Neurophysiological Reserve With Caffeine Manipulation

Caffeine Clinical Trial

Official title:

Neurophysiological Reserve: Peripheral and Central Effects of Caffeine Manipulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01167478
• Other study ID #: EEFE026
• Secondary ID: 2010/01317-0
• Status: Completed
• Phase: N/A
• First received: July 21, 2010
• Last updated: December 4, 2014
• Start date: March 2011
• Est. completion date: September 2011

Study information

• Verified date: December 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• trained cyclists

• trained in long distance races

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Caffeine
• Placebo

Intervention

Dietary Supplement:
• Caffeine
After ingestion of 6 mg.kg-1 of body mass of caffeine, subjects will perform the one exercise trial.
• Caffeine
6 mg/kg of body mass of caffeine will be ingested by subjects before exercise.

Locations

Country	Name	City	State
Brazil	University of São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	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.	Immediately after the administration (around 10 minutes)	No