Actively Recruiting
Low Oxygen Exposure and Weight Status
Led by Pennington Biomedical Research Center · Updated on 2025-03-17
60
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
Sponsors
P
Pennington Biomedical Research Center
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Low Oxygen Exposure and Weight Status
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Obese with 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 research activity
- Not taking medications that affect oxygen delivery or transport for 4 weeks before and during the study (e.g., sedatives, sleeping aids, tranquilizers, diuretics, alpha and beta blockers)
- Willing to refrain from smoking, vaping, chewing tobacco, and dietary supplement use during the study
- Willing to have a hypoxic tent set up at home and spend 8 consecutive hours per night in it for 8 weeks
- Lives with someone who can respond if the monitoring alarm sounds during tent use
You will not qualify if you...
- Living in or recently traveled to areas above 1,200 meters (~4,000 feet) for 5 or more days within the last 2 months
- Has not completed full FDA authorized or approved COVID-19 vaccination series at least 14 days before any in-person research activity
- Has cardiovascular abnormalities, gastrointestinal disorders, or any condition interfering with oxygen delivery or transport (including kidney or cardiovascular disease)
- Oxygen saturation is less than 95% while awake or falls below 88% for at least 10 minutes overnight in normal oxygen conditions
- Has apnea or other sleep disorders
- History of high-altitude pulmonary or cerebral edema diagnosis
- Diagnosis or family history of sickle cell anemia or trait
- Hematocrit below 42% for males or below 36% for females
- Hemoglobin below 13 g/dL for males or below 12 g/dL for females
- Donated blood within 8 weeks before starting the study
- Has alcoholism, anabolic steroid use, or other substance abuse issues
- Women who are pregnant, breastfeeding, planning pregnancy, or had irregular menstrual cycles in the past 6 months
- Experienced weight gain or loss greater than 10% of body weight in the past 6 months
- Adults unable to provide informed consent (legally unable to consent)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
Research Team
C
Claire E. Berryman, PhD, RD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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