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Experimental Approach to Test Predictions of Body Weight Regulation Models

NCT06309576 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-12-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Fasting-refeeding cycle

Participants will be maintained in metabolic chambers and exposed to 1 day of energy balance with a standard diet, 2 days of fasting (only water), and 2 days of ad-libitum refeeding using a liquid diet provided in hydration bladders to avoid portion control.

Sponsors & Collaborators

  • Tulane University

    collaborator OTHER

  • Pennington Biomedical Research Center

    lead OTHER

Principal Investigators

  • Rodrigo Fernandez-Verdejo, PhD · Pennington Biomedical Research Center

  • Eric Ravussin, PhD · Pennington Biomedical Research Center

  • Dragana Lovre, MD · Tulane University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-17
Primary Completion
2026-05-30
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06309576 on ClinicalTrials.gov