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Low Oxygen Exposure for Obesity (LOWS Trial)

N/A
Recruiting
Led By Claire E. Berryman, PhD, RD
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Obese (BMI between 30-39.9 kg/m2)
Completed a full FDA authorized or approved COVID-19 vaccination series at least 14 days before any in-person human research activity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 0-7, 14, 21, 28, 35, 42, and 56
Awards & highlights

LOWS Trial Summary

This trial will test whether 8 weeks of calorie restriction, combined with exposure to either normobaric hypoxia or normoxia, leads to changes in body weight and composition in adults with obesity.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort from reduced oxygen such as headaches or shortness of breath. Long-term effects on body weight and energy balance will be monitored.

LOWS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is between 30 and 39.9.
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I completed my COVID-19 vaccination series over 14 days ago.
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I am willing to sleep in a special tent at home for 8 hours every night for 8 weeks.

LOWS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 0-7, 14, 21, 28, 35, 42, and 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0-7, 14, 21, 28, 35, 42, and 56 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
24-hour continuous glucose concentrations
24-hour glucose variability
4-compartment body composition using DEXA and deuterium dilution
+26 more

LOWS Trial Design

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 Location

Who is running the clinical trial?

Florida State UniversityLead Sponsor
200 Previous Clinical Trials
31,698 Total Patients Enrolled
16 Trials studying Obesity
1,358 Patients Enrolled for Obesity
Pennington Biomedical Research CenterLead Sponsor
305 Previous Clinical Trials
181,976 Total Patients Enrolled
64 Trials studying Obesity
117,505 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,532 Total Patients Enrolled
446 Trials studying Obesity
588,878 Patients Enrolled for Obesity

Media Library

Normobaric hypoxia (NH) Clinical Trial Eligibility Overview. Trial Name: NCT05289310 — N/A
Obesity Research Study Groups: Normobaric hypoxia (NH), Normobaric normoxia (NN)
Obesity Clinical Trial 2023: Normobaric hypoxia (NH) Highlights & Side Effects. Trial Name: NCT05289310 — N/A
Normobaric hypoxia (NH) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05289310 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT05289310 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must be met for someone to qualify as a participant in this clinical experiment?

"In order to be selected for this medical trial, potential participants must suffer from obesity and be between 22-45 years of age. A total of 60 individuals can join the study."

Answered by AI

Does the trial cater to individuals aged 55 or older?

"This trial's inclusion criteria dictates that only individuals aged 22 to 45 are eligible. By contrast, 202 studies target minors and 596 those above the age of 65."

Answered by AI

Is this research project presently recruiting participants?

"According to information presented on clinicaltrials.gov, this medical research has ceased patient recruitment for the time being. Initially posted January 1st 2023 and last modified September 15th 2022, further enrollment is not currently planned - but 955 alternative studies are actively searching for volunteers."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
65+
What site did they apply to?
Florida State University
Pennington Biomedical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

More details, what restrictions will I have, is there any compensation, how large is the tent?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I am interested in losing weight and I have struggled with many different diet and exercise plans. In addition, I want to help advance the science to help the next generation.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Florida State University: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Low Oxygen Exposure and Weight Status
Claire Berryman 2023. "Low Oxygen Exposure and Weight Status". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05289310.
~37 spots leftby Dec 2025
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