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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; Menopause
• Interventions: Dietary Supplement: Quercetin; Dietary Supplement: Placebo

• Registration Number: NCT05877235
• Lead Sponsor: InCor Heart Institute

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

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 Timeline

• Study Start: 2021-10-03
• Status Verified: 2023-05
• Study First Submitted: 2023-05-17
• Study First Submitted QC: 2023-05-17
• Last Update Submitted: 2023-05-17
• Study First Posted: 2023-05-26
• Last Update Posted: 2023-05-26
• Primary Completion: 2023-12-23
• Study Completion: 2024-06-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quercetin	Quercetin	Trans-quercetin, 1000 mg daily for 60 days
Control	Placebo	Starch, 1000mg daily for 60 days.
Atorvastatin	Quercetin	Atorvastatin, 80mg daily for 60 days.

Primary Outcome Measures

Name	Time	Method
Estradiol	60 days	serum concentrations
Estrone	60 days	serum concentrations
Sirtuin-1	60 days	Serum concentrations and gene expression

Secondary Outcome Measures

Name	Time	Method
Cardiometabolic risk factors	60 days	Lipid and glucometabolic profiles

Trial Locations

Locations (1)

INCOR- Heart Institute; 🇧🇷 Sao Paulo, São Paulo, Brazil