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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
Sponsor:
Collaborator:
The Moody Foundation
Information provided by (Responsible Party):
Brent Masel, The Transitional Learning Center, Galveston, TX

Study Description
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Brief Summary:
Years after a suffering a brain injury, individuals remain in a physically and cognitively impaired state. The investigators believe that the concentrations of amino acids in the blood are chronically altered and yield negative effects on the individuals health. Preliminary data has shown significantly lower concentrations of amino acids in serum samples from the TBI population, these diminished levels of amino acids may be due to changes in the microbiome. Understanding these changes will help guide rehabilitative services for this population. Individuals with a chronic brain injury will donate samples of blood, oral tissue, and fecal matter to be compared to that of non-injured individuals. Genetic information from the hosts will be striped and discarded; participant's genetic information will not be retained. To better understand changes in the microbiome, any history of antibiotics and probiotics will be assessed.

Condition or disease
Chronic Traumatic Brain Injury

Detailed Description:

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 Design
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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.
Uninjured control
This group of individuals have no history of brain injury. Ages range between 21 and 70.


Outcome Measures
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Primary Outcome Measures :
  1. 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
Whole blood, oral tissue swab, fecal matter

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Individuals in the chronic brain injured group are recruited from traumatic brain injury rehabilitation facilities. These facilities include Tideway in Galveston, Texas, Centre for Neuro Skills in Bakersfield, CA, and Centre for Neuro Skills in Dallas, TX. The cohorts for this study will be recruited from the communities surrounding the rehabilitation facilities.
Criteria

Inclusion Criteria:

  • Willing to donate 10 ml of blood
  • Willing to donate oral tissue sample
  • Willing to donate fecal sample

Exclusion Criteria:

  • (for brain injured group) have a chronic (greater than two years) traumatic brain injury.
  • Unable to provide to give voluntary informed consent
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Brent Masel
The Moody Foundation
Investigators
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Principal Investigator: Brent E Masel, MD Transitional Learning Center
More Information
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Responsible Party: Brent Masel, Brent Masel, M.D., The Transitional Learning Center, Galveston, TX
ClinicalTrials.gov Identifier: NCT02113124    
Other Study ID Numbers: TLC IRB #200
First Posted: April 14, 2014    Key Record Dates
Results First Posted: November 17, 2015
Last Update Posted: December 15, 2015
Last Verified: November 2015
Keywords provided by Brent Masel, The Transitional Learning Center, Galveston, TX:
Chronic Brain Injury
Traumatic brain injury (TBI)
Amino Acids
Microbiome
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Injury, Chronic
Wounds and Injuries
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Damage, Chronic