CaffeineNCT06210984
Caffeine and Training Intensity Quantification
A study testing Low caffeine dose and Moderate caffeine dose in people with Caffeine, run by St. Mary's University, Twickenham.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Caffeine
- What is being tested?
- Low caffeine dose and Moderate caffeine dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- -
About this study
Official title: The Effects of Caffeine Supplementation on Training Intensity Quantification
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.
Read more
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.
- Conditions
- Caffeine
- Being tested
- Low caffeine dose, Moderate caffeine dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low caffeine doseDrug
2 mg/kg dose of caffeine in pill form
Moderate caffeine doseDrug
5 mg/kg dose of caffeine in pill form
PlaceboDrug
5 mg/kg dose of maltodextrin in pill form
| Study group | Role | What they receive |
|---|---|---|
| Low caffeine dose | Experimental | 2 mg/kg dose of caffeine (in pill form) Receives: Drug: Low caffeine dose |
| Moderate caffeine dose | Experimental | 5 mg/kg dose of caffeine (in pill form) Receives: Drug: Moderate caffeine dose |
| Placebo | Placebo comparator | 5 mg/kg dose of placebo (Maltodextrin in pill form) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline to completion, up to 31 days
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
Measured: From baseline to completion, up to 31 days
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
Measured: From baseline to completion, up to 31 days
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
Measured: From baseline to completion, up to 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start31 Jan 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaffeineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Mary's University, Twickenham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210984
- Sponsor's protocol ID
- Stmarys1
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Caffeine Supplementation on Training Intensity Quantification
- ClinicalTrials.gov ID
- NCT06210984
- Acronym / sponsor ID
- Stmarys1
- Conditions
- Caffeine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- St. Mary's University, TwickenhamUniversity, hospital or other
- Study start
- 31 Jan 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low caffeine dose | Experimental | Drug: Low caffeine dose2 mg/kg dose of caffeine (in pill form) |
| Moderate caffeine dose | Experimental | Drug: Moderate caffeine dose5 mg/kg dose of caffeine (in pill form) |
| Placebo | Placebo comparator | Drug: Placebo5 mg/kg dose of placebo (Maltodextrin in pill form) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low caffeine dose2 mg/kg dose of caffeine in pill form | Drug | Low caffeine dose |
| Moderate caffeine dose5 mg/kg dose of caffeine in pill form | Drug | Moderate caffeine dose |
| Placebo5 mg/kg dose of maltodextrin in pill form | Drug | Placebo |
Primary outcome
Blood lactate concentration
Time frame: From baseline to completion, up to 31 days
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
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 (50, 55, 60, 65, 70, 75, and 80% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer
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 (50, 55, 60, 65, 70, 75, and 80% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer
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 (50, 55, 60, 65, 70, 75, and 80% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low caffeine dose and Moderate caffeine dose in people with Caffeine, run by St. Mary's University, Twickenham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood lactate concentration (time frame: From baseline to completion, up to 31 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.