Coronary Artery DiseaseNCT05877235
Serum Concentration of Endogenous Estrogens and Sirtuin-1 After Administration of Atorvastatin and Quercetin:
A study testing Quercetin in people with Coronary Artery Disease and Menopause, run by InCor Heart Institute at 1 site in Brazil.
Trial summary
Chronic coronary syndrome (CCS) is the leading cause of death in women in the most developed regions of Brazil. The primary etiopathogenic mechanism is the process of atherosclerosis. A healthy diet rich in fruits and vegetables is associated with a lower incidence of CCS. Read more about this study
- Who is it for?
- Ages 55 to 70 years, women only
- Conditions the study is for
- Coronary Artery Disease, Menopause
- What is being tested?
- Quercetin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Oct 2021to 23 Jun 2024
- 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 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.
About this study
Official title: Serum Concentration of Endogenous Estrogens and Sirtuin-1 in Postmenopausal Women With Atherosclerotic Coronary Heart Disease After Administration of Atorvastatin and Supplementation With Quercetin: a Randomized Study
Chronic coronary syndrome (CCS) is the leading cause of death in women in the most developed regions of Brazil. The primary etiopathogenic mechanism is the process of atherosclerosis. A healthy diet rich in fruits and vegetables is associated with a lower incidence of CCS. The higher consumption of these foods promotes greater availability of phenolic compounds, and the higher intake of these compounds is one of the main hypotheses for vascular health. Quercetin, a phenolic compound, is the most abundant natural antioxidant belonging to the group of flavonoids. Quercetin improves lipoprotein metabolism, has an antioxidant capacity, produces vasodilating substances in the vascular endothelium, and reduces platelet aggregability. Likewise, statins are medications known to reduce cardiovascular events in women with CCS by reducing serum LDL-cholesterol levels and, to a lesser extent, by possible pleiotropic effects. In turn, SIRT1 is one of the 7 classes of proteins. It mediates various metabolic pathways in response to nutritional stimuli, particularly for caloric restriction and phenolic compounds, as well as coordinating the production and secretion of important hormones. However, the impact of quercetin supplementation and statin administration on serum endogenous estrogen levels is unknown
Read the detailed description
The main objective of this study is to investigate the influence of atorvastatin and of quercetin in the serum concentrations of estradiol and estrone after the administration of atorvastatin and supplementation with quercetin. This is a randomized, double-blind, placebo-controlled, 60-day study in 60 postmenopausal women with CAD, divided into three groups of 20 women each: Group 1 - quercetin (500 mg/day); Group 2 - atorvastatin (80 mg/day); Group 3 - control (placebo).
- Conditions
- Coronary Artery Disease, Menopause
- Being tested
- Quercetin, Placebo
- Keywords
- Coronary disease, Atherosclerosis, Estradiol, Estrone, Sirt1, Quercetin, Atorvastatin, Polyphenols
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuercetinDietary supplement
Trans-quercetin, 1000 mg daily for 60 days
PlaceboDietary supplement
Starch, 1000 mg daily for 60 days
| Study group | Role | What they receive |
|---|---|---|
| Quercetin | Experimental | Trans-quercetin, 1000 mg daily for 60 days Receives: Dietary Supplement: Quercetin |
| Atorvastatin | Experimental | Atorvastatin, 80mg daily for 60 days. Receives: Dietary Supplement: Quercetin |
| Control | Placebo comparator | Starch, 1000mg daily for 60 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estradiol
serum concentrations
Measured: 60 days
Estrone
serum concentrations
Measured: 60 days
Sirtuin-1
Serum concentrations and gene expression
Measured: 60 days
Secondary outcomes (1)
Cardiometabolic risk factors
Lipid and glucometabolic profiles
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start3 Oct 2021
- Primary completion23 Dec 2023
- Study completion23 Jun 2024
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
- 60 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877235
- Sponsor's protocol ID
- 64417922.0.0000.0068
- Status last verified
- May 2023
- First submitted
- 17 May 2023
- Last updated
- 19 Dec 2025
- 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 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Concentration of Endogenous Estrogens and Sirtuin-1 in Postmenopausal Women With Atherosclerotic Coronary Heart Disease After Administration of Atorvastatin and Supplementation With Quercetin: a Randomized Study
- ClinicalTrials.gov ID
- NCT05877235
- Acronym / sponsor ID
- 64417922.0.0000.0068
- Conditions
- Coronary Artery Disease, Menopause
- Keywords
- Coronary disease, Atherosclerosis, Estradiol, Estrone, Sirt1, Quercetin, Atorvastatin, Polyphenols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- InCor Heart InstituteUniversity, hospital or other
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 23 Jun 2024 (actual)
- First posted
- 26 May 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.
Chronic coronary syndrome (CCS) is the leading cause of death in women in the most developed regions of Brazil. The primary etiopathogenic mechanism is the process of atherosclerosis. A healthy diet rich in fruits and vegetables is associated with a lower incidence of CCS. The higher consumption of these foods promotes greater availability of phenolic compounds, and the higher intake of these compounds is one of the main hypotheses for vascular health. Quercetin, a phenolic compound, is the most abundant natural antioxidant belonging to the group of flavonoids. Quercetin improves lipoprotein metabolism, has an antioxidant capacity, produces vasodilating substances in the vascular endothelium, and reduces platelet aggregability. Likewise, statins are medications known to reduce cardiovascular events in women with CCS by reducing serum LDL-cholesterol levels and, to a lesser extent, by possible pleiotropic effects. In turn, SIRT1 is one of the 7 classes of proteins. It mediates various metabolic pathways in response to nutritional stimuli, particularly for caloric restriction and phenolic compounds, as well as coordinating the production and secretion of important hormones. However, the impact of quercetin supplementation and statin administration on serum endogenous estrogen levels is unknown
Detailed description
The main objective of this study is to investigate the influence of atorvastatin and of quercetin in the serum concentrations of estradiol and estrone after the administration of atorvastatin and supplementation with quercetin. This is a randomized, double-blind, placebo-controlled, 60-day study in 60 postmenopausal women with CAD, divided into three groups of 20 women each: Group 1 - quercetin (500 mg/day); Group 2 - atorvastatin (80 mg/day); Group 3 - control (placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Double blind randomized controlled trial, parallel and placebo-controlled.
| Arm | Type | Receives |
|---|---|---|
| Quercetin | Experimental | Dietary Supplement: QuercetinTrans-quercetin, 1000 mg daily for 60 days |
| Atorvastatin | Experimental | Dietary Supplement: QuercetinAtorvastatin, 80mg daily for 60 days. |
| Control | Placebo comparator | Dietary Supplement: PlaceboStarch, 1000mg daily for 60 days. |
Who may qualify
- Ages
- 55 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 |
|---|---|---|
| QuercetinTrans-quercetin, 1000 mg daily for 60 days | Dietary supplement | Atorvastatin, Quercetin |
| PlaceboStarch, 1000 mg daily for 60 days | Dietary supplement | Control |
Primary outcome
Estradiol
Time frame: 60 days
serum concentrations
Estrone
Time frame: 60 days
serum concentrations
Sirtuin-1
Time frame: 60 days
Serum concentrations and gene expression
1 secondary outcome
Cardiometabolic risk factors
Time frame: 60 days
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 19 Dec 2025.
- 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 Quercetin 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: finished, as of the sponsor's last update on 19 Dec 2025. 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?
Estradiol (time frame: 60 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 19 Dec 2025.