- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06817681
Exercise-Induced Lactate and Cognitive Function (ExLBC)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jeremy J Walsh, PhD
- Phone Number: 23523 905-525-9140
- Email: walshj18@mcmaster.ca
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S 4K1
- McMaster University
-
Contact:
- Jeremy J Walsh, PhD
- Phone Number: 23523 905-525-9140
- Email: walshj18@mcmaster.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between the ages of 18-35 years old.
- Perform ≥150 minutes of moderate-to-vigorous aerobic activity per week.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
Single dose of a placebo supplement (0.4 g/kg body weight of sodium chloride gelatin capsules).
|
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.
Other Names:
|
|
Experimental: Sodium bicarbonate (NaHCO3)
Single dose of sodium bicarbonate supplement (0.4 g/kg body weight of NaHCO3 gelatin capsules).
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive Function (Executive Function)
Time Frame: 3-hour
|
The Stroop Task will be used to measure executive function (selective attention and inhibitory control).
|
3-hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive Function (Working Memory)
Time Frame: 3-hour
|
The N-Back Test will be used to assess working memory.
|
3-hour
|
|
Cognitive Function (Visuospatial Memory)
Time Frame: 3-hour
|
The Spatial Span Test will be used to assess visuospatial memory.
|
3-hour
|
|
Blood Lactate
Time Frame: 3-hour
|
Venous blood samples will be obtained via intravenous catheter.
|
3-hour
|
|
Sodium Bicarbonate (NaHCO3)
Time Frame: 3-hour
|
Venous blood samples will be obtained via intravenous catheter.
|
3-hour
|
|
Blood pH
Time Frame: 3-hour
|
Venous blood samples will be obtained via intravenous catheter.
|
3-hour
|
|
Brain-Derived Neurotrophic Factor (BDNF)
Time Frame: 3-hour
|
Serum and plasma BDNF measured in venous blood samples will be obtained via intravenous catheter.
|
3-hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeremy J Walsh, PhD, McMaster University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ExLBC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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