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Watermelon/UBIQuinone Study (WUBI-Q)

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ClinicalTrials.gov Identifier: NCT04972552
Recruitment Status : Not yet recruiting
First Posted : July 22, 2021
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Dietary Supplement: coenzyme Q10 Other: Watermelon diet Other: Usual Diet Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2x2 placebo-controlled factorial trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Randomization will be performed by a pharmacy and investigators will not know the assignment until trial completion.
Primary Purpose: Other
Official Title: Watermelon/UBIQuinone Study (WUBI-Q Trial)
Estimated Study Start Date : October 15, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Watermelon Diet & Coenzyme Q10
800-1200 mg of coenzyme Q10 daily plus diet high in watermelon
Dietary Supplement: coenzyme Q10
Participants will take 800-1200 mg of coenzyme Q10 capsule per day
Other Name: CoQ10

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

Active Comparator: Usual Diet & Coenzyme Q10
800-1200 mg of coenzyme Q10 daily plus no watermelon in diet
Dietary Supplement: coenzyme Q10
Participants will take 800-1200 mg of coenzyme Q10 capsule per day
Other Name: CoQ10

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

Placebo Comparator: Watermelon Diet & Placebo
Placebo pill plus diet high in watermelon
Other: Watermelon diet
Participants will be asked to eat watermelon at a minimum of one meal per day 3-5 days a week

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

Placebo Comparator: Usual Diet & Placebo
Placebo pill plus no watermelon in diet
Other: Usual Diet
Participants will be asked to eat a usual diet but not eat any watermelon as part of their usual diet

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




Primary Outcome Measures :
  1. Number of patients who complete the study after randomized assignment [ Time Frame: Measured at the 20 weeks mark ]
    We will determine the number of patients who drop out of the study following randomized assignment

  2. Number of participants who develop adverse safety events (including low systolic blood pressure or hyperkalemia) during participation in the study [ Time Frame: Measured from 0-20 weeks ]
    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

  3. Number of participants who are adherent by pill count to coenzyme Q10 [ Time Frame: Measures from 0-20 weeks ]
    Pill count adherence will be computed as the percentage of the number of prescribed pills corrected for the number of returned pills divided by the period (in days) multiplied by 100%


Secondary Outcome Measures :
  1. Mean change in weight from baseline to 20 weeks [ Time Frame: Baseline to 20 weeks ]
    We will check for a change in weight, measured in kg, at the start and end of the intervention period.

  2. Changes in amount of protein excretion in the urine over a 20-week period [ Time Frame: Baseline to 20 weeks ]
    We will check for a change in urine protein/creatinine ratio (g/g) at the start and end of the intervention period.

  3. Change in kidney function (eGFR) over a 20 week period [ Time Frame: Baseline to 20 weeks ]
    We will assess changes in patient kidney function based on eGFR measured by CKD-EPI equation in mL/min/1.73 m2 throughout the intervention period.

  4. Amount of interstitial fibrosis and tubular atrophy [ Time Frame: At 20 weeks (cross-sectional) ]
    We will compare the degree of interstitial fibrosis or tubular atrophy (as a percentage on a biopsy specimen) based on kidney biopsy results.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Received a kidney transplant in the last four weeks
  • Potassium < 4.8 at time of randomization (not having high potassium already)
  • History of hemodialysis dependency (and not peritoneal dialysis) 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)
  • Receiving standard immunosuppression regimen (mycophenolate, and tacrolimus)
  • 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
  • Potassium >=4.8 meq/L at randomization
  • History of peritoneal dialysis dependency or preemptive transplantation
  • Unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04972552


Contacts
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Contact: Elaine Ku, MD, MAS 415-514-0989 elaine.ku@ucsf.edu
Contact: Divya Seth, BA 415-514-0989 divya.seth@ucsf.edu

Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Contact: Elaine Ku, MD       elaine.ku@ucsf.edu   
Contact: Deborah Adey, MD       deborah.adey@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Elaine Ku University of California, San Francisco
Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04972552    
Other Study ID Numbers: 21-34366
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ubiquinone
Coenzyme Q10
Micronutrients
Physiological Effects of Drugs
Vitamins