- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07912307
Sex Differences in BDNF Study (BDNF-SD)
Investigation of Sex-differences the BDNF Response to Exercise
A single bout of exercise can improve cognitive abilities like memory and attention. These functions help us navigate through everyday life. However, we do not fully understand how exercise improves cognitive abilities. We believe that exercise improves the brain by increasing the amount of BDNF in the blood. BDNF is very important for learning and memory. However, we still do not know if BDNF responds differently to exercise between females and males.
The purpose of this work is to characterize potential sex-differences in the circulating BDNF response to acute exercise. We will test the hypothesis that males will have greater serum and plasma BDNF responses compared to females following a maximal exercise test.
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
- Recruiting
- McMaster University
-
Contact:
- Jeremy J Walsh, PhD
- Phone Number: 23523 9055259140
- Email: walshj18@mcmaster.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Between the ages of 18 and 35
Exclusion Criteria:
- presence of type 2 diabetes
- history of hypoglycaemia
- history of concussion(s) with persistent symptoms
- presence of major depressive disorder
- history of cardiovascular events requiring hospitalization (i.e., heart attack, stroke)
- presence of respiratory disease (e.g. asthma)
- pre-existing injuries that prevent aerobic exercise participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VO2peak Test
Responses will be compared between males and females following a single experimental visit. Participants will complete a incremental ramp test to volitional exhaustion on a cycle ergometer, with venous blood draws characterizing BDNF responses at baseline and during the recovery period up to 1-hour post-exercise. |
Incremental ramp test to volitional exhaustion on a cycle ergometer. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plasma and Serum BDNF
Time Frame: At baseline and 0, 15, 30, 45, and 60 minutes post-exercise.
|
Measured via ELISA analysis of venous samples obtained from a forearm vein |
At baseline and 0, 15, 30, 45, and 60 minutes post-exercise.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Platelet Count
Time Frame: At baseline and 0, 15, 30, 45, and 60 minutes post-exercise.
|
Measured from venous samples obtained from a forearm vein |
At baseline and 0, 15, 30, 45, and 60 minutes post-exercise.
|
|
Blood lactate
Time Frame: At baseline and 0, 15, 30, 45, and 60 minutes post-exercise.
|
Measured from venous samples obtained from a forearm vein |
At baseline and 0, 15, 30, 45, and 60 minutes post-exercise.
|
|
Oxygen uptake
Time Frame: During incremental ramp test to volitional exhaustion
|
Breath-by-breath analysis performed via metabolic cart |
During incremental ramp test to volitional exhaustion
|
|
Flow-mediated dilation (FMD)
Time Frame: At baseline and 15 and 60 minutes post-exercise.
|
Measured via brachial artery ultrasound |
At baseline and 15 and 60 minutes post-exercise.
|
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BDNF-SD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The investigators will share individual patient data (de-identified) with researchers upon request
IPD Sharing Time Frame
Beginning 12 months and ending 36 months following article publication.
IPD Sharing Access Criteria
Anyone who wishes to access the data.
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
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