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Clinical Trials/NCT03943459
NCT03943459UnknownPhase 3

Serum Concentration and Gene Expression of Sirtuin-1 and Advanced Glycation End-products in Postmenopausal Women With Atherosclerotic Coronary Disease After Administration of Atorvastatin and Supplementation With Quercetin: Randomized Trial

InCor Heart Institute1 site in 1 country60 target enrollmentStarted: August 2, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Sirtuin-1

Study Overview

Brief Summary

Higher consumption of fruits and vegetables promote greater availability of phenolic compounds and these compounds were associated with vascular health. Quercetin, a phenolic compound, is the most abundant natural antioxidant belonging to the group of flavonoids. Quercetin improved lipoprotein metabolism, had antioxidant capacity, produced vasodilating substances in the vascular endothelium and reduced platelet aggregability. Likewise, statins are medications known to reduce cardiovascular events in women with coronary disease by reducing serum LDL-cholesterol. Therefore, a number of metabolic pathways are responsible for vascular health. The serum concentration and gene expression of sirtuin 1 (Sirt1) and RAGE soluble (sRAGE) are directly associated with vascular protection. This study will analyse the influence of atorvastatin and quercetin on serum concentrations and gene expression of Sirt1 and sRAGE in postmenopausal women with stable coronary artery disease.

Detailed Description

Higher consumption of fruits and vegetables promote greater availability of phenolic compounds and these compounds were associated with vascular health. Quercetin, a phenolic compound, is the most abundant natural antioxidant belonging to the group of flavonoids. Quercetin improved lipoprotein metabolism, had antioxidant capacity, produced vasodilating substances in the vascular endothelium and reduced platelet aggregability. Likewise, statins are medications known to reduce cardiovascular events in women with coronary artery disease (CAD) by reducing serum LDL-cholesterol. Therefore, a number of metabolic pathways are responsible for vascular health. The serum concentration and gene expression of sirtuin 1 (Sirt1) and RAGE soluble (sRAGE) are directly associated with vascular protection. This study will analyse the influence of atorvastatin and quercetin on serum concentrations and gene expression of Sirt1 and sRAGE in postmenopausal women with stable coronary artery disease and also the correlation between the changes in serum concentration of Sirt1 and sRAGE and the changes in lipid profile, inflammatory biomarkers and sex hormones in response to these drugs. This is a 60-day randomized, double blind, placebo-controlled study in 60 postmenopausal women with CAD, divided into three groups with 20 women each: Group 1 - Quercetin (500 mg / day); Group 2 - atorvastatin (80 mg / day): Group 3 - control.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Masking Description

double-blind

Eligibility Criteria

Ages
50 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • postmenopausal women,
  • angiographic documented coronary artery disease,
  • stable coronary artery disease

Exclusion Criteria

  • BMI <18,1 Kg/m2,
  • hypo or hyperthyroidism,
  • rheumatic disease,
  • use of alcohol,
  • hepatic failure,
  • renal failure
  • hormone replacement therapy
  • use of insulin

Arms & Interventions

Quercetin

Experimental

20 patients treated with quercetin 500 mg/day

Intervention: Quercetin (Drug)

Outcomes

Primary Outcomes

Sirtuin-1

Time Frame: 60 days

serum concentration of sirtuin-1

Soluble receptor for advanced glycation end products

Time Frame: 60 days

serum concentration of soluble receptor for advanced glycation end products

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
InCor Heart Institute
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

ANTONIO DE PADUA MANSUR

Associate Professor

InCor Heart Institute

Study Sites (1)

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