Effects of Daily Low Oxygen Exposure on Weight Status, Body Composition, and Metabolic Health

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
United States
Louisiana
Pennington Biomedical Research Center
RECRUITING
Baton Rouge
Contact Information
Primary
Claire E. Berryman, PhD, RD
claire.berryman@pbrc.edu
3042161050
Time Frame
Start Date: 2023-05-16
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 60
Treatments
Experimental: Normobaric hypoxia (NH)
8 weeks of overnight exposure (8 hrs/night) 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).
Sham_comparator: Normobaric normoxia (NN)
8 weeks of overnight exposure (8 hrs/night) to NN conditions (\~21% oxygen; sea level) using a commercially available tent and generator system (Hypoxico, Inc., New York, NY).
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Pennington Biomedical Research Center

This content was sourced from clinicaltrials.gov