Autonomic Nervous SystemNCT03899675
Impact of Caffeine Intake on Autonomic Parameters in the Exercise of Strength
A study testing Caffeine in people with Autonomic Nervous System and Cardiovascular Outcomes, run by University of Pernambuco at 1 site in Brazil.
Trial summary
The objective of this study was to evaluate the variability of the heart rate of exercise physicists with and without caffeine intake. Practitioners of resisted physical exercise, specifically bodybuilding, who are young adults between the ages of 18 and 30 will participate in the study. 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, Cardiovascular Outcomes
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Dec 2018to 20 Mar 2019
- 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
- Male
- 18 to 30 years of age
- Body Mass Index (BMI) within the range of Eutrophy (18.5 to 24.9kg / m²)
- Experience with resistance training, uninterrupted for at least 3 months and weekly frequency of 3 sessions or more
- Do not use any medication that may interfere with cardiac autonomic modulation
- Do have no skeletal muscle damage.
Who cannot join
- Smoking patients
- As well as individuals who have already used anabolic steroids
- Cardiorespiratory diseases
- Cardiometabolic diseases
- Neurological disorders
- Other known compromises that prevent the subject from performing the procedures.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Cicero Jonas Rodrigues Benjamim
Juazeiro do Norte, Ceará, 63020070
About this study
Official title: Impact of Caffeine Intake Before Exercise on the Neural Regulation of the Cardiovascular System in Physically Active Adults
The objective of this study was to evaluate the variability of the heart rate of exercise physicists with and without caffeine intake. Practitioners of resisted physical exercise, specifically bodybuilding, who are young adults between the ages of 18 and 30 will participate in the study. To define the sample size, a sample calculation was performed based considering as variable the RMSSD index (square root of the square mean of the differences between the adjacent normal iRRs). The significant difference magnitude assumed was 12 ms, considering a standard deviation of 16.2 ms, with alpha risk of 5% and beta of 80%. A minimum of 14 subjects per group were required in the survey. A total of 32 subjects will participate in the research, being these divided and allocated in different groups. Sampling will be of the intentional kind.
Read the detailed description
Caffeine supplementation has been studied in several sports modalities with the objective of investigating its repercussions on athletes' physical performance. Caffeine may lead to an obstruction of adenosine receptors (A1 and A2) and increase the activity of the Autonomic Nervous System (ANS) by releasing catecholamines in plasma, inducing tachycardia and elevating blood pressure. Such modulation of nervous system activity can be traced by assessing heart rate variability (HRV). HRV is one of the most practical methods to analyze the physiological functioning of ANS, both in pathological conditions of the individual and in the induction of other variables, being a noninvasive measure of cardiac autonomic modulation markers that analyzes the peak-R intervals a peak-R (RRI) of consecutive heartbeat. The objective of this study was to evaluate the variability of the heart rate of exercise physicists with and without caffeine intake. Practitioners of resisted physical exercise, specifically bodybuilding, who are young adults between the ages of 18 and 30 will participate in the study. To define the sample size, a sample calculation was performed based considering as variable the RMSSD index (square root of the square mean of the differences between the adjacent normal iRRs). The significant difference magnitude assumed was 12 ms, considering a standard deviation of 16.2 ms, with alpha risk of 5% and beta of 80%. A minimum of 14 subjects per group were required in the survey. A total of 32 subjects will participate in the research, being these divided and allocated in different groups. Sampling will be of the intentional kind.
The expected benefits with the result of this research are to instigate the creation of new lines of research in this context, being able to intervene in a more effective way in practitioners of physical exercise of strength, with the possibility of prevention to the autonomic alterations that are associated with the consumption of stimulant supplements, such as caffeine, and its consequences on the cardiovascular system.
- Conditions
- Autonomic Nervous System, Cardiovascular Outcomes
- Being tested
- Placebo, Caffeine
- Keywords
- Caffeine, Exercise, Heart Rate Variability, Autonomic Nervous System, Cardiovascular Risk Factor
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
On the first day of collection, the volunteers will not take placebo intake, the data will be collected in a standardized way, respecting the times defined for the analysis of the cardiac activity. Then the collection will be continued. On the next day of evaluation, volunteers will receive a capsule containing 300 mg of placebo and will be advised to consume 1 hour before the procedure.
CaffeineOther
On the first day of collection, the volunteers will not take caffeine intake, the data will be collected in a standardized way, respecting the times defined for the analysis of the cardiac activity. Then the collection will be continued. On the next day of evaluation, volunteers will receive a capsule containing 300 mg of caffeine and will be advised to consume 1 hour before the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Experimental | Volunteers will ingest 300mg caffeine one hour before strength training. Receives: Other: Caffeine |
| Placebo | Placebo comparator | Volunteers will ingest 300mg placebo one hour before strength training. Receives: Dietary Supplement: Placebo |
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 strength exercise
Measured: up to 1 year
Heart rate (beats per minute)
Caffeine effects heart rate recovery following strength 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 posted2 Apr 2019
- Study start19 Dec 2018
- Primary completion19 Mar 2019
- Study completion20 Mar 2019
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a randomized, single-blind clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cicero Jonas Rodrigues Benjamim, University of Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899675
- Sponsor's protocol ID
- UPernambuco
- Status last verified
- Apr 2019
- First submitted
- 26 Mar 2019
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, we intend to disseminate the results in scientific journals.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Caffeine Intake Before Exercise on the Neural Regulation of the Cardiovascular System in Physically Active Adults
- ClinicalTrials.gov ID
- NCT03899675
- Acronym / sponsor ID
- UPernambuco
- Conditions
- Autonomic Nervous System, Cardiovascular Outcomes
- Keywords
- Caffeine, Exercise, Heart Rate Variability, Autonomic Nervous System, Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PernambucoUniversity, hospital or other
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 2 Apr 2019 (actual)
- 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.
The objective of this study was to evaluate the variability of the heart rate of exercise physicists with and without caffeine intake. Practitioners of resisted physical exercise, specifically bodybuilding, who are young adults between the ages of 18 and 30 will participate in the study. To define the sample size, a sample calculation was performed based considering as variable the RMSSD index (square root of the square mean of the differences between the adjacent normal iRRs). The significant difference magnitude assumed was 12 ms, considering a standard deviation of 16.2 ms, with alpha risk of 5% and beta of 80%. A minimum of 14 subjects per group were required in the survey. A total of 32 subjects will participate in the research, being these divided and allocated in different groups. Sampling will be of the intentional kind.
Detailed description
Caffeine supplementation has been studied in several sports modalities with the objective of investigating its repercussions on athletes' physical performance. Caffeine may lead to an obstruction of adenosine receptors (A1 and A2) and increase the activity of the Autonomic Nervous System (ANS) by releasing catecholamines in plasma, inducing tachycardia and elevating blood pressure. Such modulation of nervous system activity can be traced by assessing heart rate variability (HRV). HRV is one of the most practical methods to analyze the physiological functioning of ANS, both in pathological conditions of the individual and in the induction of other variables, being a noninvasive measure of cardiac autonomic modulation markers that analyzes the peak-R intervals a peak-R (RRI) of consecutive heartbeat. The objective of this study was to evaluate the variability of the heart rate of exercise physicists with and without caffeine intake. Practitioners of resisted physical exercise, specifically bodybuilding, who are young adults between the ages of 18 and 30 will participate in the study. To define the sample size, a sample calculation was performed based considering as variable the RMSSD index (square root of the square mean of the differences between the adjacent normal iRRs). The significant difference magnitude assumed was 12 ms, considering a standard deviation of 16.2 ms, with alpha risk of 5% and beta of 80%. A minimum of 14 subjects per group were required in the survey. A total of 32 subjects will participate in the research, being these divided and allocated in different groups. Sampling will be of the intentional kind.
The expected benefits with the result of this research are to instigate the creation of new lines of research in this context, being able to intervene in a more effective way in practitioners of physical exercise of strength, with the possibility of prevention to the autonomic alterations that are associated with the consumption of stimulant supplements, such as caffeine, and its consequences on the cardiovascular system.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It is a randomized, single-blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Experimental | Other: CaffeineVolunteers will ingest 300mg caffeine one hour before strength training. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboVolunteers will ingest 300mg placebo one hour before strength training. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- 18 to 30 years of age
- Body Mass Index (BMI) within the range of Eutrophy (18.5 to 24.9kg / m²)
- Experience with resistance training, uninterrupted for at least 3 months and weekly frequency of 3 sessions or more
- Do not use any medication that may interfere with cardiac autonomic modulation
Key exclusion criteria (6 listed)
- Smoking patients
- As well as individuals who have already used anabolic steroids
- Cardiorespiratory diseases
- Cardiometabolic diseases
- Neurological disorders
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 |
|---|---|---|
| PlaceboOn the first day of collection, the volunteers will not take placebo intake, the data will be collected in a standardized way, respecting the times defined for the analysis of the cardiac activity. Then the collection will be continued. On the next day of evaluation, volunteers will receive a capsule containing 300 mg of placebo and will be advised to consume 1 hour before the procedure. | Dietary supplement | Placebo |
| CaffeineOn the first day of collection, the volunteers will not take caffeine intake, the data will be collected in a standardized way, respecting the times defined for the analysis of the cardiac activity. Then the collection will be continued. On the next day of evaluation, volunteers will receive a capsule containing 300 mg of caffeine and will be advised to consume 1 hour before the procedure. | Other | Caffeine |
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 strength exercise
Heart rate (beats per minute)
Time frame: up to 1 year
Caffeine effects heart rate recovery following strength exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: No. No, we intend to disseminate the results in scientific journals.
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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 in people with Autonomic Nervous System and Cardiovascular Outcomes, run by University of Pernambuco 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 18 Apr 2019. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 3 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 18 Apr 2019.