Watermelon/UBIQuinone Study

Kidney Transplantation Clinical Trial

— WUBI-Q  

Official title:

Watermelon/UBIQuinone Study (WUBI-Q Trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04972552
• Other study ID #: 21-34366
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• < 18 years of age at the time of transplant

• Preemptive transplantation

• Unable to provide informed consent

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Dietary Supplement:
• coenzyme Q10
Participants will take 800-1200 mg of coenzyme Q10 capsule per day

Other:
• Watermelon diet
Participants will be asked to eat watermelon at a minimum of one meal per day 3-5 days a week
• Usual Diet
Participants will be asked to eat a usual diet but not eat any watermelon as part of their usual diet
• Placebo
Participants will be asked to take 800-1200 mg of a placebo capsule per day

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	Proportion of participants with an eGFR < 60 mL/min/1.73 m2	We will assess kidney function outcomes at week 20	Baseline to 20 weeks
Secondary	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)