Coronary Artery DiseaseRE-AGESNCT05808387
The Effects of Resveratrol on Sirtuins and Apoptosis Biomarkers
A study testing Resveratrol in people with Coronary Artery Disease and Menopause, run by InCor Heart Institute at 1 site in Brazil.
Trial summary
Cardiovascular diseases (CVD) and neoplasms are the main causes of death in Brazilian women. Coronary artery disease (CAD) and stroke were responsible for approximately 54% of deaths from CVD in this population. In Brazil, cancers were the second cause of death and in 2017 were responsible for 58% of deaths in women. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Coronary Artery Disease, Menopause, Endothelial Dysfunction
- What is being tested?
- Resveratrol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Mar 2023to 5 Jun 2026
- 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 55 years and older
- 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.
Brazil1 site, 1 recruiting
- Recruiting
INCOR- Heart Institute
São Paulo, São Paulo, 05403900
Antonio de Pádua Mansur, PHD, 26615387 ext. 11, apmansur@yahoo.com
Antonio P Mansur, PhD
About this study
Official title: The Effects of Resveratrol on Inhibitors of Apoptosis Proteins, on Soluble Receptors of Advanced Glycation End Products and on Sirtuins-1 and -3 in Postmenopausal Women With Coronary Artery Disease
Cardiovascular diseases (CVD) and neoplasms are the main causes of death in Brazilian women. Coronary artery disease (CAD) and stroke were responsible for approximately 54% of deaths from CVD in this population. In Brazil, cancers were the second cause of death and in 2017 were responsible for 58% of deaths in women. CVD and cancer share some risk factors, and control of these factors is associated with a significant reduction in cancer incidence. These two causes of death, although apparently disparate, share similar lifestyles and health risk factors, suggesting some common pathways and basic molecular networks. In women, the presence of estrogen has protective effects against atherosclerosis and, with the decline in hormone production at menopause, the incidence and prevalence of CAD increase substantially. Although the estrogen pathway is supposed to have a central effect on this increased risk, it is still debated whether other non-estrogenic mechanisms are related, since hormone replacement alone does not reduce cardiovascular events. Sirtuins and soluble advanced glycation product receptors (sRAGE) are associated with increased vascular protection, while the role of apoptosis inhibiting proteins, a pathway linked to increased cancer incidence, is still unclear in the context of atherosclerosis. Resveratrol is a key activator of sirtuins and potentially modulates these metabolic pathways, reducing cardiovascular risk. This randomized, double-blind, parallel, placebo-controlled clinical trial will be carried out in 80 postmenopausal women with CAD to analyze the effect of treatment with resveratrol on serum concentration and gene expression of sirtuins-1 -3, in the serum sRAGE concentration and in the gene expression of apoptosis inhibitory proteins.
Read the detailed description
The objective of the study is to evaluate the influence of sirtuins stimulation by resveratrol on inhibitors of apoptosis proteins gene expression of circulation angiogenic cells of postmenopausal women with stable coronary artery disease.
A randomized, double-blind, parallel, placebo-controlled clinical trial in postmenopausal women with CAD submitted to 90 days of daily resveratrol supplementation days of daily supplementation with 1000 mg of resveratrol. Eighty women aged ≥55 years, with overweight or obesity grade 1 (BMI between 25 and 35 kg/m2) will be selected. The participants will be randomized into two groups, control (CON) and resveratrol (RES). After the screening, the participants will undergo the first clinical and laboratory evaluation including lipid and glucose metabolism, inflammatory biomarkers, serum concentrations and gene expression of sirtuin-1 and sirtuin-3 and soluble receptor of advanced glycation end products, and the gene expression of inhibitors of apoptosis proteins.
- Conditions
- Coronary Artery Disease, Menopause, Endothelial Dysfunction
- Being tested
- Resveratrol, Placebo
- Keywords
- Coronary artery disease, Menopause, Endothelial Dysfunction, Sirtuin, Receptors of advanced glycation end products, Apoptosis, Resveratrol, Polyphenols, Cardiovascular risk
- 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.
ResveratrolDietary supplement
Trans-resveratrol, 1000 mg daily for 90 days
PlaceboDietary supplement
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: Resveratrol |
| Control | Placebo comparator | Starch, 1000mg daily for 90 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sirtuin-1 and sirtuin-3
Serum concentrations and gene expression
Measured: 90 days
Inhibitors of apoptosis proteins
Gene expression of Bcl-2, XIAP, c-IAP1, and survivin
Measured: 90 days
sRAGE
Serum concentrations and gene expression
Measured: 90 days
Secondary outcomes (3)
Inflammation
Serum concentrations of proinflammatory cytokines
Measured: 90 days
Cardiometabolic risk factors
Lipid and glucometabolic profiles
Measured: 90 days
Anthropometric measures
BMI, skinfold thickness, and body composition
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 posted11 Apr 2023
- Study start6 Mar 2023
- Primary completion5 Jun 2025 (estimated)
- Study completion5 Jun 2026 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized controlled trial, parallel and placebo-controlled.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- 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 P Mansur, PhD, Principal investigator, InCor Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808387
- Sponsor's protocol ID
- 61901722.6.0000.0068
- Acronym
- RE-AGES
- Status last verified
- Mar 2023
- First submitted
- 29 Mar 2023
- Last updated
- 11 Apr 2023
- 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 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Resveratrol on Inhibitors of Apoptosis Proteins, on Soluble Receptors of Advanced Glycation End Products and on Sirtuins-1 and -3 in Postmenopausal Women With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05808387
- Acronym / sponsor ID
- RE-AGES / 61901722.6.0000.0068
- Conditions
- Coronary Artery Disease, Menopause, Endothelial Dysfunction
- Keywords
- Coronary artery disease, Menopause, Endothelial Dysfunction, Sirtuin, Receptors of advanced glycation end products, Apoptosis, Resveratrol, Polyphenols
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- InCor Heart InstituteUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 5 Jun 2025 (estimated)
- Study completion
- 5 Jun 2026 (estimated)
- First posted
- 11 Apr 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.
Cardiovascular diseases (CVD) and neoplasms are the main causes of death in Brazilian women. Coronary artery disease (CAD) and stroke were responsible for approximately 54% of deaths from CVD in this population. In Brazil, cancers were the second cause of death and in 2017 were responsible for 58% of deaths in women. CVD and cancer share some risk factors, and control of these factors is associated with a significant reduction in cancer incidence. These two causes of death, although apparently disparate, share similar lifestyles and health risk factors, suggesting some common pathways and basic molecular networks. In women, the presence of estrogen has protective effects against atherosclerosis and, with the decline in hormone production at menopause, the incidence and prevalence of CAD increase substantially. Although the estrogen pathway is supposed to have a central effect on this increased risk, it is still debated whether other non-estrogenic mechanisms are related, since hormone replacement alone does not reduce cardiovascular events. Sirtuins and soluble advanced glycation product receptors (sRAGE) are associated with increased vascular protection, while the role of apoptosis inhibiting proteins, a pathway linked to increased cancer incidence, is still unclear in the context of atherosclerosis. Resveratrol is a key activator of sirtuins and potentially modulates these metabolic pathways, reducing cardiovascular risk. This randomized, double-blind, parallel, placebo-controlled clinical trial will be carried out in 80 postmenopausal women with CAD to analyze the effect of treatment with resveratrol on serum concentration and gene expression of sirtuins-1 -3, in the serum sRAGE concentration and in the gene expression of apoptosis inhibitory proteins.
Detailed description
The objective of the study is to evaluate the influence of sirtuins stimulation by resveratrol on inhibitors of apoptosis proteins gene expression of circulation angiogenic cells of postmenopausal women with stable coronary artery disease.
A randomized, double-blind, parallel, placebo-controlled clinical trial in postmenopausal women with CAD submitted to 90 days of daily resveratrol supplementation days of daily supplementation with 1000 mg of resveratrol. Eighty women aged ≥55 years, with overweight or obesity grade 1 (BMI between 25 and 35 kg/m2) will be selected. The participants will be randomized into two groups, control (CON) and resveratrol (RES). After the screening, the participants will undergo the first clinical and laboratory evaluation including lipid and glucose metabolism, inflammatory biomarkers, serum concentrations and gene expression of sirtuin-1 and sirtuin-3 and soluble receptor of advanced glycation end products, and the gene expression of inhibitors of apoptosis proteins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Double blind randomized controlled trial, parallel and placebo-controlled.
| Arm | Type | Receives |
|---|---|---|
| Resveratrol | Experimental | Dietary Supplement: ResveratrolTrans-resveratrol, 1000mg daily for 90 days. |
| Control | Placebo comparator | Dietary Supplement: PlaceboStarch, 1000mg daily for 90 days. |
Who may qualify
- Ages
- 55 years and older
- 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 |
|---|---|---|
| ResveratrolTrans-resveratrol, 1000 mg daily for 90 days | Dietary supplement | Resveratrol |
| PlaceboStarch, 1000 mg daily for 90 days | Dietary supplement | Control |
Primary outcome
Sirtuin-1 and sirtuin-3
Time frame: 90 days
Serum concentrations and gene expression
Inhibitors of apoptosis proteins
Time frame: 90 days
Gene expression of Bcl-2, XIAP, c-IAP1, and survivin
sRAGE
Time frame: 90 days
Serum concentrations and gene expression
3 secondary outcomes
Inflammation
Time frame: 90 days
Cardiometabolic risk factors
Time frame: 90 days
Anthropometric measures
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- 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.
Antonio P Mansur, PhD 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 Resveratrol in people with Coronary Artery Disease 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: status not confirmed, as of the sponsor's last update on 11 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio P 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?
Sirtuin-1 and sirtuin-3 (time frame: 90 days). The study lists 3 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 11 Apr 2023.