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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by The University of Texas, Galveston
Sponsor:
Collaborator:
The Moody Foundation
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT01495871
First received: December 16, 2011
Last updated: May 6, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Essential Amino Acid Concentrations [ Time Frame: 6 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.


Secondary Outcome Measures:
  • Functional impairments [ Time Frame: 6 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 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495871

Contacts
Contact: Kate M Randolph, B.S. 409-772-8126 kmrandol@utmb.edu
Contact: William Durham, Ph.D. 409-772-8702 wjdurham@utmb.edu

Locations
United States, Texas
Transitional Learning Center Recruiting
Galveston, Texas, United States, 77550
Contact: Jack Forman    409-762-6661 ext 220    jforeman@tlcgalveston.org   
Principal Investigator: Brent Masel, MD         
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Kate M Randolph, B.S.    409-772-8126    kmrandol@utmb.edu   
Principal Investigator: Melinda Sheffield-Moore, PhD         
Sponsors and Collaborators
The University of Texas, Galveston
The Moody Foundation
Investigators
Principal Investigator: Melinda Sheffield-Moore, 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: May 6, 2014
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 September 29, 2014