GABAergic SystemNCT06464172
Association Between Serum and Neuroimaging Measurements of the GABAergic System
A study testing Acute Oral gamma-aminobutyric acid (Natural Health Product in Canada) in people with GABAergic System, run by Francois Corbin.
Trial summary
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: 1. Does GABA cross the blood-brain barrier? 2. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- GABAergic System
- What is being tested?
- Acute Oral gamma-aminobutyric acid (Natural Health Product in Canada)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between 18 and 35 years old
- Be of right manual dominance
- In good health
Who cannot join
- Have an implant or pacemaker,
- Having tinnitus,
- Have a history of fainting,
- Have already had an epileptic seizure or have a family history of epilepsy,
- Have a known neurological disease,
- Have a diagnosis of diabetes
Show all 16Show fewer
- Be under psychotropic medication,
- Have suffered from substance abuse or dependence in the last 6 months,
- Have a neurostimulator,
- Have a splinter or metallic implant in the head or the rest of the body,
- Have a cochlear implant,
- Have an automated injection system implanted (insulin pump),
- Have a transdermal patch,
- Have tattoos in the area to be studied,
- Be pregnant or breastfeeding,
- Being claustrophobic or having other reasons that would prevent the volunteer from tolerating the imaging exam.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The GABAergic System: Study of the Association Between Serum Measurements and Those Obtained Through Neuroimaging in Healthy Human Adults
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:
- Does GABA cross the blood-brain barrier?
- Can peripheral measurements of the GABAergic system be used to study GABA in the brain?
Participants will receive oral GABA and Placebo and undergo blood draws, MRI scans and transcranial magnetic stimulation sessions.
Read the detailed description
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.
- Conditions
- GABAergic System
- Being tested
- Acute Oral gamma-aminobutyric acid (Natural Health Product in Canada), Acute Placebo
- Keywords
- GABAergic system, Neuroimaging, Transcranial Magnetic Stimulation, Magnetic Resonance Spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Oral gamma-aminobutyric acid (Natural Health Product in Canada)Other
Also called GABA
1800 mg (3 capsules of 600mg) of GABA taken at the research center under the supervision of the research team.
Acute PlaceboOther
A capsule filled with powdered sugar taken under the supervision of the research team.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Acute Oral gamma-aminobutyric acid (Natural Health Product in Canada); Other: Acute Placebo |
| 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. Receives: Other: Acute Oral gamma-aminobutyric acid (Natural Health Product in Canada); Other: Acute Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo
Secondary outcomes (4)
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).
Measured: 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
Measured: 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)
Measured: 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.
Measured: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start5 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GABAergic SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, crossover, single-blind, placebo-controlled design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francois Corbin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francois Corbin, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464172
- Sponsor's protocol ID
- 2024-5398
- Other IDs
- 2024-5398
- Status last verified
- Feb 2025
- First submitted
- 10 Jun 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GABAergic System: Study of the Association Between Serum Measurements and Those Obtained Through Neuroimaging in Healthy Human Adults
- ClinicalTrials.gov ID
- NCT06464172
- Acronym / sponsor ID
- 2024-5398
- Conditions
- GABAergic System
- Keywords
- GABAergic system, Neuroimaging, Transcranial Magnetic Stimulation, Magnetic Resonance Spectroscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Francois CorbinUniversity, hospital or other
- Study start
- 5 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does GABA cross the blood-brain barrier?
- Can peripheral measurements of the GABAergic system be used to study GABA in the brain?
Participants will receive oral GABA and Placebo and undergo blood draws, MRI scans and transcranial magnetic stimulation sessions.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, crossover, single-blind, placebo-controlled design
| Arm | Type | Receives |
|---|---|---|
| GABA Start Group | Experimental | Other: Acute Oral gamma-aminobutyric acid (Natural Health Product in Canada), Other: Acute PlaceboParticipants 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. |
| Placebo Start Group | Experimental | Other: Acute Oral gamma-aminobutyric acid (Natural Health Product in Canada), Other: Acute PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Be between 18 and 35 years old
- Be of right manual dominance
- In good health
Key exclusion criteria (16 listed)
- Have an implant or pacemaker,
- Having tinnitus,
- Have a history of fainting,
- Have already had an epileptic seizure or have a family history of epilepsy,
- Have a known neurological disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Oral gamma-aminobutyric acid (Natural Health Product in Canada)Also: GABA1800 mg (3 capsules of 600mg) of GABA taken at the research center under the supervision of the research team. | Other | GABA Start Group, Placebo Start Group |
| Acute PlaceboA capsule filled with powdered sugar taken under the supervision of the research team. | Other | GABA Start Group, Placebo Start Group |
Primary outcome
Impact of Acute GABA consumption on peripheral serum GABA concentrations
Time frame: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo
Serum GABA concentration will be measured before and after acute administration of GABA and placebo.
Impact of Acute GABA consumption on short intracortical inhibition
Time frame: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo
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)
4 secondary outcomes
Impact of Acute GABA consumption on short intracortical facilitation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Oral gamma-aminobutyric acid (Natural Health Product in Canada) in people with GABAergic System, run by Francois Corbin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François Corbin, MD, Ph.D. (819-346-1110 ext. 15801, Francois.Corbin@USherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Acute GABA consumption on peripheral serum GABA concentrations (time frame: Pre-GABA, 40 minutes after acute administration of GABA, Pre-Placebo, 40 minutes after acute administration of Placebo). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.