CClinicalTrials.gg
RecruitingNCT07865377RESHUpdated Oct 8, 2026

Serum Endogenous Estrogens, Estrogen Receptors, and Sirtuin-1 and -3 After Resveratrol Supplementation

An interventional study of Trans-resveratrol, 1000 mg daily for 90 days and Placebo in Coronary Artery Disease (CAD), Menopause and Hormones, sponsored by InCor Heart Institute. Recruiting at 1 site in Brazil. Open to female participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by InCor Heart Institute · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Aug 2026; still recruiting 1 month later.
Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
Female
01

Study summary

Atherosclerotic coronary artery disease (CAD) is a leading cause of mortality among postmenopausal women. Resveratrol, a phenolic compound with antioxidant properties, may influence lipid metabolism, endothelial function, and platelet aggregation, while sirtuin-1 and sirtuin-3 regulate metabolic and hormonal responses to nutritional stimuli. This randomized, double-blind, placebo-controlled trial evaluates the effects of trans-resveratrol supplementation (1000 mg/day) versus placebo, over 90 days, on serum estradiol and estrone levels, gene expression of estrogen receptors alpha and beta, and sirtuins 1 and 3 in 80 postmenopausal women with CAD. Findings may inform therapeutic strategies for postmenopausal women with chronic coronary disease.

Read the detailed description

Atherosclerotic coronary artery disease (CAD) is the leading cause of mortality among women in developed regions of Brazil. Diets rich in fruits and vegetables, which are sources of phenolic compounds, have been associated with a lower incidence of CAD, possibly due to their beneficial effects on vascular health. Resveratrol, a phenolic compound of the flavonoid group, is notable for its antioxidant properties, contributing to lipoprotein metabolism, production of endothelial vasodilator substances, and reduction of platelet aggregation.

Sirtuin-1 and sirtuin-3 play crucial roles in metabolic regulation in response to nutritional stimuli, such as caloric restriction and phenolic compound intake, and are also involved in hormonal modulation. However, the impact of resveratrol supplementation on serum estrogen and sirtuin levels has not yet been fully elucidated.

The primary objective of this study is to investigate the effects of resveratrol on serum concentrations of estradiol and estrone, gene expression of total estrogen receptors alpha and beta, and gene expression of sirtuins 1 and 3, in postmenopausal women with CAD undergoing resveratrol supplementation.

This is a randomized, double-blind, placebo-controlled clinical trial with a duration of 90 days, involving 80 postmenopausal women with CAD, allocated into two groups:

Group 1 (n=40): supplemented with trans-resveratrol, 1000 mg/day. Group 2 (n=40): placebo control. Clinical, nutritional, and laboratory assessments will be performed at baseline and at 90 days. Additional clinical nutritional assessments will be performed at 30 and 60 days from study initiation.

This investigation is expected to contribute to the understanding of the molecular mechanisms involved in the interaction between resveratrol and hormonal and biochemical markers, providing evidence to support more effective therapeutic strategies for postmenopausal women with chronic coronary disease.

02

Conditions studied

  • Coronary Artery Disease (CAD)
  • Menopause
  • Hormones

Keywords

  • Coronary disease
  • Estradiol
  • Estrone
  • Sirtuin-1
  • Resveratrol
  • Sirtuin-3
  • Menopause
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 80 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

InCor Heart Institute is the lead sponsor of 27 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Hypo- or hyperthyroidism,
  • Rheumatic disease,
  • Use of alcohol,
  • hepatic failure,
  • renal failure
  • hormone replacement therapy
  • use of insulin
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Resveratrol

    Trans-resveratrol, 1000mg daily for 90 days.

    Dietary Supplement: Trans-resveratrol, 1000 mg daily for 90 days

  • Placebo comparator
    Control

    Starch, 1000mg daily for 90 days.

    Other: Placebo

Interventions

  • Dietary supplementTrans-resveratrol, 1000 mg daily for 90 days

    Trans-resveratrol, 1000 mg daily for 90 days

    Also known as: Resveratrol

  • OtherPlacebo

    Starch, 1000 mg daily for 90 days

06

What researchers measure

Primary outcomes

  1. 1. Sirtuin-1 and sirtuin-3

    Serum concentrations and gene expression

    Time frame: 90 days

  2. Estradiol

    Serum concentrations

    Time frame: 90 days

  3. Estrone

    Serum concentrations

    Time frame: 90 days

  4. SHBG

    Serum concentrations

    Time frame: 90 days

Secondary outcomes

  1. Estrogen receptor alpha

    Gene expression

    Time frame: 90 days

  2. Cardiometabolic risk factors

    Lipid and glucometabolic profiles

    Time frame: 90 days

  3. BMI

    kg/m²

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
  • Servico de Prevencao, Cardiopatia na Mulher e Reabilitacao Cardiovascular, Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP,
    São Paulo, São Paulo 05403- 900, Brazil
    • Antonio de Padua Mansur, Dr · Contact · apmansur@yahoo.com · +55.11.26615811
    • Nathalia Ferreira de Oliveira Faria, MSC · Contact · nathalia.fariaof@usp.br · +55.11.950869613
    • Antonio de Padua Mansur, PhD · Principal investigator
    • Nathalia Ferreira de Oliveira Faria, MSC · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07865377
Lead sponsor
InCor Heart Institute
Responsible party
ANTONIO DE PADUA MANSUR (Associate Professor, InCor Heart Institute) — Principal investigator
First posted
Oct 8, 2026
Start date
Aug 24, 2026
Primary completion
Aug 24, 2029 (estimated)
Completion
Aug 24, 2029 (estimated)
Last update
Oct 8, 2026

Study contacts

Antonio de Padua Mansur, PhD
Contact
apmansur@yahoo.com
+551126615448
Antonio de Padua Mansur, PhD Incor
principal investigator · InCor Heart Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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