NCT02115763

Brief Summary

Caffeine has been shown to consistently improve time-trial performance, warranting restrictions on consumption under regulation of the National Collegiate Athletics Association (NCAA) and World Anti-Doping Agency (WADA). This ergogenic effect is not well understood, possibly occurring as a result of altered metabolism, improved strength, and/or reduced muscle pain. The hypothesis of altered metabolism has recently fallen out of favor while muscular strength has a tenuous relationship with endurance exercise performance. Reductions in muscle pain have been observed during low and moderate intensity endurance exercise, and this may be the mechanism of caffeine's ergogenic effect. In lieu of reducing pain during high intensity exercise, caffeine significantly improves performance. Therefore, caffeine appears to improve the amount of work that can be done for a given muscle pain rating, suggesting that participants may pace based upon sensations of muscle pain during endurance exercise. Most time-trial exercise is conducted in a fixed distance manner, measuring the time it takes participants to cover a given distance. Little research has been conducted on a fixed pain time-trial that would require participants to produce and sustain a given level of muscle pain while measuring the distance covered in an allotted time. A fixed pain time-trial could allow researchers to better understand the effect of pain on endurance performance. The purpose of this study is to examine the effects of caffeine on a fixed pain time-trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Apr 2014

Longer than P75 for phase_1 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

April 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 5, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

April 11, 2014

Last Update Submit

June 2, 2017

Conditions

Keywords

physically active,18-35 year old men

Outcome Measures

Primary Outcomes (1)

  • Stationary Cycle Ergometer

    The distance covered (meters) while exercising on the cycle ergometer will be recorded.

    30 minutes per session (6 sessions total)

Study Arms (1)

Caffeine

EXPERIMENTAL

There is only one arm, it receives both caffeine and placebo.

Drug: CaffeineDrug: Placebo

Interventions

Caffeine
Caffeine

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Caffeine Naive (\<40mg per day) physically active 18-35 year old men with no contraindications to exercise.

You may not qualify if:

  • People who do not match the gender, age or caffeine limits;
  • those with contraindications to exercise or who are not physically active

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Sensory and Muscle Function Lab

Norman, Oklahoma, 73019, United States

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2014

First Posted

April 16, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

June 5, 2017

Record last verified: 2017-06

Locations