Amino Acid Supplementation in Recovery From Traumatic Brain Injury

NCT01495871 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-02-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • The Moody Foundation

    collaborator OTHER
  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Melinda Sheffield-Moore, Ph.D. · The University of Texas Medical Branch, Galveston

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01495871 on ClinicalTrials.gov