The Acute Effects of Exercise and Caffeine on Working Memory During Acute Caffeine Deprivation
Primary Purpose
Acute Exercise, Caffeine Withdrawal, Memory Deficits
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Acute Exercise
Caffeine Powder
Sponsored by
About this trial
This is an interventional treatment trial for Acute Exercise
Eligibility Criteria
Inclusion Criteria:
- Are over the age of 18 years
- Consume at least 150 mg of caffeine a day
- Do not have any cognitive problems
- Are not pregnant
- Do not have a medical condition that prevents you to exercise
- Do not have an orthopaedic limitation
- Have access to a telephone or an email account for communication
- Can read and write in English
Exclusion Criteria:
- Participants taking prescription medication for depression or anxiety
- Participants that cannot give informed consent will be excluded.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Acute Exercise
Caffeine Ingestion
Arm Description
20 minutes of moderate intensity acute exercise (treadmill speed to achieve ⅔ of maximum heart rate).
1.2mg/kg of powdered caffeine (Caffeine powder, ReagentPlus® from Sigma-Aldrich) dissolved in 1 cup of water then sitting for 20 minutes.
Outcomes
Primary Outcome Measures
Change in Working Memory as assessed by N-back task
Participants will complete three n-back assessments, one baseline, one after 24 hours of caffeine deprivation, and one after treatment (either caffeine ingestion or acute exercise). Percent error rates will be compared.
Secondary Outcome Measures
Full Information
NCT ID
NCT05170464
First Posted
December 10, 2021
Last Updated
January 3, 2022
Sponsor
Western University, Canada
1. Study Identification
Unique Protocol Identification Number
NCT05170464
Brief Title
The Acute Effects of Exercise and Caffeine on Working Memory During Acute Caffeine Deprivation
Official Title
Comparing the Acute Effects of Exercise and Caffeine on Working Memory During a Short Period of Caffeine Deprivation in Moderate to Heavy Caffeine Consumers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
To determine the effects of moderate intensity exercise and caffeine on working memory in deprived caffeine consumers.
Detailed Description
Participants will be asked to keep consumption of caffeine before the first visit to their regular dose (ex. morning coffee) and to abstain from alcohol and drugs for at least 18 hours prior to testing. Participants will be urged to arrive at the same time for each visit. Upon arrival to the Exercise and Health Psychology lab (located in room 408 of the Arthur and Sonia Labatt Health Science Building at Western University) participants will be given the letter of information and asked to sign the informed consent form. Participants will also be asked to complete a demographic survey, PAR-Q (Physical Activity Readiness Questionnaire) readiness for exercise, Godin Leisure-Time Exercise Questionnaire, CCQ-R (Caffeine Consumption Questionnaire), and the CWSQ (Caffeine Withdrawal Symptom Questionnaire). Vitals (heart rate and blood pressure) will be assessed following the completion of the questionnaires as well as post assessment in the seated position. Prior to evaluation on the N-back task (cognitive memory task described below) a practice stage with be conducted until the participant can consistently score 75% or higher on three consecutive trials to eliminate a learning effect. After establishing familiarity, a baseline cognition score will be conducted through the n-back assessment.
Prior to arrival for the second visit, participants will be asked to refrain from caffeine for at least 24 hours and to abstain from abstain from alcohol and drugs for at least 18 hours prior to testing. During the second visit (approximately 24 hours after the first) the participants will complete the pre-caffeine or pre-exercise questionnaire, the CWSQ and vitals will be monitored pre and post intervention. Caffeine abstinence will be validated through self-report with the use of deception (participants being told that their saliva sample is being tested for the presence of caffeine). To collect saliva, a cotton swab will be placed under their tongue for 1minute, placed into a tube, and then a co-investigator will discard the tube into a biohazard deposal container immediately. Participants will then complete another n-back assessment.
The participants will be randomized into either the moderate intensity exercise or caffeine ingestion group. The interventions are as followed; Moderate Intensity Exercise will consist of a 20-minute bout of moderate intensity aerobic exercise. Exercise will consist of a 2-minute warm-up, followed by 15 minutes of walking at a rate, which will allow you to reach 2/3 of your max heart rate (moderate intensity exercise= (220-age) x 0.6), and then a 3-minute cool down on a treadmill (together equaling 20 minutes). HR will be monitored through heart rate monitors worn by the participants. The caffeine ingestion group will ingest 1.2 mg/kg of caffeine in powder form with water to drink, after ingestion of caffeine participants will wait 20 minutes to ensure peak plasma levels. The post intervention n-back assessment will begin within two minutes of the completion of either intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Exercise, Caffeine Withdrawal, Memory Deficits
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acute Exercise
Arm Type
Experimental
Arm Description
20 minutes of moderate intensity acute exercise (treadmill speed to achieve ⅔ of maximum heart rate).
Arm Title
Caffeine Ingestion
Arm Type
Active Comparator
Arm Description
1.2mg/kg of powdered caffeine (Caffeine powder, ReagentPlus® from Sigma-Aldrich) dissolved in 1 cup of water then sitting for 20 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Acute Exercise
Other Intervention Name(s)
Aerobic Exercise
Intervention Description
Brisk walking on a treadmill at ⅔ maximum heart rate as defined by 220-age (in years).
Intervention Type
Drug
Intervention Name(s)
Caffeine Powder
Other Intervention Name(s)
Caffeine Ingestion
Intervention Description
Participants will receive powdered caffeine dissolved in one cup of water (1.2mg/kg)
Primary Outcome Measure Information:
Title
Change in Working Memory as assessed by N-back task
Description
Participants will complete three n-back assessments, one baseline, one after 24 hours of caffeine deprivation, and one after treatment (either caffeine ingestion or acute exercise). Percent error rates will be compared.
Time Frame
Baseline and 24 hours later (deprived and post-treatment).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Are over the age of 18 years
Consume at least 150 mg of caffeine a day
Do not have any cognitive problems
Are not pregnant
Do not have a medical condition that prevents you to exercise
Do not have an orthopaedic limitation
Have access to a telephone or an email account for communication
Can read and write in English
Exclusion Criteria:
Participants taking prescription medication for depression or anxiety
Participants that cannot give informed consent will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aidan S Woodward
Phone
289-251-6120
Email
awoodwa5@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry Prapavessis, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Given the lack of research currently, it is unlikely for other researchers to request data. If other studies are done, we will put together a plan to share IPD.
Citations:
PubMed Identifier
31873185
Citation
Morava A, Fagan MJ, Prapavessis H. Effects of Caffeine and Acute Aerobic Exercise on Working Memory and Caffeine Withdrawal. Sci Rep. 2019 Dec 23;9(1):19644. doi: 10.1038/s41598-019-56251-y.
Results Reference
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The Acute Effects of Exercise and Caffeine on Working Memory During Acute Caffeine Deprivation
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