Trial Outcomes & Findings for Association of Amino Acid Prevalence and Chronic Brain Injury (NCT NCT02113124)
NCT ID: NCT02113124
Last Updated: 2015-12-15
Results Overview
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.
COMPLETED
43 participants
Samples collected on day 1 following 8 hour fasting period and again 90 minutes after eating a predetermined meal
2015-12-15
Participant Flow
Participant milestones
| Measure |
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.
|
Uninjured Control
This group of individuals have no history of brain injury. Ages range between 35 and 70.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
25
|
|
Overall Study
COMPLETED
|
17
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
Uninjured Control
This group of individuals have no history of brain injury. Ages range between 35 and 70.
|
|---|---|---|
|
Overall Study
Unable to retrieve blood sample
|
1
|
1
|
Baseline Characteristics
Association of Amino Acid Prevalence and Chronic Brain Injury
Baseline characteristics by cohort
| Measure |
Chronic Brain Injury
n=17 Participants
Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
|
Uninjured Control
n=24 Participants
This group of individuals have no history of brain injury. Ages range between 35 and 70.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 10 • n=5 Participants
|
45 years
STANDARD_DEVIATION 15 • n=7 Participants
|
46 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Samples collected on day 1 following 8 hour fasting period and again 90 minutes after eating a predetermined meal5 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.
Outcome measures
| Measure |
Chronic Brain Injury
n=17 Participants
Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
|
Uninjured Control
n=24 Participants
This group of individuals have no history of brain injury. Ages range between 35 and 70.
|
|---|---|---|
|
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
|
553.70 µM
Standard Error 38.26
|
|
Change From Baseline of Concentrations of Essential Amino Acid at 1.5 Hours After Eating
Essential Amino Acids
|
1224.19 µM
Standard Error 27.50
|
1339.54 µM
Standard Error 73.17
|
Adverse Events
Chronic Brain Injury
Uninjured Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Brent Masel
The Transitional Learning Center at Galveston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place