Ischaemic Heart DeseaseNCT06914934
Study of High-Dose Resveratrol in Patients With Stable Ischemic Heart Disease
A study testing High-dose resveratrol 500 mg/day in people with Ischaemic Heart Desease, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Ischaemic Heart Desease
- What is being tested?
- High-dose resveratrol 500 mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteRussia
- Study dates
- 1 Feb 2024to 10 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischaemic Heart Desease
- Being tested
- High-dose resveratrol 500 mg/day, Placebo
- Keywords
- Supplements, Resveratol, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-dose resveratrol 500 mg/dayDietary supplement
High-dose resveratrol 500 mg/day (preferably a high-bioavailability formulation, e.g., trans-resveratrol with piperine or liposomal).
PlaceboOther
Placebo capsules, identical in appearance and schedule.
| Study group | Role | What they receive |
|---|---|---|
| Resveratrol arm | Experimental | Not described Receives: Dietary Supplement: High-dose resveratrol 500 mg/day |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in endothelial function
Change in endothelial function: measured by brachial artery flow-mediated dilation from baseline to 6 months
Measured: 6 months
Change in systemic inflammation
Change in systemic inflammation: measured by hs-CRP from baseline to 6 months
Measured: 6 months
Secondary outcomes (8)
Inflammatory cytokines change IL-6
Measured: 6 months
Inflammatory cytokines TNF-α
Measured: 6 months
Total cholesterol change
Measured: 6 months
LDL change
Measured: 6 months
Triglycerides change mg/dl
Measured: 6 months
Arterial stiffness change
measured by pulse wave velocity
Measured: 6 months
Quality of life Seattle Angina Questionnaire change
Measured: 6 months
Exercise tolerance 6-minute walk test change
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2025
- Study start1 Feb 2024
- Primary completion20 Jan 2025
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemic Heart DeseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914934
- Sponsor's protocol ID
- SW028
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Month, Double-Blind, Placebo-Controlled Pilot Study of High-Dose Resveratrol in Patients With Stable Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT06914934
- Acronym / sponsor ID
- SW028
- Conditions
- Ischaemic Heart Desease
- Keywords
- Supplements, Resveratol, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 7 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol arm | Experimental | Dietary Supplement: High-dose resveratrol 500 mg/day |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-dose resveratrol 500 mg/dayHigh-dose resveratrol 500 mg/day (preferably a high-bioavailability formulation, e.g., trans-resveratrol with piperine or liposomal). | Dietary supplement | Resveratrol arm |
| PlaceboPlacebo capsules, identical in appearance and schedule. | Other | Placebo |
Primary outcome
Change in endothelial function
Time frame: 6 months
Change in endothelial function: measured by brachial artery flow-mediated dilation from baseline to 6 months
Change in systemic inflammation
Time frame: 6 months
Change in systemic inflammation: measured by hs-CRP from baseline to 6 months
8 secondary outcomes
Inflammatory cytokines change IL-6
Time frame: 6 months
Inflammatory cytokines TNF-α
Time frame: 6 months
Total cholesterol change
Time frame: 6 months
LDL change
Time frame: 6 months
Triglycerides change mg/dl
Time frame: 6 months
Arterial stiffness change
Time frame: 6 months
Quality of life Seattle Angina Questionnaire change
Time frame: 6 months
Exercise tolerance 6-minute walk test change
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-dose resveratrol 500 mg/day in people with Ischaemic Heart Desease, run by S.LAB (SOLOWAYS) at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in endothelial function (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.