Alcohol, Inflammation and Atherosclerosis

Study Overview
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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.

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

Conditions
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Arteriosclerosis, Myocardial Infarction

Intervention / Treatment
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* Drug: red wine, beer, ethanol
* Drug: de-alcoholised red wine, de-alcoholised beer, water


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: non-alcoholic beverages<br>dealcoholised red wine, de-alcoholised beer, water | Drug: de-alcoholised red wine, de-alcoholised beer, water<br>* de-alcoholised red wine, de-alcoholised beer, water<br>|
| Active Comparator: alcoholic beverages<br>red wine, beer, ethanol | Drug: red wine, beer, ethanol<br>* Alcoholic beverages equivalent to 30g of alcohol per day for men and 20g/d for women for 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ex vivo migration of monocytes |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcoholic beverages, non-alcoholic beverages, inflammation, Serum concentration of inflammatory markers before and after intervention