Watermelon/UBIQuinone Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Watermelon/UBIQuinone Study (WUBI-Q Trial)

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Dietary Supplement: coenzyme Q10
* Other: Watermelon diet
* Other: Usual Diet
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2x2 placebo-controlled factorial trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Watermelon Diet & Coenzyme Q10<br>800-1200 mg of coenzyme Q10 daily plus diet high in watermelon | Dietary Supplement: coenzyme Q10<br>* Participants will take 800-1200 mg of coenzyme Q10 capsule per day<br>* Other names: CoQ10;Other: Watermelon diet<br>* Participants will be asked to eat watermelon at a minimum of one meal per day 3-5 days a week<br>|
| Active Comparator: Usual Diet & Coenzyme Q10<br>800-1200 mg of coenzyme Q10 daily plus no watermelon in diet | Dietary Supplement: coenzyme Q10<br>* Participants will take 800-1200 mg of coenzyme Q10 capsule per day<br>* Other names: CoQ10;Other: Usual Diet<br>* Participants will be asked to eat a usual diet but not eat any watermelon as part of their usual diet<br>|
| Placebo Comparator: Watermelon Diet & Placebo<br>Placebo pill plus diet high in watermelon | Other: Watermelon diet<br>* Participants will be asked to eat watermelon at a minimum of one meal per day 3-5 days a week<br>Other: Placebo<br>* Participants will be asked to take 800-1200 mg of a placebo capsule per day<br>|
| Placebo Comparator: Usual Diet & Placebo<br>Placebo pill plus no watermelon in diet | Other: Usual Diet<br>* Participants will be asked to eat a usual diet but not eat any watermelon as part of their usual diet<br>Other: Placebo<br>* Participants will be asked to take 800-1200 mg of a placebo capsule per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who complete the study after randomized assignment | We will determine the number of patients who drop out of the study following randomized assignment | Measured at the 20 weeks mark | 
| Number of participants who develop adverse safety events (including low systolic blood pressure or hyperkalemia) during participation in the study | 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 | Measured from 0-20 weeks | 
| Number of participants who are adherent by pill count to coenzyme Q10 | Pill count adherence will be computed as the percentage of the number of prescribed pills corrected for the number of returned pills divided by the period (in days) multiplied by 100% | Measures from 0-20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in weight from baseline to 20 weeks | We will check for a change in weight, measured in kg, at the start and end of the intervention period. | Baseline to 20 weeks | 
| Changes in amount of protein excretion in the urine over a 20-week period | We will check for a change in urine protein/creatinine ratio (g/g) at the start and end of the intervention period. | Baseline to 20 weeks | 
| Change in kidney function (eGFR) over a 20 week period | We will assess changes in patient kidney function based on eGFR measured by CKD-EPI equation in mL/min/1.73 m2 throughout the intervention period. | Baseline to 20 weeks | 
| Amount of interstitial fibrosis and tubular atrophy | We will compare the degree of interstitial fibrosis or tubular atrophy (as a percentage on a biopsy specimen) based on kidney biopsy results. | At 20 weeks (cross-sectional) |