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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05877235
Other study ID # 64417922.0.0000.0068
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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