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CompletedNCT01167478Updated Dec 5, 2014

Neurophysiological Reserve With Caffeine Manipulation

An interventional study of Caffeine and Caffeine in Caffeine and Placebo, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to male participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2014-12-05.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Male
01

Study 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

Read the detailed description

A neurophysiological reserve related to central mechanisms is supposed to be present, which should be observed when an increased central drive occurs. In theory, according to the central regulation model of effort, an increased performance could be due to the elevation on Central Nervous System excitability and activity, since exercise is not peripherally limited. Conversely, the absence of muscle performance improvement to the increased central drive promoted by caffeine would be an evidence for a peripherally localized neurophysiological limit and would indicate the absence of reserve. Therefore, if present, this reserve could be verified by using peripheral and central measures derived from electric-stimulation, evoked twitch and interpolated twitch techniques, associated to measures of EMG and peripheral metabolism, when caffeine is manipulated during closed- and opened-loop exercise.

In addition, there should also be possible to access the reserve without stimulant substance manipulation (placebo effect). By teleological argument derived from the central regulation model of effort, a neurophysiological reserve would be a natural mechanism to protect the cellular integrity. Therefore, it would be reasonable to hypothesize that, if present, a reserve would be observed by an increase in performance promoted by an elevation in central drive when placebo is perceived as caffeine. Unfortunately, however, no study utilized this experimental approach, including measures of central and peripheral activity during closed- and opened-loop exercise, to consistently respond the reserve question.

02

Conditions studied

  • Caffeine
  • Placebo

Keywords

  • Exercise
  • Caffeine
  • Reserve
03

In context

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,003 studies on the registry; 88 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • trained cyclists
  • trained in long distance races

Exclusion criteria

Exclusion Criteria:

  • Maximum oxygen uptake lower than 55 ml/kg/min
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Caffeine

    Dietary Supplement: Caffeine

Interventions

  • Dietary supplementCaffeine

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

  • Dietary supplementCaffeine

    6 mg/kg of body mass of caffeine will be ingested by subjects before exercise.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately after the administration (around 10 minutes)

  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 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.

    Time frame: Immediately after the administration (around 10 minutes)

Secondary outcomes

  1. Neurophysiological reserve evidenced by placebo

    The placebo should also promote decrease in time of trial or increase in mean power output during a closed-loop exercise, elevation in time to exhaustion and maximal power output during an opened-loop exercise, and increase in maximal voluntary isometric contraction (MVIC) and time to contraction in a target force. Also, there should be a higher CNS excitability such as: 1) higher EMG during closed-loop exercise and higher EMG at the exhaustion point in an opened-loop exercise; 2) increased amplitude of H reflex; 3) elevation on the rate of increase in H reflex/M wave relationship.

    Time frame: Immediately after the administration (around 10 minutes)

07

Study locations

1 site
  • University of São Paulo
    São Paulo, 05508-030, Brazil
08

References and documents

Publications

  • 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. PubMed 15618343 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01167478
Lead sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Flavio de Oliveira Pires (Post-doctoral, University of Sao Paulo) — Principal investigator
First posted
Jul 22, 2010
Start date
Mar 2011
Primary completion
Jun 2011
Completion
Sep 2011
Last update
Dec 5, 2014

Study contacts

Carlos Ugrinowitsch, PhD
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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