClinicalTrials.gov Identifier: NCT00764426     History of Changes
Other Study ID Numbers: EA 03 06
Study First Received: September 30, 2008
Last Updated: October 1, 2008
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Arteriosclerosis
Infarction
Inflammation
Myocardial Infarction
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013