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临床试验/NCT01495871
NCT01495871撤回不适用

Amino Acid Supplementation in Recovery From Traumatic Brain Injury

The University of Texas Medical Branch, Galveston4 个研究点 分布在 1 个国家开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
4
主要终点
Essential Amino Acid Concentrations

研究概览

简要总结

Traumatic brain injury (TBI) is a leading cause of death and disability in young people. It has been called the "signature wound" of the Iraq war because of its frequency among troops. TBI is associated with many chronic disabilities. Physical alterations include reduced exercise tolerance and profound muscle weakness, whereas psychological alterations include diminished sense of well-being, depression, fatigue and anxiety. Muscle and brain tissues rely upon circulating blood amino acids as precursors for metabolic functions. The investigators have shown that even one year after injury, plasma valine, an essential amino acid (EAA), was markedly reduced in patients with TBI compared to healthy controls. The investigators speculate that low plasma valine concentration contributes to chronic fatigue after TBI, since valine and tryptophan compete for the same transporter into the brain, and a low plasma valine concentration will allow more tryptophan to be transported. As a consequence, increased brain tryptophan will increase serotonin production, which may significantly contribute to the development of fatigue. Thus, the investigators will test if restoring valine concentration in persons with TBI may reduce fatigue perception and improve physical and neuropsychological function. Further, the investigators have previously shown that EAA intake has an anabolic effect in healthy young and elderly individuals. However, no data are currently available in persons recovering from TBI. Thus,the investigators will also test if EAA and/or valine can improve muscle mass in patients with TBI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presence of traumatic brain injury
  • Age 18-65 years
  • Ability to sign informed consent
  • >3 months post-injury, <36 months post-injury
  • Ambulatory or require minimal to moderate assistance for safe ambulation

排除标准

  • Subjects with cardiac abnormalities considered exclusionary by the study physicians
  • Subjects with uncontrolled metabolic disease, including liver or renal disease
  • Subjects with cancer or recently (6 months) treated cancer other than basal cell carcinoma
  • Any subject currently on a weight-loss diet or a body mass index >34 kg/m2
  • Recent anabolic or corticosteroids use (within 3 months)
  • Inability to tolerate an upright position
  • Postural reflexes prohibiting ambulation and inability to follow 2-step commands
  • Any other condition or event considered exclusionary by the PIs and covering physician

结局指标

主要结局

Essential Amino Acid Concentrations

时间窗: 6 weeks

TBI patients are deficient in a number of essential amino acids (EAA) post injury and we have shown that TBI patient are deficient in valine up to 17 months post injury. We propose to assess plasma amino acid concentrations in TBI patients who are receiving EAA supplementation or valine supplementation compared to placebo patients.

次要结局

  • Functional impairments(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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