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

• Sponsor: InCor Heart Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05877235
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 32.7
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Menopause	Dietary Supplement: Quercetin; Dietary Supplement: Placebo	N/A

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double blind randomized controlled trial, parallel and placebo-controlled.Double blind randomized controlled trial, parallel and placebo-controlled.
• Masking: Double (Participant, Care Provider)
• Masking Description: Participants in the control group will receive capsules identical to those in the intervention group, but with cornstarch. The care provider and the participants do not have the information about which capsules the participant is taking, and do not have access to which groups the patients belong. Statistical analyses will be performed on a blinded database, i.e. without information of which groups the participants belong to. Only the principal investigator of the study has this information.
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Oct 3, 2021
• Anticipated Primary Completion Date: Dec 23, 2023
• Anticipated Study Completion Date: Jun 23, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Quercetin Trans-quercetin, 1000 mg daily for 60 days	Dietary Supplement: Quercetin; Trans-quercetin, 1000 mg daily for 60 days
Experimental: Atorvastatin Atorvastatin, 80mg daily for 60 days.	Dietary Supplement: Quercetin; Trans-quercetin, 1000 mg daily for 60 days
Placebo Comparator: Control Starch, 1000mg daily for 60 days.	Dietary Supplement: Placebo; Starch, 1000 mg daily for 60 days

Outcome Measures

Primary Outcome Measures

1. Estradiol [60 days]

   serum concentrations

2. Estrone [60 days]

   serum concentrations

3. Sirtuin-1 [60 days]

   Serum concentrations and gene expression

Secondary Outcome Measures

1. Cardiometabolic risk factors [60 days]

   Lipid and glucometabolic profiles

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	INCOR- Heart Institute	Sao Paulo	São Paulo	Brazil	05403900

Sponsors and Collaborators

• InCor Heart Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ANTONIO DE PADUA MANSUR, Associate Professor, InCor Heart Institute
• ClinicalTrials.gov Identifier: NCT05877235
• Other Study ID Numbers: 64417922.0.0000.0068
• First Posted: May 26, 2023
• Last Update Posted: May 26, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ANTONIO DE PADUA MANSUR, Associate Professor, InCor Heart Institute: Coronary disease; Atherosclerosis; Estradiol; Estrone; Sirt1; Quercetin; Atorvastatin; Polyphenols
• Additional relevant MeSH terms: Coronary Artery Disease; Quercetin

Study Results

No Results Posted as of May 26, 2023