Autonomic Nervous SystemNCT02917889
Acute Caffeine Effects on Cardiac Autonomic and Cardiorespiratory Parameters Responses After Aerobic Exercise
A study testing Caffeine, Cardiopulmonary test and Treadmill aerobic exercise in people with Autonomic Nervous System and Cardiorespiratory Parameters, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System, Cardiorespiratory Parameters
- What is being tested?
- Caffeine, Cardiopulmonary test and Treadmill aerobic exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Estadual Paulista
Presidente Prudente, São Paulo, 19060-900
About this study
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.
Read the 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:
- 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.
- Being tested
- Caffeine, Placebo, Cardiopulmonary test, Treadmill aerobic exercise
- Keywords
- Caffeine, Autonomic Nervous System, Recovery, Aerobic exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
Volunteers will consume 300 mg of caffeine in pills fifteen minutes before treadmill aerobic exercise.
PlaceboDrug
Volunteers will consume 300 mg of placebo in pills fifteen minutes before treadmill aerobic exercise.
Cardiopulmonary testOther
assessment of the maximum oxygen consumption (VO2max) on a treadmill (Inbrasport / Millennium), using Buce protocol.
.
Treadmill aerobic exerciseOther
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 ).
| Study group | Role | What they receive |
|---|---|---|
| Caffeine protocol | Experimental | 300 mg in pills Receives: Drug: Caffeine; Other: Cardiopulmonary test; Other: Treadmill aerobic exercise |
| Placebo protocol | Experimental | 300 mg in pills Receives: Drug: Placebo; Other: Cardiopulmonary test; Other: Treadmill aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caffeine effects on heart rate variability (based on frequency, time domain and Chaos)
Measured: up to 1 year
Blood pressure (mmHg)
Caffeine effects blood pressure recovery following aerobic exercise
Measured: up to 1 year
Heart rate (beats per minute)
Caffeine effects heart rate recovery following aerobic exercise
Measured: up to 1 year
Respiratory rate (per minute)
Caffeine effects arespiratory rate recovery following aerobic exercise
Measured: up to 1 year
Oxygen saturation pulse (oximeter-SpO2)
Caffeine effects SpO2 recovery following aerobic exercise
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study startFeb 2015
- Primary completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luana Almeida Gonzaga, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917889
- Sponsor's protocol ID
- 44888015.8.0000.5406
- Status last verified
- Sep 2016
- First submitted
- 19 Sep 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Caffeine Effects on Cardiac Autonomic and Cardiorespiratory Parameters Responses After Aerobic Exercise
- ClinicalTrials.gov ID
- NCT02917889
- Acronym / sponsor ID
- 44888015.8.0000.5406
- Keywords
- Caffeine, Autonomic Nervous System, Recovery, Aerobic exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2016 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine protocol | Experimental | Drug: Caffeine, Other: Cardiopulmonary test, Other: Treadmill aerobic exercise300 mg in pills |
| Placebo protocol | Experimental | Drug: Placebo, Other: Cardiopulmonary test, Other: Treadmill aerobic exercise300 mg in pills |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy men.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaffeineVolunteers will consume 300 mg of caffeine in pills fifteen minutes before treadmill aerobic exercise. | Drug | Caffeine protocol |
| PlaceboVolunteers will consume 300 mg of placebo in pills fifteen minutes before treadmill aerobic exercise. | Drug | Placebo protocol |
| Cardiopulmonary testassessment of the maximum oxygen consumption (VO2max) on a treadmill (Inbrasport / Millennium), using Buce protocol. . | Other | Caffeine protocol, Placebo protocol |
| Treadmill aerobic exercise30 mim of aerobic exercise (5 minutes at speed of 5.0 km/h for warming-up followed by 25 minutes at 60% of VO2max ). | Other | Caffeine protocol, Placebo protocol |
Primary outcome
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
Caffeine effects blood pressure recovery following aerobic exercise
Heart rate (beats per minute)
Time frame: up to 1 year
Caffeine effects heart rate recovery following aerobic exercise
Respiratory rate (per minute)
Time frame: up to 1 year
Caffeine effects arespiratory rate recovery following aerobic exercise
Oxygen saturation pulse (oximeter-SpO2)
Time frame: up to 1 year
Caffeine effects SpO2 recovery following aerobic exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine, Cardiopulmonary test and Treadmill aerobic exercise in people with Autonomic Nervous System and Cardiorespiratory Parameters, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caffeine effects on heart rate variability (based on frequency, time domain and Chaos) (time frame: up to 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.