NCT06210984

Brief Summary

The goal of this clinical trial is to learn about the effects of caffeine on exercise physiology and the subsequent quantification of athlete training zones in trained cyclists. The main questions that it aims to answer are:

  • What are the effects of low and moderate doses of caffeine on exercise physiology.
  • How do the effects of caffeine on exercise physiology affect the calculation of training zones.
  • Do the effects of caffeine on exercise physiology differ between men and women. Participants will complete four trials on a cycle ergometer as follows:
  • Trial 1: participants will complete two incremental tests to determine the power outputs required to elicit 50-80% of maximal oxygen consumption for trials 2-4.
  • Trials 2-4: participants will consume (in a randomized order) either a low (2 mg/kg) dose of caffeine, a moderate (5 mg/kg) dose of caffeine, or a placebo (maltodextrin), 45 minutes prior to to completing an incremental cycling test from 50-80% of maximal oxygen uptake. Measures of heart rate, oxygen uptake, blood lactate, and perceived exertion will be recorded throughout all trials. Researchers will compare the effects of exercise intensity, caffeine dose, and sex to see if they affect exercise physiology and training zone quantification.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

January 31, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

1.9 years

First QC Date

January 8, 2024

Last Update Submit

January 8, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Blood lactate concentration

    Change from baseline in blood lactate concentration measured at rest and at seven different exercise intensities (50, 55, 60, 65, 70, 75, and 80% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer

    From baseline to completion, up to 31 days

  • Heart rate

    Change from baseline in heart rate measured at rest and at seven different exercise intensities (50, 55, 60, 65, 70, 75, and 80% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer

    From baseline to completion, up to 31 days

  • Oxygen uptake

    Change from baseline in oxygen uptake measured at rest and at seven different exercise intensities (50, 55, 60, 65, 70, 75, and 80% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer

    From baseline to completion, up to 31 days

  • Perceived exertion

    Change from baseline in rating of perceived exertion measured (using the 6-20 Borg scale) at seven different exercise intensities (50, 55, 60, 65, 70, 75, and 80% percent of maximal oxygen uptake) on an electromagnetically-braked cycle ergometer

    From baseline to completion, up to 31 days

Study Arms (3)

Low caffeine dose

EXPERIMENTAL

2 mg/kg dose of caffeine (in pill form)

Drug: Low caffeine dose

Moderate caffeine dose

EXPERIMENTAL

5 mg/kg dose of caffeine (in pill form)

Drug: Moderate caffeine dose

Placebo

PLACEBO COMPARATOR

5 mg/kg dose of placebo (Maltodextrin in pill form)

Drug: Placebo

Interventions

2 mg/kg dose of caffeine in pill form

Low caffeine dose

5 mg/kg dose of caffeine in pill form

Moderate caffeine dose

5 mg/kg dose of maltodextrin in pill form

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 18, 2024

Study Start

January 31, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 18, 2024

Record last verified: 2024-01