Low Oxygen Exposure and Weight Status
ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorPennington Biomedical Research Center
About this trial
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
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Normobaric hypoxia (NH)
- Normobaric normoxia (NN)
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Pennington Biomedical Research Center
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov