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

University of São Paulo (USP)

Status: Completed

Conditions: Coronary Artery Disease; Menopause

Treatments: Dietary Supplement: Quercetin; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05877235

64417922.0.0000.0068

Details and patient eligibility

About

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

Full 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).

Enrollment: 60 patients

Sex: Female

Ages: 55 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Quercetin

Experimental group

Description:

Trans-quercetin, 1000 mg daily for 60 days

Treatment:

Dietary Supplement: Quercetin

Atorvastatin

Experimental group

Description:

Atorvastatin, 80mg daily for 60 days.

Treatment:

Dietary Supplement: Quercetin

Control

Placebo Comparator group

Description:

Starch, 1000mg daily for 60 days.

Treatment:

Dietary Supplement: Placebo