Clinical trial NCT06912230: Hypoxia, Appetite, and Energy Intake in Young Female Adults
Official title: Appetite and Energy Intake in Young Female Adults During and After Simulated High-Altitude
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypoxia
Altitude
Appetite
Energy Intake
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
name: Hopital Montfort
name: Institut du Savoir Montfort
First posted: 2025-04-04
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* English or French speaking
* Ability to provide informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline in desire to eat
timeFrame: Baseline and 6 hours; Baseline and 24 hours
measure: Change from baseline in hunger
timeFrame: Baseline and 6 hours; Baseline and 24 hours
measure: Change from baseline in fullness
timeFrame: Baseline and 6 hours; Baseline and 24 hours
measure: Change from baseline in prospective food consumption
timeFrame: Baseline and 6 hours; Baseline and 24 hours
measure: Energy intake immediately after 6 hours of exposure (buffet)
timeFrame: Hour 6 of exposure
measure: Energy intake post-buffet
timeFrame: 6.5 hours of exposure and 24 hours
Secondary outcomes:
measure: Heart rate
timeFrame: 6 hours
measure: Oxyhemoglobin saturation
timeFrame: 6 hours
measure: Systolic blood pressure
timeFrame: 6 hours
measure: Diastolic blood pressure
timeFrame: 6 hours
measure: Lake Louise Acute Mountain Sickness Score
timeFrame: 6 hours
measure: Fluid consumption during exposure
timeFrame: 6 hours
measure: Fluid loss during exposure
timeFrame: 6 hours
measure: Change from baseline in explicit liking using the LFPQ
timeFrame: Baseline and 6.5 hours of exposure
measure: Change from baseline in explicit wanting using the LFPQ
timeFrame: Baseline and 6.5 hours of exposure
measure: Change from baseline in implicit wanting using the LFPQ
timeFrame: Baseline and 6.5 hours of exposure
measure: Change from baseline in olfaction
timeFrame: Baseline and Hour 4 of exposure
measure: Change from baseline in gustation
timeFrame: Baseline and Hour 4 of exposure
measure: Change from baseline in resting energy expenditure
timeFrame: Baseline and Hour 5 of exposure
measure: Change from baseline in respiratory exchange ratio
timeFrame: Baseline and Hour 5 of exposure
measure: Change from baseline in plasma glucose concentrations
timeFrame: 6 hours
measure: Change from baseline in plasma insulin concentrations
timeFrame: 6 hours
measure: Change from baseline in plasma non-esterified fatty acid concentrations
timeFrame: 6 hours
measure: Change from baseline in plasma triglyceride concentrations
timeFrame: 6 hours
measure: Change from baseline in plasma beta-hydroxybutyrate concentrations
timeFrame: 6 hours
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Behavioural and Metabolic Research Unit, School of Human Kinetics, Faculty of Health Sciences, University of Ottawa
state: Ontario
Study officials:
References: