The Effect of Low-protein Rice on Nutritional Status and Other Outcomes of Patients With Chronic Kidney Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 主要终点
- estimated glomerular filtration rate (eGFR) (mL/min/1.73m2)
研究概览
简要总结
- To examine nutrient intake change in chronic kidney disease patients consuming " Low Protein Rice MATSUBUMAI "compared to a regular care group at 0,1,3,6 month.
- To assess nutritional status improved or maintained after low protein rice intervention.
- To assess whether the patient's renal function improved or maintained after low protein rice intervention.
详细描述
- Recruited the subjects procedures A physical checking the history and blood biochemical data will be carried out by the study physician to verify eligibility for enrollment study at outpatient. A physical explain and answer about the study procedure and criteria to subjects.
Subjects review informed consent and sign it. 2. The trail procedures(brief describe)
1.After the subjects will sign informed consent form at the outpatient, they will be enrolled (phone) and schedule study visit1 (M0) by study staff. 2.The study visit1 will collect demographics, blood, urine and distribute product and product consumption diaries, and perform SGA (Subjective Global Assessment). 3.The study visit2 (M1), after the product be used for 4 weeks, will collect adverse event, blood,urine, and SGA. 4.The study visit3(M3), after the product be used for 12 weeks, will collect adverse event, blood,urine, and SGA. 5.The study visit4(M6), after the product be used for 24 weeks, will collect adverse event, blood,urine, and SGA. 3.Subject and study design： Investigators will recruit 100 subjects participating in the"PRE-ESRD education plan" at KMUH.
Subjects will receive dietary education of low protein diet (providing energy 25 to 35 Kcal/Kg/day, protein 0.6 to 0.8 g/Kg/day) by dietitians. Subjects will be randomly assigned to a observational group or rue low protein rice group. Observational group (n=40): Forty subjects will be enrolled. Subjects will receive routine dietary education of low protein diet. True Low Protein Rice group (n=60): Subjects will replace regular staple foods with low protein rice. Subjects will replace regular staple foods with low protein rice at levels of 40-160grams/ day. According to subjects' intake, subjects will be further divided into low & high intake groups for analysis. High intake group: Subjects consuming low Protein Rice at levels of 81-160 grams/day. Low intake group: Subjects consuming low Protein Rice at levels of 40-80 grams/day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
estimated glomerular filtration rate (eGFR) (mL/min/1.73m2)
时间窗: baseline, 6 month
residual renal function
albumin (g/dL)
时间窗: baseline, 6 month
nutritional indicators
creatinine (mg/dL)
时间窗: baseline, 6 month
residual renal function
handgrip strength (kg)
时间窗: baseline, 6 month
nutritional indicators
blood urea nitrogen (mg/dL)
时间窗: baseline, 6 month
residual renal function
nitrogen balance (g/day)
时间窗: baseline, 6 month
nutritional indicators
次要结局
- Body weight (kg)(baseline, 6 month)
- fat mass (%)(baseline, 6 month)
- potassium (mmol/L)(baseline, 6 month)
- phosphorus (mg/dL)(baseline, 6 month)
- protein intake (g/day)(baseline, 6 month)
- muscle mass (kg)(baseline, 6 month)
- energy intake (Kcal/day)(baseline, 6 month)
研究者
Shang-Jyh,Hwang
Associate Dean
Kaohsiung Medical University Chung-Ho Memorial Hospital