- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01495871
Amino Acid Supplementation in Recovery From Traumatic Brain Injury (TBIS)
February 10, 2015 updated by: The University of Texas Medical Branch, Galveston
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Galveston, Texas, United States, 77550
- Transitional Learning Center
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Galveston, Texas, United States, 77555
- University of Texas Medical Branch
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Amino acids
Amino acid supplementation for 6 weeks
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15 grams amino acids two times per day for 6 weeks
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Placebo Comparator: Placebo
Supplementation of placebo (inert components)for 6 weeks
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Placebo two times per day for 6 weeks
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Active Comparator: Valine
Valine supplementation for 6 weeks
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2.5 grams valine supplementation two times a day for 6 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Melinda Sheffield-Moore, Ph.D., The University of Texas Medical Branch, Galveston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
December 16, 2011
First Submitted That Met QC Criteria
December 19, 2011
First Posted (Estimate)
December 20, 2011
Study Record Updates
Last Update Posted (Estimate)
February 11, 2015
Last Update Submitted That Met QC Criteria
February 10, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-276
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Queen Mary University of LondonCompleted
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Clinical Trials on Amino Acids
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Texas A&M UniversityRecruiting
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University of TorontoCompletedHealthy | Increased Metabolic Requirement
-
University of British ColumbiaUnknown
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Baylor College of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedKwashiorkor | Marasmus | Protein-energy MalnutritionJamaica
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Assistance Publique - Hôpitaux de ParisKyowa Hakko Kogyo (Japan) providing the amino acidsCompletedElderly | MetabolismFrance
-
The Hospital for Sick ChildrenCanadian Institutes of Health Research (CIHR)Completed
-
Hospital Universitari Vall d'Hebron Research InstituteCompletedHepatic EncephalopathySpain
-
Montana State UniversityM.J. Murdoch Charitable Trust; Kreighbaum EndowmentCompleted
-
McGill University Health Centre/Research Institute...CompletedPostoperative Protein CatabolismCanada