Alcohol, Inflammation and Atherosclerosis

October 1, 2008 updated by: European Research Advisory Board

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany, 89081
        • University of Ulm, Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of inflammatory markers including C-reactive protein
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Ex vivo migration of monocytes
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Research Advisory Board

Investigators

  • Principal Investigator: Armin P Imhof, MD, University of Ulm, Medical Center, Ulm, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

October 1, 2008

First Posted (Estimate)

October 2, 2008

Study Record Updates

Last Update Posted (Estimate)

October 2, 2008

Last Update Submitted That Met QC Criteria

October 1, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA 03 06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on de-alcoholised red wine, de-alcoholised beer, water

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe