[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461488":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":37,"responsibleParty":54,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":24,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":39,"whyStopped":24,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Pennington Biomedical Research Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Normobaric hypoxia (NH)","EXPERIMENTAL","8 weeks of overnight exposure (8 hrs\u002Fnight) to NH conditions (\\~15% oxygen; achieved with nitrogen dilution, equivalent to \\~8500 feet elevation) using a commercially available tent and generator system (Hypoxico, Inc., New York, NY).",[13],"Other: Normobaric hypoxia (NH)",{"label":15,"type":16,"description":17,"interventionNames":18},"Normobaric normoxia (NN)","SHAM_COMPARATOR","8 weeks of overnight exposure (8 hrs\u002Fnight) to NN conditions (\\~21% oxygen; sea level) using a commercially available tent and generator system (Hypoxico, Inc., New York, NY).",[19],"Other: Normobaric normoxia (NN)",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"Low oxygen exposure to mimic \\~8500 feet elevation (experimental).",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Normal oxygen exposure to mimic sea level conditions (sham comparator).",[15],[29],{"name":30,"affiliation":5,"role":31},"Claire E. Berryman, PhD, RD","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","3042161050","claire.berryman@pbrc.edu",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Baton Rouge","Louisiana","70808","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-91.18747,30.44332,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":24,"phoneExt":24,"email":36},"Claire E Berryman, PhD,RD",{"type":31,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Claire Berryman","Assistant Professor",[58],{"name":59,"class":60},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100461488","low-oxygen-exposure-and-weight-status-100461488",false,"NCT05289310","Low Oxygen Exposure and Weight Status","Effects of Daily Low Oxygen Exposure on Weight Status, Body Composition, and Metabolic Health","LOWS","Inclusion Criteria:\n\n* Obese (BMI between 30-39.9 kg\u002Fm2)\n* Born at altitudes below 2,100 meters (\\~7,000 feet)\n* Currently residing in Tallahassee, Florida or surrounding area\n* Completed a full FDA authorized or approved COVID-19 vaccination series at least 14 days before any in-person human research activity.\n* Not taking any medication(s) that interfere with oxygen delivery\u002Ftransport for 4 weeks prior to and throughout the entire study (e.g., includes sedatives, sleeping aids, tranquilizers and\u002For any medication that depresses ventilation, diuretics, alpha and beta blockers).\n* Willing to refrain from smoking, vaping, chewing tobacco, and dietary supplement use throughout the entire study.\n* Willing to have a hypoxic tent set-up in their home and spend 8 consecutive hours per night in the tent for 8 weeks\n* Lives with a family member, partner\u002Fspouse, 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.\n\nExclusion Criteria:\n\n* 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\n* 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.\n* Cardiovascular abnormalities, gastrointestinal disorders, or any condition that interferes with oxygen delivery\u002Ftransport (e.g., kidney disease, cardiovascular disease, etc.)\n* Oxygen saturation \\\u003C 95% while awake or oxygen saturation dips below 88% for a total of ≥ 10 min overnight in normoxic conditions\n* Evidence of apnea or other sleeping disorders\n* Evidence of prior high-altitude pulmonary edema (HAPE) or high-altitude cerebral edema (HACE) diagnosis\n* Diagnosis or family history of sickle cell anemia\u002Ftrait\n* Hematocrit \\\u003C42% for males, \\\u003C36% for females\n* Hemoglobin \\\u003C13 g\u002FdL for males, \\\u003C12 g\u002FdL for females\n* Blood donation within 8 weeks of beginning the study\n* Present condition of alcoholism, anabolic steroids, or other substance abuse issues\n* Women who are pregnant, lactating, planning to become pregnant, or who have had an irregular menstrual cycle in the past 6 mo.\n* Weight gain or loss \\> 10% of body weight during the past 6 months\n* Adults unable to consent",true,"ALL","22 Years","65 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78],"NA","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\u002Fd) in combination with either overnight exposure to normobaric hypoxia (8 h\u002Fnight, 15% FiO2, \\~2640 m) or normoxia (8 h\u002Fnight, 21% FiO2), using a commercially available, in-home tent system, in adults with obesity.",[81],"Obesity",[83,84,85,86,87],"Body weight","Normobaric hypoxia","Negative energy balance","Energy intake","Energy expenditure","2026-07-15",{"date":90,"type":91},"2026-07-16","ACTUAL",{"date":93,"type":91},"2023-05-16",{"date":95,"type":75},"2027-04-30",{"name":5,"class":6},1]