Low Oxygen Exposure and Weight Status

Description

The objective of the proposed double-blind, parallel-arm, randomized clinical trial is to evaluate changes in body weight and composition, assess determinants of energy balance (intake and expenditure), and measure modulators of energy balance, following 8 wk of calorie restriction (-500 kcal/d) in combination with either overnight exposure to normobaric hypoxia (8 h/night, 15% FiO2, \~2640 m) or normoxia (8 h/night, 21% FiO2), using a commercially available, in-home tent system, in adults with obesity.

Conditions

Obesity

Study Overview

Study Details

Study overview

The objective of the proposed double-blind, parallel-arm, randomized clinical trial is to evaluate changes in body weight and composition, assess determinants of energy balance (intake and expenditure), and measure modulators of energy balance, following 8 wk of calorie restriction (-500 kcal/d) in combination with either overnight exposure to normobaric hypoxia (8 h/night, 15% FiO2, \~2640 m) or normoxia (8 h/night, 21% FiO2), using a commercially available, in-home tent system, in adults with obesity.

Effects of Daily Low Oxygen Exposure on Weight Status, Body Composition, and Metabolic Health

Low Oxygen Exposure and Weight Status

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Baton Rouge

Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States, 70808

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Obese (BMI between 30-39.9 kg/m2)
  • * Born at altitudes below 2,100 meters (\~7,000 feet)
  • * Currently residing in Tallahassee, Florida or surrounding area
  • * Completed a full FDA authorized or approved COVID-19 vaccination series at least 14 days before any in-person human research activity.
  • * Not taking any medication(s) that interfere with oxygen delivery/transport for 4 weeks prior to 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 have a hypoxic tent set-up in their home and spend 8 consecutive hours per night in the tent for 8 weeks
  • * Lives with a family member, partner/spouse, or roommate who can hear and respond in the unlikely event that the blood oxygen, air oxygen, or air carbon dioxide monitoring alarm would sound.
  • * 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 2 months
  • * Individuals who have not completed a full FDA authorized or approved COVID-19 vaccination series at least 14 days before any in-person human research activity.
  • * Cardiovascular abnormalities, gastrointestinal disorders, or any condition that interferes with oxygen delivery/transport (e.g., kidney disease, cardiovascular disease, etc.)
  • * Oxygen saturation \< 95% while awake or oxygen saturation dips below 88% for a total of ≥ 10 min overnight in normoxic conditions
  • * Evidence of apnea or other sleeping disorders
  • * Evidence of prior high-altitude pulmonary edema (HAPE) or high-altitude cerebral edema (HACE) diagnosis
  • * Diagnosis or family history of sickle cell anemia/trait
  • * Hematocrit \<42% for males, \<36% for females
  • * Hemoglobin \<13 g/dL for males, \<12 g/dL for females
  • * Blood donation within 8 weeks of beginning the study
  • * Present condition of alcoholism, anabolic steroids, 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 6 mo.
  • * Weight gain or loss \> 10% of body weight during the past 6 months
  • * Adults unable to consent

Ages Eligible for Study

22 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Pennington Biomedical Research Center,

Claire E. Berryman, PhD, RD, PRINCIPAL_INVESTIGATOR, Pennington Biomedical Research Center

Study Record Dates

2026-04-30