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

NCT03899675 | Completed DMC

• 1 other identifier: UPernambuco
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Autonomic Nervous System; Cardiovascular Outcomes

Keywords

Caffeine; Exercise; Heart Rate Variability; Autonomic Nervous System; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (3)

• Caffeine effects on heart rate variability (based on frequency, time domain and Chaos)

  up to 1 year

• Blood pressure (mmHg)

  Caffeine effects blood pressure recovery following strength exercise

  up to 1 year

• Heart rate (beats per minute)

  Caffeine effects heart rate recovery following strength exercise

  up to 1 year

Study Arms (2)

Caffeine

EXPERIMENTAL

Volunteers will ingest 300mg caffeine one hour before strength training.

Other: Caffeine

Placebo

PLACEBO COMPARATOR

Volunteers will ingest 300mg placebo one hour before strength training.

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_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.

Placebo

Caffeine OTHER

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.

Caffeine

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pernambuco: lead

Study Sites (1)

Cicero Jonas Rodrigues Benjamim

Juazeiro do Norte, Ceará, 63020070, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: It is a randomized, single-blind clinical trial

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 2, 2019
• Study Start: December 19, 2018
• Primary Completion: March 19, 2019
• Study Completion: March 20, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)