Amino Acid Supplementation in Recovery From Traumatic Brain Injury (TBIS)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Traumatic Brain Injury |
Dietary Supplement: Amino Acids Dietary Supplement: Placebo of inert compounds Dietary Supplement: Valine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Amino Acid Supplementation in Recovery From Traumatic Brain Injury |
- 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.
- 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.
| Estimated Enrollment: | 45 |
| Study Start Date: | November 2011 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Amino acids
Amino acid supplementation for 10 weeks
|
Dietary Supplement: Amino Acids
15 grams amino acids two times per day for 10 weeks
|
|
Placebo Comparator: Placebo
Supplementation of placebo (inert components)for 10 weeks
|
Dietary Supplement: Placebo of inert compounds
Placebo two times per day for 10 weeks
|
|
Active Comparator: Valine
Valine supplementation for 10 weeks
|
Dietary Supplement: Valine
2.5 grams valine supplementation two times a day for 10 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Presence of traumatic brain injury
- Age 18-50 years
- Ability to sign informed consent
- >3 months post-injury, <36 months post-injury
- Ambulatory or require minimal to moderate assistance for safe ambulation
Exclusion Criteria:
- Subjects with cardiac abnormalities considered exclusionary by the study physicians
- Subjects with uncontrolled metabolic disease, including liver or renal disease
- Subjects with cancer or recently (6 months) treated cancer other than basal cell carcinoma
- Any subject currently on a weight-loss diet or a body mass index >34 kg/m2
- Recent anabolic or corticosteroids use (within 3 months)
- Dementia
- Inability to tolerate an upright position
- Postural reflexes prohibiting ambulation and inability to follow 2-step commands
- Any other condition or event considered exclusionary by the PIs and covering physician
Contacts and Locations| Contact: Kristi L Craig, B.S. | 409-770-6619 | klcraig@utmb.edu |
| Contact: Craig Porter, Ph.D. | 409-770-6676 | cr2porte@utmb.edu |
| United States, Texas | |
| Transitional Learning Center | Recruiting |
| Galveston, Texas, United States, 77550 | |
| Contact: Renee Pearcy 409-797-1448 rpearcy@tlc-galveston.org | |
| University of Texas Medical Branch | Recruiting |
| Galveston, Texas, United States, 77550 | |
| Contact: Kristi L Craig, B.S. 409-770-6619 klcraig@utmb.edu | |
| Principal Investigator: | Elisabet Borsheim, Ph.D. | The University of Texas, Galveston |
More Information
No publications provided
| Responsible Party: | The University of Texas, Galveston |
| ClinicalTrials.gov Identifier: | NCT01495871 History of Changes |
| Other Study ID Numbers: | 10-276 |
| Study First Received: | December 16, 2011 |
| Last Updated: | February 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013