NCT04801810

Daily Low Oxygen Exposure and Weight Status

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Florida State University · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective of this single-blind, parallel-arm, randomized clinical trial is to evaluate changes in body weight and composition, assess determinants of energy balance, and measure modulators of energy intake and expenditure, following 8 wk of calorie restriction (CR, -500 kcal/d) in combination with either overnight exposure (8 h/night) to normobaric hypoxia (NH; 15% oxygen, \~8500 ft elevation) or normoxia (NN; 21% oxygen, sea level), using a commercially available, in-home tent system, in adults who are overweight or obese.

Detailed description

The current research study will evaluate changes in body weight and composition, assess determinants of energy balance, and measure modulators of energy intake and expenditure, following 8 wk of calorie restriction (CR, -500 kcal/d) in combination with either overnight exposure to normobaric hypoxia (NH) or normoxia (NN). Participants will be instructed to follow their normal diet but with a 500 kcal/day deficit as advised by a Registered Dietitian. Participants will spend 8 hours/night in a tent, set-up around their bed, in their home, for 8 weeks. Participants sleeping in the hypoxic tent (Hypoxico Inc., New York, NY, commercially available tents: https://hypoxico.com/) will breath \~15% oxygen (achieved with nitrogen dilution, equivalent to \~8500 ft elevation), whereas those in the control tent (Hypoxico Inc.) will breath \~21% oxygen (achieved with nitrogen dilution, equivalent to sea level elevation). Trained research staff will set-up the hypoxic or control tent system in each participant's home on day 0 and will visit the participant's home on days 1, 2, and 3 to check and/or adjust the tent settings. After day 3, research staff will visit the participant's home weekly to check and/or adjust the tent settings. participants will be weighed each morning following an overnight fast and morning void. Participants will come to the laboratory on two separate days for baseline testing (days -1 and 0) and again on two separate days at the end of the study (days 55 and 56) for endpoint testing.

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
OTHER	Normobaric hypoxia	Low oxygen exposure to mimic \~8500 feet elevation (experimental).
OTHER	Normobaric normoxia	Normal oxygen exposure to mimic sea level conditions (sham comparator).

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2021-03-17
• Last updated: 2022-04-01

Locations

1 site across 1 country: United States