Association of Amino Acid Prevalence and Chronic Brain Injury
Chronic Traumatic Brain Injury
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Association of Amino Acid Prevalence and Chronic Brain Injury|
- Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating [ Time Frame: Samples collected on day 1 following 8 hour fasting period and again 90 minutes after eating a predetermined meal ] [ Designated as safety issue: No ]5 ml of blood will be acquired following a 8-hour fasting period to determine baseline concentrations of amino acids. A meal will then be provided and another blood sample will be acquired 90 minutes after completing the meal to examine the change in amino acid concentration. These samples will be used to determine the levels of each essential amino acid present.
Biospecimen Retention: Samples Without DNA
|Study Start Date:||December 2013|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Chronic brain injury
Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 21 to 70.
This group of individuals have no history of brain injury. Ages range between 21 and 70.
The purpose of this study is to evaluate the levels of Amino Acids in adult individuals with chronic (> 2 years) traumatic brain injury (TBI) when compared to a non-brain injured cohort population.
Preliminary data from an assay of amino acids in individuals with chronic TBI compared to an assay of individuals without a TBI revealed significantly lower concentrations of amino acids within the TBI group.
The composition and structure of the oral and fecal microbiome will be determined by 16S rDNA sequencing. Taxonomic and community structure profiles will be treated as outcome variables and modeled together with the participant's plasma amino acid concentration, years post-injury, age, sex and other variables to determine correlations. These correlations may improve our understanding of the diminished amino acid metabolism within the chronic TBI population.
The endpoint will identify the microbiome structure and composition by 16S rRNA gene sequencing within the TBI and healthy participants and to assess the participant's amino acid concentrations and other participant demographics and phenotypic characteristics (years post-injury, age, sex). This comparison may improve our understanding of the diminished amino acid metabolism within the chronic TBI population.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02113124
|United States, California|
|Centre for Neuro Skills|
|Bakersfield, California, United States, 93313|
|United States, Texas|
|Centre for Neuro Skills|
|Dallas, Texas, United States, 75038|
|Transitional Learning Center|
|Galveston, Texas, United States, 77550|
|Principal Investigator:||Brent E Masel, MD||Transitional Learning Center|