Normobaric hypoxia (NH) for Obesity

Pennington Biomedical Research Center, Baton Rouge, LA
ObesityNormobaric hypoxia (NH) - Other
Eligibility
22 - 45
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Similar Trials

1
Normal Saline
1
Hypoxia Exposure
1
Meal times

Study Objectives

0 Primary · 29 Secondary · Reporting Duration: Days 0-7, 14, 21, 28, 35, 42, and 56

10 weeks (70 days)
Assessment of sleep
Heart rate variability
Overnight oxygen saturation (index finger pulse oximetry)
Overnight oxygen saturation (wrist-worn device)
Week 4
Change in body weight
Day 56
Barrier Questionnaire
Days -1, 13, and 55
Urinary dopamine
Urinary epinephrine
Urinary norepinephrine
Days -1, 14, and 56
Pittsburgh Sleep Quality Index
Days -14-0, 1-14, and 42-56
24-hour continuous glucose concentrations
24-hour glucose variability
Days -7 and 49
4-compartment body composition using DEXA and deuterium dilution
Blood volume
Fasting blood pressure
Waist circumference
Days -7 to 0 and 49-56
Total daily energy expenditure (TDEE)
Days -7-0, 1-14, and 49-56
Subjective sleep quality
Days 0 and 56
Ad libitum energy intake
Fasting measures of iron status
Plasma glucose concentrations
Plasma insulin concentrations
Resting metabolic rate
Resting substrate oxidation
Subjective appetite measures
Thermic effect of glucose
Whole-body insulin sensitivity index
Day 0
Psychosocial Factors
Day 0
Prevalence of acute mountain sickness

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Normal Saline
1
Hypoxia Exposure
1
Meal times

Trial Design

2 Treatment Groups

Normobaric hypoxia (NH)
1 of 2
Normobaric normoxia (NN)
1 of 2

Experimental Treatment

Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Normobaric hypoxia (NH) · Has Placebo Group · N/A

Normobaric hypoxia (NH)
Other
Experimental Group · 1 Intervention: Normobaric hypoxia (NH) · Intervention Types: Other
Normobaric normoxia (NN)
Other
ShamComparator Group · 1 Intervention: Normobaric normoxia (NN) · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: days 0-7, 14, 21, 28, 35, 42, and 56

Who is running the clinical trial?

Florida State UniversityLead Sponsor
173 Previous Clinical Trials
28,682 Total Patients Enrolled
16 Trials studying Obesity
1,358 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,213 Previous Clinical Trials
4,193,493 Total Patients Enrolled
419 Trials studying Obesity
495,506 Patients Enrolled for Obesity
Pennington Biomedical Research CenterLead Sponsor
273 Previous Clinical Trials
177,329 Total Patients Enrolled
58 Trials studying Obesity
115,902 Patients Enrolled for Obesity
Claire E. Berryman, PhD, RDPrincipal InvestigatorPennington Biomedical Research Center

Eligibility Criteria

Age 22 - 45 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a body mass index (BMI) between 30 and 39.9, which is considered obese.
You were born in a place that is less than 7,000 feet above sea level.
You are willing to have a special tent set up in your home and sleep in it for 8 hours every night for 8 weeks.
You agree to not use any tobacco products, including smoking and vaping, and not take any dietary supplements during the study.

Who else is applying?

What state do they live in?
Florida100.0%
How old are they?
65+100.0%
What site did they apply to?
Florida State University100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Most responsive sites:
  1. Florida State University: < 24 hours
Typically responds via
Email100.0%
Average response time
  • < 1 Day
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top