- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05521386
The Effects of Caffeine on Heart Rate and Heart Rate Variability
August 26, 2022 updated by: St Mary's University College
The Effects of Caffeine Supplementation on Heart Rate and Heart Rate Variability at Rest and During Submaximal Exercise
In previous research we have shown that an acute caffeine dose of 5 mg/kg body mass reduces heart rate at rest and during low intensity exercise, with the effect dissipating as exercise intensity increases.
If, as suspected, the effect at rest and at low intensities is due to an effect of caffeine on parasympathetic activity, this is likely to be reflected in an increase in heart rate variability (the beat-to-beat fluctuation in heart rate).
The aim of this study is therefore to investigate the effect of caffeine on heart rate and heart rate variability at rest and during submaximal exercise.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
16
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Trained cyclists
Exclusion Criteria:
- Injured or a contraindicative medical condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Caffeine
caffeine dose of 5 mg per kg of body mass administered orally via a gelatine capsule
|
Single pill in an acute dose of 5 mg per kg of body mass
|
PLACEBO_COMPARATOR: Placebo
maltodextrin (placebo) dose of 5 mg per kg of body mass administered orally via a gelatine capsule
|
Single pill in an acute dose of 5 mg per kg of body mass
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate variability
Time Frame: From baseline to completion, up to 31 days
|
Change from baseline in heart rate variability measured at rest and at five different exercise intensities (40, 50, 60, 70 and 80% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer
|
From baseline to completion, up to 31 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate
Time Frame: From baseline to completion, up to 31 days
|
Change from baseline in heart rate measured at rest and at five different exercise intensities (40, 50, 60, 70 and 80% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer
|
From baseline to completion, up to 31 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
September 1, 2022
Primary Completion (ANTICIPATED)
March 31, 2023
Study Completion (ANTICIPATED)
April 30, 2023
Study Registration Dates
First Submitted
August 26, 2022
First Submitted That Met QC Criteria
August 26, 2022
First Posted (ACTUAL)
August 30, 2022
Study Record Updates
Last Update Posted (ACTUAL)
August 30, 2022
Last Update Submitted That Met QC Criteria
August 26, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- StMarysUC5
Drug and device information, study documents
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
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.
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