Watermelon/UBIQuinone Study (WUBI-Q Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Number of patients who complete the study after randomized assignment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Randomization will be performed by a pharmacy and investigators will not know the assignment until trial completion.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •< 18 years of age at the time of transplant
- •Preemptive transplantation
- •Unable to provide informed consent
结局指标
主要结局
Number of patients who complete the study after randomized assignment
时间窗: Measured at the 20 weeks mark
We will determine the number of patients who drop out of the study following randomized assignment
Number of participants who develop adverse safety events (including low systolic blood pressure or hyperkalemia) during participation in the study
时间窗: 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
次要结局
- 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))