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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 belowSelect...
My BMI is between 30 and 39.9.
Select...
I completed my COVID-19 vaccination series over 14 days ago.
Select...
I am willing to sleep in a special tent at home for 8 hours every night for 8 weeks.
LOWS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 0-7, 14, 21, 28, 35, 42, and 56
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 0-7, 14, 21, 28, 35, 42, and 56
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 moreLOWS 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
202 Previous Clinical Trials
31,726 Total Patients Enrolled
16 Trials studying Obesity
1,294 Patients Enrolled for Obesity
Pennington Biomedical Research CenterLead Sponsor
306 Previous Clinical Trials
181,977 Total Patients Enrolled
64 Trials studying Obesity
117,505 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,377 Previous Clinical Trials
4,315,747 Total Patients Enrolled
451 Trials studying Obesity
588,904 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is between 30 and 39.9.I have been diagnosed with HAPE or HACE before.I am unable to give consent for medical procedures.You agree not to use tobacco products, e-cigarettes, or dietary supplements during the study.I do not have heart, kidney, or stomach conditions that affect oxygen delivery.I haven't taken any meds that affect oxygen delivery for the last 4 weeks.I completed my COVID-19 vaccination series over 14 days ago.I completed my COVID-19 vaccination series over 14 days ago.My oxygen levels drop below 95% when awake or below 88% for 10+ minutes at night.My blood's hematocrit level is below the normal range for my gender.I haven't taken any medication that affects oxygen delivery for the last 4 weeks.I am willing to sleep in a special tent at home for 8 hours every night for 8 weeks.I haven't completed my COVID-19 vaccination series 14 days before the study.I have been diagnosed with sleep apnea or another sleep disorder.I have or someone in my family has sickle cell anemia.I live with someone who can respond if my health monitoring alarms go off.
Research Study Groups:
This trial has the following groups:- Group 1: Normobaric hypoxia (NH)
- Group 2: Normobaric normoxia (NN)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT05289310 — N/A
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