CognitionNCT06817681
Exercise-Induced Lactate and Cognitive Function (ExLBC)
A study testing Sodium Bicarbonate (NaHCO3) in people with Cognition and Sodium Bicarbonate, run by McMaster University at 2 sites in Canada.
Trial summary
A single bout of exercise can rapidly improve cognitive functions including memory, attention, and executive functions, which help us navigate through everyday life. However, we do not fully understand the mechanism behind this process. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition, Sodium Bicarbonate, Lactate
- What is being tested?
- Sodium Bicarbonate (NaHCO3)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesCanada
- Study dates
- 10 Mar 2025to 20 Feb 2027
- 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
- Between the ages of 18-35 years old.
- Perform ≥150 minutes of moderate-to-vigorous aerobic activity per week.
Who cannot join
- Diagnosis of Type 2 Diabetes.
- Presence of hypoglycaemia.
- History of concussion(s) with persistent symptoms.
- History of mental health conditions.
- History of cardiovascular events requiring hospitalization (e.g., heart attack).
- Pre-existing injuries that prevent completion of aerobic exercise.
- Presence of colour-blindness.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster University
Hamilton, Ontario, L8S 4K1
McMaster University
Hamilton, Ontario, L8S 4L8
About this study
Official title: The Effect of Exercise-Induced Lactate on BDNF and Cognition
A single bout of exercise can rapidly improve cognitive functions including memory, attention, and executive functions, which help us navigate through everyday life. However, we do not fully understand the mechanism behind this process. A promising candidate mechanism is lactate, which was previously considered merely a waste product of our muscles during exercise. It is now recognized as an important molecule that is used by the brain as an energy source. Studies have shown that increases in lactate during exercise are positively related to improved cognitive function after completion of exercise. Another potential mechanism involves the increase in neurotrophins such as brain-derived neurotrophic factor (BDNF) following exercise. The increase in lactate and BDNF during exercise may be connected to cause these cognitive improvements.
However, because lactate increases with higher exercise intensities, we currently do not know how lactate specifically impacts brain health. To address this, muscle and blood lactate concentrations can be experimentally manipulated during exercise using sodium bicarbonate (NaHCO3) supplementation and will allow us to explore how lactate specifically affects brain function.
The purpose of this project is to investigate the effect of exercise-induced lactate on BDNF and cognition following oral NaHCO3 supplementation in young adults. We hypothesize that BDNF levels will be higher, and cognition will be improved in executive function, visuospatial memory, and working memory in the NaHCO3 condition due to higher plasma lactate during exercise compared to placebo.
- Conditions
- Cognition, Sodium Bicarbonate, Lactate, Exercise
- Being tested
- Sodium Bicarbonate (NaHCO3), Placebo (Sodium Chloride)
- Keywords
- Lactate, Sodium Bicarbonate, NaHCO3, Cognition, Executive Function, Acute Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Bicarbonate (NaHCO3)Dietary supplement
Also called Baking Soda
Ingestion of gelatin capsules containing 0.4 g/kg body weight of sodium bicarbonate (NaHCO3) followed by 90 minutes of rest. Continuous high intensity cycling to be performed following 90-minute resting measures.
Placebo (Sodium Chloride)Other
Also called Table Salt
Ingestion of gelatin capsules containing 0.4 g/kg body weight of sodium chloride (NaCl) followed by 90 minutes of rest. Continuous high intensity cycling to be performed following 90-minute resting measures.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Single dose of a placebo supplement (0.4 g/kg body weight of sodium chloride gelatin capsules). Receives: Other: Placebo (Sodium Chloride) |
| Sodium bicarbonate (NaHCO3) | Experimental | Single dose of sodium bicarbonate supplement (0.4 g/kg body weight of NaHCO3 gelatin capsules). Receives: Dietary Supplement: Sodium Bicarbonate (NaHCO3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Function (Executive Function)
The Stroop Task will be used to measure executive function (selective attention and inhibitory control).
Measured: 3-hour
Secondary outcomes (6)
Cognitive Function (Working Memory)
The N-Back Test will be used to assess working memory.
Measured: 3-hour
Cognitive Function (Visuospatial Memory)
The Spatial Span Test will be used to assess visuospatial memory.
Measured: 3-hour
Blood Lactate
Venous blood samples will be obtained via intravenous catheter.
Measured: 3-hour
Sodium Bicarbonate (NaHCO3)
Venous blood samples will be obtained via intravenous catheter.
Measured: 3-hour
Blood pH
Venous blood samples will be obtained via intravenous catheter.
Measured: 3-hour
Brain-Derived Neurotrophic Factor (BDNF)
Serum and plasma BDNF measured in venous blood samples will be obtained via intravenous catheter.
Measured: 3-hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start10 Mar 2025
- Primary completion30 Mar 2026
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies 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
- A randomized double-blind placebo-controlled crossover design will be used to test 2 conditions. Participants will ingest gelatin capsules containing: 1) 0.4 g/kg body weight of sodium bicarbonate (NaHCO3); or 2) 0.4 g/kg body weight of sodium chloride (NaCl) (placebo supplement).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Walsh, McMaster University
- Investigators
- Jeremy J Walsh, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817681
- Sponsor's protocol ID
- ExLBC
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share individual patient data (de-identified) with researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise-Induced Lactate on BDNF and Cognition
- ClinicalTrials.gov ID
- NCT06817681
- Acronym / sponsor ID
- ExLBC
- Conditions
- Cognition, Sodium Bicarbonate, Lactate, Exercise
- Keywords
- Lactate, Sodium Bicarbonate, NaHCO3, Cognition, Executive Function, Acute Exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 10 Feb 2025 (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.
A single bout of exercise can rapidly improve cognitive functions including memory, attention, and executive functions, which help us navigate through everyday life. However, we do not fully understand the mechanism behind this process. A promising candidate mechanism is lactate, which was previously considered merely a waste product of our muscles during exercise. It is now recognized as an important molecule that is used by the brain as an energy source. Studies have shown that increases in lactate during exercise are positively related to improved cognitive function after completion of exercise. Another potential mechanism involves the increase in neurotrophins such as brain-derived neurotrophic factor (BDNF) following exercise. The increase in lactate and BDNF during exercise may be connected to cause these cognitive improvements.
However, because lactate increases with higher exercise intensities, we currently do not know how lactate specifically impacts brain health. To address this, muscle and blood lactate concentrations can be experimentally manipulated during exercise using sodium bicarbonate (NaHCO3) supplementation and will allow us to explore how lactate specifically affects brain function.
The purpose of this project is to investigate the effect of exercise-induced lactate on BDNF and cognition following oral NaHCO3 supplementation in young adults. We hypothesize that BDNF levels will be higher, and cognition will be improved in executive function, visuospatial memory, and working memory in the NaHCO3 condition due to higher plasma lactate during exercise compared to placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized double-blind placebo-controlled crossover design will be used to test 2 conditions. Participants will ingest gelatin capsules containing: 1) 0.4 g/kg body weight of sodium bicarbonate (NaHCO3); or 2) 0.4 g/kg body weight of sodium chloride (NaCl) (placebo supplement).
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo (Sodium Chloride)Single dose of a placebo supplement (0.4 g/kg body weight of sodium chloride gelatin capsules). |
| Sodium bicarbonate (NaHCO3) | Experimental | Dietary Supplement: Sodium Bicarbonate (NaHCO3)Single dose of sodium bicarbonate supplement (0.4 g/kg body weight of NaHCO3 gelatin capsules). |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between the ages of 18-35 years old.
- Perform ≥150 minutes of moderate-to-vigorous aerobic activity per week.
Key exclusion criteria (7 listed)
- Diagnosis of Type 2 Diabetes.
- Presence of hypoglycaemia.
- History of concussion(s) with persistent symptoms.
- History of mental health conditions.
- History of cardiovascular events requiring hospitalization (e.g., heart attack).
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 |
|---|---|---|
| Sodium Bicarbonate (NaHCO3)Also: Baking SodaIngestion of gelatin capsules containing 0.4 g/kg body weight of sodium bicarbonate (NaHCO3) followed by 90 minutes of rest. Continuous high intensity cycling to be performed following 90-minute resting measures. | Dietary supplement | Sodium bicarbonate (NaHCO3) |
| Placebo (Sodium Chloride)Also: Table SaltIngestion of gelatin capsules containing 0.4 g/kg body weight of sodium chloride (NaCl) followed by 90 minutes of rest. Continuous high intensity cycling to be performed following 90-minute resting measures. | Other | Placebo |
Primary outcome
Cognitive Function (Executive Function)
Time frame: 3-hour
The Stroop Task will be used to measure executive function (selective attention and inhibitory control).
6 secondary outcomes
Cognitive Function (Working Memory)
Time frame: 3-hour
Cognitive Function (Visuospatial Memory)
Time frame: 3-hour
Blood Lactate
Time frame: 3-hour
Sodium Bicarbonate (NaHCO3)
Time frame: 3-hour
Blood pH
Time frame: 3-hour
Brain-Derived Neurotrophic Factor (BDNF)
Time frame: 3-hour
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 7 Oct 2026.
- Individual participant dataSharing planned: Yes. The investigators will share individual patient data (de-identified) with researchers upon request.
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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. This study is not recruiting at the moment.
Jeremy J Walsh, PhD principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Bicarbonate (NaHCO3) in people with Cognition and Sodium Bicarbonate, run by McMaster University at 2 sites in Canada.
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 2 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function (Executive Function) (time frame: 3-hour). 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 7 Oct 2026.