HealthyPhase 1/2NCT06535620
Comparison of the Effect of Red Wine With Alcohol on Flow-mediated Dilation Versus Red Wine Without Alcohol
A Phase 1/2 study testing red wine with alcohol and red wine without alcohol in people with Healthy and Healthy Diet, run by Instituto de Cardiologia de Santa Catarina.
Trial summary
Introduction: Cardiovascular diseases (CVDs) are the leading cause of global mortality, despite being preventable. Moderate wine consumption has been associated with one of the preventative approaches due to its benefits on cardiovascular health, including endothelial protection and antioxidant effects, attributed to… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Healthy Diet
- What is being tested?
- red wine with alcohol and red wine without alcohol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 13 Aug 2024to 15 Nov 2024
- Phase
- Phase 1/2
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- consume alcohol sporadically
Who cannot join
- continuous medication, including anti-inflammatories
- pregnant women
About this study
Official title: Comparison of the Effect of Red Wine With Alcohol on Flow-mediated Dilation Versus Red Wine Without Alcohol - a Randomized Clinical Trial
Introduction: Cardiovascular diseases (CVDs) are the leading cause of global mortality, despite being preventable. Moderate wine consumption has been associated with one of the preventative approaches due to its benefits on cardiovascular health, including endothelial protection and antioxidant effects, attributed to its chemical composition, such as flavonoids.
Objective: To assess endothelial function through flow-mediated dilation after the consumption of red wine compared to non-alcoholic wine.
Methodology: A parallel, randomized, placebo-controlled clinical trial with a blinded evaluator will be conducted with 20 healthy participants, evaluated at two distinct time points. Participants will be selected to receive either red wine or non-alcoholic wine and will be crossed over after 7 days to receive the opposite beverage from the initial one. The primary outcome will be the change in flow-mediated dilation of the brachial artery pre- and post-intervention in both groups. The secondary outcomes will include the flow-mediated dilation values, brachial artery diameter after the intervention, and measurements of systolic blood pressure (SBP) and diastolic blood pressure (DBP).
- Conditions
- Healthy, Healthy Diet
- Being tested
- red wine with alcohol, red wine without alcohol
- Keywords
- wine, cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
red wine with alcoholOther
200 ml of red wine - Demi sec Bordeaux wine 'La Dorni' (alcohol content at 20ºC of 10.1% - Alves \& Martins Bebidas Especiais LTDA - Bandeirantes, Parana - Brazil)
red wine without alcoholOther
200 ml of red wine without alcohol - Demi sec Bordeaux wine 'Casa Navaronne' (alcohol content at 20ºC of 0.23% - Alves \& Martins Bebidas Especiais LTDA - Bandeirantes, Parana - Brazil)
| Study group | Role | What they receive |
|---|---|---|
| red wine with alcohol | Experimental | The red wine group Receives: Other: red wine with alcohol |
| red wine without alcohol | Placebo comparator | The non-alcoholic wine group Receives: Other: red wine without alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation
Evaluate flow-mediated dilation after the consumption of red wine compared to placebo
Measured: 40 minutes after the substance intake
Secondary outcomes (4)
Heart rate
Analyze the difference in heart rate (in bpm) after the consumption of red wine compared to the consumption of non-alcoholic wine.
Measured: 40 minutes after the substance intake
Blood pressure
Analyze the difference in blood pressure (in mmHg) after the consumption of red wine compared to the consumption of non-alcoholic wine.
Measured: 40 minutes after the substance intake
Brachial artery diameter at rest
Evaluate the difference in the diameter (at rest) of the brachial artery (measured in millimeters) before and after consuming red wine.
Measured: 40 minutes after the substance intake
Brachial artery diameter after endothelial stress
Evaluate the difference in the diameter (after endothelial stress) of the brachial artery (measured in millimeters) before and after consuming red wine.
Measured: 40 minutes after the substance intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start13 Aug 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia de Santa Catarina
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Sul de Santa Catarina
- Responsible party
- Principal investigator, Daniel Medeiros Moreira, Instituto de Cardiologia de Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535620
- Sponsor's protocol ID
- 78483823.4.0000.0261
- Status last verified
- Aug 2024
- First submitted
- 28 Jul 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Red Wine With Alcohol on Flow-mediated Dilation Versus Red Wine Without Alcohol - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06535620
- Acronym / sponsor ID
- 78483823.4.0000.0261
- Conditions
- Healthy, Healthy Diet
- Keywords
- wine, cardiovascular disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia de Santa CatarinaUniversity, hospital or other
- Collaborators
- Universidade do Sul de Santa Catarina
- Study start
- 13 Aug 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 2 Aug 2024 (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.
Introduction: Cardiovascular diseases (CVDs) are the leading cause of global mortality, despite being preventable. Moderate wine consumption has been associated with one of the preventative approaches due to its benefits on cardiovascular health, including endothelial protection and antioxidant effects, attributed to its chemical composition, such as flavonoids.
Objective: To assess endothelial function through flow-mediated dilation after the consumption of red wine compared to non-alcoholic wine.
Methodology: A parallel, randomized, placebo-controlled clinical trial with a blinded evaluator will be conducted with 20 healthy participants, evaluated at two distinct time points. Participants will be selected to receive either red wine or non-alcoholic wine and will be crossed over after 7 days to receive the opposite beverage from the initial one. The primary outcome will be the change in flow-mediated dilation of the brachial artery pre- and post-intervention in both groups. The secondary outcomes will include the flow-mediated dilation values, brachial artery diameter after the intervention, and measurements of systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| red wine with alcohol | Experimental | Other: red wine with alcoholThe red wine group |
| red wine without alcohol | Placebo comparator | Other: red wine without alcoholThe non-alcoholic wine group |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- consume alcohol sporadically
Key exclusion criteria (2 listed)
- continuous medication, including anti-inflammatories
- pregnant women
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 with alcohol200 ml of red wine - Demi sec Bordeaux wine 'La Dorni' (alcohol content at 20ºC of 10.1% - Alves \& Martins Bebidas Especiais LTDA - Bandeirantes, Parana - Brazil) | Other | red wine with alcohol |
| red wine without alcohol200 ml of red wine without alcohol - Demi sec Bordeaux wine 'Casa Navaronne' (alcohol content at 20ºC of 0.23% - Alves \& Martins Bebidas Especiais LTDA - Bandeirantes, Parana - Brazil) | Other | red wine without alcohol |
Primary outcome
Flow-mediated dilation
Time frame: 40 minutes after the substance intake
Evaluate flow-mediated dilation after the consumption of red wine compared to placebo
4 secondary outcomes
Heart rate
Time frame: 40 minutes after the substance intake
Blood pressure
Time frame: 40 minutes after the substance intake
Brachial artery diameter at rest
Time frame: 40 minutes after the substance intake
Brachial artery diameter after endothelial stress
Time frame: 40 minutes after the substance intake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing red wine with alcohol and red wine without alcohol in people with Healthy and Healthy Diet, run by Instituto de Cardiologia de Santa Catarina.
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 2 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Flow-mediated dilation (time frame: 40 minutes after the substance intake). 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 16 Aug 2024.