Low Oxygen Exposure and Weight Status
Effects of Daily Low Oxygen Exposure on Weight Status, Body Composition, and Metabolic Health
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 22 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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
Study sites (1)
LA
- Pennington Biomedical Research Center · Baton Rouge, LA 70808Claire E Berryman, PhD,RD · Study contact · claire.berryman@pbrc.eduMore trials in Baton Rouge