Association of Amino Acid Prevalence and Chronic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to donate 10 ml of blood
- •Willing to donate oral tissue sample
- •Willing to donate fecal sample
排除标准
- •(for brain injured group) have a chronic (greater than two years) traumatic brain injury.
- •Unable to provide to give voluntary informed consent
结局指标
主要结局
Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating
时间窗: 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.
次要结局
未报告次要终点
研究者
Brent Masel
Brent Masel, M.D.
The Transitional Learning Center, Galveston, TX