Obesity Trial, Recruiting NCT05289310 Sponsor: Pennington Biomedical Research Center Condition: Obesity
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Obesity Trial, Recruiting

NCT05289310
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People with a body mass index (BMI) between 30 and 39.9, which falls in the obese range
  • People who were born at altitudes below 2,100 meters (about 7,000 feet) above sea level
  • People who currently live in Tallahassee, Florida or the surrounding area
  • People who have completed a full COVID-19 vaccination series approved or authorised by the FDA, with the final dose received at least 14 days before any in-person study activities
  • People who have not taken any medications that affect how the body delivers or uses oxygen — such as sedatives, sleeping aids, tranquilisers, diuretics, or alpha and beta blockers — for at least 4 weeks before and during the entire study
  • People who are willing to avoid smoking, vaping, chewing tobacco, and dietary supplements for the full duration of the study
  • People who are willing to have a special low-oxygen tent set up in their home and sleep in it for 8 hours each night over 8 weeks
  • People who live with a family member, partner, spouse, or roommate who can hear and respond to safety alarms that monitor oxygen and carbon dioxide levels during sleep

Who may not be able to join:

  • People who live at altitudes above 1,200 meters (about 4,000 feet), or who have spent five or more days at such altitudes within the past 2 months
  • People who have not completed a full FDA-authorised or approved COVID-19 vaccination series at least 14 days before any in-person study activities
  • People with heart or cardiovascular problems, digestive disorders, kidney disease, or any condition that affects how the body delivers or uses oxygen
  • People whose blood oxygen levels fall below 95% while awake, or drop below 88% for 10 minutes or more during a night's sleep under normal air conditions
  • People with sleep apnea or other diagnosed sleep disorders
  • People with a history of high-altitude pulmonary oedema (fluid in the lungs caused by altitude) or high-altitude cerebral oedema (swelling in the brain caused by altitude)
  • People who have been diagnosed with sickle cell anaemia or the sickle cell trait, or who have a family history of it
  • People with low blood cell volume levels — below 42% for males or below 36% for females (confirm with trial site)
  • People with low haemoglobin levels — below 13 g/dL for males or below 12 g/dL for females (confirm with trial site)
  • People who have donated blood within 8 weeks of the study starting
  • People currently experiencing alcoholism, anabolic steroid use, or other substance use issues
  • People who are pregnant, breastfeeding, planning to become pregnant, or who have had an irregular menstrual cycle in the past 6 months
  • People whose body weight has changed by more than 10% in the past 6 months
  • People who are not able to give their own informed consent to participate

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Claire E. Berryman, PhD, RD, Pennington Biomedical Research Center

Phone: 3042161050

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Pennington Biomedical Research Center
Registry
ClinicalTrials.gov
Start date
16 May 2023
Est. completion
31 October 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in body weight

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov