Effects of Overnight Low Oxygen Exposure on Energy Balance

NCT04151927 | Completed

• 1 other identifier: STUDY00000184
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Resting Metabolic Rate; Appetite; Heart Rate Variability

Keywords

High altitude; Metabolic adaptations; Energy balance

Outcome Measures

Primary Outcomes (1)

• Resting metabolic rate (kcal/d) following exposure to NH or NN conditions

  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.

  8 hours

Secondary Outcomes (13)

• Objective appetite following exposure to NH or NN conditions

  8 hours

• Food preferences following exposure to NH or NN conditions

  8 hours

• Fasting and postprandial hunger following exposure to NH or NN conditions

  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

• Fasting and postprandial satiety following exposure to NH or NN conditions

  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

• Fasting and postprandial prospective food consumption following exposure to NH or NN conditions

  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

Study Arms (2)

Normobaric Hypoxia (NH)

EXPERIMENTAL

Overnight exposure (8 hours) to NH conditions (\~15% oxygen; achieved with nitrogen dilution, equivalent to \~8500 feet elevation) using a commercially available tent and generator system (Hypoxico, Inc., New York, NY).

Device: Normobaric Hypoxia; Device: Normobaric Normoxia

Normobaric Normoxia (NN)

SHAM COMPARATOR

Overnight exposure (8 hours) to NN conditions (\~20% oxygen; achieved with nitrogen dilution, equivalent to \~1000 feet elevation) using a commercially available tent and generator system (Hypoxico, Inc., New York, NY).

Device: Normobaric Hypoxia; Device: Normobaric Normoxia

Interventions

Normobaric Hypoxia DEVICE

Low oxygen exposure to mimic \~8500 feet elevation.

Normobaric Hypoxia (NH); Normobaric Normoxia (NN)

Normobaric Normoxia DEVICE

Normal oxygen exposure to mimic \~1000 feet elevation (sham comparator).

Normobaric Hypoxia (NH); Normobaric Normoxia (NN)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Related Publications (1)

• Baker PA, Long AN, Dawson MA, Berryman CE. An overnight, 8-hour low oxygen exposure increases energy expenditure with no effect on energy intake: a randomized, sham-controlled, crossover study. J Nutr. 2026 Jan 5:101319. doi: 10.1016/j.tjnut.2025.101319. Online ahead of print.

  PMID: 41500361 DERIVED

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Claire E Berryman, Ph.D.

  Department of Nutrition, Food, and Exercise Science at Florida State University.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 26, 2019
• First Posted: November 5, 2019
• Study Start: December 11, 2019
• Primary Completion: October 2, 2021
• Study Completion: October 2, 2021
• Last Updated: November 29, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)