The Repeatability of the Effect of Caffeine Supplementation on Submaximal Physiological Responses and Cycling Time Trial Performance

April 11, 2025 updated by: St. Mary's University, Twickenham
Recently, Grgic (2018) discussed the concept of responders and non-responders to caffeine supplementation highlighting the importance of the repeatability of results. However, the number of studies that have investigated this idea by repeating the same time-trial performance test multiple times with the same caffeine dose is sparse (Astorino et al., 2012; Del Coso et al., 2019). Furthermore, studies have shown that differences in the CYP1A2 genotype may account for some of the variation in time-trial performance (Guest et al., 2018). Thus, the current study aims to identify whether the effects of moderate caffeine supplementation (5 mg/kg) on time-trial performance are repeatable to aid the identification of responders and non-responders. Additionally, the study aims to determine if the CYP1A2 genotype may explain any of the variability in time-trial performance in trained male cyclists.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • To be considered for inclusion in the study, participants must be regular cyclists, between 18 and 35 years of age, capable of completing a 20 km cycling time trial at a minimum speed of 30 km/h (arbitrary inclusion criteria to ensure a sufficient standard of athlete).

Exclusion Criteria:

-

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Caffeine
5 mg/kg dose of caffeine (in pill form) - Trial 1
Dietary supplement: Caffeine
5 mg/kg of caffeine in pill form
Dietary supplement: Caffeine
5 mg/kg dose of caffeine in pill form
Placebo Comparator: Placebo
5 mg/kg dose of placebo (Maltodextrin in pill form) - Trial 2
Dietary supplement: Placebo
5 mg/kg dose of maltodextrin in pill form

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood lactate concentration
Time Frame: From baseline to completion, up to 31 days
Description: Change from baseline in blood lactate concentration measured at rest and at six different exercise intensities (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
Heart rate
Time Frame: From baseline to completion, up to 31 days
Change from baseline in heart rate measured at rest and at seven different exercise intensities (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
Oxygen uptake
Time Frame: From baseline to completion, up to 31 days
Change from baseline in oxygen uptake measured at rest and at seven different exercise intensities (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
Perceived exertion
Time Frame: From baseline to completion, up to 31 days
Change from baseline in rating of perceived exertion measured (using the 6-20 Borg scale) at seven different exercise intensities (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
Time trial completion time
Time Frame: From baseline to completion, up to 31 days
Change from baseline in time to complete a time trial at a target amount of work on an electromagnetically-braked cycle ergometer calculated from the power output at maximal oxygen uptake and designed to last approximately 25 minutes.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Mary's University, Twickenham

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 23, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMU_ETHICS_2024-25_992

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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