Traumatic Brain Injury
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTAmino Acids
15 grams amino acids two times per day for 6 weeks
DIETARY_SUPPLEMENTPlacebo of inert compounds
Placebo two times per day for 6 weeks
DIETARY_SUPPLEMENTValine
2.5 grams valine supplementation two times a day for 6 weeks
Sponsors
The Moody Foundation
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Essential Amino Acid Concentrations | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional impairments | 6 weeks | 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. |
Countries
United States
Outcome results
None listed