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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 26, 2019
First Posted Date  ICMJE April 2, 2019
Last Update Posted Date April 18, 2019
Actual Study Start Date  ICMJE December 19, 2018
Actual Primary Completion Date March 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Caffeine Intake on Autonomic Parameters in the Exercise of Strength
Official Title  ICMJE Impact of Caffeine Intake Before Exercise on the Neural Regulation of the Cardiovascular System in Physically Active Adults
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Autonomic Nervous System
  • Cardiovascular Outcomes
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Caffeine
    Volunteers will ingest 300mg caffeine one hour before strength training.
    Intervention: Other: Caffeine
  • Placebo Comparator: Placebo
    Volunteers will ingest 300mg placebo one hour before strength training.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2019)
30
Original Actual Enrollment  ICMJE
 (submitted: March 29, 2019)
32
Actual Study Completion Date  ICMJE March 20, 2019
Actual Primary Completion Date March 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03899675
Other Study ID Numbers  ICMJE UPernambuco
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No, we intend to disseminate the results in scientific journals.
Responsible Party Cicero Jonas Rodrigues Benjamim, University of Pernambuco
Study Sponsor  ICMJE University of Pernambuco
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Pernambuco
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP