Acute ExercisePhase 2/3NCT05170464
The Acute Effects of Exercise and Caffeine on Working Memory During Acute Caffeine Deprivation
A Phase 2/3 study testing Acute Exercise and Caffeine Powder in people with Acute Exercise and Caffeine Withdrawal, run by Western University, Canada at 1 site in Canada.
Trial summary
To determine the effects of moderate intensity exercise and caffeine on working memory in deprived caffeine consumers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Exercise, Caffeine Withdrawal, Memory Deficits
- What is being tested?
- Acute Exercise and Caffeine Powder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2022to 1 Apr 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants taking prescription medication for depression or anxiety
- Participants that cannot give informed consent will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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
To determine the effects of moderate intensity exercise and caffeine on working memory in deprived caffeine consumers.
Read the 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.
- Conditions
- Acute Exercise, Caffeine Withdrawal, Memory Deficits
- Being tested
- Acute Exercise, Caffeine Powder
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute ExerciseBehavioural
Also called Aerobic Exercise
Brisk walking on a treadmill at ⅔ maximum heart rate as defined by 220-age (in years).
Caffeine PowderDrug
Also called Caffeine Ingestion
Participants will receive powdered caffeine dissolved in one cup of water (1.2mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| Acute Exercise | Experimental | 20 minutes of moderate intensity acute exercise (treadmill speed to achieve ⅔ of maximum heart rate). Receives: Behavioral: Acute Exercise |
| Caffeine Ingestion | Active comparator | 1.2mg/kg of powdered caffeine (Caffeine powder, ReagentPlus® from Sigma-Aldrich) dissolved in 1 cup of water then sitting for 20 minutes. Receives: Drug: Caffeine Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 24 hours later (deprived and post-treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start10 Jan 2022
- Primary completion31 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute ExerciseStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Harry Prapavessis, Western University, Canada
- Investigators
- Harry Prapavessis, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170464
- Sponsor's protocol ID
- 120038
- Status last verified
- Feb 2024
- First submitted
- 10 Dec 2021
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 31873185
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05170464
- Acronym / sponsor ID
- 120038
- Conditions
- Acute Exercise, Caffeine Withdrawal, Memory Deficits
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Exercise | Experimental | Behavioral: Acute Exercise20 minutes of moderate intensity acute exercise (treadmill speed to achieve ⅔ of maximum heart rate). |
| Caffeine Ingestion | Active comparator | Drug: Caffeine Powder1.2mg/kg of powdered caffeine (Caffeine powder, ReagentPlus® from Sigma-Aldrich) dissolved in 1 cup of water then sitting for 20 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Participants taking prescription medication for depression or anxiety
- Participants that cannot give informed consent will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute ExerciseAlso: Aerobic ExerciseBrisk walking on a treadmill at ⅔ maximum heart rate as defined by 220-age (in years). | Behavioural | Acute Exercise |
| Caffeine PowderAlso: Caffeine IngestionParticipants will receive powdered caffeine dissolved in one cup of water (1.2mg/kg) | Drug | Caffeine Ingestion |
Primary outcome
Change in Working Memory as assessed by N-back task
Time frame: Baseline and 24 hours later (deprived and post-treatment).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Background: PubMed 31873185Morava 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Prapavessis, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acute Exercise and Caffeine Powder in people with Acute Exercise and Caffeine Withdrawal, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Working Memory as assessed by N-back task (time frame: Baseline and 24 hours later (deprived and post-treatment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05170464, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.