NCT05289310Recruiting
Low Oxygen Exposure and Weight Status
Effects of Daily Low Oxygen Exposure on Weight Status, Body Composition, and Metabolic Health
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 13 Mar 2022
- Start date
- 16 May 2023
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Pennington Biomedical Research Center
- Diseases
- Obesity
- NCT number
- NCT05289310
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 16 May 2023 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Evidence of prior high-altitude pulmonary edema (HAPE) or high-altitude cerebral edema (HACE) diagnosis
Other illness
- 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
- Diagnosis or family history of sickle cell anemia/trait
- Present condition of alcoholism, anabolic steroids, or other substance abuse issues
Lab values
- Hemoglobin \<13 g/dL for males, \<12 g/dL for females
Other
- 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
- Hematocrit \<42% for males, \<36% for females
- Blood donation within 8 weeks of beginning the study
- 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
Who the study is looking for
- 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.
Age in the registry: 22 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pennington Biomedical Research Center Coordinator of this site? Confirm its status | Baton Rouge | United States | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.