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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether concentrated grape powder can prevent postoperative atrial fibrillation (POAF) after heart surgery. The researchers aim to determine if grape powder, with its natural anti-inflammatory properties, can reduce inflammation without the side effects of standard anti-inflammatory drugs. Participants will receive either freeze-dried California table grape powder or a placebo (a harmless pill resembling the real treatment) to compare outcomes. Suitable candidates for this trial include those undergoing elective heart surgery for mitral valve repair who have not experienced atrial fibrillation or previous heart surgeries. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative approach.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research on grape products, such as grape powder, shows they are generally safe for people. Studies have not identified any major side effects from using grape powder. In fact, it is associated with benefits like healthier blood vessels.

In studies examining the immune system, participants tolerated grape powder well, with no adverse reactions reported. This is encouraging for those considering joining a trial using grape powder for atrial fibrillation, an irregular heartbeat. Overall, the safety data suggests that grape powder is a low-risk option. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using freeze-dried California table grapes for atrial fibrillation because this treatment offers a natural, food-based alternative to conventional medications. Unlike standard treatments such as beta-blockers and antiarrhythmic drugs, which can have significant side effects, grape powder is derived from a natural source, potentially offering a gentler approach. The active compounds in grapes, like antioxidants, may work differently by supporting heart health and reducing oxidative stress, which is a new angle compared to traditional treatments. This innovative approach could lead to fewer side effects and provide a complementary option for managing atrial fibrillation.

What evidence suggests that grape powder might be an effective treatment for atrial fibrillation?

Research shows that grape powder, particularly from freeze-dried California grapes, might help reduce inflammation. In this trial, participants will receive either concentrated grape powder or a placebo. Studies have found that foods high in polyphenols, such as grapes, can improve heart and blood vessel health and lower the risk of heart problems. This suggests they might also help prevent postoperative atrial fibrillation (POAF), a condition linked to inflammation after heart surgery. Grape compounds can alter gene activity related to inflammation, possibly reducing POAF. Early trials demonstrated positive effects on the immune system and heart health, indicating a potential benefit for preventing POAF. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-2-atrial-fibrillation-8-2023-71ef2

Grape Powder for Atrial Fibrillation · Info for Participants The grape powder treatment for atrial fibrillation is unique because it uses freeze-dried California table grapes, which are considered a 'food medicine' due ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07079982

Effects of Freeze-dried Grape Powder on Immune Profiles ... Study Details | NCT07079982 | Effects of Freeze-dried Grape Powder on Immune Profiles in Healthy Aging Adults | ClinicalTrials.gov.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6155751/

Grape Polyphenols' Effects in Human Cardiovascular ... Observational studies indicate that the intake of polyphenol-rich foods improves vascular health, thereby significantly reducing the risk of hypertension, and ...

4. grapesfromcalifornia.com grapesfromcalifornia.com/wp-content/uploads/2021/10/20211019-guidelines-for-use-of-california-table-grape-powder-in-health-research-studies-2022-23.pdf

Guidelines for Use of California Table Grape Powder in ... Any results observed in clinical studies using grape powder should be directly attributed to grape consumption. In the powder, the grapes are provided in ...

5. cpp.edu cpp.edu/agri/agricultural-research-institute/showcase/abstracts_2025_bbw.pdf

The Effects of Freeze-Dried Whole Grape Powder on ... The potential impact on humans at risk for CVD is priceless-if we can demonstrate that grape consumption decreases CVD risk, we postulate that ...

6. grapesfromcalifornia.com grapesfromcalifornia.com/wp-content/uploads/2025/09/20250912-guidelines-for-use-of-california-table-grape-powder-in-health-research-studies-2026-27.pdf

Guidelines for Use of California Table Grape Powder in ... Any results observed in clinical studies using grape powder should be directly attributed to grape consumption. In the powder, the grapes ...