Association of Amino Acid Prevalence and Chronic Brain Injury
|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.|
|ClinicalTrials.gov Identifier: NCT02113124|
Recruitment Status : Completed
First Posted : April 14, 2014
Results First Posted : November 17, 2015
Last Update Posted : December 15, 2015
|Condition or disease|
|Chronic Traumatic Brain Injury|
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.
|Study Type :||Observational|
|Actual Enrollment :||43 participants|
|Observational Model:||Case Control|
|Official Title:||Association of Amino Acid Prevalence and Chronic Brain Injury|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
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.
- 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 ]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
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 ClinicalTrials.gov identifier (NCT number): 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|