Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Watermelon Diet & Coenzyme Q10 | Active Comparator | 800-1200 mg of coenzyme Q10 daily plus diet high in watermelon |
|
| Usual Diet & Coenzyme Q10 | Active Comparator | 800-1200 mg of coenzyme Q10 daily plus no watermelon in diet |
|
| Watermelon Diet & Placebo | Placebo Comparator | Placebo pill plus diet high in watermelon |
|
| Usual Diet & Placebo | Placebo Comparator | Placebo pill plus no watermelon in diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coenzyme Q10 | Dietary Supplement | Participants will take 800-1200 mg of coenzyme Q10 capsule per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in amount of protein excretion in the urine over a 20-week period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elaine Ku | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30870970 | Background | 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. | |
| 25631716 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C024989 | coenzyme Q10 |
Not provided
Not provided
Not provided
2x2 placebo-controlled factorial trial
Not provided
Not provided
Randomization will be performed by a pharmacy and investigators will not know the assignment until trial completion.
|
| Watermelon diet | Other | Participants will be asked to eat watermelon at a minimum of one meal per day 3-5 days a week |
|
| Usual Diet | Other | Participants will be asked to eat a usual diet but not eat any watermelon as part of their usual diet |
|
| Placebo | Other | Participants will be asked to take 800-1200 mg of a placebo capsule per day |
|
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 |
| 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 |
| 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) |
| 27749691 | 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. |
| 22402472 | 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. |
| 27927588 | 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. |
| 31431058 | 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. |
| 15368706 | 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. |
| 26531095 | 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. |
| 27556488 | 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. |