- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03899675
Impact of Caffeine Intake on Autonomic Parameters in the Exercise of Strength
Impact of Caffeine Intake Before Exercise on the Neural Regulation of the Cardiovascular System in Physically Active Adults
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ceará
-
Juazeiro do Norte, Ceará, Brazil, 63020070
- Cicero Jonas Rodrigues Benjamim
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Caffeine
Volunteers will ingest 300mg caffeine one hour before strength training.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caffeine effects on heart rate variability (based on frequency, time domain and Chaos)
Time Frame: up to 1 year
|
up to 1 year
|
|
|
Blood pressure (mmHg)
Time Frame: up to 1 year
|
Caffeine effects blood pressure recovery following strength exercise
|
up to 1 year
|
|
Heart rate (beats per minute)
Time Frame: up to 1 year
|
Caffeine effects heart rate recovery following strength exercise
|
up to 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPernambuco
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autonomic Nervous System
-
The Hong Kong Polytechnic UniversityUnknownAutonomic Nervous System DisorderChina
-
Northwell HealthEnrolling by invitationAutonomic Nervous System Diseases | Autonomic Dysfunction | Autonomic Imbalance | Vagus Nerve Autonomic DisorderUnited States
-
Istanbul Medipol University HospitalCompletedVagus Nerve Autonomic DisorderTurkey
-
University Health Network, TorontoRecruitingAutonomic DysfunctionCanada
-
Virginia Polytechnic Institute and State UniversityEnrolling by invitation
-
University of Mississippi Medical CenterVicor Technologies, Inc.CompletedAutonomic DysfunctionUnited States
-
Federal University of Health Science of Porto AlegreCompletedVertebra; Degeneration | Other Disorders of the Autonomic Nervous SystemBrazil
-
National Institute of Neurological Disorders and...Completed
-
Fondazione Don Carlo Gnocchi OnlusCompletedAutonomic Nervous System Disease | Osteopathy
Clinical Trials on Caffeine
-
University of RochesterNot yet recruitingInfants | Neonatal Apnea
-
Indiana UniversityIndiana Clinical and Translational Sciences InstituteRecruitingPremature Birth | Respiratory Distress Syndrome | Bronchopulmonary Dysplasia | Apnea of Prematurity | Preterm Labor With Preterm DeliveryUnited States
-
Northumbria UniversityCompletedExercise | Dietary SupplementTurkey (Türkiye)
-
Istanbul University - Cerrahpasaİstanbul Yeni Yüzyıl ÜniversitesiNot yet recruitingMuscle Strength | Exercise Performance | Adaptation | Muscle HypotrophyTurkey (Türkiye)
-
Sinop UniversityCompletedAthletic Performance | Cognitive Performance | Healthy Adult FemalesTurkey (Türkiye)
-
Universidad Rey Juan CarlosEnrolling by invitationExercise | Caffeine | Ergogenics | Cycling | Fat MetabolismSpain
-
KTO Karatay UniversityRecruitingPostoperative Pain | Gastrointestinal Motility | Psychological Well-BeingTurkey (Türkiye)
-
University of Wisconsin, MadisonEunice Kennedy Shriver National Institute of Child Health and Human Development...Recruiting
-
Southern Illinois University CarbondaleCompleted
-
National Taiwan Sport UniversityCompleted