Watermelon/UBIQuinone Study (WUBI-Q)

University of California San Francisco (UCSF)

Status: Active, not recruiting

Conditions: Kidney Transplantation

Treatments: Other: Usual Diet; Other: Watermelon diet; Dietary Supplement: coenzyme Q10; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04972552

21-34366

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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70 participants in 4 patient groups, including a placebo group

Watermelon Diet & Coenzyme Q10

Active Comparator group

Description:

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

Treatment:

Other: Watermelon diet

Dietary Supplement: coenzyme Q10

Usual Diet & Coenzyme Q10

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: coenzyme Q10

Other: Usual Diet

Watermelon Diet & Placebo

Placebo Comparator group

Description:

Placebo pill plus diet high in watermelon

Treatment:

Other: Placebo

Other: Watermelon diet

Usual Diet & Placebo

Placebo Comparator group

Description:

Placebo pill plus no watermelon in diet

Treatment:

Other: Placebo

Other: Usual Diet