NCT02985606

Brief Summary

Investigate how manipulating the time between caffeine ingestion and exercise may alter exercise performance and cognition

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable healthy

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

November 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

8 months

First QC Date

November 30, 2016

Last Update Submit

October 11, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Work done in kilojoules (kJ) during a 15 minute time trial on a cycle ergometer

    15 minutes

Secondary Outcomes (4)

  • Whole body fuel substrate utilisation measured using indirect calorimetry

    10 minutes

  • Change in plasma caffeine concentration and metabolites

    2 hours 45 minutes

  • Change in cognitive function measured using stroop test

    2 hours 45 minutes

  • Collection of saliva for genotyping of CYP1A2

    30 mintes

Study Arms (4)

Caffeine -60

ACTIVE COMPARATOR

Caffeine at 60 minutes prior to time trial

Other: Caffeine powder -60Other: Placebo powder -30Other: Placebo powder 0

Caffeine -30

ACTIVE COMPARATOR

Caffeine at 30 minutes prior to time trial

Other: Caffeine powder -30Other: Placebo powder -60Other: Placebo powder 0

Caffeine 0

ACTIVE COMPARATOR

Caffeine immediately prior to time trial

Other: Caffeine powder 0Other: Placebo powder -60Other: Placebo powder -30

Placebo

PLACEBO COMPARATOR

Placebo drink at all time points

Other: Placebo powder -60Other: Placebo powder -30Other: Placebo powder 0

Interventions

Caffeine powder -60OTHER
Caffeine -60
Caffeine powder -30OTHER
Caffeine -30
Caffeine powder 0OTHER
Caffeine 0
Placebo powder -60OTHER
Caffeine -30Caffeine 0Placebo
Placebo powder -30OTHER
Caffeine -60Caffeine 0Placebo
Placebo powder 0OTHER
Caffeine -30Caffeine -60Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • vo2max \> 55 ml/kg/min
  • females on contraceptive pill

You may not qualify if:

  • recent skeletal muscle injury
  • cardiovascular injury
  • metabolic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport and Health Sciences

Exeter, Devon, EX1 2LU, United Kingdom

Location

Related Publications (1)

  • Davenport AD, Jameson TSO, Kilroe SP, Monteyne AJ, Pavis GF, Wall BT, Dirks ML, Alamdari N, Mikus CR, Stephens FB. A Randomised, Placebo-Controlled, Crossover Study Investigating the Optimal Timing of a Caffeine-Containing Supplement for Exercise Performance. Sports Med Open. 2020 Mar 30;6(1):17. doi: 10.1186/s40798-020-00246-x.

    PMID: 32232597DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 7, 2016

Study Start

November 1, 2016

Primary Completion

June 30, 2017

Study Completion

September 15, 2018

Last Updated

October 16, 2018

Record last verified: 2018-10

Locations

GB(1)