Experimental Approach to Test Predictions of Body Weight Regulation Models

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

• Body mass index lower than 20 kg/m2 for the low body weight group, or 30 kg/m2 or greater for the obesity group

• 18-40 years old

• Nulliparous and regular menstrual cycle (25-35 days) during the last six months (in women)

• Normal thyroid function, blood count, and chemistry 15 panel (normal plasma glucose will be considered at \<100 mg/dL; normal serum HDL cholesterol at \>=50 mg/dL for women and \>=40 mg/dL for men; and normal serum triglycerides at \<150 mg/dL).

• Self-reported weight stability during the last six months (±3 kg)

• Rate the liking of at least one of the flavored liquid meals (Ensure Plus, Abbot Nutrition) between 5 and 8 on a 9-point Likert scale

• Willing to only drink up to two assigned flavors of Ensure Plus for two consecutive days

Locations
United States
Louisiana
Pennington Biomedical Research Center
RECRUITING
Baton Rouge
Contact Information
Primary
Rodrigo Fernandez-Verdejo, PhD
Rodrigo.Fernandez@pbrc.edu
2257632594
Backup
Eric Ravussin, PhD
Eric.Ravussin@pbrc.edu
2257633186
Time Frame
Start Date: 2025-01-17
Estimated Completion Date: 2025-11
Participants
Target number of participants: 12
Treatments
Experimental: Fasting-refeeding cycle
Participants will be maintained in metabolic chambers and exposed to 1 day of energy balance, 2 days of fasting, and 2 days of ad-libitum refeeding.
Related Therapeutic Areas
Sponsors
Collaborators: Tulane University
Leads: Pennington Biomedical Research Center

This content was sourced from clinicaltrials.gov