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

NCT ID: NCT02473575

Last Updated: 2016-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Running Performance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Caffeine gum

caffeine (300 mg) in gum form x 1 ingestion

Group Type EXPERIMENTAL

caffeine gum

Intervention Type DIETARY_SUPPLEMENT

Gum is consumed 30 minutes before commencement of run

Placebo gum

placebo gum consumed x 1 ingestion

Group Type PLACEBO_COMPARATOR

placebo gum

Intervention Type DIETARY_SUPPLEMENT

Gum is consumed 30 minutes before commencement of run

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

caffeine gum

Gum is consumed 30 minutes before commencement of run

Intervention Type DIETARY_SUPPLEMENT

placebo gum

Gum is consumed 30 minutes before commencement of run

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sheffield Hallam University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tony Lynn

Senior Lecturer in Nutrition

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anthony Lynn, PhD

Role: PRINCIPAL_INVESTIGATOR

Sheffield Hallam University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sheffield Hallam University

Sheffield, South Yorkshire, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38400919 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SBSREC1314/39

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.