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Alcohol, Inflammation and Atherosclerosis

NCT ID: NCT00764426

Last Updated: 2008-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Brief Summary

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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

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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.

Conditions

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Arteriosclerosis Myocardial Infarction

Keywords

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alcoholic beverages non-alcoholic beverages inflammation Serum concentration of inflammatory markers before and after intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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non-alcoholic beverages

dealcoholised red wine, de-alcoholised beer, water

Group Type ACTIVE_COMPARATOR

de-alcoholised red wine, de-alcoholised beer, water

Intervention Type DRUG

de-alcoholised red wine, de-alcoholised beer, water

alcoholic beverages

red wine, beer, ethanol

Group Type ACTIVE_COMPARATOR

red wine, beer, ethanol

Intervention Type DRUG

Alcoholic beverages equivalent to 30g of alcohol per day for men and 20g/d for women for 3 weeks

Interventions

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red wine, beer, ethanol

Alcoholic beverages equivalent to 30g of alcohol per day for men and 20g/d for women for 3 weeks

Intervention Type DRUG

de-alcoholised red wine, de-alcoholised beer, water

de-alcoholised red wine, de-alcoholised beer, water

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 20-60 years
* non-smoker
* healthy

Exclusion Criteria

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

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Research Advisory Board

OTHER

Sponsor Role lead

Principal Investigators

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Armin P Imhof, MD

Role: PRINCIPAL_INVESTIGATOR

University of Ulm, Medical Center, Ulm, Germany

Locations

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University of Ulm, Medical Center

Ulm, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 18398813 (View on PubMed)

Other Identifiers

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EA 03 06

Identifier Type: -

Identifier Source: org_study_id