ClinicalTrials.gg
RecruitingNCT07297823Updated May 15, 2026

Sex Differences in Cold-Induced Changes in Maximal Fat Oxidation

An interventional study of Cold temperature and Room Temperature in Exercise, sponsored by Colorado State University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-15.

Primary conditionMotor Activity(the registry's first term)UnverifiedIs this wrong?Motor Activity is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by Colorado State University · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Exercise

Browse trials for

Keywords

  • exercise
  • fat
  • temperature
  • cold
  • metabolism
03

In context

Motor Activity Unverified

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Colorado State University is the lead sponsor of 117 studies on the registry; 19 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Compared within Motor Activity, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 . 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

Exclusion Criteria:

  • Use of hormonal
  • 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Exercise at room temperature

    Study participants will ride an exercise bike

    Other: Room Temperature

  • Experimental
    Exercise at cold temperature

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

    Other: Cold temperature

Interventions

  • OtherCold temperature

    Room temperature will be decreased to 5 ºC

  • OtherRoom Temperature

    Exercise condition for control arm

06

What researchers measure

Primary outcomes

  1. Maximal Fat Oxidation

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

    Time frame: During exercise while in the lab

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 8 months after the start.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 8 months is below that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 9, 2025
First posted
Dec 22, 2025
StartActual
Apr 15, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Jun 30, 2027
Last update
May 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07297823
Responsible party
Sponsor
First posted
Dec 22, 2025
Start date
Apr 15, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
May 15, 2026

Study contacts

Christopher Bell
Contact
Christopher.Bell@colostate.edu
9704917522
Christina Cheng
Contact
c.cheng@colostate.edu
9704913495
Christopher Bell
principal investigator · Colorado State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion