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Completed

NCT Number: NCT05877235

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

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

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Key information

Age range

55 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

INCOR- Heart Institute

São Paulo, 05403900, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quercetin

Dietary Supplement

Trans-quercetin, 1000 mg daily for 60 days

Placebo

Dietary Supplement

Starch, 1000 mg daily for 60 days

Primary outcomes

  1. Estradiol

    Time frame: 60 days

    serum concentrations

  2. Estrone

    Time frame: 60 days

    serum concentrations

  3. Sirtuin-1

    Time frame: 60 days

    Serum concentrations and gene expression

Secondary outcomes

  1. Cardiometabolic risk factors

    Time frame: 60 days

    Lipid and glucometabolic profiles

Sponsors and collaborators

Lead sponsor

InCor Heart Institute

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
May 26, 2023
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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