Watermelon/UBIQuinone Study

Not Applicable

Active, not recruiting

Interventions: Dietary Supplement: coenzyme Q10
Other: Usual Diet
Other: Placebo
Other: Watermelon diet

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Watermelon Diet & Placebo	Placebo	Placebo pill plus diet high in watermelon
Usual Diet & Placebo	Placebo	Placebo pill plus no watermelon in diet
Watermelon Diet & Coenzyme Q10	coenzyme Q10	800-1200 mg of coenzyme Q10 daily plus diet high in watermelon
Usual Diet & Coenzyme Q10	coenzyme Q10	800-1200 mg of coenzyme Q10 daily plus no watermelon in diet
Watermelon Diet & Coenzyme Q10	Watermelon diet	800-1200 mg of coenzyme Q10 daily plus diet high in watermelon
Watermelon Diet & Placebo	Watermelon diet	Placebo pill plus diet high in watermelon
Usual Diet & Placebo	Usual Diet	Placebo pill plus no watermelon in diet
Usual Diet & Coenzyme Q10	Usual Diet	800-1200 mg of coenzyme Q10 daily plus no watermelon in diet

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Locations (1): University of California San Francisco
🇺🇸
San Francisco, California, United States