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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
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 10, 2021
    Last Updated
    January 3, 2022
    Sponsor
    Western University, Canada
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    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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