Daily Low Oxygen Exposure and Weight Status

NCT04801810 | Withdrawn

• 1 other identifier: STUDY00000334
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Body weight; Normobaric hypoxia; Overwieght and obesity; Negative energy balance; Energy expenditure; Energy intake

Outcome Measures

Primary Outcomes (1)

• Percent change in body weight

  Body weight will be measured during baseline (days -7 to 0) and each morning during the study (days 1 to 56) following an overnight fast and morning void, using a calibrated digital scale provided to participants to use at home (A\&D Medical wireless weight scale UC-352BLE, San Jose, CA). Percent change in body weight will be calculated as: \[Body weight - baseline body weight (average of days -7 to 0)\]/ baseline body weight \* 100

  8 weeks (56 days)

Secondary Outcomes (26)

• Percent change in body weight

  4 weeks after intervention ends

• 4-compartment body composition using DEXA and deuterium dilution

  Days -1 and 55

• Resting metabolic rate

  Days 0 and 56

• Resting substrate oxidation

  Days 0 and 56

• Total daily energy intake

  Weeks -1, 1, 2, 4, 6, and 8

Study Arms (2)

Normobaric hypoxia (NH)

EXPERIMENTAL

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).

Other: Normobaric hypoxia

Normobaric normoxia (NN)

SHAM COMPARATOR

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).

Other: Normobaric normoxia

Interventions

Normobaric hypoxia OTHER

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

Normobaric hypoxia (NH)

Normobaric normoxia OTHER

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

Normobaric normoxia (NN)

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claire E Berryman, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 17, 2021
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)