Low Oxygen Exposure and Weight Status

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Pennington Biomedical Research Center
Study ID
NCT05289310
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Normobaric hypoxia (NH) — OTHER
    Low oxygen exposure to mimic \~8500 feet elevation (experimental).
  • Normobaric normoxia (NN) — OTHER
    Normal oxygen exposure to mimic sea level conditions (sham comparator).

Study Details

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.

Key Dates

Start date
May 16, 2023
Status verified
Mar 2025
Primary completion
Oct 31, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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).

Primary Outcome Measure

Change in body weight [ Time Frame: 10 weeks (70 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pennington Biomedical Research CenterBaton RougeLouisiana70808
Claire E Berryman, PhD,RD
[email protected]

Find similar trials in Baton Rouge, LA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Pennington Biomedical Research Center· Baton Rouge, LA

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