Low Oxygen Exposure and Weight Status

Launched by PENNINGTON BIOMEDICAL RESEARCH CENTER · Mar 13, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at how living in a low-oxygen environment, combined with eating fewer calories, might help people with obesity lose weight and change their body composition. The study involves adults aged 18 to 75 who have a body mass index (BMI) between 30 and 39.9, which classifies them as obese. Participants will need to spend 8 hours each night in a special oxygen-reducing tent at home for 8 weeks while also following a diet that restricts their calorie intake by 500 calories each day.

To be eligible for the trial, participants must have received a full COVID-19 vaccination, live in or near Tallahassee, Florida, and be able to have a family member or roommate nearby during the study for safety reasons. Importantly, they should not be taking certain medications or have any health conditions that could affect their oxygen levels or overall health. Those who join the study can expect regular monitoring and support, and their experiences will help researchers understand the effects of low oxygen exposure on weight and energy balance in individuals with obesity.

Gender

ALL

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