Watermelon/UBIQuinone Study (WUBI-Q Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Number of patients who complete the study after randomized assignment
Study Overview
Brief Summary
The objective of the proposed pilot trial is to determine the feasibility and safety of increasing watermelon consumption, with or without coenzyme Q supplementation in patients after kidney transplantation on kidney function and urinary protein excretion.
Detailed Description
While many observational studies have examined the effects of consuming watermelon in patients without chronic kidney disease, there have been few studies on the consumption of a diet high in watermelon as a means of improving kidney function or reducing protein in the urine. Coenzyme Q is also recognized as a supplement that has benefits for heart health and has anti-oxidative effects, but whether it could be used to improve kidney function or reduce protein in the urine has not been thoroughly examined, especially in the kidney transplant population. The objective of the proposed pilot trial is to determine the feasibility and safety of increasing watermelon consumption, with or without coenzyme Q supplementation in patients after kidney transplantation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Randomization will be performed by a pharmacy and investigators will not know the assignment until trial completion.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or older
- •Received a kidney transplant in the last four weeks
- •History of dialysis dependency prior to kidney transplant
- •Able to provide informed consent
- •Not currently consuming a high-watermelon diet or taking co-enzyme Q10
- •Not underweight (body mass index <19 kg/m2)
- •Not enrolled in any other interventional trial
- •Planning to return for follow-up at UCSF (or willing to return for study visits)
Exclusion Criteria
- •< 18 years of age at the time of transplant
- •Preemptive transplantation
- •Unable to provide informed consent
Arms & Interventions
Watermelon Diet & Coenzyme Q10
800-1200 mg of coenzyme Q10 daily plus diet high in watermelon
Intervention: Watermelon diet (Other)
Usual Diet & Coenzyme Q10
800-1200 mg of coenzyme Q10 daily plus no watermelon in diet
Intervention: Usual Diet (Other)
Watermelon Diet & Placebo
Placebo pill plus diet high in watermelon
Intervention: Watermelon diet (Other)
Watermelon Diet & Placebo
Placebo pill plus diet high in watermelon
Intervention: Placebo (Other)
Usual Diet & Placebo
Placebo pill plus no watermelon in diet
Intervention: Usual Diet (Other)
Usual Diet & Placebo
Placebo pill plus no watermelon in diet
Intervention: Placebo (Other)
Usual Diet & Coenzyme Q10
800-1200 mg of coenzyme Q10 daily plus no watermelon in diet
Intervention: coenzyme Q10 (Dietary Supplement)
Watermelon Diet & Coenzyme Q10
800-1200 mg of coenzyme Q10 daily plus diet high in watermelon
Intervention: coenzyme Q10 (Dietary Supplement)
Outcomes
Primary Outcomes
Number of patients who complete the study after randomized assignment
Time Frame: Measured at the 20 weeks mark
We will determine the number of patients who drop out of the study following randomized assignment
Number of participants who develop adverse safety events (including low systolic blood pressure or hyperkalemia) during participation in the study
Time Frame: Measured from 0-20 weeks
We will measure the number of patients who develop low blood pressure and high potassium levels (hyperkalemia) following randomized assignment. Low blood pressure will be defined as systolic blood pressure \< 90 mmHg; hyperkalemia will be defined as serum potassium \> 5.5 meq/L
Secondary Outcomes
- Mean change in weight from baseline to 20 weeks(Baseline to 20 weeks)
- Changes in amount of protein excretion in the urine over a 20-week period(Baseline to 20 weeks)
- Proportion of participants with an eGFR < 60 mL/min/1.73 m2(Baseline to 20 weeks)
- Amount of interstitial fibrosis and tubular atrophy(At 20 weeks (cross-sectional))