Study of High-Dose Resveratrol in Patients With Stable Ischemic Heart Disease

A 6-Month, Double-Blind, Placebo-Controlled Pilot Study of High-Dose Resveratrol in Patients With Stable Ischemic Heart Disease

This 6-month, randomized, double-blind, placebo-controlled pilot study investigates whether high-dose resveratrol (500 mg/day), when added to standard therapy, can improve endothelial function and reduce inflammation in patients with stable ischemic heart disease. While preclinical data and small trials have shown promising effects on vascular health and inflammation, larger studies have lacked consistent results. This study aims to provide more robust clinical evidence by assessing flow-mediated dilation (FMD) and high-sensitivity C-reactive protein (hs-CRP) as primary outcomes in a well-defined patient group.

Study Overview

• Status: Completed
• Conditions: Ischaemic Heart Desease
• Intervention / Treatment: Dietary supplement: High-dose resveratrol 500 mg/day; Other: Placebo

Detailed Description

This study is a 6-month, double-blind, placebo-controlled pilot randomized clinical trial designed to evaluate the effects of high-dose resveratrol (500 mg/day) on endothelial function and systemic inflammation in patients with stable ischemic heart disease (IHD). Despite widespread interest in resveratrol's cardioprotective potential, there remains limited high-quality clinical evidence supporting its benefit in established cardiovascular disease. Preclinical and small human studies suggest that resveratrol may enhance endothelial function via eNOS activation and oxidative stress reduction, reduce inflammation by lowering pro-inflammatory markers like CRP and cytokines, and mimic caloric restriction pathways through sirtuin activation. However, its clinical efficacy may be hindered by factors such as poor bioavailability, heterogeneous patient populations, and overlapping effects of standard cardiovascular drugs. This trial will randomize eligible participants, aged 45 to 75 with stable IHD and elevated inflammation or impaired endothelial function, to receive either resveratrol or placebo alongside their regular medication. The primary endpoints are changes in flow-mediated dilation (FMD) and high-sensitivity C-reactive protein (hs-CRP) from baseline to six months. Secondary outcomes include changes in inflammatory biomarkers, lipid profile, arterial stiffness, blood pressure, quality of life, and exercise tolerance. The study also assesses the safety and tolerability of long-term high-dose supplementation. With an estimated 70 participants (35 per arm), the study aims to detect a clinically meaningful 3% improvement in FMD with 80% power, contributing valuable data to guide future larger-scale investigations.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630090
    • Center for New Medical Technologies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men and women aged 45-75 years.
• Clinically documented stable ischemic heart disease (≥6 months post-myocardial infarction or post-revascularization).
• On stable, guideline-recommended cardiac medications (e.g., statins, beta-blockers, ACE inhibitors).
• Elevated hs-CRP (>2 mg/L) or impaired endothelial function (FMD <7%) at baseline (optional enrichment criterion).
• Able and willing to give written informed consent.

Exclusion Criteria:

• Heart failure with reduced ejection fraction <30% or New York Heart Association (NYHA) class III-IV.
• Severe hepatic or renal dysfunction.
• Decompensated diabetes (e.g., HbA1c >10%).
• Current or recent (past 3 months) use of high-dose antioxidant/anti-inflammatory supplements (other than a standard multivitamin).
• Known allergy or intolerance to resveratrol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo capsules, identical in appearance and schedule.
Experimental: Resveratrol arm	Dietary supplement: High-dose resveratrol 500 mg/day; High-dose resveratrol 500 mg/day (preferably a high-bioavailability formulation, e.g., trans-resveratrol with piperine or liposomal).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in endothelial function	Change in endothelial function: measured by brachial artery flow-mediated dilation from baseline to 6 months	6 months
Change in systemic inflammation	Change in systemic inflammation: measured by hs-CRP from baseline to 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory cytokines change IL-6		6 months
Total cholesterol change		6 months
LDL change		6 months
Arterial stiffness change	measured by pulse wave velocity	6 months
Inflammatory cytokines TNF-α		6 months
Quality of life Seattle Angina Questionnaire change		6 months
Exercise tolerance 6-minute walk test change		6 months
Triglycerides change mg/dl		6 months

Collaborators and Investigators

• Sponsor: S.LAB (SOLOWAYS)
• Collaborators: Center for New Medical Technologies, Novosibirsk, Russia

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): January 20, 2025
• Study Completion (Actual): February 10, 2025

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 7, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Inflammation; Supplements; Resveratol
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Ischemia; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Antioxidants; Protective Agents; Resveratrol
• Other Study ID Numbers: SW028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No