Study Summary
This trial will test whether watermelon and/or coenzyme Q supplementation is safe and improves kidney function in patients after a kidney transplant.
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
3 Primary · 4 Secondary · Reporting Duration: Baseline to 20 weeks
At 20 weeks (cross-sectional)
Amount of interstitial fibrosis and tubular atrophy
Baseline to 20 weeks
Change in kidney function (eGFR) over a 20 week period
Changes in amount of protein excretion in the urine over a 20-week period
Mean change in weight from baseline to 20 weeks
Week 20
Number of patients who complete the study after randomized assignment
Measured from 0-20 weeks
Number of participants who develop adverse safety events (including low systolic blood pressure or hyperkalemia) during participation in the study
Measures from 0-20 weeks
Number of participants who are adherent by pill count to coenzyme Q10
Trial Safety
Phase-Based Safety
Trial Design
4 Treatment Groups
Usual Diet & Coenzyme Q10
1 of 4
Watermelon Diet & Coenzyme Q10
1 of 4
Usual Diet & Placebo
1 of 4
Watermelon Diet & Placebo
1 of 4
Active Control
Non-Treatment Group
84 Total Participants · 4 Treatment Groups
Primary Treatment: Usual Diet & Coenzyme Q10 · Has Placebo Group · N/A
Usual Diet & Coenzyme Q10ActiveComparator Group · 2 Interventions: coenzyme Q10, Usual Diet · Intervention Types: DietarySupplement, Other
Usual Diet & PlaceboPlaceboComparator Group · 2 Interventions: Placebo, Usual Diet · Intervention Types: Other, Other
Watermelon Diet & Coenzyme Q10ActiveComparator Group · 2 Interventions: coenzyme Q10, Watermelon diet · Intervention Types: DietarySupplement, Other
Watermelon Diet & PlaceboPlaceboComparator Group · 2 Interventions: Watermelon diet, Placebo · Intervention Types: Other, Other
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 20 weeks
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,347 Previous Clinical Trials
11,783,028 Total Patients Enrolled
Elaine KuPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
63 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You had a kidney transplant within the last four weeks.
You are not currently following a high-watermelon diet or taking co-enzyme Q10 supplements.
You are not very thin, with a body mass index of less than 19 kg/m2.
References
- Lum, Tiffany, Megan Connolly, Amanda Marx, Joshua Beidler, Shirin Hooshmand, Mark Kern, Changqi Liu, and Mee Hong. 2019. “Effects of Fresh Watermelon Consumption on the Acute Satiety Response and Cardiometabolic Risk Factors in Overweight and Obese Adults”. Nutrients. MDPI AG. doi:10.3390/nu11030595.
- Hong, Mee Young, Nicole Hartig, Katy Kaufman, Shirin Hooshmand, Arturo Figueroa, and Mark Kern. 2015. “Watermelon Consumption Improves Inflammation and Antioxidant Capacity in Rats Fed an Atherogenic Diet”. Nutrition Research. Elsevier BV. doi:10.1016/j.nutres.2014.12.005.
- Figueroa, A., M. A. Sanchez-Gonzalez, A. Wong, and B. H. Arjmandi. 2012. “Watermelon Extract Supplementation Reduces Ankle Blood Pressure and Carotid Augmentation Index in Obese Adults with Prehypertension or Hypertension”. American Journal of Hypertension. Oxford University Press (OUP). doi:10.1038/ajh.2012.20.
- Rivara, Matthew B., Catherine K. Yeung, Cassianne Robinson-Cohen, Brian R. Phillips, John Ruzinski, Denise Rock, Lori Linke, Danny D. Shen, T. Alp Ikizler, and Jonathan Himmelfarb. 2017. “Effect of Coenzyme Q10 on Biomarkers of Oxidative Stress and Cardiac Function in Hemodialysis Patients: The Coq10 Biomarker Trial”. American Journal of Kidney Diseases. Elsevier BV. doi:10.1053/j.ajkd.2016.08.041.
- Yu, Ji Hyun, Sun Woo Lim, Kang Luo, Sheng Cui, Yi Quan, Yoo Jin Shin, Kyung Eun Lee, et al.. 2019. “Coenzyme Q 10 Alleviates Tacrolimus‐induced Mitochondrial Dysfunction in Kidney”. The FASEB Journal. Wiley. doi:10.1096/fj.201900386rr.
- Yeung, Catherine K., Frederic T. Billings IV, Adam J. Claessens, Baback Roshanravan, Lori Linke, Mary B. Sundell, Suhail Ahmad, et al.. 2015. “Coenzyme Q10 Dose-escalation Study in Hemodialysis Patients: Safety, Tolerability, and Effect on Oxidative Stress”. BMC Nephrology. Springer Science and Business Media LLC. doi:10.1186/s12882-015-0178-2.
- Figueroa, Arturo, Alexei Wong, Salvador J. Jaime, and Joaquin U. Gonzales. 2017. “Influence of L-citrulline and Watermelon Supplementation on Vascular Function and Exercise Performance”. Current Opinion in Clinical Nutrition & Metabolic Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mco.0000000000000340.
- Długosz, A., J. Kuźniar, E. Sawicka, Z. Marchewka, J. Lembas-Bogaczyk, W. Sajewicz, and M. Boratyńska. 2004. “Oxidative Stress and Coenzyme Q10supplementation in Renal Transplant Recipients”. International Urology and Nephrology. Springer Science and Business Media LLC. doi:10.1023/b:urol.0000034652.88578.a8.
- Shanely, R., David Nieman, Penelope Perkins-Veazie, Dru Henson, Mary Meaney, Amy Knab, and Lynn Cialdell-Kam. 2016. “Comparison of Watermelon and Carbohydrate Beverage on Exercise-induced Alterations in Systemic Inflammation, Immune Dysfunction, and Plasma Antioxidant Capacity”. Nutrients. MDPI AG. doi:10.3390/nu8080518.
- Yeung, Catherine K., Frederic T. Billings IV, Adam J. Claessens, Baback Roshanravan, Lori Linke, Mary B. Sundell, Suhail Ahmad, et al.. 2015. “Coenzyme Q10 Dose-escalation Study in Hemodialysis Patients: Safety, Tolerability, and Effect on Oxidative Stress”. BMC Nephrology. Springer Science and Business Media LLC. doi:10.1186/s12882-015-0178-2.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2021. "Watermelon/UBIQuinone Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04972552.
Frequently Asked Questions
How many participants has this trial recruited thus far?
"Affirmative. Clinicaltrials.gov contains information showing that this research investigation is currently recruiting patients, having first been published on November 15th 2021 with the most recent amendment dated March 21st 2022. 84 participants are required between a single site of enrolment." - Anonymous Online Contributor
Unverified Answer
Is this investigation open to participants at present?
"Affirmative. Clinicaltrials.gov displays that this research study, which was first published on November 15th 2021, is currently recruiting participants. 84 volunteers must be sourced from a single clinical centre." - Anonymous Online Contributor
Unverified Answer
What is the primary goal of this clinical experiment?
"The primary outcome measure of this 20-week clinical trial is the number of patients who develop any adverse safety events, including hypotension and hyperkalemia. Secondary objectives involve tracking changes to kidney function as measured by eGFR (in mL/min/1.73m2), monitoring variations in urine protein/creatinine ratio (g/g) over time, and assessing the degree of interstitial fibrosis or tubular atrophy on a biopsy specimen." - Anonymous Online Contributor
Unverified Answer