The purpose of the study is to determine whether administration of a prebiotic, inulin, can improve the symptom complex associated with traumatic brain injury and whether inulin administration can alter the bacteria that live in the gut.
The investigators will study subjects (aged 18-70 years) with a history of moderate/severe traumatic brain injury (n=10) and healthy controls (aged 18-70 years) (n=10). All subjects will undergo a 3-month intervention of oral inulin treatment. The traumatic brain injury subjects will be administered oral inulin twice daily for 3 months. Testing including cognitive function assessment (Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), and questionnaires of fatigue, mood and quality of life and sleep will occur at month 0, 3 and 6. Blood sampling for measurement of amino acid levels, hormones, short chain fatty acids and markers of neuroinflammation will be drawn before and 90 minutes (+/- 10 minutes) after a standardized meal will occur at month 0 and month 3. In addition, fecal samples for analysis of the GI microbiome will be collected at month -1, month 0, month 1, month 2, month 3, and month 6 along with an assessment of gastrointestinal health. Traumatic brain injury subjects will be selected from residents at a long term residential rehabilitation center. Healthy control subjects will be administered oral inulin twice daily with meals for 3 months. Quality of life will be assessed by questionnaires at months 0, 3 and 6. Blood sampling for measurement of amino acid levels, hormones, short chain fatty acids and markers of neuroinflammation will be drawn before and 90 minutes (+/- 10 minutes) after a standardized meal will occur at month 0 and month 3. Fecal samples will be collected at month -1, month 0, month 3 and month 6 for analysis of the GI microbiome along with an assessment of gastrointestinal health. A member of the study team will check monthly for adverse events and overall well-being and ensure compliance and ongoing consent.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Subjects will be administered inulin at a starting dose of 1g twice daily (2g/day) and ramping up an additional 2g/day until the final dose of 4g twice daily (8g/day), which will continue on until the end of month 3 (week 12). After the month 3 study visit, inulin dosing will begin to ramp down over the next week.
Centre for Neuro Skills
Bakersfield, California, United States
Characterization of fecal microbiome using molecular methods at baseline
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Time frame: Baseline
Characterization of fecal microbiome using molecular methods at month 1
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Time frame: month 1
Characterization of fecal microbiome using molecular methods at month 2
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Time frame: month 2
Characterization of fecal microbiome using molecular methods at month 3
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Time frame: month 3
Characterization of fecal microbiome using molecular methods at month 6
Characterization of the fecal microbiome using a commercially available sampling kit and our lab's patented array for Polymerase Chain Reaction.
Time frame: month 6
Sleep Quality as measured by Pittsburgh Sleep Quality Index at baseline
Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month-time interval. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: Total \< 5 associated with good sleep quality. Total \> 5 associated with poor sleep quality.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline (month 0)
Sleep Quality as measured by Pittsburgh Sleep Quality Index at month 3
Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month-time interval. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: Total \< 5 associated with good sleep quality. Total \> 5 associated with poor sleep quality.
Time frame: month 3
Sleep Quality as measured by Pittsburgh Sleep Quality Index at month 6
Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1 month-time interval. Minimum Score = 0 (better); Maximum Score = 21 (worse). Interpretation: Total \< 5 associated with good sleep quality. Total \> 5 associated with poor sleep quality.
Time frame: month 6
Symptoms of Growth Hormone Deficiency measured by the questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at baseline
Symptoms of growth hormone deficiency will be measured using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA). This 25-item questionnaire measures specific symptoms associated with growth hormone deficiency, with a score range of 0 to 25, with a higher score indicating worse symptoms. This assessment is completed by the Traumatic Brain Injury group only.
Time frame: Baseline (month 0)
Symptoms of Growth Hormone Deficiency measured by the questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at month 3
Symptoms of growth hormone deficiency will be measured using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA). This 25-item questionnaire measures specific symptoms associated with growth hormone deficiency, with a score range of 0 to 25, with a higher score indicating worse symptoms. This assessment is completed by the Traumatic Brain Injury group only.
Time frame: month 3
Symptoms of Growth Hormone Deficiency measured by the questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults at month 6
Symptoms of growth hormone deficiency will be measured using the Quality of Life - Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA). This 25-item questionnaire measures specific symptoms associated with growth hormone deficiency, with a score range of 0 to 25, with a higher score indicating worse symptoms. This assessment is completed by the Traumatic Brain Injury group only.
Time frame: month 6
Depression measured by the Beck Depression Inventory-II at baseline
The Beck Depression Inventory- II (BDI-II) assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe.
Time frame: Baseline (month 0)
Depression measured by the Beck Depression Inventory-II at month 3
The Beck Depression Inventory- II (BDI-II) assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe.
Time frame: month 3
Depression measured by the Beck Depression Inventory-II at month 6
The Beck Depression Inventory- II (BDI-II) assesses depressive symptom severity. The BDI-II is comprised of 21 individual items reflecting specific cognitive, affective, and physical symptoms of depression. Each item includes four statements that vary in the description of symptom of severity. Scores range from 0 to 3, with a score of "3" indicating a severe symptoms and a score of "0" indicating an absence of concern with that particular aspect of depressive symptomology. The total score is the sum of all endorsed statements. The maximum total score is 63. The BDI-II Manual designates the following raw score classifications depression severity: ≤13 = minimal; 14-19 = mild; 20-28 = moderate; ≥ 29 = severe.
Time frame: month 6
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at baseline
The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome).
Time frame: Baseline (month 0)
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at month 1
The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome).
Time frame: month 1
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at month 2
The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome).
Time frame: month 2
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at month 3
The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome).
Time frame: month 3
Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale at month 6
The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort) . The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome).
Time frame: month 6
Perceptual Fatigue as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at baseline
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Time frame: Baseline (month 0)
Perceptual Fatigue as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 3
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Time frame: month 3
Perceptual Fatigue as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 6
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Time frame: month 6
Perceptual Cognition as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at baseline
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Time frame: Baseline (month 0)
Perceptual Cognition as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 3
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Time frame: month 3
Perceptual Cognition as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 6
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Time frame: month 6
Total BIAFAC (Brain Injury Fatigue and Altered Cognition) Score as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at baseline
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Time frame: Baseline (month 0)
Total BIAFAC (Brain Injury Fatigue and Altered Cognition) Score as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 3
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Time frame: month 3
Total BIAFAC (Brain Injury Fatigue and Altered Cognition) Score as measured by the Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire at month 6
Perceptual fatigue and perceptual cognition will be assessed using the 20-item Brain Injury Fatigue and Altered Cognition (BIAFAC) Questionnaire. Each item will be measured on an individual visual analog scale of 0 - 100, where the subject will mark how true each item is for them on the line with a pencil or pen with "0" indicating "not at all" and "100" indicating "extremely". Subtests of fatigue and cognition will be measured as well as a total score. Subscores and total scores range from 0-100, with a higher score indicating worse symptoms of BIAFAC.
Time frame: month 6
Cognition as assessed by the Repeatable Battery Assessment for Neuropsychological Status (RBANS) at baseline
The Repeatable Battery Assessment for Neuropsychological Status (RBANS) is a cognitive battery that has been utilized among Traumatic Brain Injury patients. It is comprised of 12 tests that assess five cognitive domains including immediate and delayed memory, language, visuospatial/constructional abilities, and attention. Immediate memory is assessed by two tests (list learning and story learning), visuospatial/constructional abilities is assessed by two tests (figure copy and line orientation), language is assessed by two tests (picture naming and semantic fluency), attention is two tests (digit span and coding), and delayed memory is assessed by four tests (list recall, list recognition, story recall and figure recall). RBANS raw subtests scores are converted to index standard scores. The RBANS has a mean score of 100 with a Standard Deviation of 15. Scores range from 40 to 160. Only the Traumatic Brain Injury group will undergo cognitive assessment.
Time frame: Baseline
Cognition as assessed by the Repeatable Battery Assessment for Neuropsychological Status (RBANS) at month 3
The Repeatable Battery Assessment for Neuropsychological Status (RBANS) is a cognitive battery that has been utilized among Traumatic Brain Injury patients. It is comprised of 12 tests that assess five cognitive domains including immediate and delayed memory, language, visuospatial/constructional abilities, and attention. Immediate memory is assessed by two tests (list learning and story learning), visuospatial/constructional abilities is assessed by two tests (figure copy and line orientation), language is assessed by two tests (picture naming and semantic fluency), attention is two tests (digit span and coding), and delayed memory is assessed by four tests (list recall, list recognition, story recall and figure recall). RBANS raw subtests scores are converted to index standard scores. The RBANS has a mean score of 100 with a Standard Deviation of 15. Scores range from 40 to 160. Only the Traumatic Brain Injury group will undergo cognitive assessment.
Time frame: month 3
Cognition as assessed by the Repeatable Battery Assessment for Neuropsychological Status (RBANS) at month 6
The Repeatable Battery Assessment for Neuropsychological Status (RBANS) is a cognitive battery that has been utilized among Traumatic Brain Injury patients. It is comprised of 12 tests that assess five cognitive domains including immediate and delayed memory, language, visuospatial/constructional abilities, and attention. Immediate memory is assessed by two tests (list learning and story learning), visuospatial/constructional abilities is assessed by two tests (figure copy and line orientation), language is assessed by two tests (picture naming and semantic fluency), attention is two tests (digit span and coding), and delayed memory is assessed by four tests (list recall, list recognition, story recall and figure recall). RBANS raw subtests scores are converted to index standard scores. The RBANS has a mean score of 100 with a Standard Deviation of 15. Scores range from 40 to 160. Only the Traumatic Brain Injury group will undergo cognitive assessment.
Time frame: month 6
1 methyl Histidine at baseline
Amino acid 1 methyl histidine (1MHis) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
1 methyl Histidine at month 3
Amino acid 1 methyl histidine (1MHis) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
3 methyl Histidine at baseline
Amino acid 3 methyl histidine (3MHis) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
3 methyl Histidine at month 3
Amino acid 3 methyl histidine (3MHis) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
L-alpha-Aminoadipic acid at baseline
Amino acid L-alpha-Aminoadipic (Aad) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
L-alpha-Aminoadipic acid at month 3
Amino acid L-alpha-Aminoadipic (Aad) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
2-Aminobutyric Acid at baseline
Amino acid 2-Aminobutyric Acid (Abu) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
2-Aminobutyric Acid at month 3
Amino acid 2-Aminobutyric Acid (Abu) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Alanine at baseline
Amino acid Alanine (Ala) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Alanine at month 3
Amino acid Asparagine (Asn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Asparagine at baseline
Amino acid Asparagine (Asn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Asparagine at baseline
Amino acid Asparagine (Asn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Arginine at baseline
Amino acid Arginine (Arg) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Arginine at month 3
Amino acid Arginine (Arg) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Aspartate at baseline
Amino acid Aspartate(Asp) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Aspartate at month 3
Amino acid Aspartate(Asp) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
D, L-beta-Aminoisobutyric acid
Amino acid D, L-beta-Aminoisobutyric acid (bAid) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
D, L-beta-Aminoisobutyric acid
Amino acid D, L-beta-Aminoisobutyric acid (bAid) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
beta-Alanine at baseline
Amino acid beta-Alanine (bAla) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
beta-Alanine at month 3
Amino acid beta-Alanine (bAla) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
L-Carnosine
Amino acid L-Carnosine (Car) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
L-Carnosine
Amino acid L-Carnosine (Car) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Citrulline at baseline
Amino acid citrulline (Cit) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Citrulline at month 3
Amino acid citrulline (Cit) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Cystathionine
Amino acid Cystathionine (Cth) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Cystathionine
Amino acid Cystathionine (Cth) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Cysteine at baseline
Amino acid cysteine (Cys) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Cysteine at month 3
Amino acid cysteine (Cys) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Ethanolamine at baseline
Amino acid ethanolamine (Etn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Ethanolamine at month 3
Amino acid ethanolamine (Etn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Gamma aminobutyric acid at baseline
Amino acid gamma aminobutyric acid (GABA) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Gamma aminobutyric acid at month 3
Amino acid gamma aminobutyric acid (GABA) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Glutamine at baseline
Amino acid glutamine (Gln) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Glutamine at month 3
Amino acid glutamine (Gln) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Glutamate at baseline
Amino acid glutamate (Glu) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Glutamate at month 3
Amino acid glutamate (Glu) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Glycine at baseline
Amino acid glycine (Gly) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Glycine at month 3
Amino acid glycine (Gly) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Homocysteine at baseline
Amino acid homocysteine (Hcy) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Homocysteine at month 3
Amino acid homocysteine (Hcy) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Histidine at baseline
Amino acid histidine (His) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Histidine at month 3
Amino acid histidine (His) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Hydroxylysine at baseline
Amino acid hydroxylysine (Hyl) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Hydroxylysine at month 3
Amino acid hydroxylysine (Hyl) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Hydroxyproline at baseline
Amino acid hydroxyproline (Hyp) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Hydroxyproline at month 3
Amino acid hydroxyproline (Hyp) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Isoleucine at baseline
Amino acid Isoleucine (Ile) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Isoleucine at month 3
Amino acid Isoleucine (Ile) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Leucine at baseline
Amino acid Leucine (Leu) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Leucine at month 3
Amino acid Leucine (Leu) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Lysine at baseline
Amino acid Lysine (Lys) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Lysine at month 3
Amino acid Lysine (Lys) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Methionine at baseline
Amino acid Methionine (Met) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Methionine at month 3
Amino acid Methionine (Met) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Norleucine at baseline
Amino acid Norleucine (Nle) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Norleucine at month 3
Amino acid Norleucine (Nle) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Norvaline at baseline
Amino acid Norvaline (Nva) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Norvaline at month 3
Amino acid Norvaline (Nva) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Ornithine at baseline
Amino acid Ornithine (Orn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Ornithine at month 3
Amino acid Ornithine (Orn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
phospho-ethanolamine at baseline
Amino acid phosphoethanolamine (pEtn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
phospho-ethanolamine at month 3
Amino acid phosphoethanolamine (pEtn) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Phenylalanine at baseline
Amino acid phenylalanine (Phe) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Phenylalanine at month 3
Amino acid phenylalanine (Phe) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Proline at baseline
Amino acid proline (Pro) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Proline at month 3
Amino acid proline (Pro) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
phospho-serine at baseline
Amino acid phospho-serine (pSer) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
phospho-serine at month 3
Amino acid phospho-serine (pSer) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Sarcosine at baseline
Amino acid sarcosine (Sar) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Sarcosine at month 3
Amino acid sarcosine (Sar) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Serine at baseline
Amino acid serine (Ser) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Serine at month 3
Amino acid serine (Ser) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Taurine at baseline
Amino acid taurine (Tau) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Taurine at month 3
Amino acid taurine (Tau) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Threonine at baseline
Amino acid threonine (Thr) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Threonine at month 3
Amino acid threonine (Thr) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Tryptophan at baseline
Amino acid tryptophan (Trp) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Tryptophan at month 3
Amino acid tryptophan (Trp) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Tyrosine at baseline
Amino acid tyrosine (Tyr) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Tyrosine at month 3
Amino acid tyrosine (Tyr) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3
Valine at baseline
Amino acid valine (val) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: Baseline (month 0)
Valine at month 3
Amino acid valine (val) will be measured in serum before and after a standardized meal. Results will be reported as change concentration in micrometers (uM).
Time frame: month 3