Effect of High Protein Diet in Stroke Patients With Low Muscle Mass
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- modified Rankin Scale 0-1
研究概览
简要总结
Our prior studies demonstrated that dehydration was a predictor for poor outcome in stroke and Blood urea nitrogen/Cr ratio-based saline hydration therapy in patients with acute ischemic stroke may increase the rate of favorable clinical outcome with functional independence at 3 months after stroke. However, dehydration is likely to be only a part of representation in poor nutrition status and physical fragility for a stroke patient.
Our prior study found that acute stroke patients admitted to neurological intensive care unit with low urinary creatinine excretion rate (CER), a marker of muscle mass, was associated with poor outcome at 6 months after stroke. An animal study suggested inadequate food and water intake determine mortality following stroke in mice and nutritional support reduced the 14-day mortality rate from 59% to 15%. A study also showed that high protein intake was associated with a better outcome in previous cardiovascular events.
We will calculate CER based on published equation. Based on our prior study, acute stroke patients with their CER<1500 mg/day will be enrolled. A randomized controlled trial will be conducted and patients will be randomly assigned to high protein diet or normal protein diet for at least 2 weeks. We plan to enroll 300 patients, with 150 patients in ach group, during 3-year study period. We will consult dietitians for arrangement of their diet. We assume that patients receiving high protein diet will have higher opportunity to walk independently (modified Rankin Scale 0-1) at 3 month after stroke.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute ischemic stroke during hospitalization
- •urine albumin creatinine ratio < 30 mg/g
- •urinary creatinine excretion rate (CER) < 1500g/day
排除标准
- •chronic kidney disease stage 4 or 5 (i.e. eGFR < 30)
- •proteinuria (protein 1+ or more in urine routine)
- •known impairment of functional status (mRS ≥ 2) prior to the index stroke
- •refuse to participate in this study.
研究组 & 干预措施
High protein diet
received high protein diet, prescribed by dietitian
干预措施: high protein diet (Dietary Supplement)
Normal protein diet
received normal protein diet, prescribed by dietitian
干预措施: normal protein diet (Dietary Supplement)
结局指标
主要结局
modified Rankin Scale 0-1
时间窗: 3 months
No significant disability
次要结局
- modified Rankin Scale 0-2(3 months)
