NCT01167478

Brief Summary

The objective of this study is to verify if there is a neurophysiologic reserve when caffeine and placebo perceived as caffeine are manipulated in closed- and opened-loop exercises. Parameters of excitability level of skeletal muscle and Central Nervous System (CNS), and peripheral metabolism will be measured

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

3 months

First QC Date

July 21, 2010

Last Update Submit

December 4, 2014

Conditions

Keywords

ExerciseCaffeineReserve

Outcome Measures

Primary Outcomes (2)

  • Neurophysiological reserve evidenced by caffeine

    The time to cover a 4-km trial (closed-loop) or the time to exhaustion in an incremental intensity test (opened-loop) can show if the caffeine manipulation affects the performance. In addition, measures of CNS excitability such as EMG during the closed-loop exercise or at the exhaustion point in the opened-loop exercise, and measures such as the amplitude of H reflex, the rate of increase in H reflex/M wave relationship, can indicate if some central or peripheral alteration occurred during the exercises.

    Immediately after the administration (around 10 minutes)

  • Neurophysiological reserve evidenced by caffeine

    The time to cover a 4-km trial (closed-loop) or the time to exhaustion in an incremental intensity test (opened-loop) can show if the placebo manipulation affects the performance. In addition, measures of CNS excitability such as EMG during the closed-loop exercise or at the exhaustion point in the opened-loop exercise, and measures such as the amplitude of H reflex, the rate of increase in H reflex/M wave relationship, can indicate if some central or peripheral alteration ocurred during the exercises.

    Immediately after the administration (around 10 minutes)

Secondary Outcomes (1)

  • Neurophysiological reserve evidenced by placebo

    Immediately after the administration (around 10 minutes)

Study Arms (1)

Caffeine

EXPERIMENTAL
Dietary Supplement: Caffeine

Interventions

CaffeineDIETARY_SUPPLEMENT

After ingestion of 6 mg.kg-1 of body mass of caffeine, subjects will perform the one exercise trial.

Caffeine

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • trained cyclists
  • trained in long distance races

You may not qualify if:

  • Maximum oxygen uptake lower than 55 ml/kg/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05508-030, Brazil

Location

Related Publications (1)

  • Lambert EV, St Clair Gibson A, Noakes TD. Complex systems model of fatigue: integrative homoeostatic control of peripheral physiological systems during exercise in humans. Br J Sports Med. 2005 Jan;39(1):52-62. doi: 10.1136/bjsm.2003.011247.

    PMID: 15618343BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Carlos Ugrinowitsch, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doctoral

Study Record Dates

First Submitted

July 21, 2010

First Posted

July 22, 2010

Study Start

March 1, 2011

Primary Completion

June 1, 2011

Study Completion

September 1, 2011

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations