Association of Amino Acid Prevalence and Chronic Brain Injury

Chronic Traumatic Brain Injury Clinical Trial

Official title:

Association of Amino Acid Prevalence and Chronic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113124
• Other study ID #: TLC IRB #200
• Status: Completed
• Phase: N/A
• First received: April 8, 2014
• Last updated: November 17, 2015
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: The Transitional Learning Center, Galveston, TX
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury, Chronic
• Chronic Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Centre for Neuro Skills	Bakersfield	California
United States	Centre for Neuro Skills	Dallas	Texas
United States	Transitional Learning Center	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Brent Masel	The Moody Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No