Low Oxygen Exposure and Weight Status

NCT ID: NCT05289310

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2027-04-30

Brief Summary

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.

Detailed Description

Obesity and associated metabolic conditions are a significant public health burden, costing the U.S. ~$150 billion annually. Obesity is both a disease, affecting 1 in 3 Americans, and a risk factor for other chronic diseases, such as cardiovascular disease, type 2 diabetes, and 13 forms of cancers. Diet and exercise are the cornerstone of obesity prevention and treatment. However, a considerable number of individuals are non-responsive to existing weight-loss interventions and obesity rates continue to rise. Therefore, non-conventional approaches are needed to supplement current weight-loss strategies. Daily exposure to low-oxygen conditions may aid in current weight- loss strategies. Moderate (1500-3500 m) and higher (≥ 3500 m) altitude environments are naturally hypoxic due to the lower atmospheric pressure (for reference, Denver, CO is ~1600 m and Mt. Hood in Oregon is ~3500 m). Studies show that sea-level natives exposed to moderate- or high- altitude continuously for 5 or more days lose weight, which is a consequence of prolonged reductions in blood and tissue oxygenation that lead to increased energy expenditure and decreased appetite. However, implementation of hypoxia as a means for weight loss has been limited, to date, by the logistical constraints of traveling to remote locations or access to an altitude chamber. A safe, less expensive, and more logistically feasible alternative is the use of commercially available, low-oxygen systems at sea level, which create a normobaric hypoxic environment. Whether in-home, overnight, normobaric hypoxic exposure, compared to normobaric normoxic exposure, promotes body mass loss in adults with obesity remains unknown. Furthermore, determinants of energy balance, including energy intake and expenditure, and their relative contribution to normobaric hypoxia-induced weight loss have not been investigated. 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. Chronic (8 weeks), overnight (8 hours/night) low oxygen exposure may provide a non-conventional approach to supplement current weight-loss strategies, inform new strategies to accelerate weight loss, aid long-term weight management efforts, and benefit metabolic health in individuals with obesity.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Normobaric hypoxia (NH)

Intervention Type: OTHER

Low oxygen exposure to mimic \~8500 feet elevation (experimental).

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).

Group Type: SHAM_COMPARATOR

Normobaric normoxia (NN)

Intervention Type: OTHER

Normal oxygen exposure to mimic sea level conditions (sham comparator).

Interventions

Normobaric hypoxia (NH)

Low oxygen exposure to mimic \~8500 feet elevation (experimental).

Intervention Type: OTHER

Normobaric normoxia (NN)

Normal oxygen exposure to mimic sea level conditions (sham comparator).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Obese (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 human research activity.
• 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
• Lives with a family member, partner/spouse, or roommate who can hear and respond in the unlikely event that the blood oxygen, air oxygen, or air carbon dioxide monitoring alarm would sound.

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
• Individuals who have not completed a full FDA authorized or approved COVID-19 vaccination series at least 14 days before any in-person human research activity.
• 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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Claire Berryman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claire E. Berryman, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Claire E. Berryman, PhD, RD

Role: CONTACT

claire.berryman@pbrc.edu

3042161050

Facility Contacts

Claire E Berryman, PhD,RD

Role: primary

claire.berryman@pbrc.edu

Other Identifiers

1R01DK127162-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PBRC 2022-046

Identifier Type: -

Identifier Source: org_study_id