Overview

This trial is active, not recruiting.

Conditions autonomic nervous system, cardiorespiratory parameters
Treatments caffeine, placebo, cardiopulmonary test, treadmill aerobic exercise
Sponsor Universidade Estadual Paulista Júlio de Mesquita Filho
Start date February 2015
End date August 2016
Trial size 35 participants
Trial identifier NCT02917889, 44888015.8.0000.5406

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (subject)
Arm
(Experimental)
300 mg in pills
caffeine
Volunteers will consume 300 mg of caffeine in pills fifteen minutes before treadmill aerobic exercise.
cardiopulmonary test
assessment of the maximum oxygen consumption (VO2max) on a treadmill (Inbrasport / Millennium), using Buce protocol.
treadmill aerobic exercise
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 ).
(Experimental)
300 mg in pills
placebo
Volunteers will consume 300 mg of placebo in pills fifteen minutes before treadmill aerobic exercise.
cardiopulmonary test
assessment of the maximum oxygen consumption (VO2max) on a treadmill (Inbrasport / Millennium), using Buce protocol.
treadmill aerobic exercise
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 ).

Primary Outcomes

Measure
Caffeine effects on heart rate variability (based on frequency, time domain and Chaos)
time frame: up to 1 year
Blood pressure (mmHg)
time frame: up to 1 year
Heart rate (beats per minute)
time frame: up to 1 year
Respiratory rate (per minute)
time frame: up to 1 year
Oxygen saturation pulse (oximeter-SpO2)
time frame: up to 1 year

Eligibility Criteria

Male participants from 18 years up to 30 years old.

Inclusion Criteria: - healthy men. Exclusion Criteria: - 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.

Additional Information

Official title Acute Caffeine Effects on Cardiac Autonomic and Cardiorespiratory Parameters Responses After Aerobic Exercise
Description The experimental procedure is divided into three phases, all performed on a treadmill, with a minimum interval of 48 hours between them, in order to allow adequate recovery of the participants. Before the start of the first stage of the experimental protocol or control anthropometric measurements will be carried out, body weight by a digital scale (Plenna, TIN 00139 MAXIMA, Brazil)) and then, using a stadiometer (Plenna, TIN 00139 MAXIMA, Brazil)). The protocols are: I) Maximum stress test protocol: assessment of the maximum oxygen consumption (VO2max) on a treadmill (Inbrasport / Millennium), using the Bruce protocol. II) Control Protocol (PC): at this stage the volunteer will ingest compressed form of placebo similar to Protocol III and remained at rest after 15 minutes in the supine position, followed by 30 minutes of aerobic exercise on a treadmill, 5 minutes with speed 6.0 km / h followed by 25 minutes with 60% of VO2max and the final 60 minutes lying recovery. III) Experimental protocol (PE): In this stage, the volunteer had performed activities similar to the PC, but will make the tablet intake consists of 300mg of caffeine, a value that is within the maximum daily amount allowed under the FDA.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Universidade Estadual Paulista Júlio de Mesquita Filho.