Hypoxia, Appetite, and Energy Intake in Young Female Adults

NCT06912230 | Recruiting

• 1 other identifier: H-06-18-837
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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.

  Baseline and 6 hours; Baseline and 24 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.

  Baseline and 6 hours; Baseline and 24 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.

  Baseline and 6 hours; Baseline and 24 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.

  Baseline and 6 hours; Baseline and 24 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.

  Hour 6 of exposure

• 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.

  6.5 hours of exposure and 24 hours

Secondary Outcomes (19)

• Heart rate

  6 hours

• Oxyhemoglobin saturation

  6 hours

• Systolic blood pressure

  6 hours

• Diastolic blood pressure

  6 hours

• Lake Louise Acute Mountain Sickness Score

  6 hours

Study Arms (2)

Normoxia

EXPERIMENTAL

Other: Normoxia

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

EXPERIMENTAL

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

Interventions

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.

Normoxia

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.

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

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• English or French speaking
• Ability to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ottawa: lead
• Natural Sciences and Engineering Research Council, Canada: collaborator
• Hopital Montfort: collaborator
• Institut du Savoir Montfort: collaborator

Study Sites (1)

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

Ottawa, Ontario, K1N 6N5, Canada

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pascal Imbeault, PhD

CONTACT

6135625800; imbeault@uottawa.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 4, 2025
• Study Start: November 13, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)