Coronary Heart DiseaseEarly Phase 1NCT00382551
The Effect of Beer, Red Wine and Fruit Juice on Blood Vessel Function in Persons With Cardiovascular Disease
A Early Phase 1 study testing Moderate daily consumption of Red wine, Moderate daily consumption of beer and Moderate consumption of fruit juice rich in polyphenolics in people with Coronary Heart Disease, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
To study the effect of red wine, beer and fruit juice on endothelial function in patients with coronary Heart disease. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Moderate daily consumption of Red wine, Moderate daily consumption of beer and Moderate consumption of fruit juice rich in polyphenolics
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 49 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2006to not given
- Phase
- Early Phase 1
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or postmenopausal women with stable coronary heart disease
- Coronary heart disease should be verified by coronary angiography with at least 50% stenosis in at least one coronary vessel.
Who cannot join
- Patients with myocardial infarction within the last tree months
- Persons with a present or earlier alcohol abuse
- Persons with a present or earlier drug abuse
- Person with malign disease
- Persons, that we consider unsuitable to carry through the examines.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology, Aalborg Hospital, Science and Innovation Center
Aalborg, Aalborg, 9000
About this study
Official title: The Effect of Alcohol and Polyphenolic Compounds on Endothelial Function
To study the effect of red wine, beer and fruit juice on endothelial function in patients with coronary Heart disease.
- Conditions
- Coronary Heart Disease
- Being tested
- Moderate daily consumption of Red wine, Moderate daily consumption of beer, Moderate consumption of fruit juice rich in polyphenolics
- Keywords
- Alcohol, Red wine, Endothelial function, Flow-mediated vasodilation, Cardiovascular disease
- Medical subject headings
- Coronary Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate daily consumption of Red wineBehavioural
Moderate daily consumption of beerBehavioural
Moderate consumption of fruit juice rich in polyphenolicsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in flow-mediated vasodilation after 2 weeks intervention compared with baseline
Secondary outcomes (5)
Lipid status after 2 weeks intervention compared with baseline
Effects in Coagulation factors after 2 weeks intervention
Effects on markers of inflammation after 2 weeks intervention
Effects on markers of endothelial function after 2 weeks intervention
Changes in the overall antioxidant activity in plasma after 2 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study startOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Erik B Schmidt, Professor, Study director, Department of Cardiology, Aalborg Hospital , Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382551
- Sponsor's protocol ID
- VN-20060043
- Status last verified
- Jan 2009
- First submitted
- 28 Sep 2006
- Last updated
- 30 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alcohol and Polyphenolic Compounds on Endothelial Function
- ClinicalTrials.gov ID
- NCT00382551
- Acronym / sponsor ID
- VN-20060043
- Conditions
- Coronary Heart Disease
- Keywords
- Alcohol, Red wine, Endothelial function, Flow-mediated vasodilation, Cardiovascular disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- Oct 2006
- First posted
- 29 Sep 2006 (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.
To study the effect of red wine, beer and fruit juice on endothelial function in patients with coronary Heart disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or postmenopausal women with stable coronary heart disease
- Coronary heart disease should be verified by coronary angiography with at least 50% stenosis in at least one coronary vessel.
Key exclusion criteria (5 listed)
- Patients with myocardial infarction within the last tree months
- Persons with a present or earlier alcohol abuse
- Persons with a present or earlier drug abuse
- Person with malign disease
- Persons, that we consider unsuitable to carry through the examines.
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 |
|---|---|---|
| Moderate daily consumption of Red wine | Behavioural | – |
| Moderate daily consumption of beer | Behavioural | – |
| Moderate consumption of fruit juice rich in polyphenolics | Behavioural | – |
Primary outcome
Changes in flow-mediated vasodilation after 2 weeks intervention compared with baseline
5 secondary outcomes
Lipid status after 2 weeks intervention compared with baseline
Effects in Coagulation factors after 2 weeks intervention
Effects on markers of inflammation after 2 weeks intervention
Effects on markers of endothelial function after 2 weeks intervention
Changes in the overall antioxidant activity in plasma after 2 weeks intervention
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 30 Jan 2009.
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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.
Erik B Schmidt, Professor study director
Department of Cardiology, Aalborg Hospital , Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Moderate daily consumption of Red wine, Moderate daily consumption of beer and Moderate consumption of fruit juice rich in polyphenolics in people with Coronary Heart Disease, run by Aalborg University Hospital at 1 site in Denmark.
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 2 inclusion and 5 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 30 Jan 2009. 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 Denmark. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in flow-mediated vasodilation after 2 weeks intervention compared with baseline. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2009.