NCT03400423

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

March 4, 2024

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

January 9, 2018

Last Update Submit

February 29, 2024

Conditions

Keywords

CaffeineCaffeine WithdrawalAcute Aerobic ExerciseCognitionWorking Memory

Outcome Measures

Primary Outcomes (1)

  • 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.

    Approximately 5 minutes

Secondary Outcomes (1)

  • 0,1, and 2 back on the N-back task

    Approximately 15 minutes

Study Arms (6)

Non-caffeine exercise

EXPERIMENTAL

Exercise cognition score

Behavioral: Moderate Intensity Exercise

Non-caffeine cognition

ACTIVE COMPARATOR

Caffeine cognition score

Drug: Caffeine

Caffeine consumption exercise

EXPERIMENTAL

Exercise cognition score

Behavioral: Moderate Intensity Exercise

Caffeine consumption cognition

ACTIVE COMPARATOR

Caffeine cognition score

Drug: Caffeine

Deprived Caffeine consumers exercise

EXPERIMENTAL

Exercise cognition score

Behavioral: Moderate Intensity Exercise

Deprived caffeine consumers cognition

ACTIVE COMPARATOR

Caffeine administration cognition score

Drug: Caffeine

Interventions

Oral administration of 1.2mg/kg of powdered caffeine with water.

Caffeine consumption cognitionDeprived caffeine consumers cognitionNon-caffeine cognition

Moderate intensity exercise conducted on a treadmill. Moderate intensity exercise defined as (220-age)\*0.6.

Caffeine consumption exerciseDeprived Caffeine consumers exerciseNon-caffeine exercise

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western University

London, Ontario, Canada

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 17, 2018

Study Start

February 1, 2018

Primary Completion

June 1, 2019

Study Completion

August 1, 2019

Last Updated

March 4, 2024

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

We do not plan to share IPD.

Locations