Kidney Transplantation
Conditions
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.
Interventions
DIETARY_SUPPLEMENTcoenzyme Q10
Participants will take 800-1200 mg of coenzyme Q10 capsule per day
OTHERWatermelon diet
Participants will be asked to eat watermelon at a minimum of one meal per day 3-5 days a week
OTHERUsual Diet
Participants will be asked to eat a usual diet but not eat any watermelon as part of their usual diet
OTHERPlacebo
Participants will be asked to take 800-1200 mg of a placebo capsule per day
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Randomization will be performed by a pharmacy and investigators will not know the assignment until trial completion.
Intervention model description
2x2 placebo-controlled factorial trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who complete the study after randomized assignment | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean change in weight from baseline to 20 weeks | Baseline to 20 weeks | We will check for a change in weight, measured in kg, at the start and end of the intervention period. |
| Changes in amount of protein excretion in the urine over a 20-week period | Baseline to 20 weeks | We will check for a change in urine protein/creatinine ratio (g/g) at the start and end of the intervention period. |
| Proportion of participants with an eGFR < 60 mL/min/1.73 m2 | Baseline to 20 weeks | We will assess kidney function outcomes at week 20 |
| Amount of interstitial fibrosis and tubular atrophy | At 20 weeks (cross-sectional) | We will compare the degree of interstitial fibrosis or tubular atrophy (as a percentage on a biopsy specimen) based on kidney biopsy results. |
Countries
United States
Outcome results
None listed