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Recruiting NCT06912230

Hypoxia, Appetite, and Energy Intake in Young Female Adults

No phase Interventional Hypoxia Altitude Appetite Energy Intake

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Normoxia, Hypoxia (simulated altitude of 5000 meters above sea-level).
Who it may be relevant to
Registry conditions: Hypoxia, Altitude, Appetite, Energy Intake. Basic parameters: 18 years — 30 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other 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.
  • Other 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 measures

  • 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]
Secondary outcome measures (12)
  • Heart rate [Time frame: 6 hours]
  • Oxyhemoglobin saturation [Time frame: 6 hours]
  • Systolic blood pressure [Time frame: 6 hours]
  • Diastolic blood pressure [Time frame: 6 hours]
  • Lake Louise Acute Mountain Sickness Score [Time frame: 6 hours]
  • Fluid consumption during exposure [Time frame: 6 hours]
  • Fluid loss during exposure [Time frame: 6 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Behavioural and Metabolic Research Unit, School of Human Kinetics, Faculty of Health Scien — Ottawa

Identifiers

NCT: NCT06912230 · H-06-18-837

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗