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

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: Recruiting
• Conditions: Coronary Artery Disease; Menopause
• Intervention / Treatment: Dietary supplement: Quercetin; Dietary supplement: Placebo

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 (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Sao Paulo, São Paulo, Brazil, 05403900
      • Recruiting
      • INCOR- Heart Institute
      • Contact: Antonio de Pádua Mansur, PHD; Phone Number: 11 26615387; Email: apmansur@yahoo.com
      • Principal Investigator: Antonio P Mansur, PhD
      • Sub-Investigator: Nathalia FO Faria

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	serum concentrations	60 days
Estrone	serum concentrations	60 days
Sirtuin-1	Serum concentrations and gene expression	60 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: InCor Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2021
• Primary Completion (Estimated): December 23, 2023
• Study Completion (Estimated): 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): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Atherosclerosis; Atorvastatin; Polyphenols; Estradiol; Estrone; Quercetin; Coronary disease; Sirt1
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Quercetin
• 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