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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Coronary Artery Disease, Menopause

Intervention / Treatment
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* Dietary Supplement: Quercetin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind randomized controlled trial, parallel and placebo-controlled.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quercetin<br>Trans-quercetin, 1000 mg daily for 60 days | Dietary Supplement: Quercetin<br>* Trans-quercetin, 1000 mg daily for 60 days<br>|
| Experimental: Atorvastatin<br>Atorvastatin, 80mg daily for 60 days. | Dietary Supplement: Quercetin<br>* Trans-quercetin, 1000 mg daily for 60 days<br>|
| Placebo Comparator: Control<br>Starch, 1000mg daily for 60 days. | Dietary Supplement: Placebo<br>* Starch, 1000 mg daily for 60 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estradiol | serum concentrations | 60 days | 
| Estrone | serum concentrations | 60 days | 
| Sirtuin-1 | Serum concentrations and gene expression | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiometabolic risk factors | Lipid and glucometabolic profiles | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary disease, Atherosclerosis, Estradiol, Estrone, Sirt1, Quercetin, Atorvastatin, Polyphenols