Tart Cherry Concentrate for Post-Operative Atrial Fibrillation

NS
CG
Overseen ByChina Green, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how tart cherry concentrate might benefit individuals undergoing heart surgery, specifically in preventing post-operative atrial fibrillation (POAF), a common heart rhythm issue after surgery. Researchers are also studying the treatment's effects on inflammation and related outcomes. Participants will consume a specific amount of Montmorency tart cherry juice concentrate daily for three days. Suitable candidates for this trial are those undergoing elective mitral valve repair surgery without any prior heart rhythm issues, such as atrial fibrillation. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and assess its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

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 (medications that affect the immune system).

Is there any evidence suggesting that Tart Cherry Concentrate is likely to be safe for humans?

Studies have shown that tart cherry concentrate is generally safe for people. One study found that tart cherry juice, containing natural plant compounds called anthocyanins, did not affect heart health in terms of artery stiffness or heart disease risk, indicating it is usually well-tolerated by the body.

Research also shows that tart cherries can reduce oxidative stress, where harmful molecules damage cells, and lower inflammation in the hearts of obese rats. Although more studies are needed in humans, these findings suggest tart cherry concentrate might have soothing effects on the heart.

Experts generally consider tart cherry juice and supplements safe because they help reduce inflammation, with no known serious side effects. However, as with any supplement, individuals should be aware of any personal allergies or interactions with other medications.

In summary, current evidence suggests tart cherry concentrate is safe and well-tolerated, with potential benefits for heart health.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for post-operative atrial fibrillation, which often include medications like beta-blockers and amiodarone, tart cherry concentrate is a natural approach that leverages the properties of Montmorency tart cherries. Researchers are excited about this treatment because tart cherries are rich in antioxidants and anti-inflammatory compounds, which may help reduce inflammation and oxidative stress, factors that can contribute to atrial fibrillation. Another appealing feature is its rapid potential for effectiveness, as the concentrate is consumed in small, daily servings over just three days, offering a quick and convenient alternative to traditional medications.

What evidence suggests that Tart Cherry Concentrate might be an effective treatment for post-operative atrial fibrillation?

Research has shown that tart cherry concentrate might help reduce inflammation and stress-related damage in the body, benefiting heart health. Animal studies found that tart cherries can lower heart inflammation. Drinking tart cherry juice daily has also been linked to slowing the hardening of arteries, crucial for maintaining heart health. Other research suggests that tart cherries aid recovery after intense exercise, indicating broader recovery benefits. Although specific information on tart cherries' effects on post-operative atrial fibrillation (a heart rhythm issue) is limited, these benefits suggest potential advantages for heart health and recovery. Participants in this trial will receive tart cherry concentrate to evaluate its effects on post-operative atrial fibrillation.16789

Who Is on the Research Team?

SF

Steven F Bolling, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for men and women aged 50-79 who are undergoing elective mitral valve repair surgery but not the Cox MAZE procedure. Candidates should be in normal heart rhythm with no history of atrial fibrillation, no prior heart surgeries, pacemakers, or active smoking. They shouldn't have inflammatory diseases, autoimmune conditions, or be on immunosuppressive drugs.

Inclusion Criteria

I am between 50-79 years old and having elective surgery for mitral valve repair without Cox MAZE, but may have CABG/tricuspid repair.
Your heartbeat is regular, and you have not had atrial fibrillation before.

Exclusion Criteria

I am 80 years old or older.
You are allergic to sorbitol.
I have been diagnosed with chronic or occasional atrial fibrillation before surgery.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tart Cherry Concentrate for three days

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 days
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Tart Cherry Concentrate
Trial Overview The study tests if Tart Cherry Concentrate can reduce the incidence of post-operative atrial fibrillation (POAF) after cardiac surgery. It also looks at how this concentrate affects inflammation-related genes in heart tissue and its impact on clinical and economic outcomes.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Tart Cherry ConcentrateExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

Cherry Marketing Institute, Dewitt MI (USA)

Collaborator

Trials
1
Recruited
50+

Published Research Related to This Trial

Tart cherry does not significantly affect blood pressure or heart rate, but it can reduce inflammation markers like serum C-reactive protein, with a moderate level of certainty based on 21 randomized controlled trials.
A dose-response analysis suggests that increasing the tart cherry dosage by 30 ml can lead to a reduction in C-reactive protein levels by approximately 0.19 mg/l, indicating that proper dosing is important for its anti-inflammatory effects.
Dose-dependent effect of tart cherry on blood pressure and selected inflammation biomarkers: A GRADE-assessed systematic review and meta-analysis of randomized controlled trials.Norouzzadeh, M., Hasan Rashedi, M., Shahinfar, H., et al.[2023]
A meta-analysis of 10 randomized controlled trials involving 147 participants showed that tart cherry concentrate significantly improves endurance exercise performance when consumed 7 days to 1.5 hours before exercise, with a standardized mean difference of 0.36.
The benefits of tart cherry concentrate for endurance performance may be attributed to its low glycemic index, anti-inflammatory and antioxidant properties, and its ability to enhance blood flow.
Effect of Tart Cherry Concentrate on Endurance Exercise Performance: A Meta-analysis.Gao, R., Chilibeck, PD.[2021]

Citations

Anti-Inflammatory and Antioxidant Properties of Tart Cherry ...Our results showed that tart cherries reduced oxidative stress and mitigated the inflammation in the hearts of obese rats.
Cherry juice : I'm starting to try... - Atrial Fibrillati...I'm starting to try cherry juice to help with pain relief from my neuropathy pain as I've read it helps have checked it all up about safety ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/32429737/
Effects of Montmorency Tart Cherry Juice Consumption on ...These results suggest that daily tart cherry consumption may attenuate processes involved in accelerated atherogenesis without affecting hemodynamics or ...
Research highlights powers of recovery with Montmorency ...“In previous studies, we found tart cherries to have significant benefits on recovery after strenuous exercise involving runners, cyclists and ...
A 3-arm placebo randomized controlled trial was conducted to ...This project proposes a randomized controlled experiment to evaluate the impact of Montmorency tart cherry and blueberry juice on cardiometabolic outcomes ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/24570273/
Effect of a tart cherry juice supplement on arterial stiffness ...A tart cherry juice concentrate rich in anthocyanins has no effect on arterial stiffness, c-reactive protein and risk markers for cardiovascular disease.
Tart Cherry Juice and Blood Thinners: Risks and InteractionsThis means tart cherry juice and supplements are generally considered safe. “Tart cherries primarily act via an anti-inflammatory mechanism. They have no known ...
Phenolic Compounds from Cherries and Berries for ...This review summarises the current research on the effects of cherry and berry consumption on cardiovascular health, including in vivo studies and clinical ...
What is Tart Cherry Advanced: Uses, Warnings & InteractionsLearn about Tart Cherry Advanced: What it is used for, how to take Tart Cherry Advanced, serious side effects, food and drug interactions, forms, doses, ...
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