NCT05877235

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: InCor Heart Institute · Academic / Other
• Sex: Female
• Age: 55 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Coronary Artery Disease
• Menopause

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Quercetin	Trans-quercetin, 1000 mg daily for 60 days
DIETARY_SUPPLEMENT	Placebo	Starch, 1000 mg daily for 60 days

Timeline

• Start date: 2021-10-03
• Primary completion: 2023-12-23
• Completion: 2024-06-23
• First posted: 2023-05-26
• Last updated: 2025-12-19

Locations

1 site across 1 country: Brazil