Clinical trial NCT04151927: Effects of Overnight Low Oxygen Exposure on Energy Balance
Official title: Effects of an Overnight, 8-hour Low Oxygen Exposure on Resting Energy Expenditure and Appetite: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resting Metabolic Rate
Appetite
Heart Rate Variability
Keywords: High altitude
Metabolic adaptations
Energy balance
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Men and women aged 20 - 45 years
* Body mass index between 18.5 - 24.5 kg/m2
* Born at altitudes less than 2,100 meters (\~7,000 feet)
* Currently residing in Tallahassee, Florida or the surrounding area
* Not taking any medication(s) that interfere with metabolism or oxygen delivery/transport for four weeks before and throughout the entire study (e.g., includes sedatives, sleeping aids, tranquilizers, and/or any medication that depresses ventilation, diuretics, alpha, and beta-blockers).
* Willing to refrain from smoking, vaping, chewing tobacco, and dietary supplement use throughout the entire study
* Willing to spend two overnight visits on the Florida State University campus.

Exclusion Criteria:

* Living in areas that are more than 1,200 m (\~4,000 feet), or have traveled to areas that are more than 1,200 m for five days or more within the last two months
* Metabolic or cardiovascular abnormalities, gastrointestinal disorders, or any condition that interferes with metabolism or oxygen delivery/transport (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
* Prior diagnosis of apnea or other sleeping disorders
* Prior diagnosis of high-altitude pulmonary edema or high-altitude cerebral edema
* Prior diagnosis of anemia or sickle cell anemia/trait
* Present condition of alcoholism, anabolic steroid, or other substance abuse issues
* Women who are pregnant, lactating, planning to become pregnant, or who have had an irregular menstrual cycle in the past six months.
* Allergies or intolerance to foods included in the standardized or ad libitum meal (e.g., lactose intolerance/milk allergy)

Primary outcomes:
measure: Resting metabolic rate (kcal/d) following exposure to NH or NN conditions
timeFrame: 8 hours
Secondary outcomes:
measure: Objective appetite following exposure to NH or NN conditions
timeFrame: 8 hours
measure: Food preferences following exposure to NH or NN conditions
timeFrame: 8 hours
measure: Fasting and postprandial hunger following exposure to NH or NN conditions
timeFrame: 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
measure: Fasting and postprandial satiety following exposure to NH or NN conditions
timeFrame: 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
measure: Fasting and postprandial prospective food consumption following exposure to NH or NN conditions
timeFrame: 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
measure: Fasting and postprandial subjective appetite following exposure to NH or NN conditions
timeFrame: 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
measure: Energy intake following exposure to NH or NN conditions
timeFrame: 8 hours
measure: Macronutrient intake following exposure to NH or NN conditions
timeFrame: 8 hours
measure: Heart rate variability following exposure to NH or NN conditions
timeFrame: 8 hours
measure: Prevalence of acute mountain sickness following exposure to NH or NN conditions
timeFrame: 8 hours
measure: Severity of acute mountain sickness following exposure to NH or NN conditions
timeFrame: 8 hours
measure: Continuous oxygen saturation during exposure to NH or NN
timeFrame: 8 hours
measure: Sleep quality following exposure to NH or NN conditions
timeFrame: 8 hours
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Department of Nutrition, Food, and Exercise Science at Florida State University.
name: Claire E Berryman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: