RecruitingNot ApplicableNCT05289310

Low Oxygen Exposure and Weight Status

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


Sponsor

Pennington Biomedical Research Center

Enrollment

60 participants

Start Date

May 16, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 22 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether sleeping in a low-oxygen tent at home (similar to conditions at moderate altitude) can help adults with obesity lose more weight when combined with a reduced-calorie diet. Participants will use a specially designed tent for 8 hours each night over 8 weeks, with half assigned to low-oxygen air and half to normal air, alongside a 500-calorie daily reduction. You may be eligible if you are an adult with a BMI between 30 and 39.9, live near Tallahassee, Florida, do not have heart, kidney, or sleep apnea conditions, and are willing to have the tent set up in your home. Participation involves sleeping in the tent nightly, following a reduced-calorie diet, and attending clinic visits for body composition and metabolic measurements. This summary was prepared using AI to help patients understand this research.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNormobaric hypoxia (NH)

Low oxygen exposure to mimic \~8500 feet elevation (experimental).

OTHERNormobaric normoxia (NN)

Normal oxygen exposure to mimic sea level conditions (sham comparator).


Locations(1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

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NCT05289310


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