Daily Low Oxygen Exposure and Weight Status

NCT ID: NCT04801810

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2023-05-31

Brief Summary

The objective of this single-blind, parallel-arm, randomized clinical trial is to evaluate changes in body weight and composition, assess determinants of energy balance, and measure modulators of energy intake and expenditure, following 8 wk of calorie restriction (CR, -500 kcal/d) in combination with either overnight exposure (8 h/night) to normobaric hypoxia (NH; 15% oxygen, ~8500 ft elevation) or normoxia (NN; 21% oxygen, sea level), using a commercially available, in-home tent system, in adults who are overweight or obese.

Detailed Description

The current research study will evaluate changes in body weight and composition, assess determinants of energy balance, and measure modulators of energy intake and expenditure, following 8 wk of calorie restriction (CR, -500 kcal/d) in combination with either overnight exposure to normobaric hypoxia (NH) or normoxia (NN). Participants will be instructed to follow their normal diet but with a 500 kcal/day deficit as advised by a Registered Dietitian. Participants will spend 8 hours/night in a tent, set-up around their bed, in their home, for 8 weeks. Participants sleeping in the hypoxic tent (Hypoxico Inc., New York, NY, commercially available tents: https://hypoxico.com/) will breath ~15% oxygen (achieved with nitrogen dilution, equivalent to ~8500 ft elevation), whereas those in the control tent (Hypoxico Inc.) will breath ~21% oxygen (achieved with nitrogen dilution, equivalent to sea level elevation). Trained research staff will set-up the hypoxic or control tent system in each participant's home on day 0 and will visit the participant's home on days 1, 2, and 3 to check and/or adjust the tent settings. After day 3, research staff will visit the participant's home weekly to check and/or adjust the tent settings. participants will be weighed each morning following an overnight fast and morning void. Participants will come to the laboratory on two separate days for baseline testing (days -1 and 0) and again on two separate days at the end of the study (days 55 and 56) for endpoint testing.

Conditions

Overweight and Obesity

Study Design

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

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

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

Intervention Type: OTHER

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

Interventions

Normobaric hypoxia

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

Intervention Type: OTHER

Normobaric normoxia

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men and women aged 20 - 50 years
• Overweight or obese (BMI between 27.5-34.9 kg/m2)
• Born at altitudes less than 2,100 meters (~7,000 feet)
• Currently residing in Tallahassee, Florida, or the surrounding area
• Not taking any medication(s) that interfere with metabolism or 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
• Metabolic or cardiovascular abnormalities, gastrointestinal disorders, and any condition that interferes with metabolism or oxygen delivery/transport (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
• 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
• Allergies or intolerance to foods included in the standardized and ad libitum meal tests (e.g., lactose intolerance/milk allergy)
• 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
• Individuals who are not yet adults (infants, children, teenagers)
• Prisoners

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Claire E. Berryman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claire E Berryman, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

Florida State University

Tallahassee, Florida, United States

Countries

United States

Other Identifiers

STUDY00000334

Identifier Type: -

Identifier Source: org_study_id