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

NCT05877235 | Completed

• 1 other identifier: 64417922.0.0000.0068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Coronary Artery Disease; Menopause

Keywords

Coronary disease; Atherosclerosis; Estradiol; Estrone; Sirt1; Quercetin; Atorvastatin; Polyphenols

Outcome Measures

Primary Outcomes (3)

• Estradiol

  serum concentrations

  60 days

• Estrone

  serum concentrations

  60 days

• Sirtuin-1

  Serum concentrations and gene expression

  60 days

Secondary Outcomes (1)

• Cardiometabolic risk factors

  60 days

Study Arms (3)

Quercetin

EXPERIMENTAL

Trans-quercetin, 1000 mg daily for 60 days

Dietary Supplement: Quercetin

Atorvastatin

EXPERIMENTAL

Atorvastatin, 80mg daily for 60 days.

Dietary Supplement: Quercetin

Control

PLACEBO COMPARATOR

Starch, 1000mg daily for 60 days.

Dietary Supplement: Placebo

Interventions

Quercetin DIETARY_SUPPLEMENT

Trans-quercetin, 1000 mg daily for 60 days

Atorvastatin; Quercetin

Placebo DIETARY_SUPPLEMENT

Starch, 1000 mg daily for 60 days

Control

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• InCor Heart Institute: lead

Study Sites (1)

INCOR- Heart Institute

São Paulo, São Paulo, 05403900, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Atherosclerosis

Interventions

Quercetin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants in the control group will receive capsules identical to those in the intervention group, but with cornstarch. The care provider and the participants do not have the information about which capsules the participant is taking, and do not have access to which groups the patients belong. Statistical analyses will be performed on a blinded database, i.e. without information of which groups the participants belong to. Only the principal investigator of the study has this information.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double blind randomized controlled trial, parallel and placebo-controlled.

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 26, 2023
• Study Start: October 3, 2021
• Primary Completion: December 23, 2023
• Study Completion: June 23, 2024
• Last Updated: December 19, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)