Resveratrol for Coronary Artery Disease

(SIRT-CVS Trial)

Overseen By Douglas Sawyer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MaineHealth

Must be taking: Oral agents, Insulin

Disqualifiers: Heart failure, Liver dysfunction, Renal dysfunction, Alcohol use, others

Compensation: Varies

Number of Visits: Unknown

Duration: 14 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if resveratrol, a compound found in grapes and red wine, can improve heart health in people with type 2 diabetes. Researchers seek to understand whether resveratrol can boost heart metabolism, reduce inflammation, and enhance heart cell function. Participants should have type 2 diabetes, manage it with medication or insulin, and be scheduled for heart surgery due to coronary artery disease. The trial will compare resveratrol to a placebo to identify any significant benefits. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance heart health for those with type 2 diabetes.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial includes patients with type 2 diabetes controlled by oral agents or insulin, it seems likely that you can continue those medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that resveratrol is generally safe for use. Studies have found that doses between 300 mg and 1000 mg per day are safe. In one study with older, overweight adults, resveratrol caused no serious side effects. Another study demonstrated that short-term use of resveratrol did not affect blood test results negatively.

In addition to its safety, resveratrol offers benefits for heart health. It may reduce inflammation and improve blood vessel function, which is particularly important for individuals with heart issues.

Overall, current evidence suggests that resveratrol is a safe option for supporting heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for coronary artery disease, which often include medications like statins or beta-blockers, trans-resveratrol is a natural compound found in red wine and grapes. Researchers are particularly excited about trans-resveratrol because it offers a unique antioxidant effect that targets oxidative stress, a key contributor to artery damage. This treatment could potentially provide a more natural alternative with fewer side effects, while also improving heart function and reducing inflammation. Additionally, its novel mechanism of action could complement existing therapies, offering a new layer of protection for heart health.

What evidence suggests that resveratrol might be an effective treatment for coronary artery disease?

Studies have shown that resveratrol benefits heart health, particularly for those with coronary artery disease. In this trial, some participants will receive resveratrol, which previous studies have found to improve heart function by reducing inflammation, a major issue in heart diseases. Another study found that resveratrol lowered blood sugar and insulin levels, crucial for people with diabetes. Additionally, research has shown that resveratrol improved heart function in animals by enhancing the heart's pumping ability. These findings suggest that resveratrol might help mitigate the negative effects of diabetes on the heart. ^{4 6 7 8 9}

Who Is on the Research Team?

Douglas Sawyer

Principal Investigator

Maine Health

Are You a Good Fit for This Trial?

Adults over 18 with Type 2 diabetes and coronary artery disease scheduled for elective heart bypass surgery can join. They must not have severe kidney, liver, or blood clotting issues, be pregnant, or have certain infections like HIV. Heavy drinkers and those unlikely to follow the study plan are excluded.

Inclusion Criteria

You have type 2 diabetes that is managed with pills or insulin.

You have coronary artery disease and are scheduled for elective coronary artery bypass grafting with cardiopulmonary bypass.

Exclusion Criteria

Your blood clotting tests show abnormal results.

Patients who are pregnant

Your liver function tests show results more than two times the normal range.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive resveratrol or placebo during coronary artery bypass grafting with cardiopulmonary bypass

14 days

Follow-up

Participants are monitored for changes in endothelial function and molecular signaling

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Trans-resveratrol

Trial Overview The trial is testing if resveratrol (found in grapes/red wine) can improve heart health in diabetics by comparing it against a placebo. It looks at how it affects heart metabolism, inflammation, blood vessel function, and cardiac repair cells.

How Is the Trial Designed?

Group I: Resveratrol Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

MaineHealth

Lead Sponsor

Trials

76

Recruited

43,800+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

Cis-resveratrol significantly reduces collagen-induced platelet aggregation in vitro, with a decrease of 43.5% at a concentration of 1 x 10(-5) M, indicating its potential as an anti-aggregating agent.

Trans-resveratrol also shows anti-aggregating effects but is slightly less effective than cis-resveratrol, suggesting that both isomers should be considered when evaluating resveratrol's overall activity in biological systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiplatelet activity of cis-resveratrol. Bertelli, AA., Giovannini, L., Bernini, W., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8587649/

A Comprehensive Analysis of the Efficacy of Resveratrol in ... Cardioprotection by resveratrol: A human clinical trial in patients with stable coronary artery disease. Clin. Hemorheol. Microcirc. 2012;50:179–187. doi ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0965229922000656

Anti-inflammatory effects of resveratrol in patients with ... Conclusion. Our results suggest that resveratrol can be used as a potential treatment in patients with CVD by reducing inflammatory conditions.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8466271/

The Effect of Resveratrol on the Cardiovascular System from ... The results showed that RES treatment (5.82 mg/kg/day) significantly improved the ejection fraction in rats and reduced postinfarction left ventricular and ...

4. mdpi.com mdpi.com/1422-0067/20/4/904

The Effects of Resveratrol in Patients with Cardiovascular ... Moreover, a meta-analysis of 11 studies reported that short-term consumption of resveratrol reduces fasting glucose, insulin, glycated hemoglobin, and insulin ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/14017431.2019.1657584

Acute resveratrol supplementation in coronary artery disease The key finding of our study is that RV has differential effects on vascular function in older CAD patients, depending on the type of revascularization method ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4149922/

Safety and metabolic outcomes of resveratrol ... Overall, our findings suggest that resveratrol is well tolerated at doses of 300 mg/day and 1000 mg/day in overweight, older adults, a population at high risk ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6413130/

The Effects of Resveratrol in Patients with Cardiovascular ... Most relevant to this review, resveratrol has been shown to effectively treat mice with pressure-overload-induced HF by improving diastolic ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0531556514001764

results of a twelve-week, placebo-controlled pilot study These findings suggest that short-term resveratrol supplementation at doses of 300 mg/day and 1000 mg/day does not adversely affect blood chemistries and is ...

9. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2024.1368949/full

Resveratrol and vascular health: evidence from clinical ... The present review aims to summarize the main findings from clinical trials on the effects of resveratrol interventions on endothelial and vascular outcomes