Clinical trial NCT04972552: Watermelon/UBIQuinone Study
Official title: Watermelon/UBIQuinone Study (WUBI-Q Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Transplantation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 placebo-controlled factorial trial
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients who complete the study after randomized assignment
timeFrame: Measured at the 20 weeks mark
measure: Number of participants who develop adverse safety events (including low systolic blood pressure or hyperkalemia) during participation in the study
timeFrame: Measured from 0-20 weeks
Secondary outcomes:
measure: Mean change in weight from baseline to 20 weeks
timeFrame: Baseline to 20 weeks
measure: Changes in amount of protein excretion in the urine over a 20-week period
timeFrame: Baseline to 20 weeks
measure: Proportion of participants with an eGFR < 60 mL/min/1.73 m2
timeFrame: Baseline to 20 weeks
measure: Amount of interstitial fibrosis and tubular atrophy
timeFrame: At 20 weeks (cross-sectional)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Elaine Ku
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lum T, Connolly M, Marx A, Beidler J, Hooshmand S, Kern M, Liu C, Hong MY. Effects of Fresh Watermelon Consumption on the Acute Satiety Response and Cardiometabolic Risk Factors in Overweight and Obese Adults. Nutrients. 2019 Mar 12;11(3):595. doi: 10.3390/nu11030595.
citation: Hong MY, Hartig N, Kaufman K, Hooshmand S, Figueroa A, Kern M. Watermelon consumption improves inflammation and antioxidant capacity in rats fed an atherogenic diet. Nutr Res. 2015 Mar;35(3):251-8. doi: 10.1016/j.nutres.2014.12.005. Epub 2015 Jan 3.
citation: Figueroa A, Wong A, Jaime SJ, Gonzales JU. Influence of L-citrulline and watermelon supplementation on vascular function and exercise performance. Curr Opin Clin Nutr Metab Care. 2017 Jan;20(1):92-98. doi: 10.1097/MCO.0000000000000340.
citation: Figueroa A, Sanchez-Gonzalez MA, Wong A, Arjmandi BH. Watermelon extract supplementation reduces ankle blood pressure and carotid augmentation index in obese adults with prehypertension or hypertension. Am J Hypertens. 2012 Jun;25(6):640-3. doi: 10.1038/ajh.2012.20. Epub 2012 Mar 8.
citation: Rivara MB, Yeung CK, Robinson-Cohen C, Phillips BR, Ruzinski J, Rock D, Linke L, Shen DD, Ikizler TA, Himmelfarb J. Effect of Coenzyme Q10 on Biomarkers of Oxidative Stress and Cardiac Function in Hemodialysis Patients: The CoQ10 Biomarker Trial. Am J Kidney Dis. 2017 Mar;69(3):389-399. doi: 10.1053/j.ajkd.2016.08.041. Epub 2016 Dec 4.
citation: Yu JH, Lim SW, Luo K, Cui S, Quan Y, Shin YJ, Lee KE, Kim HL, Ko EJ, Chung BH, Kim JH, Chung SJ, Yang CW. Coenzyme Q10 alleviates tacrolimus-induced mitochondrial dysfunction in kidney. FASEB J. 2019 Nov;33(11):12288-12298. doi: 10.1096/fj.201900386RR. Epub 2019 Aug 20.
citation: Dlugosz A, Kuzniar J, Sawicka E, Marchewka Z, Lembas-Bogaczyk J, Sajewicz W, Boratynska M. Oxidative stress and coenzyme Q10 supplementation in renal transplant recipients. Int Urol Nephrol. 2004;36(2):253-8. doi: 10.1023/b:urol.0000034652.88578.a8.
citation: Yeung CK, Billings FT 4th, Claessens AJ, Roshanravan B, Linke L, Sundell MB, Ahmad S, Shao B, Shen DD, Ikizler TA, Himmelfarb J. Coenzyme Q10 dose-escalation study in hemodialysis patients: safety, tolerability, and effect on oxidative stress. BMC Nephrol. 2015 Nov 3;16:183. doi: 10.1186/s12882-015-0178-2.
citation: Shanely RA, Nieman DC, Perkins-Veazie P, Henson DA, Meaney MP, Knab AM, Cialdell-Kam L. Comparison of Watermelon and Carbohydrate Beverage on Exercise-Induced Alterations in Systemic Inflammation, Immune Dysfunction, and Plasma Antioxidant Capacity. Nutrients. 2016 Aug 22;8(8):518. doi: 10.3390/nu8080518.