Short-Term Effects of Therapeutic Diet in Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Concentrations of intact fibroblast growth factor 23 (pg/mL)
研究概览
简要总结
Patients with end-stage kidney disease have hyperphosphatemia and accumulated uremic toxin level due to decreased urine excretion ability. Unhealthy diet causes altered mineral metabolism, elevated uremic toxin level, immune dysregulation, and inflammation. The investigators hypothesize that therapeutic diet intervention reverses altered mineral metabolism, elevated uremic toxin level, immune dysregulation, and inflammation. In this study, the investigators crafted 7-day special healthy diet to illustrate the clinical implications of therapeutic diet for dialysis patients.
详细描述
The risk of cardiovascular disease (CVD) and mortality in patients with end-stage kidney disease (ESKD) is far greater than those in the general population. Emerging evidence suggests that unhealthy diet causes altered mineral metabolism, disturbance of gut microbiota (dysbiosis) with elevated uremic toxin level, immune dysregulation, and inflammation; these abnormalities are strongly related to development of CVD. Little is known about the relationship between therapeutic diet intervention and cardiovascular risk in patients with ESKD. Recently, the study of the investigators showed that ESKD patients undergoing hemodialysis who consumed very low-phosphate diet, phosphate-to-protein ratio (PPR) value of 8 mg/g, experienced an extra reduction of serum phosphorus level by 0.61 mg/dL compared with that of low-phosphate diet, PPR value of 10 mg/g.
The aim of the study is to explore the effect of 7-day therapeutic diet intervention on changes of altered mineral metabolism, uremic toxin production, immune dysregulation and inflammation, highlighting the important role of dietary modification in dialysis population.
It is to conduct a randomized controlled trial with cross-over design at a hemodialysis unit of tertiary teaching hospital in Northern Taiwan. Subjects with aged older than 20 years, ESKD undergoing maintenance dialysis for more than three months, having adequate dialysis and serum intact parathyroid hormone less than 800 pg/mL will be included. Participants will be randomly assigned into two groups: those in group A will receive study diet for 7 days, followed by 4-week washout period and then receive 7-day usual diet. The opposite order of diets will be prescribed in group B. The study meals are prepared in the hospital cafeteria. Dietary compositions of the study diets were analyzed before the start of the study. The study outcome measures are difference in change-from-baseline values of altered mineral metabolism, uremic toxin production, immune dysregulation and inflammation between the therapeutic diet and the usual diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Laboratory technicians who assess the study outcomes will be masked
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with aged older than 20 years, ESKD undergoing maintenance dialysis for more than three months, having adequate dialysis, serum intact parathyroid hormone less than 800 pg/mL and good dietary compliance
排除标准
- •Patients who meet any of the following criteria will be excluded from the study:
- •Serum albumin level less than 2.5 g/dL
- •Hospitalization within the past 4 weeks
- •Prebiotics, probiotics, symbiotics or antibiotics use within the past 4 weeks
- •History of psychiatric disorders
- •Having mental retardation
- •Those who dislike of the study meals
- •Soft diet requirement
结局指标
主要结局
Concentrations of intact fibroblast growth factor 23 (pg/mL)
时间窗: 7 days
Difference in change-from-baseline intact fibroblast growth factor 23 (pg/mL) between therapeutic diet and usual diet
次要结局
- Concentrations of C-terminal fibroblast growth factor 23 (RU/mL)(7 days)
- Concentrations of C-reactive protein (mg/dL)(7 days)
- Absolute number (per μl blood) of CD8+ (cluster of differentiation 8) T cells(7 days)
- Concentrations of calcium (mg/dL)(7 days)
- Concentrations of intact parathyroid hormone (pg/mL)(7 days)
- Absolute number (per μl blood) of monocytes(7 days)
- Percentage (%) of CD4+ (cluster of differentiation 4) T cells(7 days)
- Concentrations of phosphate (mg/dL)(7 days)
- Concentrations of free p-cresol sulfate (mg/L)(7 days)
- Concentrations of pre-albumin (g/dL)(7 days)
- Concentrations of free indoxyl sulfate (mg/L)(7 days)
- Concentrations of albumin (g/dL)(7 days)
- Absolute number (per μl blood) of CD4+ (cluster of differentiation 4) T cells(7 days)
- Percentage (%) of CD8+ (cluster of differentiation 8) T cells(7 days)
- Percentage (%) of monocytes(7 days)
研究者
Wan-Chuan Tsai
Principal Investigator, Assistant Professor
Far Eastern Memorial Hospital