NCT06817681

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 10, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

February 10, 2025

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

February 4, 2025

Last Update Submit

February 4, 2025

Conditions

Keywords

LactateSodium BicarbonateNaHCO3CognitionExecutive FunctionAcute Exercise

Outcome Measures

Primary Outcomes (1)

  • Cognitive Function (Executive Function)

    The Stroop Task will be used to measure executive function (selective attention and inhibitory control).

    3-hour

Secondary Outcomes (6)

  • Cognitive Function (Working Memory)

    3-hour

  • Cognitive Function (Visuospatial Memory)

    3-hour

  • Blood Lactate

    3-hour

  • Sodium Bicarbonate (NaHCO3)

    3-hour

  • Blood pH

    3-hour

  • +1 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Single dose of a placebo supplement (0.4 g/kg body weight of sodium chloride gelatin capsules).

Other: Placebo (Sodium Chloride)

Sodium bicarbonate (NaHCO3)

EXPERIMENTAL

Single dose of sodium bicarbonate supplement (0.4 g/kg body weight of NaHCO3 gelatin capsules).

Dietary Supplement: Sodium Bicarbonate (NaHCO3)

Interventions

Sodium Bicarbonate (NaHCO3)DIETARY_SUPPLEMENT

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.

Also known as: Baking Soda
Sodium bicarbonate (NaHCO3)

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.

Also known as: Table Salt
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18-35 years old.
  • Perform ≥150 minutes of moderate-to-vigorous aerobic activity per week.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Sodium BicarbonateSodium ChlorideSodium Chloride, Dietary

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsChloridesHydrochloric AcidChlorine CompoundsSodium, Dietary

Study Officials

  • Jeremy J Walsh, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy J Walsh, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 4, 2025

First Posted

February 10, 2025

Study Start

February 10, 2025

Primary Completion

July 30, 2025

Study Completion

September 20, 2025

Last Updated

February 10, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

The investigators will share individual patient data (de-identified) with researchers upon request.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 12 months and ending 36 months following article publication.
Access Criteria
Anyone who wishes to access the data.

Locations