The Acute Effects of Caffeine on Exercise and Cognition (AEC)

February 29, 2024 updated by: Dr. Harry Prapavessis, Western University, Canada

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Harry Prapavessis, PhD
  • Phone Number: 80173 519-661-2111
  • Email: hprapev@uwo.ca

Study Contact Backup

  • Name: Anisa Morava, BSc
  • Phone Number: 81189 519-661-2111
  • Email: amorava@uwo.ca

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada
        • Western University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Non-caffeine exercise
Exercise cognition score
Behavioral: Moderate Intensity Exercise
Moderate intensity exercise conducted on a treadmill. Moderate intensity exercise defined as (220-age)*0.6.
Active Comparator: Non-caffeine cognition
Caffeine cognition score
Drug: Caffeine
Oral administration of 1.2mg/kg of powdered caffeine with water.
Experimental: Caffeine consumption exercise
Exercise cognition score
Behavioral: Moderate Intensity Exercise
Moderate intensity exercise conducted on a treadmill. Moderate intensity exercise defined as (220-age)*0.6.
Active Comparator: Caffeine consumption cognition
Caffeine cognition score
Drug: Caffeine
Oral administration of 1.2mg/kg of powdered caffeine with water.
Experimental: Deprived Caffeine consumers exercise
Exercise cognition score
Behavioral: Moderate Intensity Exercise
Moderate intensity exercise conducted on a treadmill. Moderate intensity exercise defined as (220-age)*0.6.
Active Comparator: Deprived caffeine consumers cognition
Caffeine administration cognition score
Drug: Caffeine
Oral administration of 1.2mg/kg of powdered caffeine with water.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Approximately 5 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
0,1, and 2 back on the N-back task
Time Frame: Approximately 15 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.
Approximately 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Western University, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Acute Exercise and Caffeine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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