Coronary Artery DiseaseNCT06095635
Acute Influence of Resveratrol Supplementation and Beet Extract in Recovery After Exercise in Coronary Paths
A study testing Protocol Beet, Protocol Resveratrol and Protocol Beet and Resveratrol in people with Coronary Artery Disease and Autonomic Nervous System Disease, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
Introduction: Most cardiovascular diseases (CVD) can be prevented and controlled by adopting lifestyle changes, such as regular physical exercise and nutrition. Resveratrol and beverage extract promote beneficial health effects due to their nutritional properties. Read more about this study
- Who is it for?
- Ages 40 to 79 years, men only
- Conditions the study is for
- Coronary Artery Disease, Autonomic Nervous System Disease, Blood Pressure
- What is being tested?
- Protocol Beet, Protocol Resveratrol and Protocol Beet and Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Mar 2022to 30 Sep 2023
- 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 40 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult men over 45 years of age
- diagnosed with ischemic coronary artery disease and with preserved left ventricular function (above 50%), confirmed by a previous echocardiogram
Who cannot join
- Volunteers who present at least one of the following characteristics will be excluded:
- smokers
- alcohol drinkers
- those who did not attend a cardiovascular rehabilitation program for at least 3 months prior to data collection
- individuals who have known infections, metabolic and respiratory diseases that could interfere in cardiac autonomic control, unstable angina, uncontrolled hypertension, significant valvular disease, uncontrolled metabolic disease (e.g., uncontrolled diabetes and thyroid disease)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Estadual Paulista
Presidente Prudente, São Paulo, 19060-900
About this study
Official title: Acute Influence of Resveratrol Supplementation and Beet Extract in Recovery After Exercise Submaximal Aerobic in Coronary Paths: a Study Prospective, Randomized Placebo-controlled
Introduction: Most cardiovascular diseases (CVD) can be prevented and controlled by adopting lifestyle changes, such as regular physical exercise and nutrition. Resveratrol and beverage extract promote beneficial health effects due to their nutritional properties. Objective: to analyze the effects of resveratrol supplementation and withdrawal extract on post-exercise recovery in coronary heart disease patients. Methods: men diagnosed with ischemic coronary artery disease will undergo four exercise protocols consisting of 30 minutes of aerobic exercise on an ergometric treadmill, with 5 minutes of warm-up, intensity of 30% of the heart rate reserve (HRR), followed by 25 minutes at intensity 60% of FCR and for a final 30 minutes of recovery in the supine position. Before each exercise protocol, all volunteers will consume: 500 mg of placebo (starch), or 500 mg of beetroot, or 500 mg of resveratrol and will also consume resveratrol and drink (500 mg each) 30 minutes before exercise. , the order of each supplementation will be done randomly. Cardiorespiratory parameters and heart rate variability (HRV) will be assessed at different times throughout the experimental procedure. To analyze the moments (rest versus recovery), the Bonferroni post-test will be used for parametric distribution or the Dunn post-test for non-parametric distribution. Statistical significance will be calculated at 5% for all analyses.
- Being tested
- Placebo Protocol, Protocol Beet, Protocol Resveratrol, Protocol Beet and Resveratrol
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo ProtocolOther
Also called 500 mg of starch
ingestion of 500 mg of starch following 30 minutes of exercise (treadmill)
Protocol BeetOther
Also called 500 mg of beet extract
ingestion of 500 mg of beet extect following 30 minutes of exercise (treadmill)
Protocol ResveratrolOther
Also called 500 mg of resveratrol
ingestion of 500 mg of resveratrol following 30 minutes of exercise (treadmill)
Protocol Beet and ResveratrolOther
Also called 500 mg of beet extect and 500 mg of resveratrol
ingestion 500 mg of beet extect and 500 mg of resveratrol following 30 minutes of exercise (treadmill)
| Study group | Role | What they receive |
|---|---|---|
| Placebo Protocol | Placebo comparator | exercise and placebo capsules 500 mg (starch) Receives: Other: Placebo Protocol |
| Protocol Beet | Experimental | exercise and beet extract 500 mg Receives: Other: Protocol Beet |
| Protocol Resveratrol | Experimental | exercise and resveratrol capsules 500 mg Receives: Other: Protocol Resveratrol |
| Protocol Beet and Resveratrol | Experimental | exercise and beet extract 500mg and resveratrol capsules 500 mg Receives: Other: Protocol Beet and Resveratrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability (HRV)
Time and frequency domain of HRV
Measured: through study completion, an average of 1 hour
Secondary outcomes (1)
Blood Pressure
Systolic Blood Pressure and Diastolic Blood Pressure
Measured: through study completion, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start10 Mar 2022
- Primary completion10 Jan 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luana Almeida Gonzaga, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095635
- Sponsor's protocol ID
- UEPJMG
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Influence of Resveratrol Supplementation and Beet Extract in Recovery After Exercise Submaximal Aerobic in Coronary Paths: a Study Prospective, Randomized Placebo-controlled
- ClinicalTrials.gov ID
- NCT06095635
- Acronym / sponsor ID
- UEPJMG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 23 Oct 2023 (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: Most cardiovascular diseases (CVD) can be prevented and controlled by adopting lifestyle changes, such as regular physical exercise and nutrition. Resveratrol and beverage extract promote beneficial health effects due to their nutritional properties. Objective: to analyze the effects of resveratrol supplementation and withdrawal extract on post-exercise recovery in coronary heart disease patients. Methods: men diagnosed with ischemic coronary artery disease will undergo four exercise protocols consisting of 30 minutes of aerobic exercise on an ergometric treadmill, with 5 minutes of warm-up, intensity of 30% of the heart rate reserve (HRR), followed by 25 minutes at intensity 60% of FCR and for a final 30 minutes of recovery in the supine position. Before each exercise protocol, all volunteers will consume: 500 mg of placebo (starch), or 500 mg of beetroot, or 500 mg of resveratrol and will also consume resveratrol and drink (500 mg each) 30 minutes before exercise. , the order of each supplementation will be done randomly. Cardiorespiratory parameters and heart rate variability (HRV) will be assessed at different times throughout the experimental procedure. To analyze the moments (rest versus recovery), the Bonferroni post-test will be used for parametric distribution or the Dunn post-test for non-parametric distribution. Statistical significance will be calculated at 5% for all analyses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Protocol | Placebo comparator | Other: Placebo Protocolexercise and placebo capsules 500 mg (starch) |
| Protocol Beet | Experimental | Other: Protocol Beetexercise and beet extract 500 mg |
| Protocol Resveratrol | Experimental | Other: Protocol Resveratrolexercise and resveratrol capsules 500 mg |
| Protocol Beet and Resveratrol | Experimental | Other: Protocol Beet and Resveratrolexercise and beet extract 500mg and resveratrol capsules 500 mg |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult men over 45 years of age
- diagnosed with ischemic coronary artery disease and with preserved left ventricular function (above 50%), confirmed by a previous echocardiogram
Key exclusion criteria (5 listed)
- smokers
- alcohol drinkers
- those who did not attend a cardiovascular rehabilitation program for at least 3 months prior to data collection
- individuals who have known infections, metabolic and respiratory diseases that could interfere in cardiac autonomic control, unstable angina, uncontrolled hypertension, significant valvular disease, uncontrolled metabolic disease (e.g., uncontrolled diabetes and thyroid disease)
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 |
|---|---|---|
| Placebo ProtocolAlso: 500 mg of starchingestion of 500 mg of starch following 30 minutes of exercise (treadmill) | Other | Placebo Protocol |
| Protocol BeetAlso: 500 mg of beet extractingestion of 500 mg of beet extect following 30 minutes of exercise (treadmill) | Other | Protocol Beet |
| Protocol ResveratrolAlso: 500 mg of resveratrolingestion of 500 mg of resveratrol following 30 minutes of exercise (treadmill) | Other | Protocol Resveratrol |
| Protocol Beet and ResveratrolAlso: 500 mg of beet extect and 500 mg of resveratrolingestion 500 mg of beet extect and 500 mg of resveratrol following 30 minutes of exercise (treadmill) | Other | Protocol Beet and Resveratrol |
Primary outcome
Heart rate variability (HRV)
Time frame: through study completion, an average of 1 hour
Time and frequency domain of HRV
1 secondary outcome
Blood Pressure
Time frame: through study completion, an average of 1 hour
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 23 Oct 2023.
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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 Protocol Beet, Protocol Resveratrol and Protocol Beet and Resveratrol in people with Coronary Artery Disease and Autonomic Nervous System Disease, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
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 23 Oct 2023. 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 Brazil. 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. 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.
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?
Heart rate variability (HRV) (time frame: through study completion, an average of 1 hour). 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 23 Oct 2023.