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Watermelon + Coenzyme Q10 for Kidney Transplant Care (WUBI-Q Trial)

N/A

Recruiting

Led By Elaine Ku

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 20 weeks

Awards & highlights

WUBI-Q Trial Summary

This trial will test whether watermelon and/or coenzyme Q supplementation is safe and improves kidney function in patients after a kidney transplant.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include changes in digestion due to increased watermelon intake or reactions to coenzyme Q10 like upset stomach, loss of appetite, nausea, vomiting, allergic rash but are generally considered safe.

WUBI-Q Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 20 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants who are adherent by pill count to coenzyme Q10

Number of participants who develop adverse safety events (including low systolic blood pressure or hyperkalemia) during participation in the study

Number of patients who complete the study after randomized assignment

Secondary outcome measures

Amount of interstitial fibrosis and tubular atrophy

Change in kidney function (eGFR) over a 20 week period

Changes in amount of protein excretion in the urine over a 20-week period

+1 more

WUBI-Q Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Watermelon Diet & Coenzyme Q10Active Control2 Interventions

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

Group II: Usual Diet & Coenzyme Q10Active Control2 Interventions

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

Group III: Usual Diet & PlaceboPlacebo Group2 Interventions

Placebo pill plus no watermelon in diet

Group IV: Watermelon Diet & PlaceboPlacebo Group2 Interventions

Placebo pill plus diet high in watermelon

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,500 Previous Clinical Trials

15,236,387 Total Patients Enrolled

Elaine KuPrincipal InvestigatorUniversity of California, San Francisco

1 Previous Clinical Trials

63 Total Patients Enrolled

Media Library

Watermelon diet Clinical Trial Eligibility Overview. Trial Name: NCT04972552 — N/A

Kidney Transplant Research Study Groups: Usual Diet & Placebo, Watermelon Diet & Coenzyme Q10, Usual Diet & Coenzyme Q10, Watermelon Diet & Placebo

Kidney Transplant Clinical Trial 2023: Watermelon diet Highlights & Side Effects. Trial Name: NCT04972552 — N/A

Watermelon diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT04972552 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants has this trial recruited thus far?

"Affirmative. Clinicaltrials.gov contains information showing that this research investigation is currently recruiting patients, having first been published on November 15th 2021 with the most recent amendment dated March 21st 2022. 84 participants are required between a single site of enrolment."

Answered by AI

Is this investigation open to participants at present?

"Affirmative. Clinicaltrials.gov displays that this research study, which was first published on November 15th 2021, is currently recruiting participants. 84 volunteers must be sourced from a single clinical centre."

Answered by AI

What is the primary goal of this clinical experiment?

"The primary outcome measure of this 20-week clinical trial is the number of patients who develop any adverse safety events, including hypotension and hyperkalemia. Secondary objectives involve tracking changes to kidney function as measured by eGFR (in mL/min/1.73m2), monitoring variations in urine protein/creatinine ratio (g/g) over time, and assessing the degree of interstitial fibrosis or tubular atrophy on a biopsy specimen."

Answered by AI

Recent research and studies

NutrientsJournal

Effects of Fresh Watermelon Consumption on the Acute Satiety Response and Cardiometabolic Risk Factors in Overweight and Obese Adults

Lum, Tiffany, Megan Connolly, Amanda Marx, Joshua Beidler, Shirin Hooshmand, Mark Kern, Changqi Liu, and Mee Hong. 2019. “Effects of Fresh Watermelon Consumption on the Acute Satiety Response and Cardiometabolic Risk Factors in Overweight and Obese Adults”. Nutrients. MDPI AG. doi:10.3390/nu11030595.

Nutrition ResearchJournal

Watermelon Consumption Improves Inflammation and Antioxidant Capacity in Rats Fed an Atherogenic Diet

Hong, Mee Young, Nicole Hartig, Katy Kaufman, Shirin Hooshmand, Arturo Figueroa, and Mark Kern. 2015. “Watermelon Consumption Improves Inflammation and Antioxidant Capacity in Rats Fed an Atherogenic Diet”. Nutrition Research. Elsevier BV. doi:10.1016/j.nutres.2014.12.005.

American Journal of HypertensionJournal

Watermelon Extract Supplementation Reduces Ankle Blood Pressure and Carotid Augmentation Index in Obese Adults with Prehypertension or Hypertension

Figueroa, A., M. A. Sanchez-Gonzalez, A. Wong, and B. H. Arjmandi. 2012. “Watermelon Extract Supplementation Reduces Ankle Blood Pressure and Carotid Augmentation Index in Obese Adults with Prehypertension or Hypertension”. American Journal of Hypertension. Oxford University Press (OUP). doi:10.1038/ajh.2012.20.

American Journal of Kidney DiseasesJournal