Serum Concentration of Endogenous Estrogens and Sirtuin-1 After Administration of Atorvastatin and Quercetin:

December 12, 2025 updated by: ANTONIO DE PADUA MANSUR, InCor Heart Institute

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403900
        • INCOR- Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Postmenopausal women;
  • Diagnosed coronary artery disease;
  • Stable coronary disease;

Exclusion Criteria:

  • hypo or hyperthyroidism,
  • rheumatic disease,
  • use of alcohol,
  • hepatic failure,
  • renal failure
  • hormone replacement therapy
  • use of insulin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Quercetin
Trans-quercetin, 1000 mg daily for 60 days
Dietary supplement: Quercetin
Trans-quercetin, 1000 mg daily for 60 days
Experimental: Atorvastatin
Atorvastatin, 80mg daily for 60 days.
Dietary supplement: Quercetin
Trans-quercetin, 1000 mg daily for 60 days
Placebo Comparator: Control
Starch, 1000mg daily for 60 days.
Dietary supplement: Placebo
Starch, 1000 mg daily for 60 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estradiol
Time Frame: 60 days
serum concentrations
60 days
Estrone
Time Frame: 60 days
serum concentrations
60 days
Sirtuin-1
Time Frame: 60 days
Serum concentrations and gene expression
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiometabolic risk factors
Time Frame: 60 days
Lipid and glucometabolic profiles
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InCor Heart Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2021

Primary Completion (Actual)

December 23, 2023

Study Completion (Actual)

June 23, 2024

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 12, 2025

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 64417922.0.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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