Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT01495871

Amino Acid Supplementation in Recovery From Traumatic Brain Injury

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
The University of Texas Medical Branch, Galveston · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
DIETARY_SUPPLEMENTAmino Acids15 grams amino acids two times per day for 6 weeks
DIETARY_SUPPLEMENTPlacebo of inert compoundsPlacebo two times per day for 6 weeks
DIETARY_SUPPLEMENTValine2.5 grams valine supplementation two times a day for 6 weeks

Timeline

Start date
2011-11-01
Primary completion
2014-07-01
Completion
2014-07-01
First posted
2011-12-20
Last updated
2015-02-11

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01495871. Inclusion in this directory is not an endorsement.