HealthyNCT00330213
Effects of Red Wine and Cognac on Coronary Circulation
A study testing red wine and cognac consumption in people with Healthy, run by University of Turku at 1 site in Finland.
Trial summary
Red wine consumption is associated with reduced cardiovascular disease mortality, and the cardioprotective properties may be partly related to its ability to improve endothelial function. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- red wine and cognac consumption
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2004to Apr 2005
- 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 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy males
Who cannot join
- smoking, medication of any kind
Trial locations and contacts
1 site in 1 country.
Finland1 site
Dept. Clinical Physiology and Nuclear Medicine, Turku University Hospital
Turku, FIN-20520
About this study
Red wine consumption is associated with reduced cardiovascular disease mortality, and the cardioprotective properties may be partly related to its ability to improve endothelial function. The purpose of this study was to determine whether moderate doses of red wine, de-alcoholized red wine and cognac improve coronary flow reserve.
Read the detailed description
Moderate consumption of red wine is associated with reduced coronary artery disease mortality. Cardioprotective effects of red wine may be partly related to its ability to improve endothelial function. Red wine increases endothelium-dependent flow-mediated dilatation of the brachial artery acutely after ingestion. Moreover, a heavy dose of red wine (ethanol 1.0 g/kg) has been shown to increase coronary flow reserve (CFR) as measured with transthoracic Doppler echocardiography. CFR depicts the relative increase of coronary blood flow in response to maximal myocardial hyperemia induced by adenosine. It is reduced in atherosclerosis and various conditions associated with the dysfunction of coronary microcirculation, such as diabetes and hypercholesterolemia.
Both ethanol and antioxidative polyphenols have been implicated in beneficial endothelial effects of red wine. However, their relative contributions remain uncertain in vivo. It has been suggested that red wine has stronger vasoactive properties than other alcohol beverages, and even de-alcoholized red wine may be sufficient to improve flow-mediated dilatation of the brachial artery. Cognac is also known to contain polyphenols, but its effects on coronary circulation have not been evaluated.
The purpose of this randomized controlled cross-over study was to determine with transthoracic echocardiography whether moderate doses of red wine improve CFR in response to adenosine in healthy humans. We also studied contributions of ethanol and antioxidants by comparing the effects of equal doses of alcoholic and de-alcoholized red wine, and cognac on the plasma antioxidant capacity and CFR.
- Conditions
- Healthy
- Being tested
- red wine and cognac consumption
- Keywords
- transthoracic, echocardiography, red wine, cognac, coronary reactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
red wine and cognac consumptionBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
coronary flow reserve
plasma antioxidant capacity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2006 (estimated)
- Study startOct 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Investigators
- Tuomas O Kiviniemi, MD, Principal investigator, Dept. Clinical Physiology and Nuclear Medicine, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330213
- Sponsor's protocol ID
- KLF-RW-06
- Status last verified
- Sep 2004
- First submitted
- 24 May 2006
- Last updated
- 26 May 2006
- Results posted
- No
Publications
Kiviniemi TO, Saraste M, Koskenvuo JW, Airaksinen KE, Toikka JO, Saraste A, Parkka JP, Hartiala JJ. Coronary artery diameter can be assessed reliably with transthoracic echocardiography. Am J Physiol Heart Circ Physiol. 2004 Apr;286(4):H1515-20. doi: 10.1152/ajpheart.00819.2003. Epub 2003 Dec 4.
PubMed 14656707Kiviniemi TO, Saraste A, Toikka JO, Saraste M, Raitakari OT, Parkka JP, Lehtimaki T, Hartiala JJ, Viikari J, Koskenvuo JW. Effects of cognac on coronary flow reserve and plasma antioxidant status in healthy young men. Cardiovasc Ultrasound. 2008 Jun 3;6:25. doi: 10.1186/1476-7120-6-25.
PubMed 18522727
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Red Wine and Cognac on Coronary Circulation
- ClinicalTrials.gov ID
- NCT00330213
- Acronym / sponsor ID
- KLF-RW-06
- Conditions
- Healthy
- Keywords
- transthoracic, echocardiography, red wine, cognac, coronary reactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- Oct 2004
- Study completion
- Apr 2005
- First posted
- 26 May 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.
Red wine consumption is associated with reduced cardiovascular disease mortality, and the cardioprotective properties may be partly related to its ability to improve endothelial function. The purpose of this study was to determine whether moderate doses of red wine, de-alcoholized red wine and cognac improve coronary flow reserve.
Detailed description
Moderate consumption of red wine is associated with reduced coronary artery disease mortality. Cardioprotective effects of red wine may be partly related to its ability to improve endothelial function. Red wine increases endothelium-dependent flow-mediated dilatation of the brachial artery acutely after ingestion. Moreover, a heavy dose of red wine (ethanol 1.0 g/kg) has been shown to increase coronary flow reserve (CFR) as measured with transthoracic Doppler echocardiography. CFR depicts the relative increase of coronary blood flow in response to maximal myocardial hyperemia induced by adenosine. It is reduced in atherosclerosis and various conditions associated with the dysfunction of coronary microcirculation, such as diabetes and hypercholesterolemia.
Both ethanol and antioxidative polyphenols have been implicated in beneficial endothelial effects of red wine. However, their relative contributions remain uncertain in vivo. It has been suggested that red wine has stronger vasoactive properties than other alcohol beverages, and even de-alcoholized red wine may be sufficient to improve flow-mediated dilatation of the brachial artery. Cognac is also known to contain polyphenols, but its effects on coronary circulation have not been evaluated.
The purpose of this randomized controlled cross-over study was to determine with transthoracic echocardiography whether moderate doses of red wine improve CFR in response to adenosine in healthy humans. We also studied contributions of ethanol and antioxidants by comparing the effects of equal doses of alcoholic and de-alcoholized red wine, and cognac on the plasma antioxidant capacity and CFR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy males
Key exclusion criteria (1 listed)
- smoking, medication of any kind
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 and cognac consumption | Behavioural | – |
Primary outcome
coronary flow reserve
plasma antioxidant capacity
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 26 May 2006.
- Background: PubMed 14656707Kiviniemi TO, Saraste M, Koskenvuo JW, Airaksinen KE, Toikka JO, Saraste A, Parkka JP, Hartiala JJ. Coronary artery diameter can be assessed reliably with transthoracic echocardiography. Am J Physiol Heart Circ Physiol. 2004 Apr;286(4):H1515-20. doi: 10.1152/ajpheart.00819.2003. Epub 2003 Dec 4.
- Derived from this study: PubMed 18522727Kiviniemi TO, Saraste A, Toikka JO, Saraste M, Raitakari OT, Parkka JP, Lehtimaki T, Hartiala JJ, Viikari J, Koskenvuo JW. Effects of cognac on coronary flow reserve and plasma antioxidant status in healthy young men. Cardiovasc Ultrasound. 2008 Jun 3;6:25. doi: 10.1186/1476-7120-6-25.
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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.
Tuomas O Kiviniemi, MD principal investigator
Dept. Clinical Physiology and Nuclear Medicine, Turku University Hospital
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 and cognac consumption in people with Healthy, run by University of Turku at 1 site in Finland.
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 1 inclusion and 1 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 26 May 2006. 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 Finland. 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?
coronary flow reserve. The study lists 2 primary outcomes in all. 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 NCT00330213, which also lists 2 linked publications.
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 26 May 2006.