Low Oxygen Exposure and Weight Status Study

This study is looking into whether being exposed to low oxygen, similar to living at a high altitude (called normobaric hypoxia), can help adults with obesity lose weight. You would be asked to follow a calorie-restricted diet for 8 weeks and either sleep in a tent with low oxygen or a tent with normal oxygen. Researchers will compare changes in body weight and body composition between these two groups. To join, you need to be between 22 and 65 years old, have a BMI (Body Mass Index) between 30 and 39.9 kg/m2, have been born at an altitude below 7,000 feet, currently live in or around Tallahassee, Florida, and have completed a COVID-19 vaccination series. The study aims to enroll 60 participants, but its current status is unclear.

Study design
This is a double-blind, randomized study with two groups (parallel-arm) that plans to enroll 60 participants. You would either receive low oxygen exposure (normobaric hypoxia) or normal oxygen exposure (normobaric normoxia).
What's involved
You would follow a calorie-restricted diet for 8 weeks and sleep in a special tent for 8 hours each night during this period. Your body weight will be measured at 10 weeks (70 days).
Compensation
Not stated in the trial record.
Follow-up
Your body weight will be measured at 10 weeks (70 days) to see the change.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05289310

Low Oxygen Exposure and Weight Status

Recruiting
NAAges 22–65InterventionalTreatment
Pennington Biomedical Research Center
~60 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Normobaric hypoxia (NH)Normobaric normoxia (NN)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in body weight
Measured over 10 weeks (70 days)
Obesity
1 sites across 1 states
Louisiana1
  • Claire E. Berryman, PhD, RD · PRINCIPAL_INVESTIGATOR · Pennington Biomedical Research Center

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Eligibility criteria

Inclusion

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

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
  • Change in body weight10 weeks (70 days)

    Body weight will be measured during the baseline weight maintenance phase (days -14 to 0) and each morning during the study (days 1 to 56) following an overnight fast and morning void, using a calibrated digital scale provided to participants to use at home (A\&D Medical wireless weight scale UC-352BLE, San Jose, CA). Change in body weight will be calculated as: body weight on day 56 - baseline body weight (average of days -14 to 0).