NCT05350098进行中（未招募）不适用
A Randomized Controlled Trial to Evaluate the Efficacy of Plant-protein Diets in Patients With Chronic Kidney Disease: a Pilot-study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of plant-protein diets for 12 weeks in patients with advanced chronic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with chronic kidney disease who were referred to the Outpatient Department of Nephrology at Osaka University Hospital
- •eGFR < 20 mL/min/1.73 m2
- •taking anigiotensin-converting enzyme inhibitors or angiotensin Ⅱ receptor blockers or angiotensin receptor neprilysin inhibitor
- •K < 5.5 mEq/L
排除标准
- •Being planned to intitate renal replacement therapies within 3 months
- •Having inflammatory bowel diseases
- •History of gastrointestinal tract surgery
- •Taking antibiotics within 1 month before the entry
- •Taking or being planned to start warfarin
- •Having dietary allergies
- •Having difficulty in oral intake
- •During pregnancy or breastfeeding
- •Unsuitable for participant in the trial by an attending physician
结局指标
主要结局
Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide
时间窗: 4 weeks after starting intervention
次要结局
- Change in eGFR(4 weeks after starting intervention)
- Change in serum bicarbonete levels(4 weeks after starting intervention)
- Change in serum levels of acetic acid, propionic acid and butyric acid(4 weeks after starting intervention)
- Change in urinary citrate to creatinine ratio(4 weeks after starting intervention)
- Change in blood pressure(4 weeks after starting intervention)
- Dietary adherence(4 weeks after starting intervention)
- Diversity and composition of the gut microbiota(4 weeks after starting intervention)
- Change in muscle mass(4 weeks after starting intervention)
- Change in urinary protein creatinine ratio(4 weeks after starting intervention)
- Change in serum levels of calcium, phosphate, intact parathyroid hormone and intact fibroblast growth factor 23(4 weeks after starting intervention)
- The number of oral medications including antihypertensive drugs, diuretics, potassium tablets, potassium binders, phosphate binders, calcium tablets, active vitamin D3 analogs and sodium bicarbonate(4 weeks after starting intervention)
研究者
Yusuke Sakaguchi
assistant professor
Osaka University
研究点 (2)
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