- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02917889
Acute Caffeine Effects on Cardiac Autonomic and Cardiorespiratory Parameters Responses After Aerobic Exercise
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
São Paulo
-
Presidente Prudente, São Paulo, Brazil, 19060-900
- Universidade Estadual Paulista
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Caffeine protocol
300 mg in pills
|
Volunteers will consume 300 mg of caffeine in pills fifteen minutes before treadmill aerobic exercise.
assessment of the maximum oxygen consumption (VO2max) on a treadmill (Inbrasport / Millennium), using Buce protocol. .
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: Placebo protocol
300 mg in pills
|
assessment of the maximum oxygen consumption (VO2max) on a treadmill (Inbrasport / Millennium), using Buce protocol. .
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 ).
Volunteers will consume 300 mg of placebo in pills fifteen minutes before treadmill aerobic exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caffeine effects on heart rate variability (based on frequency, time domain and Chaos)
Time Frame: up to 1 year
|
up to 1 year
|
|
Blood pressure (mmHg)
Time Frame: up to 1 year
|
Caffeine effects blood pressure recovery following aerobic exercise
|
up to 1 year
|
Heart rate (beats per minute)
Time Frame: up to 1 year
|
Caffeine effects heart rate recovery following aerobic exercise
|
up to 1 year
|
Respiratory rate (per minute)
Time Frame: up to 1 year
|
Caffeine effects arespiratory rate recovery following aerobic exercise
|
up to 1 year
|
Oxygen saturation pulse (oximeter-SpO2)
Time Frame: up to 1 year
|
Caffeine effects SpO2 recovery following aerobic exercise
|
up to 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 44888015.8.0000.5406
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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