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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05170464
Other study ID # 120038
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date January 10, 2022
Est. completion date April 1, 2022

Study information

Verified date February 2024
Source Western University, Canada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To determine the effects of moderate intensity exercise and caffeine on working memory in deprived caffeine consumers.


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.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date April 1, 2022
Est. primary completion date March 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Behavioral:
Acute Exercise
Brisk walking on a treadmill at ? maximum heart rate as defined by 220-age (in years).
Drug:
Caffeine Powder
Participants will receive powdered caffeine dissolved in one cup of water (1.2mg/kg)

Locations

Country Name City State
Canada The University of Western Ontario London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline and 24 hours later (deprived and post-treatment).
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