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Trial record 64 of 157 for:    (Dementia pugilistica OR chronic traumatic encephalopathy) AND Injuries

Amino Acid Supplementation in Recovery From Traumatic Brain Injury (TBIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01495871
Recruitment Status : Withdrawn (PI decided not to pursue this study.)
First Posted : December 20, 2011
Last Update Posted : February 11, 2015
The Moody Foundation
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Dietary Supplement: Amino Acids Dietary Supplement: Placebo of inert compounds Dietary Supplement: Valine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Amino Acid Supplementation in Recovery From Traumatic Brain Injury
Study Start Date : November 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Amino acids
Amino acid supplementation for 6 weeks
Dietary Supplement: Amino Acids
15 grams amino acids two times per day for 6 weeks

Placebo Comparator: Placebo
Supplementation of placebo (inert components)for 6 weeks
Dietary Supplement: Placebo of inert compounds
Placebo two times per day for 6 weeks

Active Comparator: Valine
Valine supplementation for 6 weeks
Dietary Supplement: Valine
2.5 grams valine supplementation two times a day for 6 weeks

Primary Outcome Measures :
  1. Essential Amino Acid Concentrations [ Time Frame: 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 Outcome Measures :
  1. Functional impairments [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01495871

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United States, Texas
Transitional Learning Center
Galveston, Texas, United States, 77550
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
The Moody Foundation
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Principal Investigator: Melinda Sheffield-Moore, Ph.D. The University of Texas Medical Branch, Galveston

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Responsible Party: The University of Texas Medical Branch, Galveston Identifier: NCT01495871     History of Changes
Other Study ID Numbers: 10-276
First Posted: December 20, 2011    Key Record Dates
Last Update Posted: February 11, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System