Low Oxygen Exposure and Weight Status
Recruiting · NCT05289310 · Interventional (participants receive a specific treatment) · Lead sponsor: Pennington Biomedical Research Center
View the official record on ClinicalTrials.gov →Interventions studied
Normobaric hypoxia (NH)Normobaric normoxia (NN)
What this trial is about
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.
Who can take part
Age range
22 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Pennington Biomedical Research Center - Baton Rouge, Louisiana, United States