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

NCT06914934 | Completed

• 1 other identifier: SW028
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischaemic Heart Desease

Keywords

Supplements; Resveratol; Inflammation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Inflammatory cytokines change IL-6

  6 months

• Inflammatory cytokines TNF-α

  6 months

• Total cholesterol change

  6 months

• LDL change

  6 months

• Triglycerides change mg/dl

  6 months

Study Arms (2)

Resveratrol arm

EXPERIMENTAL

Dietary Supplement: High-dose resveratrol 500 mg/day

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

High-dose resveratrol 500 mg/day DIETARY_SUPPLEMENT

High-dose resveratrol 500 mg/day (preferably a high-bioavailability formulation, e.g., trans-resveratrol with piperine or liposomal).

Resveratrol arm

Placebo OTHER

Placebo capsules, identical in appearance and schedule.

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Center for New Medical Technologies

Novosibirsk, 630090, Russia

Location

MeSH Terms

Conditions

Inflammation

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 7, 2025
• Study Start: February 1, 2024
• Primary Completion: January 20, 2025
• Study Completion: February 10, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)