Running PerformanceNCT02473575
Does a Caffeine Gum Improve 5 km Run Performance in a Competition/Field Setting?
A study testing caffeine gum in people with Running Performance, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether caffeine gum improves the performance of runners completing free timed mass participation 5 km runs in the United Kingdom (UK) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Running Performance
- What is being tested?
- caffeine gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Jan 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult runners with evidence of having recently ran 5 km in under 25 minutes
Who cannot join
- Current musculoskeletal injury, history of adverse response to caffeine, presence or history of cardiovascular disease, heart rhythm disorders or hypertension.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Hallam University
Sheffield, South Yorkshire, S1 1WB
About this study
Official title: Does a Commercial Caffeine Supplement Improve 5 km Run Performance in a Field Setting?
The purpose of this study is to determine whether caffeine gum improves the performance of runners completing free timed mass participation 5 km runs in the United Kingdom (UK)
Read the detailed description
The study will investigate the ability of an acute intake of caffeine gum to improve performance in recreationally trained runners completing park runs. Park runs are free, timed 5 km mass participation running events that are held in a number of parks around the UK every Saturday morning.
A total of 60 recreationally trained runners will be recruited to the study. Of these, 30 will be assigned to a randomised placebo-controlled double-blind cross-over trial. The remaining 30 will be assigned to a non-intervention comparison group. The non-intervention group will be used to account for the effect of changing environmental conditions on running performance.
All participants will complete two 5 km park runs separated by no more than 2 weeks. Participants on the intervention study arms will consume either caffeine or placebo gum 30 minutes before they run. The order of consumption will be randomised. The caffeine gum will contain 300 mg (with an approximate 85% bioavailability). Participants will be asked to abstain from any caffeine containing beverages or food for 18 hours before each run. They will also be asked to record their dietary intake for the day before and the morning of the run and to repeat this for their second trial. Physical activity on the days leading up to each 5 km run will also be recorded and participants will be asked to closely replicate their activity in the week leading up to each trial. They will also be asked to keep training intensity and duration light during the 48 hours leading up to each trial.
The primary outcome measure will be change in overall time for the 5 km runs. Other outcome measures will be ratings of perceived exertion, 1 km split times and average heart rate.
The study size was calculated using an online software package (http://www.sportsci.org/resource/stats/), adopting a power of 80% and an alpha of 0.05. Using within-person standard deviation from runners completing a local parkrun and an expected effect size of 1.2% (Bridge and Jones (2006) J Sports Sciences. 24(4):433-9) a sample size of 25 runners was calculated for the intervention study.
- Conditions
- Running Performance
- Being tested
- caffeine gum, placebo gum
- Keywords
- Caffeine, running, performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caffeine gumDietary supplement
Gum is consumed 30 minutes before commencement of run
placebo gumDietary supplement
Gum is consumed 30 minutes before commencement of run
| Study group | Role | What they receive |
|---|---|---|
| Caffeine gum | Experimental | caffeine (300 mg) in gum form x 1 ingestion Receives: Dietary Supplement: caffeine gum |
| Placebo gum | Placebo comparator | placebo gum consumed x 1 ingestion Receives: Dietary Supplement: placebo gum |
| Non-intervention group | No intervention | A third group of runners will be used to adjust for changes in environmental conditions. They will complete 2 runs without consuming either placebo or experimental treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 5 km run time
The difference in finishing time on placebo v caffeine; recorded in seconds
Measured: calculated after 2nd run (runs separated by 7 days)
Secondary outcomes (1)
Change in ratings of perceived exertion (RPE)
The difference in RPE on placebo v caffeine; using a 6-20 Borg scale
Measured: calculated after 2nd run (runs separated by 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Running PerformanceStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tony Lynn, Sheffield Hallam University
- Investigators
- Anthony Lynn, PhD, Principal investigator, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473575
- Sponsor's protocol ID
- SBSREC1314/39
- Status last verified
- Apr 2016
- First submitted
- 12 Jun 2015
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lynn A, Shaw C, Sorsby AC, Ashworth P, Hanif F, Williams CE, Ranchordas MK. Caffeine gum improves 5 km running performance in recreational runners completing parkrun events. Eur J Nutr. 2024 Jun;63(4):1283-1291. doi: 10.1007/s00394-024-03349-3. Epub 2024 Feb 24.
PubMed 38400919
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Commercial Caffeine Supplement Improve 5 km Run Performance in a Field Setting?
- ClinicalTrials.gov ID
- NCT02473575
- Acronym / sponsor ID
- SBSREC1314/39
- Conditions
- Running Performance
- Keywords
- Caffeine, running, performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Jun 2015 (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.
The purpose of this study is to determine whether caffeine gum improves the performance of runners completing free timed mass participation 5 km runs in the United Kingdom (UK)
Detailed description
The study will investigate the ability of an acute intake of caffeine gum to improve performance in recreationally trained runners completing park runs. Park runs are free, timed 5 km mass participation running events that are held in a number of parks around the UK every Saturday morning.
A total of 60 recreationally trained runners will be recruited to the study. Of these, 30 will be assigned to a randomised placebo-controlled double-blind cross-over trial. The remaining 30 will be assigned to a non-intervention comparison group. The non-intervention group will be used to account for the effect of changing environmental conditions on running performance.
All participants will complete two 5 km park runs separated by no more than 2 weeks. Participants on the intervention study arms will consume either caffeine or placebo gum 30 minutes before they run. The order of consumption will be randomised. The caffeine gum will contain 300 mg (with an approximate 85% bioavailability). Participants will be asked to abstain from any caffeine containing beverages or food for 18 hours before each run. They will also be asked to record their dietary intake for the day before and the morning of the run and to repeat this for their second trial. Physical activity on the days leading up to each 5 km run will also be recorded and participants will be asked to closely replicate their activity in the week leading up to each trial. They will also be asked to keep training intensity and duration light during the 48 hours leading up to each trial.
The primary outcome measure will be change in overall time for the 5 km runs. Other outcome measures will be ratings of perceived exertion, 1 km split times and average heart rate.
The study size was calculated using an online software package (http://www.sportsci.org/resource/stats/), adopting a power of 80% and an alpha of 0.05. Using within-person standard deviation from runners completing a local parkrun and an expected effect size of 1.2% (Bridge and Jones (2006) J Sports Sciences. 24(4):433-9) a sample size of 25 runners was calculated for the intervention study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caffeine gum | Experimental | Dietary Supplement: caffeine gumcaffeine (300 mg) in gum form x 1 ingestion |
| Placebo gum | Placebo comparator | Dietary Supplement: placebo gumplacebo gum consumed x 1 ingestion |
| Non-intervention group | No intervention | –A third group of runners will be used to adjust for changes in environmental conditions. They will complete 2 runs without consuming either placebo or experimental treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult runners with evidence of having recently ran 5 km in under 25 minutes
Key exclusion criteria (1 listed)
- Current musculoskeletal injury, history of adverse response to caffeine, presence or history of cardiovascular disease, heart rhythm disorders or hypertension.
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 gumGum is consumed 30 minutes before commencement of run | Dietary supplement | Caffeine gum |
| placebo gumGum is consumed 30 minutes before commencement of run | Dietary supplement | Placebo gum |
Primary outcome
Change in 5 km run time
Time frame: calculated after 2nd run (runs separated by 7 days)
The difference in finishing time on placebo v caffeine; recorded in seconds
1 secondary outcome
Change in ratings of perceived exertion (RPE)
Time frame: calculated after 2nd run (runs separated by 7 days)
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 19 Apr 2016.
- Derived from this study: PubMed 38400919Lynn A, Shaw C, Sorsby AC, Ashworth P, Hanif F, Williams CE, Ranchordas MK. Caffeine gum improves 5 km running performance in recreational runners completing parkrun events. Eur J Nutr. 2024 Jun;63(4):1283-1291. doi: 10.1007/s00394-024-03349-3. Epub 2024 Feb 24.
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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.
Anthony Lynn, PhD principal investigator
Sheffield Hallam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing caffeine gum in people with Running Performance, run by Sheffield Hallam University at 1 site in United Kingdom.
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: finished, as of the sponsor's last update on 19 Apr 2016. 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 Kingdom. 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. 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?
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?
Change in 5 km run time (time frame: calculated after 2nd run (runs separated by 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02473575, which also lists 1 linked publication.
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 19 Apr 2016.