Adult PopulationPhase 4AECNCT03400423
The Acute Effects of Caffeine on Exercise and Cognition
A Phase 4 study testing Caffeine and Moderate Intensity Exercise in people with Adult Population, run by Western University, Canada at 1 site in Canada.
Trial summary
The effects of moderate intensity aerobic exercise and caffeine ingestion on cognition (more specifically working memory) in non-caffeine drinker and caffeine drinkers will be examined. The non-caffeine drinkers will be recruited for two visits, whereas, the caffeine drinkers will be recruited for three visits. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult Population
- What is being tested?
- Caffeine and Moderate Intensity Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2018to 1 Aug 2019
- Phase
- Phase 4
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are over the age of 18 years (male or female)
- Do not consume more than 100 mg of caffeine a week
- 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
Show all 16Show fewer
- Have access to a telephone or an email account for communication
- Can read and write in English You are being invited to take part in phase 2 and 3 of this research study because
- Are over the age of 18 years old
- Are consuming 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
- Potential subjects will be excluded if they are pregnant. Additionally, participants taking prescription medication for depression or anxiety, and participants that cannot give informed consent will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effects of Moderate Intensity Exercise and Caffeine Ingestion on Cognition in Non-Caffeine Consumers and Caffeine Consumers
The effects of moderate intensity aerobic exercise and caffeine ingestion on cognition (more specifically working memory) in non-caffeine drinker and caffeine drinkers will be examined. The non-caffeine drinkers will be recruited for two visits, whereas, the caffeine drinkers will be recruited for three visits. The study involves a baseline assessment of cognition and examines the effects of exercise and caffeine. Finally the caffeine group will consist of a baseline and intervention assessment when deprived of caffeine (overnight abstinence). The exercise intervention is to complete 20-minutes of moderate intensity exercise (brisk walk) while the caffeine condition is to consume 1.2 mg/kg of caffeine. Immediately following both intervention the n-back assessment will be conducted.
Read the detailed description
Phase 1 will assess non-caffeine consumers
Phase 1 will utilize a within subjects counter-balanced design. Previous to arrival for phase 1, participants will be asked to abstain from alcohol and drugs for at least 18 hours previous. 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. After consent, participants will also be asked to complete a demographic survey, PAR-Q readiness for exercise, Godin Leisure-Time Exercise Questionnaire, caffeine consumption questionnaire-R (CCQ-R) and a caffeine withdrawal questionnaire (CWSQ). Vitals (heart rate and blood pressure) will be assessed following the completion of the questionnaires as well as post intervention 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 test familiarity, a baseline cognition score will be conducted through the n-back assessment. The subject will then be given a 5-minute break (i.e., to use the lavatory). Following the break, the participants will be randomized into either moderate intensity exercise or caffeine ingestion group. The interventions are as follows; 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 ((220-age)x0.6) followed by 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 orally in powder form with water to drink, after ingestion of caffeine participants will wait 20 minutes to ensure peak plasma levels. The participants both the exercise group and the caffeine ingestion group will be asked to refrain from conversation. The post intervention assessment will begin within two minutes of the completion of either intervention. The second visit of phase I will take place the following day at the same time (if possible). During the second visit the participant's will complete the pre caffeine or pre exercise questionnaire, the CWSQ and vitals will be monitored pre and post intervention. The participants will participate in the intervention that they have not received on the first visit (for example, if the participant received caffeine ingestion on the first visit the participant will receive moderate intensity aerobic exercise on the second visit). Within two minutes of completion the post treatment N-back task assessment will begin.
Phases 2 and 3 will assess caffeine consumers (phase 3 in an acutely deprived state)
Phase 2 will utilize a within subjects counter-balanced design. Previous to arrival for phase 2 participants will be asked to keep consumption of caffeine to a regular dose (morning coffee) on the day of testing, 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 readiness for exercise, Godin Leisure-Time Exercise Questionnaire, CCQ-R, and the CWSQ. Vitals (heart rate and blood pressure) will be assessed following the completion of the questionnaires as well as post intervention 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. The subject will then be given a 5 minute break (i.e., to use the lavatory). Following the break 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 participants in both the, exercise group and caffeine ingestion group will be asked to refrain from conversation. The post intervention assessment will begin within two minutes of the completion of either intervention. The second visit of phase I will take place the following day at the same time (if possible). During the second visit the participant's will complete the pre caffeine or pre exercise questionnaire, the CWSQ and vitals will be monitored pre and post intervention. The participants will participate in the intervention that they have not received on the first visit (for example, if the participant received caffeine ingestion on the first visit the participant will receive moderate intensity aerobic exercise on the second visit). Within two minutes of completion the post treatment N-back task assessment will begin.
Prior to arrival for phase 3, participants will be asked to refrain from caffeine for at least 12 hours, and abstain from alcohol and drugs for at least 18 hours prior to testing. Phase 3 will utilize the same participants as phase 2, but they will be examined in a caffeine-deprived state (12 hours) for baseline N-back scores the CWSQ will also be administered. Participants will then be randomized into either the caffeine ingestion group or exercise treatment group where post intervention N-back scores will be obtained. Participants will be asked to complete the same pre-intervention questionnaires as the previous phase. Vitals (heart rate and blood pressure) will be assessed 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).
N-back task explanation: Three tasks will be administered to subjects for each treatment condition (after caffeine administration and after exercise). The 1-back, 2-back, and 3-back cognitive tests will assess working memory by measuring both the percentage of correct responses, as well as reaction time. In these 5 minute tasks, a letter will appear on a computer screen for an interval of 500ms, followed by a 2000ms blank screen interstimulus (totaling 120 letters/5 minutes). Participants will be instructed to click the left button of a computer mouse as soon as a target appears, and to keep in mind both the speed and accuracy components of the task. In the 1-back condition, the target is defined as a letter flashing that is the same as the one preceding it. For example, "x, interstimulus, x" would be the target. In the 2-back condition, the target is defined as a letter appearing that is the same as what preceded it 2 letters before. For example, "a, interstimulus, b, interstimulus, a", would be the target. In the 3-back condition, the target is defined as a letter appearing that is the same as what preceded it 3 letters before. For example, "a, interstimulus, b, interstimulus, c, interstimulus, a", would be the target. All tasks call into action the participant's working memory abilities, as a measure of cognition.
- Conditions
- Adult Population
- Being tested
- Caffeine, Moderate Intensity Exercise
- Keywords
- Caffeine, Caffeine Withdrawal, Acute Aerobic Exercise, Cognition, Working Memory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
Oral administration of 1.2mg/kg of powdered caffeine with water.
Moderate Intensity ExerciseBehavioural
Moderate intensity exercise conducted on a treadmill. Moderate intensity exercise defined as (220-age)*0.6.
| Study group | Role | What they receive |
|---|---|---|
| Non-caffeine exercise | Experimental | Exercise cognition score Receives: Behavioral: Moderate Intensity Exercise |
| Non-caffeine cognition | Active comparator | Caffeine cognition score Receives: Drug: Caffeine |
| Caffeine consumption exercise | Experimental | Exercise cognition score Receives: Behavioral: Moderate Intensity Exercise |
| Caffeine consumption cognition | Active comparator | Caffeine cognition score Receives: Drug: Caffeine |
| Deprived Caffeine consumers exercise | Experimental | Exercise cognition score Receives: Behavioral: Moderate Intensity Exercise |
| Deprived caffeine consumers cognition | Active comparator | Caffeine administration cognition score Receives: Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-back on the N-back task
Participants will be instructed to click the left button of a computer mouse as soon as a target appears, and to keep in mind both the speed and accuracy components of the task. In the 1-back condition, the target is defined as a letter flashing that is the same as the one preceding it. For example, "x, interstimulus, x" would be the target. In the 2-back condition, the target is defined as a letter appearing that is the same as what preceded it 2 letters before. For example, "a, interstimulus, b, interstimulus, a", would be the target. In the 3-back condition, the target is defined as a letter appearing that is the same as what preceded it 3 letters before. For example, "a, interstimulus, b, interstimulus, c, interstimulus, a", would be the target. All tasks call into action the participant's working memory abilities, as a measure of cognition.
Measured: Approximately 5 minutes
Secondary outcomes (1)
0,1, and 2 back on the N-back task
Participants will be instructed to click the left button of a computer mouse as soon as a target appears, and to keep in mind both the speed and accuracy components of the task. In the 1-back condition, the target is defined as a letter flashing that is the same as the one preceding it. For example, "x, interstimulus, x" would be the target. In the 2-back condition, the target is defined as a letter appearing that is the same as what preceded it 2 letters before. For example, "a, interstimulus, b, interstimulus, a", would be the target. In the 3-back condition, the target is defined as a letter appearing that is the same as what preceded it 3 letters before. For example, "a, interstimulus, b, interstimulus, c, interstimulus, a", would be the target. All tasks call into action the participant's working memory abilities, as a measure of cognition.
Measured: Approximately 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Feb 2018
- Primary completion1 Jun 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult PopulationStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400423
- Sponsor's protocol ID
- Acute Exercise and Caffeine
- Acronym
- AEC
- Status last verified
- Jan 2018
- First submitted
- 9 Jan 2018
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD.
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
- The Acute Effects of Moderate Intensity Exercise and Caffeine Ingestion on Cognition in Non-Caffeine Consumers and Caffeine Consumers
- ClinicalTrials.gov ID
- NCT03400423
- Acronym / sponsor ID
- AEC / Acute Exercise and Caffeine
- Conditions
- Adult Population
- Keywords
- Caffeine, Caffeine Withdrawal, Acute Aerobic Exercise, Cognition, Working Memory
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 17 Jan 2018 (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.
The effects of moderate intensity aerobic exercise and caffeine ingestion on cognition (more specifically working memory) in non-caffeine drinker and caffeine drinkers will be examined. The non-caffeine drinkers will be recruited for two visits, whereas, the caffeine drinkers will be recruited for three visits. The study involves a baseline assessment of cognition and examines the effects of exercise and caffeine. Finally the caffeine group will consist of a baseline and intervention assessment when deprived of caffeine (overnight abstinence). The exercise intervention is to complete 20-minutes of moderate intensity exercise (brisk walk) while the caffeine condition is to consume 1.2 mg/kg of caffeine. Immediately following both intervention the n-back assessment will be conducted.
Detailed description
Phase 1 will assess non-caffeine consumers
Phase 1 will utilize a within subjects counter-balanced design. Previous to arrival for phase 1, participants will be asked to abstain from alcohol and drugs for at least 18 hours previous. 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. After consent, participants will also be asked to complete a demographic survey, PAR-Q readiness for exercise, Godin Leisure-Time Exercise Questionnaire, caffeine consumption questionnaire-R (CCQ-R) and a caffeine withdrawal questionnaire (CWSQ). Vitals (heart rate and blood pressure) will be assessed following the completion of the questionnaires as well as post intervention 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 test familiarity, a baseline cognition score will be conducted through the n-back assessment. The subject will then be given a 5-minute break (i.e., to use the lavatory). Following the break, the participants will be randomized into either moderate intensity exercise or caffeine ingestion group. The interventions are as follows; 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 ((220-age)x0.6) followed by 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 orally in powder form with water to drink, after ingestion of caffeine participants will wait 20 minutes to ensure peak plasma levels. The participants both the exercise group and the caffeine ingestion group will be asked to refrain from conversation. The post intervention assessment will begin within two minutes of the completion of either intervention. The second visit of phase I will take place the following day at the same time (if possible). During the second visit the participant's will complete the pre caffeine or pre exercise questionnaire, the CWSQ and vitals will be monitored pre and post intervention. The participants will participate in the intervention that they have not received on the first visit (for example, if the participant received caffeine ingestion on the first visit the participant will receive moderate intensity aerobic exercise on the second visit). Within two minutes of completion the post treatment N-back task assessment will begin.
Phases 2 and 3 will assess caffeine consumers (phase 3 in an acutely deprived state)
Phase 2 will utilize a within subjects counter-balanced design. Previous to arrival for phase 2 participants will be asked to keep consumption of caffeine to a regular dose (morning coffee) on the day of testing, 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 readiness for exercise, Godin Leisure-Time Exercise Questionnaire, CCQ-R, and the CWSQ. Vitals (heart rate and blood pressure) will be assessed following the completion of the questionnaires as well as post intervention 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. The subject will then be given a 5 minute break (i.e., to use the lavatory). Following the break 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 participants in both the, exercise group and caffeine ingestion group will be asked to refrain from conversation. The post intervention assessment will begin within two minutes of the completion of either intervention. The second visit of phase I will take place the following day at the same time (if possible). During the second visit the participant's will complete the pre caffeine or pre exercise questionnaire, the CWSQ and vitals will be monitored pre and post intervention. The participants will participate in the intervention that they have not received on the first visit (for example, if the participant received caffeine ingestion on the first visit the participant will receive moderate intensity aerobic exercise on the second visit). Within two minutes of completion the post treatment N-back task assessment will begin.
Prior to arrival for phase 3, participants will be asked to refrain from caffeine for at least 12 hours, and abstain from alcohol and drugs for at least 18 hours prior to testing. Phase 3 will utilize the same participants as phase 2, but they will be examined in a caffeine-deprived state (12 hours) for baseline N-back scores the CWSQ will also be administered. Participants will then be randomized into either the caffeine ingestion group or exercise treatment group where post intervention N-back scores will be obtained. Participants will be asked to complete the same pre-intervention questionnaires as the previous phase. Vitals (heart rate and blood pressure) will be assessed 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).
N-back task explanation: Three tasks will be administered to subjects for each treatment condition (after caffeine administration and after exercise). The 1-back, 2-back, and 3-back cognitive tests will assess working memory by measuring both the percentage of correct responses, as well as reaction time. In these 5 minute tasks, a letter will appear on a computer screen for an interval of 500ms, followed by a 2000ms blank screen interstimulus (totaling 120 letters/5 minutes). Participants will be instructed to click the left button of a computer mouse as soon as a target appears, and to keep in mind both the speed and accuracy components of the task. In the 1-back condition, the target is defined as a letter flashing that is the same as the one preceding it. For example, "x, interstimulus, x" would be the target. In the 2-back condition, the target is defined as a letter appearing that is the same as what preceded it 2 letters before. For example, "a, interstimulus, b, interstimulus, a", would be the target. In the 3-back condition, the target is defined as a letter appearing that is the same as what preceded it 3 letters before. For example, "a, interstimulus, b, interstimulus, c, interstimulus, a", would be the target. All tasks call into action the participant's working memory abilities, as a measure of cognition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Non-caffeine exercise | Experimental | Behavioral: Moderate Intensity ExerciseExercise cognition score |
| Non-caffeine cognition | Active comparator | Drug: CaffeineCaffeine cognition score |
| Caffeine consumption exercise | Experimental | Behavioral: Moderate Intensity ExerciseExercise cognition score |
| Caffeine consumption cognition | Active comparator | Drug: CaffeineCaffeine cognition score |
| Deprived Caffeine consumers exercise | Experimental | Behavioral: Moderate Intensity ExerciseExercise cognition score |
| Deprived caffeine consumers cognition | Active comparator | Drug: CaffeineCaffeine administration cognition score |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Are over the age of 18 years (male or female)
- Do not consume more than 100 mg of caffeine a week
- Do not have any cognitive problems
- Are not pregnant
- Do not have a medical condition that prevents you to exercise
Key exclusion criteria (1 listed)
- Potential subjects will be excluded if they are pregnant. Additionally, participants taking prescription medication for depression or anxiety, and 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 |
|---|---|---|
| CaffeineOral administration of 1.2mg/kg of powdered caffeine with water. | Drug | Caffeine consumption cognition, Deprived caffeine consumers cognition, Non-caffeine cognition |
| Moderate Intensity ExerciseModerate intensity exercise conducted on a treadmill. Moderate intensity exercise defined as (220-age)*0.6. | Behavioural | Caffeine consumption exercise, Deprived Caffeine consumers exercise, Non-caffeine exercise |
Primary outcome
3-back on the N-back task
Time frame: Approximately 5 minutes
Participants will be instructed to click the left button of a computer mouse as soon as a target appears, and to keep in mind both the speed and accuracy components of the task. In the 1-back condition, the target is defined as a letter flashing that is the same as the one preceding it. For example, "x, interstimulus, x" would be the target. In the 2-back condition, the target is defined as a letter appearing that is the same as what preceded it 2 letters before. For example, "a, interstimulus, b, interstimulus, a", would be the target. In the 3-back condition, the target is defined as a letter appearing that is the same as what preceded it 3 letters before. For example, "a, interstimulus, b, interstimulus, c, interstimulus, a", would be the target. All tasks call into action the participant's working memory abilities, as a measure of cognition.
1 secondary outcome
0,1, and 2 back on the N-back task
Time frame: Approximately 15 minutes
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.
- Individual participant dataSharing planned: No. We do not 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Caffeine and Moderate Intensity Exercise in people with Adult Population, 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 16 inclusion and 1 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
3-back on the N-back task (time frame: Approximately 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.