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Recruiting
NCT05289310
Low Oxygen Exposure and Weight Status
Conditions: Obesity
Sex: All
Ages: 22 Years – 65 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Pennington Biomedical Research Center
Location: Pennington Biomedical Research Center Baton Rouge Louisiana
Summary
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.
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 \
Source: ClinicalTrials.gov (NCT05289310). StuddyBuddy aggregates publicly available trial information.