Evaluating weight loss through low oxygen exposure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effects of overnight exposure to low oxygen conditions on body weight and composition in adults with obesity. Participants will undergo an 8-week calorie restriction program while spending 8 hours each night in a hypoxic or normoxic environment using a home tent system. The study will measure changes in energy balance, including intake and expenditure, to determine the effectiveness of this novel approach to weight loss. The trial is designed as a double-blind, parallel-arm, randomized format to ensure unbiased results.

Why it matters

Who can join: the full rules

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's running

• Pennington Biomedical Research Center
  Baton Rouge, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Claire E. Berryman, PhD, RD — Pennington Biomedical Research Center
• Study coordinator: Claire E. Berryman, PhD, RD
• Email: claire.berryman@pbrc.edu
• Phone: 3042161050

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.