Watermelon + Coenzyme Q10 for Kidney Transplant Care

(WUBI-Q Trial)

Overseen By Divya Seth, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Under 18, Preemptive transplant, others

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether increased watermelon consumption and Coenzyme Q10 (a common dietary supplement) can improve kidney function and reduce urinary protein in recent kidney transplant recipients. Participants will be divided into groups to evaluate different combinations of watermelon and the supplement. The trial seeks individuals who received a kidney transplant in the last four weeks and previously required dialysis. As an unphased trial, it offers a unique opportunity to explore potential dietary benefits for kidney health post-transplantation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on increasing watermelon consumption and coenzyme Q10 supplementation.

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

Research shows that both watermelon and coenzyme Q10 have been studied for safety in humans, though some considerations remain.

For watermelon, high potassium levels pose a concern, especially for individuals with certain kidney issues. Studies suggest that those with chronic kidney disease (CKD) or elevated potassium levels should be cautious, as watermelon might increase potassium excessively.

Coenzyme Q10, however, has been widely studied and is generally considered safe at doses up to 1200 mg per day. Research indicates it can be safely used even by people on dialysis, offering some benefits for kidney function.

In summary, coenzyme Q10 has strong evidence of safety, while individuals with specific kidney conditions should consume watermelon cautiously due to its potassium content. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about exploring watermelon and Coenzyme Q10 for kidney transplant care because these treatments offer a fresh approach. Unlike standard medications that focus on immune suppression to prevent organ rejection, watermelon is being investigated for its high antioxidant content, which might support kidney health naturally. Coenzyme Q10, known for its role in energy production and protecting cells from damage, could provide additional benefits by enhancing cell function in transplanted kidneys. These treatments could potentially offer a complementary strategy to existing therapies, focusing on natural ingredients to improve outcomes.

What evidence suggests that this trial's treatments could be effective for kidney transplant care?

Research has shown that coenzyme Q10, which participants in this trial may receive, can help protect kidney function. Studies have found that it improves kidney performance, particularly in individuals with kidney disease, and evidence suggests that those taking coenzyme Q10 experience better long-term kidney health. Regarding watermelon, which is part of another treatment arm in this trial, findings are mixed. Some reports indicate it may not be ideal for those with severe kidney issues due to its effect on potassium levels. However, this trial will explore the potential benefits of combining coenzyme Q10 with a watermelon diet for kidney function, despite limited data on this specific combination. ^{1 4 6 7 8}

Who Is on the Research Team?

Elaine Ku, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Adults over 18 who've had a kidney transplant within the last month can join this trial. They should be on standard post-transplant drugs, not underweight, and have normal potassium levels. They mustn't already eat lots of watermelon or take coenzyme Q10 supplements and should be able to visit UCSF for follow-up.

Inclusion Criteria

Potassium < 4.8 at time of randomization (not having high potassium already)

History of hemodialysis dependency (and not peritoneal dialysis) prior to kidney transplant

Able to provide informed consent

Exclusion Criteria

You have relied on peritoneal dialysis or have had a transplant surgery before.

Potassium >=4.8 meq/L at randomization

Unable to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a placebo or coenzyme Q10 supplementation with or without a diet high in watermelon

20 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• coenzyme Q10
• Placebo
• Usual Diet
• Watermelon diet

Trial Overview

The study is testing if eating more watermelon and possibly taking coenzyme Q10 supplements helps kidney function and reduces protein in urine after a transplant. Participants will either add these to their diet or stick with their usual diet or placebo.

How Is the Trial Designed?

Group I: Watermelon Diet & Coenzyme Q10 Active Control 2 Interventions

800-1200 mg of coenzyme Q10 daily plus diet high in watermelon

Group II: Usual Diet & Coenzyme Q10 Active Control 2 Interventions

800-1200 mg of coenzyme Q10 daily plus no watermelon in diet

Group III: Usual Diet & Placebo Placebo Group 2 Interventions

Placebo pill plus no watermelon in diet

Group IV: Watermelon Diet & Placebo Placebo Group 2 Interventions

Placebo pill plus diet high in watermelon

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

Coenzyme Q10 (CoQ10) supplementation in chronic kidney disease (CKD) patients showed significant reductions in markers of oxidative stress and inflammation, specifically lowering malonaldehyde and high-sensitivity C-reactive protein levels.

CoQ10 supplementation also improved glucose metabolism, evidenced by reductions in HbA1c and increases in QUICKI scores, although it did not affect lipid profiles such as total cholesterol or triglycerides.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review for the efficacy of coenzyme Q10 in patients with chronic kidney disease. Xu, Y., Yang, G., Zuo, X., et al.[2022]

Coenzyme Q10 (CoQ10) supplementation may help reduce cardiovascular events and improve mitochondrial function in patients with chronic kidney disease (CKD), as plasma levels of CoQ10 are often low in these patients.

This systematic review aims to comprehensively assess the efficacy and safety of CoQ10 in CKD patients, utilizing a thorough methodology that includes independent screening of studies from multiple databases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of coenzyme Q10 in patients with chronic kidney disease: protocol for a systematic review. Xu, Y., Liu, J., Han, E., et al.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6902707/

Coenzyme Q10 alleviates tacrolimus-induced ...

Our current findings demonstrate that CoQ10 reduced oxidative stress in Tac-treated cells, as evidenced by the decreases in 8-OHdG and 4-HHE expression; this ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11664338/

Renoprotective effects of coenzyme Q10 supplementation in ...

The plasma levels of CoQ10 are reduced in patients with chronic kidney disease (CKD). CoQ10 supplementation can improve mitochondrial function ...

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kidney-international.org

kidney-international.org/article/S0085-2538(22)00379-9/fulltext

Oral Coenzyme Q10 supplementation leads to better ...

CoQ10 supplementation led to significantly better preservation of kidney function (5-year kidney failure-free survival 62% vs. 19%) with an ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0085253822003799

Oral Coenzyme Q10 supplementation leads to better ...

CoQ 10 supplementation led to significantly better preservation of kidney function (5-year kidney failure-free survival 62% vs. 19%)

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clinicaltrials.gov

clinicaltrials.gov/study/NCT03579693

Trial of Nicotinamide Riboside and Co-enzyme Q10 in ...

The primary outcomes are aerobic capacity and muscle work efficiency, measured during cycle ergometry.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5616172/

Effect of Coenzyme Q10 on Biomarkers of Oxidative Stress ...

In patients undergoing maintenance hemodialysis, daily supplementation with 1200 mg of CoQ 10 is safe and results in a reduction in plasma concentrations of F ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/19096117/

Safety assessment of coenzyme Q10 (CoQ10)

Risk assessment for CoQ10 based on various clinical trial data indicates that the observed safety level (OSL) for CoQ10 is 1200 mg/day/person. Evidence from ...

8.

insight.jci.org

insight.jci.org/articles/view/167274

Randomized crossover clinical trial of coenzyme Q10 and ...

CoQ10 supplementation in our study was associated with metabolic changes suggesting improved mitochondrial β oxidation known to be disrupted in CKD. CKD is ...