Acute Caffeine Effects on Cardiac Autonomic and Cardiorespiratory Parameters Responses After Aerobic Exercise

Autonomic Nervous System Clinical Trial

Official title:

Acute Caffeine Effects on Cardiac Autonomic and Cardiorespiratory Parameters Responses After Aerobic Exercise

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02917889
• Other study ID #: 44888015.8.0000.5406
• Status: Active, not recruiting
• Phase: N/A
• First received: September 19, 2016
• Last updated: September 28, 2016
• Start date: February 2015

Study information

• Verified date: September 2016
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Plataforma Brasil
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Autonomic Nervous System
• Cardiorespiratory Parameters

Intervention

Drug:
• Caffeine
Volunteers will consume 300 mg of caffeine in pills fifteen minutes before treadmill aerobic exercise.
• Placebo
Volunteers will consume 300 mg of placebo in pills fifteen minutes before treadmill aerobic exercise.

Other:
• 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 ).

Locations

Country	Name	City	State
Brazil	Universidade Estadual Paulista	Presidente Prudente	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caffeine effects on heart rate variability (based on frequency, time domain and Chaos)		up to 1 year	No
Primary	Blood pressure (mmHg)	Caffeine effects blood pressure recovery following aerobic exercise	up to 1 year	No
Primary	Heart rate (beats per minute)	Caffeine effects heart rate recovery following aerobic exercise	up to 1 year	No
Primary	Respiratory rate (per minute)	Caffeine effects arespiratory rate recovery following aerobic exercise	up to 1 year	No
Primary	Oxygen saturation pulse (oximeter-SpO2)	Caffeine effects SpO2 recovery following aerobic exercise	up to 1 year	No