Amino Acid Supplementation in Recovery From Traumatic Brain Injury (TBIS)
Primary Purpose
Traumatic Brain Injury
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Amino Acids
Placebo of inert compounds
Valine
Sponsored by
About this trial
This is an interventional supportive care trial for Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- Presence of traumatic brain injury
- Age 18-65 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
Sites / Locations
- Transitional Learning Center
- University of Texas Medical Branch
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Amino acids
Placebo
Valine
Arm Description
Amino acid supplementation for 6 weeks
Supplementation of placebo (inert components)for 6 weeks
Valine supplementation for 6 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01495871
First Posted
December 16, 2011
Last Updated
February 10, 2015
Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
The Moody Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01495871
Brief Title
Amino Acid Supplementation in Recovery From Traumatic Brain Injury
Acronym
TBIS
Official Title
Amino Acid Supplementation in Recovery From Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Withdrawn
Why Stopped
PI decided not to pursue this study.
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
The Moody Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amino acids
Arm Type
Active Comparator
Arm Description
Amino acid supplementation for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Supplementation of placebo (inert components)for 6 weeks
Arm Title
Valine
Arm Type
Active Comparator
Arm Description
Valine supplementation for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Amino Acids
Intervention Description
15 grams amino acids two times per day for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo of inert compounds
Intervention Description
Placebo two times per day for 6 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Valine
Intervention Description
2.5 grams valine supplementation two times a day for 6 weeks
Primary Outcome Measure Information:
Title
Essential Amino Acid Concentrations
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Functional impairments
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of traumatic brain injury
Age 18-65 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melinda Sheffield-Moore, Ph.D.
Organizational Affiliation
The University of Texas Medical Branch, Galveston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Transitional Learning Center
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
12. IPD Sharing Statement
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Amino Acid Supplementation in Recovery From Traumatic Brain Injury
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