跳至主要内容
临床试验/NCT04459091
NCT04459091已完成不适用

Effects of Supplementation With Amino Essential Acids on Circulating Albumin Levels in Patients With Cerebral Ictus in Rehabilitation Phase

Istituti Clinici Scientifici Maugeri SpA2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2018年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
2
主要终点
Serum Albumin Levels

研究概览

简要总结

In addition to its physiological functions, serum albumin plays a role of neuroprotection in cerebrovascular stroke. The circulating levels of albumin may be reduced in patients with stroke due to the presence of a systemic inflammatory state and to the inadequacy of protein-energy intake. The circulating levels of albumin have proven to be predictors of functional recovery in ischemic stroke and cerebral hemorrhage.

In the present survey it is hypothesized that it is possible to significantly improve the values of hypoalbuminemia by supplementation with essential amino acids and that, in the second place, any increase in albumin may result in a strengthening of functional recovery in patients with a stroke.

详细描述

In addition to its physiological functions, serum albumin plays a role of neuroprotection in cerebrovascular stroke. The circulating levels of albumin may be reduced in patients with stroke due to the presence of a systemic inflammatory state and to the inadequacy of protein-energy intake. In the patients admitted to the Montescano Neuromotor Rehabilitation Division, the prevalence of hypoalbuminemia is high at the time of admission and remains high, even if decreased, at discharge. The circulating levels of albumin have proven to be predictors of functional recovery in ischemic stroke and cerebral hemorrhage. In the present survey it is hypothesized that it is possible to significantly improve the values of hypoalbuminemia by supplementation with essential amino acids and that, in the second place, any increase in albumin may result in a strengthening of functional recovery in patients with a stroke.

Several factors induce the use of free essential amino acids: they are the most efficient inducers of protein synthesis and albumin is a protein; free essential amino acids and not those contained in proteins allow a more reliable use of the isoleucine and tryptophan, true nutrients limiting the hepatic synthesis of albumin; the free essential amino acids have a faster and complete intestinal absorption of the essential amino acids derived from protein digestion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • first episode of cerebral stroke
  • first taken in rehabilitation after hospitalization in the acute department

排除标准

  • neoplasia
  • long-term corticosteroid therapy (> 3 weeks) in the pre-event period and at the time of admission to the rehabilitation department

结局指标

主要结局

Serum Albumin Levels

时间窗: eight weeks

Number of patients who at discharge show levels of albuminemia\> 0.35 gr / dl (normal level)

次要结局

  • Functional Independence Measure(eight weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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