60 Participants Needed

Low Oxygen Exposure for Obesity

(LOWS Trial)

Recruiting at 1 trial location
CE
Overseen ByClaire E. Berryman, PhD, RD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

CE

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

Currently residing in Tallahassee, Florida or surrounding area
Willing to refrain from smoking, vaping, chewing tobacco, and dietary supplement use throughout the entire study
My BMI is between 30 and 39.9.
See 5 more

Exclusion Criteria

I have been diagnosed with HAPE or HACE before.
Blood donation within 8 weeks of beginning the study
Weight gain or loss > 10% of body weight during the past 6 months
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline measurements including body composition, blood volume, and fasting measures are taken

2 weeks
Multiple visits for baseline assessments

Treatment

Participants undergo 8 weeks of calorie restriction combined with either normobaric hypoxia or normoxia exposure

8 weeks
Daily overnight exposure (8 hours/night)

Follow-up

Participants are monitored for sustained weight loss and metabolic health

4 weeks
1 visit for follow-up assessment

Treatment Details

Interventions

  • Normobaric hypoxia (NH)
  • Normobaric normoxia (NN)
Trial Overview The study tests if sleeping in a low-oxygen tent at home for 8 hours nightly over 8 weeks affects weight loss during calorie restriction. Participants are randomly assigned to breathe either normal air (NN) or lower oxygen levels (NH), mimicking high altitude.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Normobaric hypoxia (NH)Experimental Treatment1 Intervention
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).
Group II: Normobaric normoxia (NN)Placebo Group1 Intervention
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?

Florida State University

Lead Sponsor

Trials
234
Recruited
41,100+

Pennington Biomedical Research Center

Lead Sponsor

Trials
314
Recruited
183,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Findings from Research

In a study of 22 obese young adults over 4 weeks, those who underwent normobaric hypoxia training lost significantly more weight (-6.9 kg) compared to those who trained in normoxia (-4.3 kg), indicating that hypoxia training can enhance weight loss efforts.
Normobaric hypoxia training also led to significant improvements in systolic and mean blood pressure, suggesting additional cardiovascular benefits alongside weight loss.
Normobaric hypoxia training causes more weight loss than normoxia training after a 4-week residential camp for obese young adults.Kong, Z., Zang, Y., Hu, Y.[2021]
Normobaric hypoxic conditioning (HC) has shown promising results in improving cardio-metabolic health in obese populations, with passive HC leading to significant reductions in insulin levels and increased energy expenditure in humans.
Active HC resulted in weight loss and lower blood pressure in both obese animals and humans, suggesting that this approach could be beneficial for weight management and overall health, although more research is needed to clarify its effects on other health markers.
Normobaric hypoxic conditioning to maximize weight loss and ameliorate cardio-metabolic health in obese populations: a systematic review.Hobbins, L., Hunter, S., Gaoua, N., et al.[2020]
Oxygen availability is crucial in metabolic disorders like obesity, type 2 diabetes, and cardiovascular disease, suggesting that oxygen could be considered a nutrient essential for health.
Novel therapies, such as intermittent hypoxia training and hyperoxia, may offer new treatment options for metabolic disorders, highlighting the need for better methods to measure oxygen levels and understand their role in these conditions.
Oxygen in Metabolic Dysfunction and Its Therapeutic Relevance.Lopez-Pascual, A., Trayhurn, P., Martรญnez, JA., et al.[2022]

References

Normobaric hypoxia training causes more weight loss than normoxia training after a 4-week residential camp for obese young adults. [2021]
Normobaric hypoxic conditioning to maximize weight loss and ameliorate cardio-metabolic health in obese populations: a systematic review. [2020]
Oxygen in Metabolic Dysfunction and Its Therapeutic Relevance. [2022]
Low intense physical exercise in normobaric hypoxia leads to more weight loss in obese people than low intense physical exercise in normobaric sham hypoxia. [2023]
Effect of different levels of acute hypoxia on subsequent oral glucose tolerance in males with overweight: A balanced cross-over pilot feasibility study. [2023]
Prevalence of Sleep-disordered Breathing in Obese Patients with Chronic Hypoxemia. A Cross-Sectional Study. [2022]
High flow or titrated oxygen for obese medical inpatients: a randomised crossover trial. [2022]
Obesity-associated hypoventilation in hospitalized patients: prevalence, effects, and outcome. [2023]
Moderate concentrations of supplemental oxygen worsen hypercapnia in obesity hypoventilation syndrome: a randomised crossover study. [2014]
Effect of reverse Trendelenburg position and positive pressure ventilation on safe non-hypoxic apnea period in obese, a randomized-control trial. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Equivalent Air Altitude and the Alveolar Gas Equation. [2016]
Whole body, regional fat accumulation, and appetite-related hormonal response after hypoxic training. [2018]