NCT02917889

Brief Summary

Check the acute influence of caffeine on the autonomic modulation and cardiorespiratory parameters after aerobic exercise. Hypothesized that caffeine can promote a slower recovery of the cardiorespiratory parameters and the SNA recovery after aerobic exercise.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

1.5 years

First QC Date

September 19, 2016

Last Update Submit

September 28, 2016

Conditions

Keywords

CaffeineAutonomic Nervous SystemRecoveryAerobic exercise

Outcome Measures

Primary Outcomes (5)

  • Caffeine effects on heart rate variability (based on frequency, time domain and Chaos)

    up to 1 year

  • Blood pressure (mmHg)

    Caffeine effects blood pressure recovery following aerobic exercise

    up to 1 year

  • Heart rate (beats per minute)

    Caffeine effects heart rate recovery following aerobic exercise

    up to 1 year

  • Respiratory rate (per minute)

    Caffeine effects arespiratory rate recovery following aerobic exercise

    up to 1 year

  • Oxygen saturation pulse (oximeter-SpO2)

    Caffeine effects SpO2 recovery following aerobic exercise

    up to 1 year

Study Arms (2)

Caffeine protocol

EXPERIMENTAL

300 mg in pills

Drug: CaffeineOther: Cardiopulmonary testOther: Treadmill aerobic exercise

Placebo protocol

EXPERIMENTAL

300 mg in pills

Drug: PlaceboOther: Cardiopulmonary testOther: Treadmill aerobic exercise

Interventions

Volunteers will consume 300 mg of caffeine in pills fifteen minutes before treadmill aerobic exercise.

Caffeine protocol

Volunteers will consume 300 mg of placebo in pills fifteen minutes before treadmill aerobic exercise.

Placebo protocol

assessment of the maximum oxygen consumption (VO2max) on a treadmill (Inbrasport / Millennium), using Buce protocol. .

Caffeine protocolPlacebo protocol

30 mim of aerobic exercise (5 minutes at speed of 5.0 km/h for warming-up followed by 25 minutes at 60% of VO2max ).

Caffeine protocolPlacebo protocol

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy men.

You may not qualify if:

  • cardiovascular, orthopedic, respiratory and neurological disorders reported or other pathological conditions that prevent the subject to perform the protocols;
  • smokers, alcoholics, or who use drugs that influence the activity of the heart.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Estadual Paulista

Presidente Prudente, São Paulo, 19060-900, Brazil

Location

MeSH Terms

Interventions

CaffeineExercise Test

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2016

First Posted

September 28, 2016

Study Start

February 1, 2015

Primary Completion

August 1, 2016

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations