Low Oxygen Exposure and Weight Status
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 Start (Actual) 16 May 2023
🗓️ Primary Completion (Estimated) 19 December 2025
✅ Study Completion (Estimated) 30 April 2026
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Baton Rouge, Louisiana, United States

📋 Eligibility Criteria

Description

    Inclusion 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.

    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 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 (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 13 March 2022
  • First Submitted that Met QC Criteria 13 March 2022
  • First Posted 21 March 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 March 2024
  • Last Update Posted 15 March 2024
  • Last Verified March 2024