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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-5398 | Other Identifier | CÉR CIUSSS Estrie - CHUS |
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The goal of this study is to better understand the relationship between peripheral and central nervous system measurements of the gamma-aminobutyric acid (GABA) system in otherwise healthy individuals. the main questions it aims to answer are:
Participants will receive oral GABA and Placebo and undergo blood draws, MRI scans and transcranial magnetic stimulation sessions.
Although gamma-aminobutyric acid (GABA) is the main inhibitory neurotransmitter in the central nervous system in humans, and various pharmacological compounds and natural products aim to modulate it, it is still unknown whether GABA can cross the blood-brain barrier. The present project aims to clarify this issue by comparing measurements obtained in the central nervous system (the brain) with peripheral measurements (serum) following oral administration of the amino acid GABA. This will help determine if peripheral concentrations of GABA in the blood reflect levels in the brain. This would facility studying the GABAergic system in vulnerable clinical populations (such as children or patients with intellectual disabilities) to participate in without resorting to expensive neuroimaging exams and the inclusion of individuals who cannot undergo neuroimaging exams (e.g., claustrophobia, presence of metal in the body). To achieve this, GABA measurements (serum and neuroimaging) will be obtained before and after the oral intake of 1800mg of GABA or a placebo in 30 healthy adults participating in a cross-over, single-blind study with repeated measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GABA Start Group | Experimental | Participants who are randomly assigned to the GABA start group. These participants receive GABA at the first experimental visit and the placebo at the second experimental visit. |
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| Placebo Start Group | Experimental | Participants who are randomly assigned to the Placebo start group. These participants will receive a placebo at the first experimental visit and GABA at the second experimental visit. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute Oral gamma-aminobutyric acid (Natural Health Product in Canada) | Other | 1800 mg (3 capsules of 600mg) of GABA taken at the research center under the supervision of the research team. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Acute GABA consumption on peripheral serum GABA concentrations | Serum GABA concentration will be measured before and after acute administration of GABA and placebo. | Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo |
| Impact of Acute GABA consumption on short intracortical inhibition | TMS-derived measure of Intracortical inhibition: The degree of decrease of peak-to-peak motor evoked potential (MEP) amplitude induced by the administration of a conditioning stimulus (set at 70% of resting motor threshold) 2-4 ms before the test stimulus (stimulation intensity required to produce an MEP of 1 millivolt (mV), approximately 120% of resting motor threshold) | Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Acute GABA consumption on short intracortical facilitation | Transcranial magnetic stimulation (TMS) -derived measure of Intracortical facilitation: The degree of increase of peak-to-peak motor evoked potential (MEP) amplitude induced by the administration of a conditioning stimulus (set at 80% of resting motor threshold) 12-24 ms before the test stimulus (stimulation intensity required to produce an MEP of 1 mV, approximately 120% of resting motor threshold). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| François Corbin, MD, Ph.D. | Contact | 819-346-1110 | 15801 | Francois.Corbin@USherbrooke.ca |
| Samantha Cote, Ph.D. | Contact | 819-346-1110 | 70184 | Samantha.cote@usherbrooke.ca |
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| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| ID | Term |
|---|---|
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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Randomized, crossover, single-blind, placebo-controlled design
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The research team will conduct the randomization and participant code allocation process using REDCap and will dispense the medication or placebo based on the randomization. The placebo will be visibly identical to that of the active medication (i.e. white powder in a gel capsule of the same size and colour as the active medication)
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| Acute Placebo | Other | A capsule filled with powdered sugar taken under the supervision of the research team. |
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| Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo |
| Impact of Acute GABA consumption on GABA concentrations in the brain | Estimation of GABA concentrations in the brain from magnetic resonance spectroscopy | Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo |
| Impact of Acute GABA consumption on subjective alertness | Subjective alertness will be measured using the Biphasic Alcohol Alertness Scale (BAES). This scale which measures alertness and sedation and is comprised of 6 items, for each item participants rate how they feel from 1 (not at all) to 10 (extremely) | Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo |
| Impact of Acute GABA consumption on objective alertness | Objective alertness will be measured using the psychomotor vigilance task (PVT). This computerised task measures alertness, participants will have to respond to visual cues that are presented at random intervals on the screen. | Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo |
| D009930 |
| Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |