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

Coronary Artery Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05877235
• Other study ID #: 64417922.0.0000.0068
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2021
• Est. completion date: June 23, 2024

Study information

• Verified date: May 2023
• Source: InCor Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 23, 2024
• Est. primary completion date: December 23, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Menopause

Intervention

Dietary Supplement:
• Quercetin
Trans-quercetin, 1000 mg daily for 60 days
• Placebo
Starch, 1000 mg daily for 60 days

Locations

Country	Name	City	State
Brazil	INCOR- Heart Institute	Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estradiol	serum concentrations	60 days
Primary	Estrone	serum concentrations	60 days
Primary	Sirtuin-1	Serum concentrations and gene expression	60 days
Secondary	Cardiometabolic risk factors	Lipid and glucometabolic profiles	60 days