Does a Caffeine Gum Improve 5 km Run Performance in a Competition/Field Setting?

April 18, 2016 updated by: Tony Lynn, Sheffield Hallam University

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)

Study Overview

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

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S1 1WB
        • Sheffield Hallam University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anthony Lynn, PhD, Sheffield Hallam University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

June 12, 2015

First Submitted That Met QC Criteria

June 15, 2015

First Posted (ESTIMATE)

June 16, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

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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