HypoxiaNCT06912230
Hypoxia, Appetite, and Energy Intake in Young Female Adults
A study testing Normoxia and Hypoxia (simulated altitude of 5000 meters above sea-level) in people with Hypoxia and Altitude, run by University of Ottawa at 1 site in Canada.
Trial summary
The goal of this clinical trial is to investigate the effects of acute passive continuous hypoxemia (simulated high-altitude at rest) on appetite and energy intake in healthy young female adults. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- What is being tested?
- Normoxia and Hypoxia (simulated altitude of 5000 meters above sea-level)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 13 Nov 2024to 29 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- English or French speaking
- Ability to provide informed consent
Who cannot join
- History or evidence of chronic disease
- Current use of hypolipemic medication
- Current use of hormonal contraceptives
- Current use of antidepressants
- Current use of anticoagulants
- Ongoing smoking status
- Experiencing pregnancy, puerperium, or irregular menstrual cycles
Trial locations and contacts
1 site in 1 country.
Canada1 site
Behavioural and Metabolic Research Unit, School of Human Kinetics, Faculty of Health Sciences, University of Ottawa
Ottawa, Ontario, K1N 6N5
About this study
Official title: Appetite and Energy Intake in Young Female Adults During and After Simulated High-Altitude
The goal of this clinical trial is to investigate the effects of acute passive continuous hypoxemia (simulated high-altitude at rest) on appetite and energy intake in healthy young female adults. The main questions it aims to answer are:
- Does six hours of simulated high-altitude (5000 meters) reduce scores of subjective appetite and energy intake?
- Do changes in appetite and energy intake persist in the hours following the end of hypoxic exposure? Researchers will compare the effects of simulated high-altitude to a control normoxia (sea-level) condition to see if exposure to low oxygen levels independently affect appetite and energy intake.
Read more
Participants will:
- Visit the laboratory for a preliminary screening session to assess eligibility.
- Undergo two randomized, single-blind, experimental sessions consisting of six hours of passive exposure to normoxia or hypoxia in a climate-controlled chamber.
- Consume foods provided from a curated list, served in ad libitum quantities, after leaving the laboratory to assess post-exposure energy intake.
- Conditions
- Hypoxia, Altitude, Appetite, Energy Intake
- Being tested
- Normoxia, Hypoxia (simulated altitude of 5000 meters above sea-level)
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NormoxiaOther
Participants will undergo a 6-hour passive exposure to normoxia in a climate-controlled environmental chamber maintained at 22°C with 30% relative humidity. They will remain in a fasted state throughout the exposure period.
Hypoxia (simulated altitude of 5000 meters above sea-level)Other
Participants will undergo a 6-hour passive exposure to a simulated altitude of 5000 meters above sea-level in a climate-controlled environmental chamber maintained at 22°C with 30% relative humidity. They will remain in a fasted state throughout the exposure period.
| Study group | Role | What they receive |
|---|---|---|
| Normoxia | Experimental | Not described Receives: Other: Normoxia |
| Hypoxia (simulated altitude of 5000 meters above sea-level) | Experimental | Not described Receives: Other: Hypoxia (simulated altitude of 5000 meters above sea-level) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in desire to eat
Scores of subjective desire to eat, measured using visual analog scales. Measurements are performed upon arrival at the laboratory (baseline), hourly during the exposure, immediately after a 30-minute ad libitum buffet, immediately before bedtime, and 24 hours after the baseline measurement.
Measured: Baseline and 6 hours; Baseline and 24 hours
Secondary outcomes (23)
Heart rate
Measured continuously throughout the exposure.
Measured: 6 hours
Oxyhemoglobin saturation
Measured continuously throughout the exposure.
Measured: 6 hours
Change from baseline in hunger
Scores of subjective hunger, measured using visual analog scales. Measurements are performed upon arrival at the laboratory (baseline), hourly during the exposure, immediately after a 30-minute ad libitum buffet, immediately before bedtime, and 24 hours after the baseline measurement.
Measured: Baseline and 6 hours; Baseline and 24 hours
Systolic blood pressure
Measured upon arrival at the laboratory (baseline), hourly during the exposure, and immediately after eating.
Measured: 6 hours
Change from baseline in fullness
Scores of subjective fullness, measured using visual analog scales. Measurements are performed upon arrival at the laboratory (baseline), hourly during the exposure, immediately after a 30-minute ad libitum buffet, immediately before bedtime, and 24 hours after the baseline measurement.
Measured: Baseline and 6 hours; Baseline and 24 hours
Diastolic blood pressure
Measured upon arrival at the laboratory (baseline), hourly during the exposure, and immediately after eating.
Measured: 6 hours
Change from baseline in prospective food consumption
Scores of subjective prospective food consumption, measured using visual analog scales. Measurements are performed upon arrival at the laboratory (baseline), hourly during the exposure, immediately after a 30-minute ad libitum buffet, immediately before bedtime, and 24 hours after the baseline measurement.
Measured: Baseline and 6 hours; Baseline and 24 hours
Lake Louise Acute Mountain Sickness Score
Peak score on the Lake Louise Acute Mountain Sickness questionnaire, measured upon arrival at the laboratory (baseline), hourly during the exposure, and immediately after eating.
Measured: 6 hours
Energy intake immediately after 6 hours of exposure (buffet)
Energy intake in the laboratory during a 30-minute ad libitum buffet immediately after 6 hours of exposure, administered using a validated food menu (McNeil, 2012) and analyzed using the Food Processor SQL from ESHA Research, Inc.
Measured: Hour 6 of exposure
Fluid consumption during exposure
Average hourly fluid consumption calculated by weighing participant water intake at the start and end of each hour of exposure (normalized to the exposure duration).
Measured: 6 hours
Energy intake post-buffet
Energy intake outside the laboratory between end-buffet and bedtime, administered using a validated food menu (McNeil, 2012) and analyzed using the Food Processor SQL from ESHA Research, Inc.
Measured: 6.5 hours of exposure and 24 hours
Change from baseline in explicit liking using the LFPQ
Explicit liking will be measured using the Leeds Food Preference Questionnaire. Measurements will be taken upon arrival at the laboratory (baseline), following 5 hours of exposure, and after a 30-min ad libitum buffet.
Measured: Baseline and 6.5 hours of exposure
Change from baseline in explicit wanting using the LFPQ
Explicit wanting will be measured using the Leeds Food Preference Questionnaire. Measurements will be taken upon arrival at the laboratory (baseline), following 5 hours of exposure, and after a 30-min ad libitum buffet.
Measured: Baseline and 6.5 hours of exposure
Change from baseline in implicit wanting using the LFPQ
Implicit wanting will be measured using the Leeds Food Preference Questionnaire. Measurements will be taken upon arrival at the laboratory (baseline), following 5 hours of exposure, and after a 30-min ad libitum buffet.
Measured: Baseline and 6.5 hours of exposure
Change from baseline in olfaction
Olfaction will be measured using the Sniffin' Sticks (Burghart Instruments, Wedel, Germany), a 3-test battery of odorized markers that measure odor detection threshold, odor discrimination, and odor identification. Measurements will be performed upon arrival at the laboratory (baseline) and following 4 hours of exposure.
Measured: Baseline and Hour 4 of exposure
Change from baseline in gustation
Olfaction will be measured using Taste Strips (Burghart Instruments, Wedel, Germany). Measurements will be performed upon arrival at the laboratory (baseline) and following 4 hours of exposure.
Measured: Baseline and Hour 4 of exposure
Change from baseline in resting energy expenditure
Resting energy expenditure will be measured via indirect calorimetry upon arrival at the laboratory (baseline) and following 5 hours of exposure.
Measured: Baseline and Hour 5 of exposure
Change from baseline in respiratory exchange ratio
Respiratory exchange ratio will be measured via indirect calorimetry upon arrival at the laboratory (baseline) and following 5 hours of exposure.
Measured: Baseline and Hour 5 of exposure
Change from baseline in plasma glucose concentrations
Plasma glucose concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline) and hourly during the exposure (i.e., 0 or baseline, 60, 120, 180, 240, 300, and 360 minutes).
Measured: 6 hours
Change from baseline in plasma insulin concentrations
Plasma insulin concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline) and hourly during the exposure (i.e., 0 or baseline, 60, 120, 180, 240, 300, and 360 minutes).
Measured: 6 hours
Change from baseline in plasma non-esterified fatty acid concentrations
Plasma non-esterified fatty acid concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline) and hourly during the exposure (i.e., 0 or baseline, 60, 120, 180, 240, 300, and 360 minutes).
Measured: 6 hours
Change from baseline in plasma triglyceride concentrations
Plasma triglyceride concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline) and hourly during the exposure (i.e., 0 or baseline, 60, 120, 180, 240, 300, and 360 minutes).
Measured: 6 hours
Change from baseline in plasma beta-hydroxybutyrate concentrations
Plasma beta-hydroxybutyrate concentrations will be measured via colorimetric assays from venous blood samples collected upon arrival at the laboratory (baseline) and hourly during the exposure (i.e., 0 or baseline, 60, 120, 180, 240, 300, and 360 minutes).
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start13 Nov 2024
- Primary completion28 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Hopital Montfort, Institut du Savoir Montfort
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912230
- Sponsor's protocol ID
- H-06-18-837
- Status last verified
- Aug 2026
- First submitted
- 17 Mar 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appetite and Energy Intake in Young Female Adults During and After Simulated High-Altitude
- ClinicalTrials.gov ID
- NCT06912230
- Acronym / sponsor ID
- H-06-18-837
- Conditions
- Hypoxia, Altitude, Appetite, Energy Intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Hopital Montfort, Institut du Savoir Montfort
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 4 Apr 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 goal of this clinical trial is to investigate the effects of acute passive continuous hypoxemia (simulated high-altitude at rest) on appetite and energy intake in healthy young female adults. The main questions it aims to answer are:
- Does six hours of simulated high-altitude (5000 meters) reduce scores of subjective appetite and energy intake?
- Do changes in appetite and energy intake persist in the hours following the end of hypoxic exposure? Researchers will compare the effects of simulated high-altitude to a control normoxia (sea-level) condition to see if exposure to low oxygen levels independently affect appetite and energy intake.
Participants will:
- Visit the laboratory for a preliminary screening session to assess eligibility.
- Undergo two randomized, single-blind, experimental sessions consisting of six hours of passive exposure to normoxia or hypoxia in a climate-controlled chamber.
- Consume foods provided from a curated list, served in ad libitum quantities, after leaving the laboratory to assess post-exposure energy intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normoxia | Experimental | Other: Normoxia |
| Hypoxia (simulated altitude of 5000 meters above sea-level) | Experimental | Other: Hypoxia (simulated altitude of 5000 meters above sea-level) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- English or French speaking
- Ability to provide informed consent
Key exclusion criteria (7 listed)
- History or evidence of chronic disease
- Current use of hypolipemic medication
- Current use of hormonal contraceptives
- Current use of antidepressants
- Current use of anticoagulants
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 |
|---|---|---|
| NormoxiaParticipants will undergo a 6-hour passive exposure to normoxia in a climate-controlled environmental chamber maintained at 22°C with 30% relative humidity. They will remain in a fasted state throughout the exposure period. | Other | Normoxia |
| Hypoxia (simulated altitude of 5000 meters above sea-level)Participants will undergo a 6-hour passive exposure to a simulated altitude of 5000 meters above sea-level in a climate-controlled environmental chamber maintained at 22°C with 30% relative humidity. They will remain in a fasted state throughout the exposure period. | Other | Hypoxia (simulated altitude of 5000 meters above sea-level) |
Primary outcome
Change from baseline in desire to eat
Time frame: Baseline and 6 hours; Baseline and 24 hours
Scores of subjective desire to eat, measured using visual analog scales. Measurements are performed upon arrival at the laboratory (baseline), hourly during the exposure, immediately after a 30-minute ad libitum buffet, immediately before bedtime, and 24 hours after the baseline measurement.
23 secondary outcomes
Heart rate
Time frame: 6 hours
Oxyhemoglobin saturation
Time frame: 6 hours
Change from baseline in hunger
Time frame: Baseline and 6 hours; Baseline and 24 hours
Systolic blood pressure
Time frame: 6 hours
Change from baseline in fullness
Time frame: Baseline and 6 hours; Baseline and 24 hours
Diastolic blood pressure
Time frame: 6 hours
Change from baseline in prospective food consumption
Time frame: Baseline and 6 hours; Baseline and 24 hours
Lake Louise Acute Mountain Sickness Score
Time frame: 6 hours
Energy intake immediately after 6 hours of exposure (buffet)
Time frame: Hour 6 of exposure
Fluid consumption during exposure
Time frame: 6 hours
Energy intake post-buffet
Time frame: 6.5 hours of exposure and 24 hours
Change from baseline in explicit liking using the LFPQ
Time frame: Baseline and 6.5 hours of exposure
Change from baseline in explicit wanting using the LFPQ
Time frame: Baseline and 6.5 hours of exposure
Change from baseline in implicit wanting using the LFPQ
Time frame: Baseline and 6.5 hours of exposure
Change from baseline in olfaction
Time frame: Baseline and Hour 4 of exposure
Change from baseline in gustation
Time frame: Baseline and Hour 4 of exposure
Change from baseline in resting energy expenditure
Time frame: Baseline and Hour 5 of exposure
Change from baseline in respiratory exchange ratio
Time frame: Baseline and Hour 5 of exposure
Change from baseline in plasma glucose concentrations
Time frame: 6 hours
Change from baseline in plasma insulin concentrations
Time frame: 6 hours
Change from baseline in plasma non-esterified fatty acid concentrations
Time frame: 6 hours
Change from baseline in plasma triglyceride concentrations
Time frame: 6 hours
Change from baseline in plasma beta-hydroxybutyrate concentrations
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normoxia and Hypoxia (simulated altitude of 5000 meters above sea-level) in people with Hypoxia and Altitude, run by University of Ottawa at 1 site in Canada.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 11 Sep 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in desire to eat (time frame: Baseline and 6 hours; Baseline and 24 hours). 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 11 Sep 2026.