Trials / Completed
CompletedNCT00764426
Alcohol, Inflammation and Atherosclerosis
Clinical Study of the Effect of Different Alcoholic and Non-Alcoholic Beverages on Markers of Inflammation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- European Research Advisory Board · Academic / Other
- Sex
- All
- Age
- 20 Years – 60 Years
- Healthy volunteers
- Accepted
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | red wine, beer, ethanol | Alcoholic beverages equivalent to 30g of alcohol per day for men and 20g/d for women for 3 weeks |
| DRUG | de-alcoholised red wine, de-alcoholised beer, water | de-alcoholised red wine, de-alcoholised beer, water |
Timeline
- Start date
- 2004-06-01
- First posted
- 2008-10-02
- Last updated
- 2008-10-02
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00764426. Inclusion in this directory is not an endorsement.