NCT07297823

Brief Summary

The purpose of this research study is to determine if the cold-induced change in fat burning during exercise is different between females and males.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Jan 2026

Status
not yet recruiting

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

Study Progress19%
Jan 2026Jun 2027

First Submitted

Initial submission to the registry

December 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

December 9, 2025

Last Update Submit

December 19, 2025

Conditions

Keywords

exercisefattemperaturecoldmetabolism

Outcome Measures

Primary Outcomes (1)

  • Maximal Fat Oxidation

    Using indirect calorimetry, fat oxidation will be determined. The maximal value for fat oxidation will be recorded.

    During exercise while in the lab

Study Arms (2)

Exercise at room temperature

ACTIVE COMPARATOR

Study participants will ride an exercise bike

Other: Room Temperature

Exercise at cold temperature

EXPERIMENTAL

Study participants will ride an exercise bike. Room temperature will be 5 ºC

Other: Cold temperature

Interventions

Exercise condition for control arm

Exercise at room temperature

Room temperature will be decreased to 5 ºC

Exercise at cold temperature

Eligibility Criteria

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

You may qualify if:

  • Age 18-40 years (inclusive)
  • Weight stable (no change in body mass greater than 5 lbs. within the previous 6 months.
  • Willing to abstain from caffeine and alcohol for 24-hours prior to two different study visits
  • Competency in English as informally assessed by comprehension of the Informed Consent. This study involves maximal exercise testing; for safety reasons, the ability for clear and rapid communication will be necessary between the research participants and the investigators.
  • Regular exercise (i.e., at least 150 minutes of moderate-vigorous exercise per week)

You may not qualify if:

  • Use of hormonal contraceptives
  • History of autonomic, cardio-pulmonary, and/or metabolic disease (including heart failure, hypertension, arrhythmia, vascular disease, and/or diabetes)
  • Pregnancy or breast feeding
  • Habitual use of tobacco/nicotine products or recreational drugs (2 or more uses within the previous month)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor ActivityPlatelet Glycoprotein IV DeficiencyCommon Cold

Interventions

Cold Temperature

Condition Hierarchy (Ancestors)

BehaviorRespiratory Tract InfectionsInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TemperatureThermodynamicsPhysical PhenomenaWeatherAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Christopher Bell

    Colorado State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 22, 2025

Study Start

January 31, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

December 26, 2025

Record last verified: 2025-12