Recruiting

Diet-Induced Weight Loss, Low Oxygen Exposure

Sponsor:

Pennington Biomedical Research Center

Code:

NCT07542873

Conditions

Obesity (Disorder)

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Interventions

Normobaric hypoxia (NH)

Normobaric normoxia (NN)

Study Details

Brief summary:

Declines in iron status are common in those with obesity and may be due to obesity-related chronic inflammation; however, the effects of reducing inflammation following diet-induced weight loss on iron metabolism are poorly understood. Low environmental oxygen exposure increases dietary iron absorption and availability to supply iron for erythropoiesis but has not yet been tested in the context of weight loss. This study is designed to investigate diet-induced weight loss (inflammation reduction) and overnight low oxygen exposure (erythropoiesis stimulating agent) as strategies to improve dietary iron absorption in obesity.

Conditions

Obesity (Disorder)

Study ID

NCT07542873

Start date

Apr 21, 2025

Status verified date

Apr, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Obese (BMI between 30-39.9 kg/m2)
  • Born at altitudes below 2,100 meters (\~7,000 feet)
  • Currently residing in Baton Rouge, Louisiana or surrounding area
  • 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

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
  • 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

30 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 iron absorption [ Time Frame: 7 weeks ]

Central Contacts and Locations

Central contacts

Recruitment Core

225-763-3000clinicaltrials@pbrc.edu

Locations

Pennington Biomedical Research Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Recruitment Core

225-763-3000clinicaltrials@pbrc.edu

More Information

Sponsor

Pennington Biomedical Research Center

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • Body weight
  • Normobaric hypoxia
  • Negative energy balance
  • Energy intake
  • Energy expenditure
  • Iron absorption
  • Iron metabolism

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 2026-04-21.