Low Oxygen Exposure for Obesity
(LOWS-IRON Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore whether sleeping in a low-oxygen environment (normobaric hypoxia, NH) can help people with obesity improve iron utilization after weight loss. Participants will sleep in a special tent for eight weeks, simulating high-altitude conditions to assess its effect on iron absorption. The trial seeks individuals with obesity living in the Baton Rouge area who are not using medications affecting breathing or blood flow. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance health outcomes for people with obesity.
Do I have to stop taking my current medications for the trial?
Yes, you must stop taking any medications that interfere with oxygen delivery or transport, such as sedatives, sleeping aids, tranquilizers, diuretics, and certain heart medications, for 4 weeks before and throughout the study.
What prior data suggests that this method is safe for improving dietary iron absorption in obesity?
Research has shown that normobaric hypoxia (NH), which involves breathing air with slightly less oxygen than usual, is generally safe. In previous studies, participants using NH for weight loss did not report serious side effects. For instance, one study found that people who did light exercise in NH conditions for 8 weeks experienced positive results without major issues. This suggests that NH is well-tolerated over short periods, such as several weeks. However, as with any new treatment, discussing potential risks with a healthcare provider before participating is advisable.12345
Why are researchers excited about this trial?
Researchers are excited about normobaric hypoxia (NH) as a potential treatment for obesity because it offers a unique approach compared to traditional methods like diet, exercise, and medications. Unlike these standard options, NH involves exposure to lower oxygen levels, simulating high-altitude conditions, which may help boost metabolism and aid in weight loss without physical exertion. This method uses a tent and generator system to create these conditions overnight, making it a non-invasive and potentially more convenient option for individuals seeking alternative weight management strategies.
What evidence suggests that this trial's treatments could be effective for obesity?
Research has shown that normobaric hypoxia (NH), which involves breathing air with reduced oxygen levels, can help manage obesity. In this trial, participants will experience NH conditions overnight for 8 weeks. Studies have found that NH can improve health by reducing body fat and increasing muscle mass. For instance, a 12-week program of high-intensity interval training in NH significantly reduced body fat in overweight individuals. Other research suggests that NH training can enhance heart and metabolic health, including better body composition and metabolic markers. Although some debate exists, these findings suggest that NH might aid weight loss and improve health in people with obesity by enhancing how the body uses and stores energy.14567
Who Is on the Research Team?
Camila Weschenfelder, PhD
Principal Investigator
Pennington Biomedical Research Center
Are You a Good Fit for This Trial?
This trial is for adults with obesity (BMI 30-39.9) living near Baton Rouge, LA, who are willing to avoid tobacco and supplements, not take certain medications, and sleep in a special low-oxygen tent at home for 8 weeks. People with heart or lung problems, recent blood donation, pregnancy, substance abuse issues, or certain blood disorders cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Weight Maintenance
Participants maintain their weight while baseline iron absorption is measured
Treatment
Participants undergo 8 weeks of controlled-feeding energy restriction and intermittent exposure to normobaric hypoxia or normoxia
Follow-up
Participants are monitored for changes in iron absorption after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Normobaric hypoxia (NH)
- Normobaric normoxia (NN)
Trial Overview
The study compares the effects of sleeping in normal oxygen versus low-oxygen conditions (using a hypoxic tent) on iron absorption during diet-induced weight loss in people with obesity. Participants are assigned to different groups to see which approach improves iron levels best.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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).
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pennington Biomedical Research Center
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Citations
Dose-response relationship of normobaric hypoxia training on ...
Normobaric hypoxia training (NHT) has emerged as a potentially superior exercise intervention for obesity management, theoretically offering enhanced metabolic ...
Impact of exercise training in a hypobaric/normobaric hypoxic ...
This study aims to assess the impact of hypoxia training on body composition and glycolipid metabolism in excess body weight or living with obese people ...
3.
journals.physiology.org
journals.physiology.org/doi/full/10.1152/ajpregu.00160.2017?doi=10.1152/ajpregu.00160.2017Normobaric hypoxic conditioning to maximize weight loss and ...
Obese hypoxia (n = 7), Passive, Sustained 8 h/day, N/A, 14. Lean hypoxia (n = 7). Obese exercise and hypoxia (n = 7), Active, 90 min daily exercise sustained 8 ...
Dose-response relationship of normobaric hypoxia training on ...
This systematic review and meta-analysis found no evidence that normobaric hypoxia training produces superior body composition outcomes compared ...
Comparative effects of hypoxic exercise training modalities ...
The findings indicate that hypoxic-CT emerged as the most effective regimen for improving BMI, FM, LDL-C, SBP, and DBP. Additionally, hypoxic-AT ...
Effects of daily low oxygen exposure on weight status, body ...
Whether in-home, overnight, normobaric hypoxic exposure, compared to normobaric normoxic exposure, promotes weight loss in adults with obesity remains unknown.
Low Oxygen Exposure for Obesity (LOWS Trial)
The results mostly indicate positive outcomes with no serious side effects. One study found that participants who did light exercise in normobaric hypoxia for 8 ...
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