NCT05289310

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
11mo left

Started May 2023

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
May 2023Apr 2027

First Submitted

Initial submission to the registry

March 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 16, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

3.5 years

First QC Date

March 13, 2022

Last Update Submit

March 13, 2025

Conditions

Obesity

Keywords

Body weightNormobaric hypoxiaNegative energy balanceEnergy intakeEnergy expenditure

Outcome Measures

Primary Outcomes (1)

  • Change in body weight

    Body weight will be measured during the baseline weight maintenance phase (days -14 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). Change in body weight will be calculated as: body weight on day 56 - baseline body weight (average of days -14 to 0).

    10 weeks (70 days)

Secondary Outcomes (30)

  • 4-compartment body composition using DEXA and deuterium dilution

    Days -7 and 49

  • Waist circumference

    Days -7 and 49

  • Blood volume

    Days -7 and 49

  • Total daily energy expenditure (TDEE)

    Days -7 to 0 and 49-56

  • Resting metabolic rate

    Days 0 and 56

  • +25 more secondary outcomes

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 (NH)

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 (NN)

Interventions

Normobaric hypoxia (NH)OTHER

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

Normobaric hypoxia (NH)
Normobaric normoxia (NN)OTHER

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

Normobaric normoxia (NN)

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

Related Publications (1)

  • Riley TM, Weschenfelder C, Ravussin E, Rood JC, Greenway F, Taff S, Hickner RC, Cao H, Sutin AR, Todd G, Hennigar SR, Berryman CE. Effects of daily low oxygen exposure on weight status, body composition, and metabolic health in adults with obesity: protocol for a randomized, double-blind, controlled-feeding study. Contemp Clin Trials. 2026 Jan;160:108167. doi: 10.1016/j.cct.2025.108167. Epub 2025 Nov 26.

    PMID: 41314599DERIVED

MeSH Terms

Conditions

ObesityBody Weight

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Claire E. Berryman, PhD, RD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire E. Berryman, PhD, RD

CONTACT

3042161050claire.berryman@pbrc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 13, 2022

First Posted

March 21, 2022

Study Start

May 16, 2023

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)