Amino Acid Supplementation in Recovery From Traumatic Brain Injury (TBIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by The University of Texas, Galveston
Sponsor:
Collaborator:
The Moody Foundation
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT01495871
First received: December 16, 2011
Last updated: May 6, 2014
Last verified: May 2014

December 16, 2011
May 6, 2014
November 2011
December 2014   (final data collection date for primary outcome measure)
Essential Amino Acid Concentrations [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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.
Essential Amino Acid Concentrations [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01495871 on ClinicalTrials.gov Archive Site
Functional impairments [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Reduced plasma EAAs may be related to the psychological and metabolic complications associated with TBIs. We aim to assess measures of psychological and physical functionality in TBI patients receiving EAA supplementation.
Functional impairments [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Reduced plasma EAAs may be related to the psychological and metabolic complications associated with TBIs. We aim to assess measures of psychological and physical functionality in TBI patients receiving EAA supplementation.
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Amino Acid Supplementation in Recovery From Traumatic Brain Injury
Amino Acid Supplementation in Recovery From Traumatic Brain Injury

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.

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Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Traumatic Brain Injury
  • Dietary Supplement: Amino Acids
    15 grams amino acids two times per day for 6 weeks
  • Dietary Supplement: Placebo of inert compounds
    Placebo two times per day for 6 weeks
  • Dietary Supplement: Valine
    2.5 grams valine supplementation two times a day for 6 weeks
  • Active Comparator: Amino acids
    Amino acid supplementation for 6 weeks
    Intervention: Dietary Supplement: Amino Acids
  • Placebo Comparator: Placebo
    Supplementation of placebo (inert components)for 6 weeks
    Intervention: Dietary Supplement: Placebo of inert compounds
  • Active Comparator: Valine
    Valine supplementation for 6 weeks
    Intervention: Dietary Supplement: Valine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
Not Provided
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Presence of traumatic brain injury
  2. Age 18-65 years
  3. Ability to sign informed consent
  4. >3 months post-injury, <36 months post-injury
  5. Ambulatory or require minimal to moderate assistance for safe ambulation

Exclusion Criteria:

  1. Subjects with cardiac abnormalities considered exclusionary by the study physicians
  2. Subjects with uncontrolled metabolic disease, including liver or renal disease
  3. Subjects with cancer or recently (6 months) treated cancer other than basal cell carcinoma
  4. Any subject currently on a weight-loss diet or a body mass index >34 kg/m2
  5. Recent anabolic or corticosteroids use (within 3 months)
  6. Dementia
  7. Inability to tolerate an upright position
  8. Postural reflexes prohibiting ambulation and inability to follow 2-step commands
  9. Any other condition or event considered exclusionary by the PIs and covering physician
Both
18 Years to 65 Years
No
Contact: Kate M Randolph, B.S. 409-772-8126 kmrandol@utmb.edu
Contact: William Durham, Ph.D. 409-772-8702 wjdurham@utmb.edu
United States
 
NCT01495871
10-276
No
The University of Texas, Galveston
The University of Texas, Galveston
The Moody Foundation
Principal Investigator: Melinda Sheffield-Moore, Ph.D. The University of Texas, Galveston
The University of Texas, Galveston
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP