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Experimental Approach to Test Predictions of Body Weight Regulation Models

Study acronym: DIP
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 29, 2026 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Primary completion date: May 30, 2026 to Oct 1, 2026
    • Study completion date: Jun 30, 2026 to Dec 3, 2026
    v10
  2. Notable Primary completion date: Sep 2025 to May 30, 2026
    • Study completion date: Nov 2025 to Jun 30, 2026
    v9
  3. Notable Start date: Nov 26, 2024 to Jan 17, 2025v8
  4. Minor Primary completion date: Jun 2025 to Sep 2025
    • Study completion date: Jul 2025 to Nov 2025
    • Study description expanded, about 8 words
    • Eligibility criteria expanded, about 4 words
    v7
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary completion date: May 2025 to Jun 2025
    • Start date changed from estimate of Dec 2024 to Nov 26, 2024
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Notable Start date: Oct 2024 to Dec 2024
    • Eligibility criteria revised
    • Secondary endpoints: 14 to 12
    v5
  2. Minor Primary completion date: Feb 2025 to May 2025
    • Study completion date: Jun 2025 to Jul 2025
    • Start date: Sep 2024 to Oct 2024
    • Eligibility criteria revised
    v4
  3. Notable Start date: Jul 2024 to Sep 2024v3
  4. Notable Start date: Apr 2024 to Jul 2024
    • Primary completion date: Nov 2024 to Feb 2025
    • Study completion date: Feb 2025 to Jun 2025
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 regulation of human body weight and fatness is not fully understood. Although some models of regulation have been proposed (set point, dual-intervention point, others), no studies have been designed to test their predictions. In this pilot and feasibility study, the investigators will implement an experimental approach to test the predictions of models of body weight regulation in humans. Men and women with either low body weight or obesity will be exposed to a 2-day fasting followed by a 2-day ad-libitum refeeding. During the entire fasting-refeeding period, energy intake and expenditure will be accurately measured within metabolic chambers. The investigators will therefore determine the compensatory responses to fasting elicited to prevent weight loss. The results will serve to design and power future studies to better understand body weight regulation.
Trial Details
NCT Number NCT06309576
Lead Sponsor Pennington Biomedical Research Center
Collaborators: Tulane University
Conditions
(from sponsor)
Obesity, Underweight
Related terms Obesity, Thinness
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov