NCT07129200

Brief Summary

Maintaining a stable core temperature is vital for physiological function; yet, exercise in heat can be problematic, and there is risk of exertional heat-related illness (Flouris \& Schlader, 2015; Leyk et al., 2019; Périard et al., 2021; Tyler et al., 2016; Veltmeijer et al., 2015). While aerobic fitness improves heat tolerance (Alhadad et al., 2019), strategies like acclimation and pre-cooling also mitigate heat stress (Casadio et al., 2016; Lorenzo et al., 2010; Ross et al., 2013; Siegel et al., 2010). Caffeine, an ergogenic aid (Del Corso et al., 2011; John et al., 2024), is known to enhance performance via adenosine antagonism and increased catecholamines in normothermic environments (Fredholm et al., 1999; Graham \& Spriet, 1991). However, effects in heat are inconsistent (Ganio et al., 2009; Zhang et al., 2014), possibly due to caffeine reducing the ability to thermoregulate effectively. Therefore, the aim of this study is to investigate the effects of a moderate dose of caffeine (5 mg/kg) on thermoregulation during a 30-minute running time trial in 35°C heat.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Aug 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress83%
Aug 2025Jun 2026

First Submitted

Initial submission to the registry

August 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

August 22, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

August 12, 2025

Last Update Submit

August 12, 2025

Conditions

Keywords

caffeinethermoregulationtime trialexercise physiology

Outcome Measures

Primary Outcomes (5)

  • Blood lactate concentration

    Change from baseline in blood lactate concentration measured at rest and at five different exercise intensities (65, 70, 75, 80, and 85% percent of maximal oxygen uptake) on a treadmill.

    From baseline to completion, up to 31 days

  • Heart rate

    Change from baseline in heart rate measured at rest and at five different exercise intensities (65, 70, 75, 80, and 85% percent of maximal oxygen uptake) on a treadmill.

    From baseline to completion, up to 31 days

  • Rating of perceived exertion

    Change from baseline in rating of perceived exertion measured (using the 6-20 Borg scale) at five different exercise intensities (65, 70, 75, 80, and 85% percent of maximal oxygen uptake) on a treadmill.

    From baseline to completion, up to 31 days

  • Oxygen uptake

    Change from baseline in oxygen uptake measured at five different exercise intensities (65, 70, 75, 80, and 85% percent of maximal oxygen uptake) on a treadmill.

    From baseline to completion, up to 31 days

  • Time trial performance

    Change from baseline in distance covered during a 30 minute time trial on a treadmill.

    From baseline to completion, up to 31 days

Study Arms (2)

Caffeine

EXPERIMENTAL

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

Other: Hot environmentOther: Thermoneutral environment

Placebo

PLACEBO COMPARATOR

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

Other: Hot environmentOther: Thermoneutral environment

Interventions

Hot environment of 35 degrees Celsius

CaffeinePlacebo

Thermoneutral environment of 18 degrees Celsius

CaffeinePlacebo

Eligibility Criteria

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

You may qualify if:

  • Healthy trained runners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

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

August 12, 2025

First Posted

August 19, 2025

Study Start

August 22, 2025

Primary Completion

April 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

August 19, 2025

Record last verified: 2025-08