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PI decided not to pursue this study.
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| Name | Class |
|---|---|
| The Moody Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amino acids | Active Comparator | Amino acid supplementation for 6 weeks |
|
| Placebo | Placebo Comparator | Supplementation of placebo (inert components)for 6 weeks |
|
| Valine | Active Comparator | Valine supplementation for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amino Acids | Dietary Supplement | 15 grams amino acids two times per day for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Essential Amino Acid Concentrations | 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional impairments | 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. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melinda Sheffield-Moore, Ph.D. | The University of Texas Medical Branch, Galveston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Transitional Learning Center | Galveston | Texas | 77550 | United States | ||
| University of Texas Medical Branch |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000596 | Amino Acids |
| D014633 | Valine |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
| D000597 | Amino Acids, Branched-Chain |
| D000601 | Amino Acids, Essential |
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| Placebo of inert compounds |
| Dietary Supplement |
Placebo two times per day for 6 weeks |
|
| Valine | Dietary Supplement | 2.5 grams valine supplementation two times a day for 6 weeks |
|
| Galveston |
| Texas |
| 77555 |
| United States |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |