Recruiting

Observational Study

Sponsor:

Pennington Biomedical Research Center

Code:

NCT05289310

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Accepted

Interventions

Normobaric hypoxia (NH)

Normobaric normoxia (NN)

Study Details

Brief 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.

Conditions

Obesity

Study ID

NCT05289310

Start date

May 16, 2023

Status verified date

Jul, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Normobaric hypoxia (NH)

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

Normobaric normoxia (NN)

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Claire E. Berryman, PhD, RD

3042161050claire.berryman@pbrc.edu

Locations

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Claire E Berryman, PhD,RD

claire.berryman@pbrc.edu

More Information

Sponsor

Pennington Biomedical Research Center

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • Body weight
  • Normobaric hypoxia
  • Negative energy balance
  • Energy intake
  • Energy expenditure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pennington Biomedical Research Center on 2026-07-16.