Trials / Withdrawn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- Withdrawn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
| Type | Name | Description |
|---|---|---|
| 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 |
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.