Running Performance Clinical Trial
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)
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.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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