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NCT Number: NCT06912230

Hypoxia, Appetite, and Energy Intake in Young Female Adults

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.

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Key information

Conditions

Hypoxia Altitude Appetite Energy Intake Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Behavioural and Metabolic Research Unit, School of Human Kinetics, Faculty of Health Sciences, University of Ottawa

Ottawa, Ontario, K1N 6N5, Canada

Location status: Recruiting

Location contact

Pascal Imbeault, PhD

CONTACT

[email protected]

6135625800 ext. 7290

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normoxia

Other

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.

Primary outcomes

  1. 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.

  2. Change from baseline in hunger

    Time frame: Baseline and 6 hours; Baseline and 24 hours

    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.

  3. Change from baseline in fullness

    Time frame: Baseline and 6 hours; Baseline and 24 hours

    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.

  4. Change from baseline in prospective food consumption

    Time frame: Baseline and 6 hours; Baseline and 24 hours

    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.

  5. Energy intake immediately after 6 hours of exposure (buffet)

    Time frame: Hour 6 of exposure

    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.

  6. Energy intake post-buffet

    Time frame: 6.5 hours of exposure and 24 hours

    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.

Secondary outcomes

  1. Heart rate

    Time frame: 6 hours

    Measured continuously throughout the exposure.

  2. Oxyhemoglobin saturation

    Time frame: 6 hours

    Measured continuously throughout the exposure.

  3. Systolic blood pressure

    Time frame: 6 hours

    Measured upon arrival at the laboratory (baseline), hourly during the exposure, and immediately after eating.

  4. Diastolic blood pressure

    Time frame: 6 hours

    Measured upon arrival at the laboratory (baseline), hourly during the exposure, and immediately after eating.

  5. Lake Louise Acute Mountain Sickness Score

    Time frame: 6 hours

    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.

  6. Fluid consumption during exposure

    Time frame: 6 hours

    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).

  7. Fluid loss during exposure

    Time frame: 6 hours

    Fluid loss calculated as the change in body mass during each exposure presented as a percentage of baseline body mass (corrected for fluid consumption)

  8. Change from baseline in explicit liking using the LFPQ

    Time frame: Baseline and 6.5 hours of exposure

    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.

  9. Change from baseline in explicit wanting using the LFPQ

    Time frame: Baseline and 6.5 hours of exposure

    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.

  10. Change from baseline in implicit wanting using the LFPQ

    Time frame: Baseline and 6.5 hours of exposure

    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.

  11. Change from baseline in olfaction

    Time frame: Baseline and Hour 4 of exposure

    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.

  12. Change from baseline in gustation

    Time frame: Baseline and Hour 4 of exposure

    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.

  13. Change from baseline in resting energy expenditure

    Time frame: Baseline and Hour 5 of exposure

    Resting energy expenditure will be measured via indirect calorimetry upon arrival at the laboratory (baseline) and following 5 hours of exposure.

  14. Change from baseline in respiratory exchange ratio

    Time frame: Baseline and Hour 5 of exposure

    Respiratory exchange ratio will be measured via indirect calorimetry upon arrival at the laboratory (baseline) and following 5 hours of exposure.

  15. Change from baseline in plasma glucose concentrations

    Time frame: 6 hours

    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).

  16. Change from baseline in plasma insulin concentrations

    Time frame: 6 hours

    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).

  17. Change from baseline in plasma non-esterified fatty acid concentrations

    Time frame: 6 hours

    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).

  18. Change from baseline in plasma triglyceride concentrations

    Time frame: 6 hours

    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).

  19. Change from baseline in plasma beta-hydroxybutyrate concentrations

    Time frame: 6 hours

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Pascal Imbeault, PhD

CONTACT

[email protected]

6135625800 ext. 7290

Sponsors and collaborators

Lead sponsor

University of Ottawa

Other

Collaborators

  • Hopital Montfort
  • Institut du Savoir Montfort
  • Natural Sciences and Engineering Research Council, Canada

Registry information

Official study title

Appetite and Energy Intake in Young Female Adults During and After Simulated High-Altitude

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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