Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05808387
Status:
RECRUITING
Last Update Posted:
2023-04-11
First Post:
2023-03-29
Brief Title:
The Effects of Resveratrol on Sirtuins and Apoptosis Biomarkers
Sponsor:
InCor Heart Institute
Organization:
InCor Heart Institute
Study Overview
Official Title:
The Effects of Resveratrol on Inhibitors of Apoptosis Proteins on Soluble Receptors of Advanced Glycation End Products and on Sirtuins-1 and -3 in Postmenopausal Women With Coronary Artery Disease
Status:
RECRUITING
Status Verified Date:
2023-03
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:
RE-AGES
Brief Summary:
Cardiovascular diseases CVD and neoplasms are the main causes of death in Brazilian women Coronary artery disease CAD and stroke were responsible for approximately 54 of deaths from CVD in this population In Brazil cancers were the second cause of death and in 2017 were responsible for 58 of deaths in women CVD and cancer share some risk factors and control of these factors is associated with a significant reduction in cancer incidence These two causes of death although apparently disparate share similar lifestyles and health risk factors suggesting some common pathways and basic molecular networks In women the presence of estrogen has protective effects against atherosclerosis and with the decline in hormone production at menopause the incidence and prevalence of CAD increase substantially Although the estrogen pathway is supposed to have a central effect on this increased risk it is still debated whether other non-estrogenic mechanisms are related since hormone replacement alone does not reduce cardiovascular events Sirtuins and soluble advanced glycation product receptors sRAGE are associated with increased vascular protection while the role of apoptosis inhibiting proteins a pathway linked to increased cancer incidence is still unclear in the context of atherosclerosis Resveratrol is a key activator of sirtuins and potentially modulates these metabolic pathways reducing cardiovascular risk This randomized double-blind parallel placebo-controlled clinical trial will be carried out in 80 postmenopausal women with CAD to analyze the effect of treatment with resveratrol on serum concentration and gene expression of sirtuins-1 -3 in the serum sRAGE concentration and in the gene expression of apoptosis inhibitory proteins
Detailed Description:
The objective of the study is to evaluate the influence of sirtuins stimulation by resveratrol on inhibitors of apoptosis proteins gene expression of circulation angiogenic cells of postmenopausal women with stable coronary artery disease
A randomized double-blind parallel placebo-controlled clinical trial in postmenopausal women with CAD submitted to 90 days of daily resveratrol supplementation days of daily supplementation with 1000 mg of resveratrol Eighty women aged 55 years with overweight or obesity grade 1 BMI between 25 and 35 kgm2 will be selected The participants will be randomized into two groups control CON and resveratrol RES After the screening the participants will undergo the first clinical and laboratory evaluation including lipid and glucose metabolism inflammatory biomarkers serum concentrations and gene expression of sirtuin-1 and sirtuin-3 and soluble receptor of advanced glycation end products and the gene expression of inhibitors of apoptosis proteins
A randomized double-blind parallel placebo-controlled clinical trial in postmenopausal women with CAD submitted to 90 days of daily resveratrol supplementation days of daily supplementation with 1000 mg of resveratrol Eighty women aged 55 years with overweight or obesity grade 1 BMI between 25 and 35 kgm2 will be selected The participants will be randomized into two groups control CON and resveratrol RES After the screening the participants will undergo the first clinical and laboratory evaluation including lipid and glucose metabolism inflammatory biomarkers serum concentrations and gene expression of sirtuin-1 and sirtuin-3 and soluble receptor of advanced glycation end products and the gene expression of inhibitors of apoptosis proteins
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