Low Oxygen Exposure for Obesity
(LOWS Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any medications that interfere with oxygen delivery or transport, such as sedatives, sleeping aids, tranquilizers, diuretics, and alpha or beta blockers, for 4 weeks before and throughout the study.
What data supports the effectiveness of the treatment Low Oxygen Exposure for Obesity?
Research shows that training in low oxygen conditions (normobaric hypoxia) can lead to more weight loss in obese individuals compared to normal oxygen conditions. Additionally, this approach has been associated with improvements in energy expenditure and reductions in body weight and blood pressure, which may help manage obesity.12345
Is low oxygen exposure safe for humans?
The research does not provide specific safety data on low oxygen exposure for obesity, but it highlights potential risks of oxygen therapy in obese individuals, such as worsening breathing issues. This suggests that any oxygen-related treatment should be carefully monitored in this population.678910
How does the treatment of normobaric hypoxia differ from other treatments for obesity?
Normobaric hypoxia (NH) is unique because it involves exposure to low oxygen levels, either at rest or combined with exercise, which can enhance weight loss and improve cardio-metabolic health in obese individuals. Unlike traditional treatments, NH can increase energy expenditure and reduce insulin levels without the need for dietary changes, making it a novel approach to managing obesity.1241112
Research Team
Claire E. Berryman, PhD, RD
Principal Investigator
Pennington Biomedical Research Center
Eligibility Criteria
This trial is for adults with obesity (BMI between 30-39.9) in Tallahassee, Florida who don't smoke or use certain supplements and medications. They must have completed COVID-19 vaccination, live below ~7,000 feet altitude, and share a home with someone who can respond to safety alarms.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline measurements including body composition, blood volume, and fasting measures are taken
Treatment
Participants undergo 8 weeks of calorie restriction combined with either normobaric hypoxia or normoxia exposure
Follow-up
Participants are monitored for sustained weight loss and metabolic health
Treatment Details
Interventions
- Normobaric hypoxia (NH)
- Normobaric normoxia (NN)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Florida State University
Lead Sponsor
Pennington Biomedical Research Center
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator