NCT02473575

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 16, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

7 months

First QC Date

June 12, 2015

Last Update Submit

April 18, 2016

Conditions

Keywords

Caffeine, running, performance

Outcome Measures

Primary Outcomes (1)

  • Change in 5 km run time

    The difference in finishing time on placebo v caffeine; recorded in seconds

    calculated after 2nd run (runs separated by 7 days)

Secondary Outcomes (1)

  • Change in ratings of perceived exertion (RPE)

    calculated after 2nd run (runs separated by 7 days)

Other Outcomes (2)

  • Change in pacing

    calculated after 2nd run (runs separated by 7 days); placebo v caffeine

  • Change in average heart rate

    calculated after 2nd run

Study Arms (3)

Caffeine gum

EXPERIMENTAL

caffeine (300 mg) in gum form x 1 ingestion

Dietary Supplement: caffeine gum

Placebo gum

PLACEBO COMPARATOR

placebo gum consumed x 1 ingestion

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

Interventions

caffeine gumDIETARY_SUPPLEMENT

Gum is consumed 30 minutes before commencement of run

Caffeine gum
placebo gumDIETARY_SUPPLEMENT

Gum is consumed 30 minutes before commencement of run

Placebo gum

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult runners with evidence of having recently ran 5 km in under 25 minutes

You may not qualify if:

  • Current musculoskeletal injury, history of adverse response to caffeine, presence or history of cardiovascular disease, heart rhythm disorders or hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Hallam University

Sheffield, South Yorkshire, S1 1WB, United Kingdom

Location

Related Publications (1)

  • 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.

Study Officials

  • Anthony Lynn, PhD

    Sheffield Hallam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Nutrition

Study Record Dates

First Submitted

June 12, 2015

First Posted

June 16, 2015

Study Start

June 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations