Serum Concentration of Endogenous Estrogens and Sirtuin-1 After Administration of Atorvastatin and Quercetin:
Primary Purpose
Coronary Artery Disease, Menopause
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Quercetin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary disease, Atherosclerosis, Estradiol, Estrone, Sirt1, Quercetin, Atorvastatin, Polyphenols
Eligibility Criteria
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
Sites / Locations
- INCOR- Heart InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Quercetin
Atorvastatin
Control
Arm Description
Trans-quercetin, 1000 mg daily for 60 days
Atorvastatin, 80mg daily for 60 days.
Starch, 1000mg daily for 60 days.
Outcomes
Primary Outcome Measures
Estradiol
serum concentrations
Estrone
serum concentrations
Sirtuin-1
Serum concentrations and gene expression
Secondary Outcome Measures
Cardiometabolic risk factors
Lipid and glucometabolic profiles
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05877235
Brief Title
Serum Concentration of Endogenous Estrogens and Sirtuin-1 After Administration of Atorvastatin and Quercetin:
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2021 (Actual)
Primary Completion Date
December 23, 2023 (Anticipated)
Study Completion Date
June 23, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
InCor Heart Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Menopause
Keywords
Coronary disease, Atherosclerosis, Estradiol, Estrone, Sirt1, Quercetin, Atorvastatin, Polyphenols
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomized controlled trial, parallel and placebo-controlled.
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Quercetin
Arm Type
Experimental
Arm Description
Trans-quercetin, 1000 mg daily for 60 days
Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
Atorvastatin, 80mg daily for 60 days.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Starch, 1000mg daily for 60 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Quercetin
Intervention Description
Trans-quercetin, 1000 mg daily for 60 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Starch, 1000 mg daily for 60 days
Primary Outcome Measure Information:
Title
Estradiol
Description
serum concentrations
Time Frame
60 days
Title
Estrone
Description
serum concentrations
Time Frame
60 days
Title
Sirtuin-1
Description
Serum concentrations and gene expression
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Cardiometabolic risk factors
Description
Lipid and glucometabolic profiles
Time Frame
60 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
INCOR- Heart Institute
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
05403900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio de Pádua Mansur, PHD
Phone
26615387
Ext
11
Email
apmansur@yahoo.com
First Name & Middle Initial & Last Name & Degree
Antonio P Mansur, PhD
First Name & Middle Initial & Last Name & Degree
Nathalia FO Faria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Serum Concentration of Endogenous Estrogens and Sirtuin-1 After Administration of Atorvastatin and Quercetin:
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