The Effects of Resveratrol on Sirtuins and Apoptosis Biomarkers

NCT ID: NCT05808387

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2026-06-05

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 kg/m2) 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.

Conditions

Coronary Artery Disease; Menopause; Endothelial Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Resveratrol

Trans-resveratrol, 1000mg daily for 90 days.

Group Type: EXPERIMENTAL

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

Trans-resveratrol, 1000 mg daily for 90 days

Control

Starch, 1000mg daily for 90 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Starch, 1000 mg daily for 90 days

Interventions

Resveratrol

Trans-resveratrol, 1000 mg daily for 90 days

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Starch, 1000 mg daily for 90 days

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

InCor Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

ANTONIO DE PADUA MANSUR

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio P Mansur, PhD

Role: PRINCIPAL_INVESTIGATOR

InCor Heart Institute

Locations

INCOR- Heart Institute

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Antonio P Mansur, PhD

Role: CONTACT

apmansur@yahoo.com

551126615448

Facility Contacts

Antonio de Pádua Mansur, PHD

Role: primary

apmansur@yahoo.com

26615387 ext. 11

Other Identifiers

61901722.6.0000.0068

Identifier Type: -

Identifier Source: org_study_id