Cardiovascular DiseaseNCT04438122
Effect of Wine Consumption on Cardiovascular Markers in CHDs Patients
A study testing Cabernet Sauvignon and Tsipouro in people with Cardiovascular Disease, run by Harokopio University at 1 site in Greece.
Trial summary
Many epidemiological studies support that 20-30gr of alcohol consumption per day is related with lower risk for cardiovascular diseases, heart attack as well as mortality related to these diseases. Read more about this study
- Who is it for?
- Ages 37 to 82 years, men only
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Cabernet Sauvignon and Tsipouro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2013to Jun 2018
- 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 37 to 82 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The presence of Coronary Heart disease established by angiography or the presence of one of the following:
- positive stress test
- positive myocardial perfusion scintigraphy with Thallium
- positive triplex heart ultrasound with Dobutamine
- If nothing of the criteria above existed then hospitalization because of myocardial infarction or stroke.
- Stable medication for at least 6 months.
- Habit to drink 10-28gr of alcohol per week.
Who cannot join
- History of any other inflammatory disease, diabetes, presence of cold or flu, acute respiratory infection, dental problems and renal/hepatic diseases.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Nutrition-Dietetics, Harokopio University
Athens, 17671
About this study
Official title: Effect of Light to Moderate Wine Consumption on Cardiovascular Markers in Coronary Heart Disease Patients
Many epidemiological studies support that 20-30gr of alcohol consumption per day is related with lower risk for cardiovascular diseases, heart attack as well as mortality related to these diseases. Since the French paradox was reported, a number of experimental and clinical studies have demonstrated the protective effect of red wine compared to other alcoholic drinks on different pathways of the pathogenesis of atherosclerosis. The investigator's previous results revealed that wine contain micro-constituents that exert potent in vitro anti-platelet and anti-inflammatory actions. Also, the wine consumption along with a standardized meal reduced platelet aggregation and biosynthesis of Platelet Activating Factor in healthy men.
Although a large number of studies have reported protective effect of wine against atherosclerosis in healthy people there are few data about the effect of long-term moderate wine consumption in population with CVD. Therefore, the aim of this randomized, intervention clinical study, with control group was to report the effects of regular light to moderate wine consumption on cardiovascular biomarkers in people with CVD.
Read the detailed description
The study was a randomized, controlled, three-arm parallel intervention study, designed to evaluate if the light to moderate wine consumption could modulate thrombosis and inflammation, in patients with cardiovascular disease. The study was carried out in accordance with the guidelines laid down in the Declaration of Helsinki (1989) of the World Medical Association and was approved by the Bioethics Committee of Harokopio University. Seventy one men patients with cardiovascular disease were initially recruited to participate in the study. The recruitment took place in several hospitals of Athens in Greece under the supervisor of corresponding cardiologist. Finally 64 met the inclusion criteria. Prior to intervention all participants signed an informed consent All volunteers followed an initial 15 days wash-out period, abstaining from alcohol; then, they randomly assigned to one of the three intervention groups. The randomization code was prepared by a staff member who was not involved in running the trial, by using computer-generated random numbers. Subjects instructed to follow their usual diet and not change their medication during the study. In Group A (control group), participants consumed no alcohol, in Group B (ethanol group) participants consumed 69 mL of tsipouro with 38% alcohol and participants in Group C consumed 200ml of red wine (Cabernet Sauvignon 13.5% alcohol vol.). The ethanol that was consumed in the last two groups was equal at 27gr of ethanol per day and alcoholic beverage was consumed along with the meal (lunch or dinner). Finally, 57 participants completed the study, in particular 20 in Group A, 16 in Group B and 21 in Group C. Intervention lasted two months and biological samples (blood, urine) were collected at the beginning (0 week), in the middle (4 week) and in the end (8 week) of each intervention.
- Conditions
- Cardiovascular Disease
- Being tested
- Cabernet Sauvignon, Tsipouro
- Keywords
- wine, cardiovascular disease, inflammatory biomarkers, platelet aggregation, Platelet Activating Factor, ethanol, PBMCs, Wine microcontsituents
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabernet SauvignonOther
Cabernet Sauvignon is a red wine from a greek company which contains 13.5% alcohol vol.
TsipouroOther
Tsipouro is a greek spirit which contains 38% alcohol vol
| Study group | Role | What they receive |
|---|---|---|
| Red Wine group | Active comparator | Participants of this group consumed 200ml of red wine along with a meal (lunch or dinner) every day for 8 weeks. Receives: Other: Cabernet Sauvignon |
| Ethanol group | Active comparator | Participants of this group consumed 69mL of tsipouro along with a meal (lunch or dinner) every day for 8 weeks. Receives: Other: Tsipouro |
| Control group | No intervention | Participants of this group consumed no alcohol along with a meal (lunch or dinner) every day for 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on platelet aggregation against PAF
% Change of EC50 value of platelet aggregation against PAF
Measured: Changes between baseline, 4 and 8 weeks.
Effect on platelet aggregation against ADP
% Change of EC50 value of platelet aggregation against ADP
Measured: Changes between baseline, 4 and 8 weeks.
Effect on platelet aggregation against collagen
% Change of EC50 value of platelet aggregation against collagen
Measured: Changes between baseline, 4 and 8 weeks.
Effect on inflammatory markers (activity of Lyso-PAF-AT)
% Change in the activity of PAF biosynthetic enzyme Lyso-PAF AT
Measured: Changes between baseline, 4 and 8 weeks.
Effect on inflammatory markers (activity of PAF-CPT)
% Change in the activity of PAF biosynthetic enzyme PAF-CPT
Measured: Changes between baseline, 4 and 8 weeks.
Effect on inflammatory markers (activity of PAF-AH)
% Change in the activity of PAF degradation enzyme PAF-AH
Measured: Changes between baseline, 4 and 8 weeks.
Effect on inflammatory markers (activity of LpPLA2)
% Change in the activity of PAF degradation enzyme Lp-PLA2
Measured: Changes between baseline, 4 and 8 weeks.
Effect on inflammatory markers
% Changes of Adiponectin, IL-6, CRP
Measured: Changes between baseline, 4 and 8 weeks.
Cytokine secretion by PBMC
Secretion of TNFa and IL-1β by PBMC under basal and inflammatory (LPS-induced) conditions at 4 and 24h incubation
Measured: Changes between baseline, 4 and 8 weeks.
Effect on endothelial function markers
% Changes of VCAM, P-selectin.
Measured: Changes between baseline, 4 and 8 weeks.
Secondary outcomes (2)
Effect on biochemical indices
% Changes of Total cholesterol, LDL-chol, HDL-chol, triacylglycerols, uric acid, glucose, insulin, SGOT/AST, SGPT/ALT, γ-GT
Measured: Changes between baseline, 4 and 8 weeks.
Effect on oxidative stress markers
% Changes of TBARS, Lag time, GPx
Measured: Changes between baseline, 4 and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study startSep 2013
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Fragopoulou, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438122
- Sponsor's protocol ID
- HarokopioU
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Light to Moderate Wine Consumption on Cardiovascular Markers in Coronary Heart Disease Patients
- ClinicalTrials.gov ID
- NCT04438122
- Acronym / sponsor ID
- HarokopioU
- Conditions
- Cardiovascular Disease
- Keywords
- wine, cardiovascular disease, inflammatory biomarkers, platelet aggregation, Platelet Activating Factor, ethanol, PBMCs, Wine microcontsituents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 18 Jun 2020 (actual)
- 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.
Many epidemiological studies support that 20-30gr of alcohol consumption per day is related with lower risk for cardiovascular diseases, heart attack as well as mortality related to these diseases. Since the French paradox was reported, a number of experimental and clinical studies have demonstrated the protective effect of red wine compared to other alcoholic drinks on different pathways of the pathogenesis of atherosclerosis. The investigator's previous results revealed that wine contain micro-constituents that exert potent in vitro anti-platelet and anti-inflammatory actions. Also, the wine consumption along with a standardized meal reduced platelet aggregation and biosynthesis of Platelet Activating Factor in healthy men.
Although a large number of studies have reported protective effect of wine against atherosclerosis in healthy people there are few data about the effect of long-term moderate wine consumption in population with CVD. Therefore, the aim of this randomized, intervention clinical study, with control group was to report the effects of regular light to moderate wine consumption on cardiovascular biomarkers in people with CVD.
Detailed description
The study was a randomized, controlled, three-arm parallel intervention study, designed to evaluate if the light to moderate wine consumption could modulate thrombosis and inflammation, in patients with cardiovascular disease. The study was carried out in accordance with the guidelines laid down in the Declaration of Helsinki (1989) of the World Medical Association and was approved by the Bioethics Committee of Harokopio University. Seventy one men patients with cardiovascular disease were initially recruited to participate in the study. The recruitment took place in several hospitals of Athens in Greece under the supervisor of corresponding cardiologist. Finally 64 met the inclusion criteria. Prior to intervention all participants signed an informed consent All volunteers followed an initial 15 days wash-out period, abstaining from alcohol; then, they randomly assigned to one of the three intervention groups. The randomization code was prepared by a staff member who was not involved in running the trial, by using computer-generated random numbers. Subjects instructed to follow their usual diet and not change their medication during the study. In Group A (control group), participants consumed no alcohol, in Group B (ethanol group) participants consumed 69 mL of tsipouro with 38% alcohol and participants in Group C consumed 200ml of red wine (Cabernet Sauvignon 13.5% alcohol vol.). The ethanol that was consumed in the last two groups was equal at 27gr of ethanol per day and alcoholic beverage was consumed along with the meal (lunch or dinner). Finally, 57 participants completed the study, in particular 20 in Group A, 16 in Group B and 21 in Group C. Intervention lasted two months and biological samples (blood, urine) were collected at the beginning (0 week), in the middle (4 week) and in the end (8 week) of each intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Red Wine group | Active comparator | Other: Cabernet SauvignonParticipants of this group consumed 200ml of red wine along with a meal (lunch or dinner) every day for 8 weeks. |
| Ethanol group | Active comparator | Other: TsipouroParticipants of this group consumed 69mL of tsipouro along with a meal (lunch or dinner) every day for 8 weeks. |
| Control group | No intervention | –Participants of this group consumed no alcohol along with a meal (lunch or dinner) every day for 8 weeks |
Who may qualify
- Ages
- 37 to 82 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The presence of Coronary Heart disease established by angiography or the presence of one of the following:
- positive stress test
- positive myocardial perfusion scintigraphy with Thallium
- positive triplex heart ultrasound with Dobutamine
- If nothing of the criteria above existed then hospitalization because of myocardial infarction or stroke.
Key exclusion criteria (1 listed)
- History of any other inflammatory disease, diabetes, presence of cold or flu, acute respiratory infection, dental problems and renal/hepatic diseases.
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 |
|---|---|---|
| Cabernet SauvignonCabernet Sauvignon is a red wine from a greek company which contains 13.5% alcohol vol. | Other | Red Wine group |
| TsipouroTsipouro is a greek spirit which contains 38% alcohol vol | Other | Ethanol group |
Primary outcome
Effect on platelet aggregation against PAF
Time frame: Changes between baseline, 4 and 8 weeks.
% Change of EC50 value of platelet aggregation against PAF
Effect on platelet aggregation against ADP
Time frame: Changes between baseline, 4 and 8 weeks.
% Change of EC50 value of platelet aggregation against ADP
Effect on platelet aggregation against collagen
Time frame: Changes between baseline, 4 and 8 weeks.
% Change of EC50 value of platelet aggregation against collagen
Effect on inflammatory markers (activity of Lyso-PAF-AT)
Time frame: Changes between baseline, 4 and 8 weeks.
% Change in the activity of PAF biosynthetic enzyme Lyso-PAF AT
Effect on inflammatory markers (activity of PAF-CPT)
Time frame: Changes between baseline, 4 and 8 weeks.
% Change in the activity of PAF biosynthetic enzyme PAF-CPT
Effect on inflammatory markers (activity of PAF-AH)
Time frame: Changes between baseline, 4 and 8 weeks.
% Change in the activity of PAF degradation enzyme PAF-AH
Effect on inflammatory markers (activity of LpPLA2)
Time frame: Changes between baseline, 4 and 8 weeks.
% Change in the activity of PAF degradation enzyme Lp-PLA2
Effect on inflammatory markers
Time frame: Changes between baseline, 4 and 8 weeks.
% Changes of Adiponectin, IL-6, CRP
Cytokine secretion by PBMC
Time frame: Changes between baseline, 4 and 8 weeks.
Secretion of TNFa and IL-1β by PBMC under basal and inflammatory (LPS-induced) conditions at 4 and 24h incubation
Effect on endothelial function markers
Time frame: Changes between baseline, 4 and 8 weeks.
% Changes of VCAM, P-selectin.
2 secondary outcomes
Effect on biochemical indices
Time frame: Changes between baseline, 4 and 8 weeks.
Effect on oxidative stress markers
Time frame: Changes between baseline, 4 and 8 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 18 Jun 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cabernet Sauvignon and Tsipouro in people with Cardiovascular Disease, run by Harokopio University at 1 site in Greece.
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 7 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 18 Jun 2020. 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 Greece. 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?
Effect on platelet aggregation against PAF (time frame: Changes between baseline, 4 and 8 weeks.). The study lists 10 primary outcomes in all. 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 18 Jun 2020.