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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06210984
Other study ID # Stmarys1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 31, 2024
Est. completion date December 31, 2025

Study information

Verified date January 2024
Source St. Mary's University, Twickenham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn about the effects of caffeine on exercise physiology and the subsequent quantification of athlete training zones in trained cyclists. The main questions that it aims to answer are: - What are the effects of low and moderate doses of caffeine on exercise physiology. - How do the effects of caffeine on exercise physiology affect the calculation of training zones. - Do the effects of caffeine on exercise physiology differ between men and women. Participants will complete four trials on a cycle ergometer as follows: - Trial 1: participants will complete two incremental tests to determine the power outputs required to elicit 50-80% of maximal oxygen consumption for trials 2-4. - Trials 2-4: participants will consume (in a randomized order) either a low (2 mg/kg) dose of caffeine, a moderate (5 mg/kg) dose of caffeine, or a placebo (maltodextrin), 45 minutes prior to to completing an incremental cycling test from 50-80% of maximal oxygen uptake. Measures of heart rate, oxygen uptake, blood lactate, and perceived exertion will be recorded throughout all trials. Researchers will compare the effects of exercise intensity, caffeine dose, and sex to see if they affect exercise physiology and training zone quantification.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - To be considered for inclusion in the study, participants must be regular cyclists, between 18 and 45 years of age, capable of completing a 20 km cycling time trial at a minimum speed of 30 km/h for men and 28 km/h for women (arbitrary inclusion criteria to ensure a sufficient standard of athlete). Female participants must have a regular menstrual cycle and not be taking oral contraceptives. Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Low caffeine dose
2 mg/kg dose of caffeine in pill form
Moderate caffeine dose
5 mg/kg dose of caffeine in pill form
Placebo
5 mg/kg dose of maltodextrin in pill form

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
St. Mary's University, Twickenham

Outcome

Type Measure Description Time frame Safety issue
Primary Blood lactate concentration Change from baseline in blood lactate concentration measured at rest and at seven different exercise intensities (50, 55, 60, 65, 70, 75, and 80% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer From baseline to completion, up to 31 days
Primary Heart rate Change from baseline in heart rate measured at rest and at seven different exercise intensities (50, 55, 60, 65, 70, 75, and 80% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer From baseline to completion, up to 31 days
Primary Oxygen uptake Change from baseline in oxygen uptake measured at rest and at seven different exercise intensities (50, 55, 60, 65, 70, 75, and 80% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer From baseline to completion, up to 31 days
Primary Perceived exertion Change from baseline in rating of perceived exertion measured (using the 6-20 Borg scale) at seven different exercise intensities (50, 55, 60, 65, 70, 75, 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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