Florida State University
Tallahassee, Florida, 32306, United States
NCT Number: NCT04151927
This research study will evaluate changes in resting metabolic rate, appetite, and heart rate variability following overnight exposure (8 h/night) to normobaric hypoxia (NH) or normobaric normoxic (NN). In randomized order, participants will sleep one night in NH conditions (~15% oxygen; achieved with nitrogen dilution, equivalent to ~8500 feet elevation) and another night in NN (control) conditions (~20% oxygen; achieved with nitrogen dilution, equivalent to ~1000 feet elevation).
Looking for future studies?
Notify Me20 year–45 year
All sexes
Interventional
Not applicable
Tallahassee, Florida, 32306, United States
Weight loss is a common factor reported in lowlanders traveling to high altitudes. Although the exact cause is unknown, studies have shown that weight loss at high altitude is associated with the amount of time and severity of the altitude exposure. Upon arrival to high altitude (≥ 5000 feet), numerous physiological adaptations occur that may promote weight loss, such as increased energy expenditure and reduced appetite. The breadth of current altitude research is limited by the logistical and monetary constraints of traveling to remote locations or access to an altitude chamber. A more logistically feasible alternative is the simulation of low oxygen conditions at sea level, using a commercially available tent and generator system to reduce ambient oxygen concentrations. The current research study will evaluate changes in resting metabolic rate, appetite, and heart rate variability following overnight exposure (8 h/night) to normobaric hypoxia (NH) or normobaric normoxic (NN). In randomized order, participants will sleep one night in NH conditions (~15% oxygen; achieved with nitrogen dilution, equivalent to ~8500 feet elevation) and another night in NN (control) conditions (~20% oxygen; achieved with nitrogen dilution, equivalent to ~1000 feet elevation). In the morning, following NH or NN exposure, resting metabolic rate will be measured using indirect calorimetry, appetite using an ad libitum buffet meal protocol, and heart rate variability by electrocardiogram. It is hypothesized that exposure to overnight NH will result in increased resting metabolic rate, decreased appetite, and decreased heart rate variability.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Low oxygen exposure to mimic ~8500 feet elevation.
Normal oxygen exposure to mimic ~1000 feet elevation (sham comparator).
Time frame: 8 hours
Resting metabolic rate will be accessed using indirect calorimetry (TrueOne 2400, Parvo Medics, Salt Lake City, UT) following 8 hours of overnight exposure to NH or NN.
Time frame: 8 hours
Objective appetite will be assessed by measuring total energy intake during an ad libitum buffet-style meal provided to participants following 8 hours of overnight exposure to NH or NN.
Time frame: 8 hours
Food preferences will be assessed by measuring macronutrient intake during an ad libitum buffet-style meal provided to participants following 8 hours of overnight exposure to NH or NN.
Time frame: Hunger will be measured pre-meal (0 min), immediately post-meal, and at 15, 30, 45, 60, 90, and 120 min following 8 hours of NH or NN exposure
Measures will be assessed before and after the ad-libitum buffet meal using visual analog scales following 8 hours of overnight exposure to NH or NN.
Time frame: Satiety will be measured pre-meal (0 min), immediately post-meal, and at 15, 30, 45, 60, 90, and 120 min following 8 hours of NH or NN exposure
Measures will be assessed before and after the ad-libitum buffet meal using visual analog scales following 8 hours of overnight exposure to NH or NN.
Time frame: Prospective food consumption will be measured pre-meal (0 min), immediately post-meal, and at 15, 30, 45, 60, 90, and 120 min following 8 hours of NH or NN exposure
Measures will be assessed before and after the ad-libitum buffet meal using visual analog scales following 8 hours of overnight exposure to NH or NN.
Time frame: Subjective appetite will be measured pre-meal (0 min), immediately post-meal, and at 15, 30, 45, 60, 90, and 120 min following 8 hours of NH or NN exposure
Measures will be assessed before and after the ad-libitum buffet meal using visual analog scales following 8 hours of overnight exposure to NH or NN.
Time frame: 8 hours
Energy intake will be accessed using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool to complete dietary records for 2 days following 8 hours of overnight exposure to NH or NN.
Time frame: 8 hours
Macronutrient intake will be accessed using the Automated Self-Administered 24-Hour (ASA24®) Dietary Assessment Tool to complete dietary records for 2 days following 8 hours of overnight exposure to NH or NN.
Time frame: 8 hours
Heart rate variability will be measured using a 3-lead electrocardiogram following 8 hours of overnight exposure to NH or NN.
Time frame: 8 hours
Prevalence of acute mountain sickness will be accessed using the Environmental Symptoms Questionnaire following 8 hours of overnight exposure to NH or NN.
Time frame: 8 hours
Severity of acute mountain sickness will be accessed using the Environmental Symptoms Questionnaire following 8 hours of overnight exposure to NH or NN.
Time frame: 8 hours
Oxygen saturation will be measured continuously using a finger pulse oximeter (PalmSAT® 2500, Nonin Medical, Inc., Plymouth, MN) during 8 hours of overnight exposure to NH or NN.
Time frame: 8 hours
Sleep quality will be measured by the Pittsburgh Sleep Quality Index following 8 hours of overnight exposure to NH or NN.
Florida State University
Other
Effects of an Overnight, 8-hour Low Oxygen Exposure on Resting Energy Expenditure and Appetite: a Pilot Study
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.
Published trials that share one or more normalized conditions with this study.
NCT07724119
Behavior, Behavior, Animal
Wroclaw, Lower Silesian Voivodeship, Poland
View Trial DetailsNCT05412511
Body Composition, Energy Expenditure
Trikala, Greece
View Trial DetailsNCT05412498
Body Composition, Energy Expenditure
Trikala, Greece
View Trial DetailsNCT05221177
Body Composition, Energy Expenditure
Trikala, Greece
View Trial Details