HealthyPhase 1NCT02115763
The Effects of Caffeine on Pain-Based Pacing During a Cycling Time-Trial
A Phase 1 study testing Caffeine in people with Healthy, run by University of Oklahoma at 1 site in United States.
Trial summary
Caffeine has been shown to consistently improve time-trial performance, warranting restrictions on consumption under regulation of the National Collegiate Athletics Association (NCAA) and World Anti-Doping Agency (WADA). Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Caffeine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to May 2015
- Phase
- Phase 1
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caffeine Naive (<40mg per day) physically active 18-35 year old men with no contraindications to exercise.
Who cannot join
- People who do not match the gender, age or caffeine limits;
- those with contraindications to exercise or who are not physically active
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Sensory and Muscle Function Lab
Norman, Oklahoma, 73019
About this study
Caffeine has been shown to consistently improve time-trial performance, warranting restrictions on consumption under regulation of the National Collegiate Athletics Association (NCAA) and World Anti-Doping Agency (WADA). This ergogenic effect is not well understood, possibly occurring as a result of altered metabolism, improved strength, and/or reduced muscle pain. The hypothesis of altered metabolism has recently fallen out of favor while muscular strength has a tenuous relationship with endurance exercise performance. Reductions in muscle pain have been observed during low and moderate intensity endurance exercise, and this may be the mechanism of caffeine's ergogenic effect. In lieu of reducing pain during high intensity exercise, caffeine significantly improves performance. Therefore, caffeine appears to improve the amount of work that can be done for a given muscle pain rating, suggesting that participants may pace based upon sensations of muscle pain during endurance exercise. Most time-trial exercise is conducted in a fixed distance manner, measuring the time it takes participants to cover a given distance. Little research has been conducted on a fixed pain time-trial that would require participants to produce and sustain a given level of muscle pain while measuring the distance covered in an allotted time. A fixed pain time-trial could allow researchers to better understand the effect of pain on endurance performance. The purpose of this study is to examine the effects of caffeine on a fixed pain time-trial.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Experimental | There is only one arm, it receives both caffeine and placebo. Receives: Drug: Caffeine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stationary Cycle Ergometer
The distance covered (meters) while exercising on the cycle ergometer will be recorded.
Measured: 30 minutes per session (6 sessions total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115763
- Sponsor's protocol ID
- 4084
- Status last verified
- Jun 2017
- First submitted
- 11 Apr 2014
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Caffeine on Pain-Based Pacing During a Cycling Time-Trial
- ClinicalTrials.gov ID
- NCT02115763
- Acronym / sponsor ID
- 4084
- Conditions
- Healthy
- Keywords
- physically active,, 18-35 year old men
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 16 Apr 2014 (estimated)
- 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.
Caffeine has been shown to consistently improve time-trial performance, warranting restrictions on consumption under regulation of the National Collegiate Athletics Association (NCAA) and World Anti-Doping Agency (WADA). This ergogenic effect is not well understood, possibly occurring as a result of altered metabolism, improved strength, and/or reduced muscle pain. The hypothesis of altered metabolism has recently fallen out of favor while muscular strength has a tenuous relationship with endurance exercise performance. Reductions in muscle pain have been observed during low and moderate intensity endurance exercise, and this may be the mechanism of caffeine's ergogenic effect. In lieu of reducing pain during high intensity exercise, caffeine significantly improves performance. Therefore, caffeine appears to improve the amount of work that can be done for a given muscle pain rating, suggesting that participants may pace based upon sensations of muscle pain during endurance exercise. Most time-trial exercise is conducted in a fixed distance manner, measuring the time it takes participants to cover a given distance. Little research has been conducted on a fixed pain time-trial that would require participants to produce and sustain a given level of muscle pain while measuring the distance covered in an allotted time. A fixed pain time-trial could allow researchers to better understand the effect of pain on endurance performance. The purpose of this study is to examine the effects of caffeine on a fixed pain time-trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Experimental | Drug: Caffeine, Drug: PlaceboThere is only one arm, it receives both caffeine and placebo. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Caffeine Naive (<40mg per day) physically active 18-35 year old men with no contraindications to exercise.
Key exclusion criteria (2 listed)
- People who do not match the gender, age or caffeine limits;
- those with contraindications to exercise or who are not physically active
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 |
|---|---|---|
| Caffeine | Drug | Caffeine |
| Placebo | Drug | Caffeine |
Primary outcome
Stationary Cycle Ergometer
Time frame: 30 minutes per session (6 sessions total)
The distance covered (meters) while exercising on the cycle ergometer will be recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Caffeine in people with Healthy, run by University of Oklahoma at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stationary Cycle Ergometer (time frame: 30 minutes per session (6 sessions total)). 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 5 Jun 2017.