The Effects of Resveratrol on Sirtuins and Apoptosis Biomarkers

NCT05808387 | Recruiting

• 1 other identifier: 61901722.6.0000.0068
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Menopause; Endothelial Dysfunction

Keywords

Coronary artery disease; Menopause; Endothelial Dysfunction; Sirtuin; Receptors of advanced glycation end products; Apoptosis; Resveratrol; Polyphenols; Cardiovascular risk

Outcome Measures

Primary Outcomes (3)

• Sirtuin-1 and sirtuin-3

  Serum concentrations and gene expression

  90 days

• Inhibitors of apoptosis proteins

  Gene expression of Bcl-2, XIAP, c-IAP1, and survivin

  90 days

• sRAGE

  Serum concentrations and gene expression

  90 days

Secondary Outcomes (3)

• Inflammation

  90 days

• Cardiometabolic risk factors

  90 days

• Anthropometric measures

  90 days

Study Arms (2)

Resveratrol

EXPERIMENTAL

Trans-resveratrol, 1000mg daily for 90 days.

Dietary Supplement: Resveratrol

Control

PLACEBO COMPARATOR

Starch, 1000mg daily for 90 days.

Dietary Supplement: Placebo

Interventions

Resveratrol DIETARY_SUPPLEMENT

Trans-resveratrol, 1000 mg daily for 90 days

Resveratrol

Placebo DIETARY_SUPPLEMENT

Starch, 1000 mg daily for 90 days

Control

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women;
• Diagnosed coronary artery disease;
• Stable coronary disease;

You may not qualify if:

• hypo or hyperthyroidism,
• rheumatic disease,
• use of alcohol,
• hepatic failure,
• renal failure
• hormone replacement therapy
• use of insulin

Sponsors & Collaborators

• InCor Heart Institute: lead

Study Sites (1)

INCOR- Heart Institute

São Paulo, São Paulo, 05403900, Brazil

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Antonio P Mansur, PhD

  InCor Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio P Mansur, PhD

CONTACT

551126615448; apmansur@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double blind randomized controlled trial, parallel and placebo-controlled.

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 11, 2023
• Study Start: March 6, 2023
• Primary Completion: June 5, 2025
• Study Completion (Estimated): June 5, 2026
• Last Updated: April 11, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)