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Low Oxygen Exposure and Weight Status

Study acronym: LOWS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv9
  2. Primary completion date: Dec 19, 2025 to Oct 31, 2026
    • Study completion date: Apr 30, 2026 to Apr 30, 2027
    v8
  3. Start date: Mar 9, 2023 to May 16, 2023
    • Primary completion date: Oct 2025 to Dec 19, 2025
    • Study completion date: Oct 2025 to Apr 30, 2026
    v7
  4. Re-verified, no change to tracked fieldsv6
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2023 to Mar 9, 2023
    • Site details revised
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Jan 2023 to Mar 2023v4
  2. Lead sponsor: Florida State University to Pennington Biomedical Research Center
    • Start date: Aug 2022 to Jan 2023
    • Study site revised
    v3
  3. Start date: Apr 2022 to Aug 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05289310
Lead Sponsor Pennington Biomedical Research Center
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Obesity
Related terms Body Weight, Obesity
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov