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临床试验/NCT04295044
NCT04295044已完成2 期

Effect of High Protein Diet in Stroke Patients With Low Muscle Mass

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2017年12月15日最近更新:
适应症
干预措施

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

Experimental

received high protein diet, prescribed by dietitian

干预措施: high protein diet (Dietary Supplement)

Normal protein diet

Active Comparator

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)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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