Sex Differences in Cold-Induced Changes in Maximal Fat Oxidation

May 13, 2026 updated by: Colorado State University

Sex Differences in Cold-Induced Changes in Maximal Fat Oxidation: A Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It is well characterized that females rely more on fat oxidation compared to men during standardized exercise. Exposure to cold during exercise increases fat oxidation in humans. It has been shown that the biological sex differences in substrate oxidation observed during exercise persist in the cold. However, it is unclear if the degree of the effect of cold on substrate oxidation during exercise is different between females and males.

The purpose of this study is to determine if the change in maximal fat oxidation that occurs in cold compared to room temperature environments is different between females and males.

The hypotheses are 1) females will have greater maximal fat oxidation than males in both conditions, and 2) the change in maximal fat oxidation between the control and cold conditions will be the same in females and males.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise at cold temperature
Study participants will ride an exercise bike. Room temperature will be 5 ºC
Other: Cold temperature
Room temperature will be decreased to 5 ºC
Active Comparator: Exercise at room temperature
Study participants will ride an exercise bike
Other: Room Temperature
Exercise condition for control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal Fat Oxidation
Time Frame: During exercise while in the lab
Using indirect calorimetry, fat oxidation will be determined. The maximal value for fat oxidation will be recorded.
During exercise while in the lab

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado State University

Investigators

  • Principal Investigator: Christopher Bell, Colorado State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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