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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05521386
Other study ID # StMarysUC5
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date April 30, 2023

Study information

Verified date August 2022
Source St Mary's University College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 16
Est. completion date April 30, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Trained cyclists Exclusion Criteria: - Injured or a contraindicative medical condition

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Caffeine
Single pill in an acute dose of 5 mg per kg of body mass
Placebo
Single pill in an acute dose of 5 mg per kg of body mass

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
St Mary's University College

Outcome

Type Measure Description Time frame Safety issue
Primary Heart rate variability 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 Heart rate 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
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