ExerciseNCT07297823
Sex Differences in Cold-Induced Changes in Maximal Fat Oxidation
A study testing Cold temperature and Room Temperature in people with Exercise, run by Colorado State University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Cold temperature and Room Temperature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Colorado State University
Fort Collins, Colorado, 80523
Christopher Bell, PhD, 9704917522, christopher.bell@colostate.edu
Taylor Ewell, MS, 9704913495, Taylor.Ewell@colostate.edu
About this study
Official title: 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.
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.
- Conditions
- Exercise
- Being tested
- Cold temperature, Room Temperature
- Keywords
- exercise, fat, temperature, cold, metabolism
- Medical subject headings
- Motor Activity, Platelet Glycoprotein IV Deficiency, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold temperatureOther
Room temperature will be decreased to 5 ºC
Room TemperatureOther
Exercise condition for control arm
| Study group | Role | What they receive |
|---|---|---|
| Exercise at room temperature | Active comparator | Study participants will ride an exercise bike Receives: Other: Room Temperature |
| Exercise at cold temperature | Experimental | Study participants will ride an exercise bike. Room temperature will be 5 ºC Receives: Other: Cold temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Fat Oxidation
Using indirect calorimetry, fat oxidation will be determined. The maximal value for fat oxidation will be recorded.
Measured: During exercise while in the lab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start15 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Bell, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297823
- Sponsor's protocol ID
- 7231
- Status last verified
- May 2026
- First submitted
- 9 Dec 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Cold-Induced Changes in Maximal Fat Oxidation: A Pilot Study
- ClinicalTrials.gov ID
- NCT07297823
- Acronym / sponsor ID
- 7231
- Conditions
- Exercise
- Keywords
- exercise, fat, temperature, cold, metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise at room temperature | Active comparator | Other: Room TemperatureStudy participants will ride an exercise bike |
| Exercise at cold temperature | Experimental | Other: Cold temperatureStudy participants will ride an exercise bike. Room temperature will be 5 ºC |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold temperatureRoom temperature will be decreased to 5 ºC | Other | Exercise at cold temperature |
| Room TemperatureExercise condition for control arm | Other | Exercise at room temperature |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Bell principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold temperature and Room Temperature in people with Exercise, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Bell (9704917522, Christopher.Bell@colostate.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Fat Oxidation (time frame: During exercise while in the lab). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.