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Watermelon + Coenzyme Q10 for Kidney Transplant Care (WUBI-Q Trial)
N/A
Waitlist Available
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
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 20 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
Amount of interstitial fibrosis and tubular atrophy
Changes in amount of protein excretion in the urine over a 20-week period
Mean change in weight from baseline to 20 weeks
+1 moreTrial 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
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,590 Previous Clinical Trials
14,901,333 Total Patients Enrolled
Elaine KuPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
63 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a kidney transplant within the last four weeks.You are not currently following a high-watermelon diet or taking co-enzyme Q10 supplements.You are not very thin, with a body mass index of less than 19 kg/m2.You have relied on peritoneal dialysis or have had a transplant surgery before.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Diet & Placebo
- Group 2: Watermelon Diet & Coenzyme Q10
- Group 3: Usual Diet & Coenzyme Q10
- Group 4: Watermelon Diet & Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.