Association of Amino Acid Prevalence and Chronic Brain Injury

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93313
      • Centre for Neuro Skills
  • Texas
    • Dallas, Texas, United States, 75038
      • Centre for Neuro Skills
    • Galveston, Texas, United States, 77550
      • Transitional Learning Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating	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.	Samples collected on day 1 following 8 hour fasting period and again 90 minutes after eating a predetermined meal

Collaborators and Investigators

• Sponsor: Brent Masel
• Collaborators: The Moody Foundation
• Investigators: Principal Investigator: Brent E Masel, MD, Transitional Learning Center

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: April 9, 2014
• First Posted (Estimate): April 14, 2014

Study Record Updates

• Last Update Posted (Estimate): December 15, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Microbiome; Traumatic brain injury (TBI); Amino Acids; Chronic Brain Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Injury, Chronic
• Other Study ID Numbers: TLC IRB #200