Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05877235
Status:
RECRUITING
Last Update Posted:
2023-05-26
First Post:
2023-05-17
Brief Title:
Serum Concentration of Endogenous Estrogens and Sirtuin-1 After Administration of Atorvastatin and Quercetin
Sponsor:
InCor Heart Institute
Organization:
InCor Heart Institute
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgday Group 2 - atorvastatin 80 mgday Group 3 - control placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None