Grape Powder for Atrial Fibrillation

Overseen By China Green, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Michigan

Must not be taking: Antiarrhythmics, Corticosteroids, Immunosuppressives

Disqualifiers: Age ≥ 80, Previous cardiac surgery, Active smoker, Autoimmune disease, others

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

Trial Summary

What is the purpose of this trial?

Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery and leads to worse outcomes. POAF is thought to be caused by the inflammatory state following cardiac surgery. It may be that anti-inflammatory medications could lower the occurrence of POAF, however many typical anti-inflammatory medications, such as ibuprofen, are contraindicated in the post cardiac surgery patient due to increased risks of bleeding. If a drug was identified with anti-inflammatory properties with minimal deleterious side effects, this could be broadly applied to cardiac surgery patients for the prevention of POAF. Interestingly, several small trials have shown that medications that alter transcription of inflammatory markers lead to decreased POAF. Furthermore, we have shown that phytochemicals, such as those found in grapes, have excellent bioavailability and can affect cardiac gene transcription related to inflammation. In this study, we propose to evaluate the efficacy of preoperative administration of concentrated grape powder in the prevention of POAF.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using antiarrhythmic agents or corticosteroids.

What data supports the effectiveness of the grape powder treatment for atrial fibrillation?

Research shows that grape products, which contain antioxidants and other beneficial compounds, can improve heart health by lowering blood pressure, reducing inflammation, and enhancing blood flow. These effects may indirectly support heart rhythm stability, which is important for conditions like atrial fibrillation. ^{1 2 3 4 5}

Is grape powder safe for human consumption?

Research on grape products, including grape powder, suggests they are generally safe for human consumption. Studies have shown benefits like improved antioxidant levels and reduced cholesterol, with no significant adverse effects reported. ^{3 6 7 8 9}

How does the grape powder treatment for atrial fibrillation differ from other treatments?

The grape powder treatment for atrial fibrillation is unique because it uses freeze-dried California table grapes, which are considered a 'food medicine' due to their natural chemical components like catechin, epicatechin, and resveratrol. This approach is different from standard treatments as it focuses on the potential health benefits of natural compounds found in grapes, rather than synthetic drugs. ^{8 10 11 12 13}

Eligibility Criteria

This trial is for men and women aged 50-79 who are undergoing elective cardiac surgery for mitral valve repair but not the Cox MAZE procedure. Candidates should be in normal heart rhythm with no history of atrial fibrillation, previous cardiac surgeries, or use of certain medications like corticosteroids and antiarrhythmics. Smokers and those with specific heart risks or autoimmune diseases cannot participate.

Inclusion Criteria

I am between 50-79 years old and having elective surgery for mitral valve repair without Cox MAZE, but possibly with CABG or tricuspid valve repair.

Your heart is beating normally without any irregular rhythm.

Exclusion Criteria

I have been diagnosed with an autoimmune disease.

I have a weak heart pump, a large left atrium, or severe valve leakage.

I have had heart surgery in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants receive preoperative administration of concentrated grape powder to evaluate its efficacy in preventing POAF

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Freeze-Dried California Table Grape
• Placebo

Trial Overview The study tests if preoperative administration of concentrated grape powder can prevent post-operative atrial fibrillation (POAF), a common complication after heart surgery linked to inflammation. Participants will receive either the grape powder or a placebo to compare effectiveness.

Participant Groups

Group I: Concentrated grape powder Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

California Table Grape Commission

Collaborator

Trials

8

Recruited

270+

Findings from Research

In a study involving rats on a high-fat diet, grape seed powder significantly reduced serum levels of total cholesterol, triglycerides, and low-density lipoprotein cholesterol, while increasing high-density lipoprotein cholesterol, indicating its potential to improve lipid profiles.

Grape seed powder also showed protective effects on the liver, as it significantly reduced fatty degeneration compared to rats that only received a high-fat diet, suggesting it may help prevent fatty liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research of grape seed powder on serum lipids and hepatic protection effects in high-fat diet rats]. Song, C., Zhong, X., Ge, H., et al.[2014]

Freeze-dried grape powder (FDGP) can degrade and become difficult to handle if it absorbs too much moisture (above ~25% w/w), which affects its important chemical components like catechin and resveratrol.

To ensure the stability and shelf life of FDGP, a new compact coating system using beeswax and other materials was developed, allowing it to remain effective for over 3 months without special handling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of critical physical and mechanical properties of freeze-dried grape powder for development of a clinical patient delivery system. Hu, D., Haware, RV., Hamad, ML., et al.[2018]

Welch's Special Grape Color Powder Type BW-AT did not adversely affect reproductive performance in Sprague-Dawley rats over two generations, indicating its safety for reproductive health.

While the grape color powder led to lower body weights in both generations of pups and reduced body-weight gain in female F1 rats during a 13-week study, these effects were attributed to the lower calorific value of the supplemented feed rather than toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproduction study of grape colour extract in rats. Becci, PJ., Hess, FG., Babish, JG., et al.[2019]

The feed additive 'dry grape extract 60-20', derived from Vitis vinifera, is proposed for use in dog food as a flavoring agent at a maximum level of 100 mg/kg, but its safety remains uncertain due to potential toxicity concerns related to grape consumption in dogs.

The FEEDAP Panel could not confirm the safety of 'dry grape extract 60-20' for dogs or for those handling the additive, highlighting the need for further safety studies despite its use in food as a flavoring agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of 'dry grape extract 60-20' when used as feed flavouring for dogs. Bampidis, V., Azimonti, G., Bastos, ML., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of grape antioxidant dietary fiber in cardiovascular disease risk factors. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Chronic intake of a phytochemical-enriched diet reduces cardiac fibrosis and diastolic dysfunction caused by prolonged salt-sensitive hypertension. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Grape products and cardiovascular disease risk factors. [2011]

4. United States pubmed.ncbi.nlm.nih.gov

One-year consumption of a grape nutraceutical containing resveratrol improves the inflammatory and fibrinolytic status of patients in primary prevention of cardiovascular disease. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Grape intake reduces thrombin generation and enhances plasma fibrinolysis. Potential role of circulating procoagulant microparticles. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Consumption of Beef Burgers Prepared with Wine Grape Pomace Flour Improves Fasting Glucose, Plasma Antioxidant Levels, and Oxidative Damage Markers in Humans: A Controlled Trial. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The effect of grape seed extract on cardiovascular risk markers: a meta-analysis of randomized controlled trials. [2018]

8. China pubmed.ncbi.nlm.nih.gov

[Research of grape seed powder on serum lipids and hepatic protection effects in high-fat diet rats]. [2014]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Standardized Grape Powder Consumption on the Gut Microbiome of Healthy Subjects: A Pilot Study. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Wine grape pomace as antioxidant dietary fibre for enhancing nutritional value and improving storability of yogurt and salad dressing. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Characterization of critical physical and mechanical properties of freeze-dried grape powder for development of a clinical patient delivery system. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Reproduction study of grape colour extract in rats. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of 'dry grape extract 60-20' when used as feed flavouring for dogs. [2023]