- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02473575
Does a Caffeine Gum Improve 5 km Run Performance in a Competition/Field Setting?
Does a Commercial Caffeine Supplement Improve 5 km Run Performance in a Field Setting?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Yorkshire
-
Sheffield, South Yorkshire, United Kingdom, S1 1WB
- Sheffield Hallam University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy adult runners with evidence of having recently ran 5 km in under 25 minutes
Exclusion Criteria:
- Current musculoskeletal injury, history of adverse response to caffeine, presence or history of cardiovascular disease, heart rhythm disorders or hypertension.
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Caffeine gum
caffeine (300 mg) in gum form x 1 ingestion
|
Gum is consumed 30 minutes before commencement of run
|
|
PLACEBO_COMPARATOR: Placebo gum
placebo gum consumed x 1 ingestion
|
Gum is consumed 30 minutes before commencement of run
|
|
NO_INTERVENTION: Non-intervention group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
calculated after 2nd run (runs separated by 7 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in ratings of perceived exertion (RPE)
Time Frame: calculated after 2nd run (runs separated by 7 days)
|
The difference in RPE on placebo v caffeine; using a 6-20 Borg scale
|
calculated after 2nd run (runs separated by 7 days)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pacing
Time Frame: calculated after 2nd run (runs separated by 7 days); placebo v caffeine
|
1 km split times in sec will be recorded manually and overall pace using GPS (km/h)
|
calculated after 2nd run (runs separated by 7 days); placebo v caffeine
|
|
Change in average heart rate
Time Frame: calculated after 2nd run
|
Recorded in beats per minute
|
calculated after 2nd run
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anthony Lynn, PhD, Sheffield Hallam University
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBSREC1314/39
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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