Alcohol, Inflammation and Atherosclerosis
Primary Purpose
Arteriosclerosis, Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
red wine, beer, ethanol
de-alcoholised red wine, de-alcoholised beer, water
Sponsored by
About this trial
This is an interventional prevention trial for Arteriosclerosis focused on measuring alcoholic beverages, non-alcoholic beverages, inflammation, Serum concentration of inflammatory markers before and after intervention
Eligibility 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
Sites / Locations
- University of Ulm, Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
non-alcoholic beverages
alcoholic beverages
Arm Description
dealcoholised red wine, de-alcoholised beer, water
red wine, beer, ethanol
Outcomes
Primary Outcome Measures
Concentration of inflammatory markers including C-reactive protein
Secondary Outcome Measures
Ex vivo migration of monocytes
Full Information
NCT ID
NCT00764426
First Posted
September 30, 2008
Last Updated
October 1, 2008
Sponsor
European Research Advisory Board
1. Study Identification
Unique Protocol Identification Number
NCT00764426
Brief Title
Alcohol, Inflammation and Atherosclerosis
Official Title
Clinical Study of the Effect of Different Alcoholic and Non-Alcoholic Beverages on Markers of Inflammation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
European Research Advisory Board
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arteriosclerosis, Myocardial Infarction
Keywords
alcoholic beverages, non-alcoholic beverages, inflammation, Serum concentration of inflammatory markers before and after intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-alcoholic beverages
Arm Type
Active Comparator
Arm Description
dealcoholised red wine, de-alcoholised beer, water
Arm Title
alcoholic beverages
Arm Type
Active Comparator
Arm Description
red wine, beer, ethanol
Intervention Type
Drug
Intervention Name(s)
red wine, beer, ethanol
Intervention Description
Alcoholic beverages equivalent to 30g of alcohol per day for men and 20g/d for women for 3 weeks
Intervention Type
Drug
Intervention Name(s)
de-alcoholised red wine, de-alcoholised beer, water
Intervention Description
de-alcoholised red wine, de-alcoholised beer, water
Primary Outcome Measure Information:
Title
Concentration of inflammatory markers including C-reactive protein
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Ex vivo migration of monocytes
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armin P Imhof, MD
Organizational Affiliation
University of Ulm, Medical Center, Ulm, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ulm, Medical Center
City
Ulm
ZIP/Postal Code
89081
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
18398813
Citation
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.
Results Reference
result
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Alcohol, Inflammation and Atherosclerosis
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