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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03899675
Other study ID # UPernambuco
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 19, 2018
Est. completion date March 20, 2019

Study information

Verified date April 2019
Source University of Pernambuco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 20, 2019
Est. primary completion date March 19, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Brazil Cicero Jonas Rodrigues Benjamim Juazeiro do Norte Ceará

Sponsors (1)

Lead Sponsor Collaborator
University of Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Caffeine effects on heart rate variability (based on frequency, time domain and Chaos) up to 1 year
Primary Blood pressure (mmHg) Caffeine effects blood pressure recovery following strength exercise up to 1 year
Primary Heart rate (beats per minute) Caffeine effects heart rate recovery following strength exercise up to 1 year
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