Comparison of the Effects of Animal Protein Diet and Plant Protein Diet on Blood Test Result and Clinical Outcome in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Statistical difference of serum biomarkers ( P value)
研究概览
简要总结
Chronic hemodialysis (CHD) patients are vulnerable to develop protein energy malnutrition and make a notion that to maintain the nutritional status is of paramount importance in these patients. However, proteins intake from vegetarian and meat diet were observed to have different impacts on nutritional and inflammatory status, mineral homeostasis and its related hormones, and clinical outcomes in non-dialysis CKD patients. In here, we aim to investigate these impacts in CHD patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hemodialysis patient
排除标准
- •Hemodialysis less than 3 months
- •Age < 20 years or >90 years
- •Serum albumin < 3 g/dL，
- •Daily protein diet < 0.6 gm/kg/day or > 1.2 gm/kg/ day，
- •Cannot obey the diet plan: Gastrectomy, difficult in swallowing
- •Active infection, severe illness: cancer patient, liver cirrhosis, etc.
- •Unable to cooperate in the study
研究组 & 干预措施
Plant protein diet
18 g of plant protein diet added every day for 3 months , and after washout for 1 month, 18 g of animal protein diet added every day for 3 months
干预措施: protein diet (Dietary Supplement)
Animal protein diet
18 g of animal protein diet added every day for 3 months, and after washout for 1 month, 18 g of plant protein diet added every day for 3 months
干预措施: protein diet (Dietary Supplement)
结局指标
主要结局
Statistical difference of serum biomarkers ( P value)
时间窗: 7 months
The items scheduled to be evaluated in this study include serum albumin, pre-albumin, phosphate, calcium, magnesium, lipid profile, ferritin, transferrin, hs-CRP, Alk-P, iPTH, 25(OH)D3, intact \& C-terminal FGF23, Klotho and hepcidin levels. We'll collect the patient's serum data in plant diet group, and collect the serum data in animal diet group, then we'll compare the data in these two groups to see whether there is any difference between each item.
次要结局
- Statistical difference of medical visits(7 months)