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Impact of Caffeine Intake on Autonomic Parameters in the Exercise of Strength

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ClinicalTrials.gov Identifier: NCT03899675
Recruitment Status : Completed
First Posted : April 2, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Cicero Jonas Rodrigues Benjamim, University of Pernambuco

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Autonomic Nervous System Cardiovascular Outcomes Dietary Supplement: Placebo Other: Caffeine Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: It is a randomized, single-blind clinical trial
Masking: Single (Participant)
Masking Description:

The research will be divided into two moments, in which subjects will participate in the same experiment on two different and non sequential days, and on the first day, the measurement of data will occur without the ingestion of caffeine or placebo. Participants will be randomized at the end of the first evaluation.

The randomization of the volunteers to define the groups will be performed using random numbers obtained at www.randomized.com. Subjects will be allocated to one of two groups: I) strength training and caffeine; II): strength training and placebo.

Primary Purpose: Prevention
Official Title: Impact of Caffeine Intake Before Exercise on the Neural Regulation of the Cardiovascular System in Physically Active Adults
Actual Study Start Date : December 19, 2018
Actual Primary Completion Date : March 19, 2019
Actual Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Caffeine
Volunteers will ingest 300mg caffeine one hour before strength training.
Other: Caffeine
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.

Placebo Comparator: Placebo
Volunteers will ingest 300mg placebo one hour before strength training.
Dietary Supplement: Placebo
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.




Primary Outcome Measures :
  1. Caffeine effects on heart rate variability (based on frequency, time domain and Chaos) [ Time Frame: up to 1 year ]
  2. Blood pressure (mmHg) [ Time Frame: up to 1 year ]
    Caffeine effects blood pressure recovery following strength exercise

  3. Heart rate (beats per minute) [ Time Frame: up to 1 year ]
    Caffeine effects heart rate recovery following strength exercise



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899675


Locations
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Brazil
Cicero Jonas Rodrigues Benjamim
Juazeiro do Norte, Ceará, Brazil, 63020070
Sponsors and Collaborators
University of Pernambuco

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Responsible Party: Cicero Jonas Rodrigues Benjamim, Principal Investigator, University of Pernambuco
ClinicalTrials.gov Identifier: NCT03899675     History of Changes
Other Study ID Numbers: UPernambuco
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No, we intend to disseminate the results in scientific journals.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Cicero Jonas Rodrigues Benjamim, University of Pernambuco:
Caffeine
Exercise
Heart Rate Variability
Autonomic Nervous System
Cardiovascular Risk Factor

Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents