Coronary Artery Disease (CAD)RESEARCHNCT07865377
Serum Endogenous Estrogens, Estrogen Receptors, and Sirtuin-1 and -3 After Resveratrol Supplementation
A study testing Trans-resveratrol, 1000 mg daily for 90 days in people with Coronary Artery Disease (CAD) and Menopause, run by InCor Heart Institute at 1 site in Brazil.
Trial summary
Atherosclerotic coronary artery disease (CAD) is a leading cause of mortality among postmenopausal women. Resveratrol, a phenolic compound with antioxidant properties, may influence lipid metabolism, endothelial function, and platelet aggregation, while sirtuin-1 and sirtuin-3 regulate metabolic and hormonal responses… Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Coronary Artery Disease (CAD), Menopause, Hormones
- What is being tested?
- Trans-resveratrol, 1000 mg daily for 90 days
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Aug 2026to 24 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women;
- Diagnosed coronary artery disease;
- Stable coronary disease;
Who cannot join
- Hypo- or hyperthyroidism,
- Rheumatic disease,
- Use of alcohol,
- hepatic failure,
- renal failure
- hormone replacement therapy
- use of insulin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Servico de Prevencao, Cardiopatia na Mulher e Reabilitacao Cardiovascular, Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP,
São Paulo, São Paulo, 05403- 900
Antonio de Padua Mansur, Dr, +55.11.26615811, apmansur@yahoo.com
Nathalia Ferreira de Oliveira Faria, MSC, +55.11.950869613, nathalia.fariaof@usp.br
About this study
Official title: Impact of Resveratrol on Endogenous Estrogens, Estrogen Receptors, and Sirtuin-1 and -3 in Postmenopausal Women With Chronic Coronary Syndrome: The RESH Randomized Trial
Atherosclerotic coronary artery disease (CAD) is a leading cause of mortality among postmenopausal women. Resveratrol, a phenolic compound with antioxidant properties, may influence lipid metabolism, endothelial function, and platelet aggregation, while sirtuin-1 and sirtuin-3 regulate metabolic and hormonal responses to nutritional stimuli. This randomized, double-blind, placebo-controlled trial evaluates the effects of trans-resveratrol supplementation (1000 mg/day) versus placebo, over 90 days, on serum estradiol and estrone levels, gene expression of estrogen receptors alpha and beta, and sirtuins 1 and 3 in 80 postmenopausal women with CAD. Findings may inform therapeutic strategies for postmenopausal women with chronic coronary disease.
Read the detailed description
Atherosclerotic coronary artery disease (CAD) is the leading cause of mortality among women in developed regions of Brazil. Diets rich in fruits and vegetables, which are sources of phenolic compounds, have been associated with a lower incidence of CAD, possibly due to their beneficial effects on vascular health. Resveratrol, a phenolic compound of the flavonoid group, is notable for its antioxidant properties, contributing to lipoprotein metabolism, production of endothelial vasodilator substances, and reduction of platelet aggregation.
Sirtuin-1 and sirtuin-3 play crucial roles in metabolic regulation in response to nutritional stimuli, such as caloric restriction and phenolic compound intake, and are also involved in hormonal modulation. However, the impact of resveratrol supplementation on serum estrogen and sirtuin levels has not yet been fully elucidated.
The primary objective of this study is to investigate the effects of resveratrol on serum concentrations of estradiol and estrone, gene expression of total estrogen receptors alpha and beta, and gene expression of sirtuins 1 and 3, in postmenopausal women with CAD undergoing resveratrol supplementation.
This is a randomized, double-blind, placebo-controlled clinical trial with a duration of 90 days, involving 80 postmenopausal women with CAD, allocated into two groups:
Group 1 (n=40): supplemented with trans-resveratrol, 1000 mg/day. Group 2 (n=40): placebo control. Clinical, nutritional, and laboratory assessments will be performed at baseline and at 90 days. Additional clinical nutritional assessments will be performed at 30 and 60 days from study initiation.
This investigation is expected to contribute to the understanding of the molecular mechanisms involved in the interaction between resveratrol and hormonal and biochemical markers, providing evidence to support more effective therapeutic strategies for postmenopausal women with chronic coronary disease.
- Conditions
- Coronary Artery Disease (CAD), Menopause, Hormones
- Being tested
- Trans-resveratrol, 1000 mg daily for 90 days, Placebo
- Keywords
- Coronary disease, Estradiol, Estrone, Sirtuin-1, Resveratrol, Sirtuin-3, Menopause
- Medical subject headings
- Coronary Artery Disease, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-resveratrol, 1000 mg daily for 90 daysDietary supplement
Also called Resveratrol
Trans-resveratrol, 1000 mg daily for 90 days
PlaceboOther
Starch, 1000 mg daily for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol | Experimental | Trans-resveratrol, 1000mg daily for 90 days. Receives: Dietary Supplement: Trans-resveratrol, 1000 mg daily for 90 days |
| Control | Placebo comparator | Starch, 1000mg daily for 90 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Sirtuin-1 and sirtuin-3
Serum concentrations and gene expression
Measured: 90 days
Estradiol
Serum concentrations
Measured: 90 days
Estrone
Serum concentrations
Measured: 90 days
SHBG
Serum concentrations
Measured: 90 days
Secondary outcomes (3)
Estrogen receptor alpha
Gene expression
Measured: 90 days
Cardiometabolic risk factors
Lipid and glucometabolic profiles
Measured: 90 days
BMI
kg/m²
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start24 Aug 2026
- Primary completion24 Aug 2029 (estimated)
- Study completion24 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized controlled trial, parallel and placebo-controlled.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InCor Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANTONIO DE PADUA MANSUR, InCor Heart Institute
- Investigators
- Antonio de Padua Mansur, PhD Incor, Principal investigator, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865377
- Sponsor's protocol ID
- 402112/2025-3
- Other IDs
- 402112/2025-3
- Acronym
- RESEARCH
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 16 Oct 2026
- 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Resveratrol on Endogenous Estrogens, Estrogen Receptors, and Sirtuin-1 and -3 in Postmenopausal Women With Chronic Coronary Syndrome: The RESH Randomized Trial
- ClinicalTrials.gov ID
- NCT07865377
- Acronym / sponsor ID
- RESEARCH / 402112/2025-3
- Conditions
- Coronary Artery Disease (CAD), Menopause, Hormones
- Keywords
- Coronary disease, Estradiol, Estrone, Sirtuin-1, Resveratrol, Sirtuin-3, Menopause
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- InCor Heart InstituteUniversity, hospital or other
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 24 Aug 2029 (estimated)
- Study completion
- 24 Aug 2029 (estimated)
- First posted
- 8 Oct 2026 (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.
Atherosclerotic coronary artery disease (CAD) is a leading cause of mortality among postmenopausal women. Resveratrol, a phenolic compound with antioxidant properties, may influence lipid metabolism, endothelial function, and platelet aggregation, while sirtuin-1 and sirtuin-3 regulate metabolic and hormonal responses to nutritional stimuli. This randomized, double-blind, placebo-controlled trial evaluates the effects of trans-resveratrol supplementation (1000 mg/day) versus placebo, over 90 days, on serum estradiol and estrone levels, gene expression of estrogen receptors alpha and beta, and sirtuins 1 and 3 in 80 postmenopausal women with CAD. Findings may inform therapeutic strategies for postmenopausal women with chronic coronary disease.
Detailed description
Atherosclerotic coronary artery disease (CAD) is the leading cause of mortality among women in developed regions of Brazil. Diets rich in fruits and vegetables, which are sources of phenolic compounds, have been associated with a lower incidence of CAD, possibly due to their beneficial effects on vascular health. Resveratrol, a phenolic compound of the flavonoid group, is notable for its antioxidant properties, contributing to lipoprotein metabolism, production of endothelial vasodilator substances, and reduction of platelet aggregation.
Sirtuin-1 and sirtuin-3 play crucial roles in metabolic regulation in response to nutritional stimuli, such as caloric restriction and phenolic compound intake, and are also involved in hormonal modulation. However, the impact of resveratrol supplementation on serum estrogen and sirtuin levels has not yet been fully elucidated.
The primary objective of this study is to investigate the effects of resveratrol on serum concentrations of estradiol and estrone, gene expression of total estrogen receptors alpha and beta, and gene expression of sirtuins 1 and 3, in postmenopausal women with CAD undergoing resveratrol supplementation.
This is a randomized, double-blind, placebo-controlled clinical trial with a duration of 90 days, involving 80 postmenopausal women with CAD, allocated into two groups:
Group 1 (n=40): supplemented with trans-resveratrol, 1000 mg/day. Group 2 (n=40): placebo control. Clinical, nutritional, and laboratory assessments will be performed at baseline and at 90 days. Additional clinical nutritional assessments will be performed at 30 and 60 days from study initiation.
This investigation is expected to contribute to the understanding of the molecular mechanisms involved in the interaction between resveratrol and hormonal and biochemical markers, providing evidence to support more effective therapeutic strategies for postmenopausal women with chronic coronary disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind randomized controlled trial, parallel and placebo-controlled.
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Dietary Supplement: Trans-resveratrol, 1000 mg daily for 90 daysTrans-resveratrol, 1000mg daily for 90 days. |
| Control | Placebo comparator | Other: PlaceboStarch, 1000mg daily for 90 days. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women;
- Diagnosed coronary artery disease;
- Stable coronary disease;
Key exclusion criteria (7 listed)
- Hypo- or hyperthyroidism,
- Rheumatic disease,
- Use of alcohol,
- hepatic failure,
- renal failure
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 |
|---|---|---|
| Trans-resveratrol, 1000 mg daily for 90 daysAlso: ResveratrolTrans-resveratrol, 1000 mg daily for 90 days | Dietary supplement | Resveratrol |
| PlaceboStarch, 1000 mg daily for 90 days | Other | Control |
Primary outcome
1. Sirtuin-1 and sirtuin-3
Time frame: 90 days
Serum concentrations and gene expression
Estradiol
Time frame: 90 days
Serum concentrations
Estrone
Time frame: 90 days
Serum concentrations
SHBG
Time frame: 90 days
Serum concentrations
3 secondary outcomes
Estrogen receptor alpha
Time frame: 90 days
Cardiometabolic risk factors
Time frame: 90 days
BMI
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- 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.
Antonio de Padua Mansur, PhD Incor principal investigator
InCor Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-resveratrol, 1000 mg daily for 90 days in people with Coronary Artery Disease (CAD) and Menopause, run by InCor Heart Institute 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio de Padua Mansur, PhD (+551126615448, apmansur@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Sirtuin-1 and sirtuin-3 (time frame: 90 days). The study lists 4 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 16 Oct 2026.