ArteriosclerosisNCT00764426
Alcohol, Inflammation and Atherosclerosis
A study testing red wine, beer, ethanol and de-alcoholised red wine, de-alcoholised beer, water in people with Arteriosclerosis and Myocardial Infarction, run by European Research Advisory Board at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Arteriosclerosis, Myocardial Infarction
- What is being tested?
- red wine, beer, ethanol and de-alcoholised red wine, de-alcoholised beer, water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2004to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-60 years
- non-smoker
- healthy
Who cannot join
- personal or family history of dependency
- any chronic disease
- acute and chronic inflammatory processes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Arteriosclerosis, Myocardial Infarction
- Being tested
- red wine, beer, ethanol, de-alcoholised red wine, de-alcoholised beer, water
- Keywords
- alcoholic beverages, non-alcoholic beverages, inflammation, Serum concentration of inflammatory markers before and after intervention
- Medical subject headings
- Arteriosclerosis, Myocardial Infarction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
red wine, beer, ethanolDrug
Alcoholic beverages equivalent to 30g of alcohol per day for men and 20g/d for women for 3 weeks
de-alcoholised red wine, de-alcoholised beer, waterDrug
de-alcoholised red wine, de-alcoholised beer, water
| Study group | Role | What they receive |
|---|---|---|
| non-alcoholic beverages | Active comparator | dealcoholised red wine, de-alcoholised beer, water Receives: Drug: de-alcoholised red wine, de-alcoholised beer, water |
| alcoholic beverages | Active comparator | red wine, beer, ethanol Receives: Drug: red wine, beer, ethanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of inflammatory markers including C-reactive protein
Measured: 12 weeks
Secondary outcomes (1)
Ex vivo migration of monocytes
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ArteriosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Research Advisory Board
- Sponsor type
- University, hospital or other
- Investigators
- Armin P Imhof, MD, Principal investigator, University of Ulm, Medical Center, Ulm, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764426
- Sponsor's protocol ID
- EA 03 06
- Status last verified
- Oct 2008
- First submitted
- 30 Sep 2008
- Last updated
- 2 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18398813
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Effect of Different Alcoholic and Non-Alcoholic Beverages on Markers of Inflammation
- ClinicalTrials.gov ID
- NCT00764426
- Acronym / sponsor ID
- EA 03 06
- Conditions
- Arteriosclerosis, Myocardial Infarction
- Keywords
- alcoholic beverages, non-alcoholic beverages, inflammation, Serum concentration of inflammatory markers before and after intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- European Research Advisory BoardUniversity, hospital or other
- Study start
- Jun 2004
- First posted
- 2 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-alcoholic beverages | Active comparator | Drug: de-alcoholised red wine, de-alcoholised beer, waterdealcoholised red wine, de-alcoholised beer, water |
| alcoholic beverages | Active comparator | Drug: red wine, beer, ethanolred wine, beer, ethanol |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-60 years
- non-smoker
- healthy
Key exclusion criteria (3 listed)
- personal or family history of dependency
- any chronic disease
- acute and chronic inflammatory processes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| red wine, beer, ethanolAlcoholic beverages equivalent to 30g of alcohol per day for men and 20g/d for women for 3 weeks | Drug | alcoholic beverages |
| de-alcoholised red wine, de-alcoholised beer, waterde-alcoholised red wine, de-alcoholised beer, water | Drug | non-alcoholic beverages |
Primary outcome
Concentration of inflammatory markers including C-reactive protein
Time frame: 12 weeks
1 secondary outcome
Ex vivo migration of monocytes
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2008.
- Results publication: PubMed 18398813Imhof 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin P Imhof, MD principal investigator
University of Ulm, Medical Center, Ulm, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing red wine, beer, ethanol and de-alcoholised red wine, de-alcoholised beer, water in people with Arteriosclerosis and Myocardial Infarction, run by European Research Advisory Board at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of inflammatory markers including C-reactive protein (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00764426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2008.