Watermelon/UBIQuinone Study

NCT04972552 | Active Not Recruiting

• 1 other identifier: 21-34366
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Mean change in weight from baseline to 20 weeks

  Baseline to 20 weeks

• Changes in amount of protein excretion in the urine over a 20-week period

  Baseline to 20 weeks

• Proportion of participants with an eGFR < 60 mL/min/1.73 m2

  Baseline to 20 weeks

• Amount of interstitial fibrosis and tubular atrophy

  At 20 weeks (cross-sectional)

Study Arms (4)

Watermelon Diet & Coenzyme Q10

ACTIVE COMPARATOR

800-1200 mg of coenzyme Q10 daily plus diet high in watermelon

Dietary Supplement: coenzyme Q10; Other: Watermelon diet

Usual Diet & Coenzyme Q10

ACTIVE COMPARATOR

800-1200 mg of coenzyme Q10 daily plus no watermelon in diet

Dietary Supplement: coenzyme Q10; Other: Usual Diet

Watermelon Diet & Placebo

PLACEBO COMPARATOR

Placebo pill plus diet high in watermelon

Other: Watermelon diet; Other: Placebo

Usual Diet & Placebo

PLACEBO COMPARATOR

Placebo pill plus no watermelon in diet

Other: Usual Diet; Other: Placebo

Interventions

coenzyme Q10 DIETARY_SUPPLEMENT

Participants will take 800-1200 mg of coenzyme Q10 capsule per day

Also known as: CoQ10

Usual Diet & Coenzyme Q10; Watermelon Diet & Coenzyme Q10

Watermelon diet OTHER

Participants will be asked to eat watermelon at a minimum of one meal per day 3-5 days a week

Watermelon Diet & Coenzyme Q10; Watermelon Diet & Placebo

Usual Diet OTHER

Participants will be asked to eat a usual diet but not eat any watermelon as part of their usual diet

Usual Diet & Coenzyme Q10; Usual Diet & Placebo

Placebo OTHER

Participants will be asked to take 800-1200 mg of a placebo capsule per day

Usual Diet & Placebo; Watermelon Diet & Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \< 18 years of age at the time of transplant
• Preemptive transplantation
• Unable to provide informed consent

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (9)

• 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.

  PMID: 30870970 BACKGROUND

• 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.

  PMID: 25631716 BACKGROUND

• 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.

  PMID: 27749691 BACKGROUND

• 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.

  PMID: 22402472 BACKGROUND

• 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.

  PMID: 27927588 BACKGROUND

• 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.

  PMID: 31431058 BACKGROUND

• 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.

  PMID: 15368706 BACKGROUND

• 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.

  PMID: 26531095 BACKGROUND

• 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.

  PMID: 27556488 BACKGROUND

MeSH Terms

Interventions

coenzyme Q10

Study Officials

• Elaine Ku

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be performed by a pharmacy and investigators will not know the assignment until trial completion.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 placebo-controlled factorial trial

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 22, 2021
• Study Start: November 15, 2021
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)