The Effects of Resveratrol on Sirtuins and Apoptosis Biomarkers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age55+
SponsorInCor Heart Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Postmenopausal women;

Diagnosed coronary artery disease;

Stable coronary disease;

Disqualifiers

hypo or hyperthyroidism,

rheumatic disease,

use of alcohol,

hepatic failure,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Resveratrol

    Dietary supplement

    Trans-resveratrol, 1000 mg daily for 90 days

  • Placebo

    Dietary supplement

    Starch, 1000 mg daily for 90 days

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: ResveratrolExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sirtuin-1 and sirtuin-3

Serum concentrations and gene expression

Time frame
90 days
2

Inhibitors of apoptosis proteins

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

Time frame
90 days
3

sRAGE

Serum concentrations and gene expression

Time frame
90 days

Secondary outcomes

1

Inflammation

Serum concentrations of proinflammatory cytokines

Time frame
90 days
2

Cardiometabolic risk factors

Lipid and glucometabolic profiles

Time frame
90 days
3

Anthropometric measures

BMI, skinfold thickness, and body composition

Time frame
90 days

Other outcomes

Sponsors and contacts

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