Recruiting

Observational Study

Sponsor:

University of Ottawa

Code:

NCT06912230

Conditions

Hypoxia

Altitude

Appetite

Energy Intake

Eligibility Criteria

Sex: Female

Age: 18 - 30

Healthy Volunteers: Accepted

Interventions

Normoxia

Hypoxia (simulated altitude of 5000 meters above sea-level)

Study Details

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.

Conditions

Hypoxia

Altitude

Appetite

Energy Intake

Study ID

NCT06912230

Start date

Nov 13, 2024

Status verified date

Oct, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 30

Healthy Volunteers: Accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Normoxia

experimental: Hypoxia (simulated altitude of 5000 meters above sea-level)

Interventions

Normoxia

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)

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 outcome measure

  • Change from baseline in desire to eat [ Time Frame: Baseline and 6 hours; Baseline and 24 hours ]
  • Change from baseline in hunger [ Time Frame: Baseline and 6 hours; Baseline and 24 hours ]
  • Change from baseline in fullness [ Time Frame: Baseline and 6 hours; Baseline and 24 hours ]
  • Change from baseline in prospective food consumption [ Time Frame: Baseline and 6 hours; Baseline and 24 hours ]
  • Energy intake immediately after 6 hours of exposure (buffet) [ Time Frame: Hour 6 of exposure ]
  • Energy intake post-buffet [ Time Frame: 6.5 hours of exposure and 24 hours ]

Central Contacts and Locations

Central contacts

Pascal Imbeault, PhD

6135625800imbeault@uottawa.ca

Locations

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

Recruiting

Ottawa, Ontario, Canada, K1N 6N5

Contacts

Pascal Imbeault, PhD

6135625800imbeault@uottawa.ca

More Information

Sponsor

University of Ottawa

Last update posted

Apr 4, 2025

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2025-04-04.