Chronic Traumatic Brain Injury
Conditions
Keywords
Chronic Brain Injury, Traumatic brain injury (TBI), Amino Acids, Microbiome
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.
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.
Interventions
None listed
Sponsors
The Moody Foundation
Brent Masel
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chronic Brain Injury Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70. | 17 |
| Uninjured Control This group of individuals have no history of brain injury. Ages range between 35 and 70. | 24 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Unable to retrieve blood sample | 1 | 1 |
Baseline characteristics
| Characteristic | Chronic Brain Injury | Uninjured Control | Total |
|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 10 | 45 years STANDARD_DEVIATION 15 | 46 years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 1 Participants | 7 Participants | 8 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 25 |
| serious Total, serious adverse events | 0 / 18 | 0 / 25 |
Outcome results
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.
Time frame: Samples collected on day 1 following 8 hour fasting period and again 90 minutes after eating a predetermined meal
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Brain Injury | Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating | Branched Chain Amino Acids | 487.28 µM | Standard Error 22.94 |
| Chronic Brain Injury | Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating | Essential Amino Acids | 1224.19 µM | Standard Error 27.5 |
| Uninjured Control | Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating | Branched Chain Amino Acids | 553.70 µM | Standard Error 38.26 |
| Uninjured Control | Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating | Essential Amino Acids | 1339.54 µM | Standard Error 73.17 |