NCT02647567

Brief Summary

Caffeine is a methylxanthine commonly consumed by the population for their psychostimulant properties, and their intake when in moderate doses seem to produce positive effects on stress, mood and memory. So, understanding that a positive effect of aerobic exercise can be displayed also on cognition, as caffeine, when in proper proportions, the investigators do not know if the joining of the two strategies into a single activity would be able to promote additional effects enhancing cognitive processes related to memory, attention, and motor reaction time.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2015

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
Last Updated

January 6, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

December 5, 2015

Last Update Submit

January 4, 2016

Conditions

Keywords

CognitiveAerobic ExercisePerformance

Outcome Measures

Primary Outcomes (3)

  • Simple Reaction Time

    Acute Change from Baseline Psychomotor test to 1 min after aerobic exercise, and after 30 min

  • Rey Auditory Verbal Learning Test

    Acute Change from Baseline Cognitive test to 1 min after aerobic exercise, and after 30 min

  • Sustained Attention Test

    Acute Change from Baseline Cognitive test to 1 min after aerobic exercise, and after 30 min

Study Arms (2)

Caffeine Intake

EXPERIMENTAL

The experimental group ingest 500 mg of caffeine before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests.

Other: Caffeine Intake

Placebo Intake

PLACEBO COMPARATOR

The control group ingest 500 mg of placebo before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests.

Other: Placebo Intake

Interventions

The experimental group ingest 500 mg of caffeine before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests.

Also known as: Caffeine
Caffeine Intake

The control group ingest 500 mg of placebo before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests.

Also known as: Placebo
Placebo Intake

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Fighting men
  • Low levels of consumption of caffeine daily

You may not qualify if:

  • Use more than 400 mg caffeine day
  • Mental diseases
  • Cognitive deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Sérgio Machado, PhD

    Salgado de Oliveira University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctorade in Mental Health

Study Record Dates

First Submitted

December 5, 2015

First Posted

January 6, 2016

Study Start

May 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

January 6, 2016

Record last verified: 2016-01