Actively Recruiting
Experimental Approach to Test Predictions of Body Weight Regulation Models
Led by Pennington Biomedical Research Center · Updated on 2025-12-04
12
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
Sponsors
P
Pennington Biomedical Research Center
Lead Sponsor
T
Tulane University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Experimental Approach to Test Predictions of Body Weight Regulation Models
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index lower than 20 kg/m2 for the low body weight group, or 30 kg/m2 or greater for the obesity group
- Age between 18 and 40 years
- Nulliparous with regular menstrual cycles (25-35 days) during the last six months (in women)
- Normal thyroid function, blood count, and chemistry panel, including normal plasma glucose, serum HDL cholesterol, and serum triglycerides
- Self-reported weight stability within ±3 kg during the last six months
- Liking of at least one flavored liquid meal rated between 5 and 8 on a 9-point scale
- Willing to consume only up to two assigned flavors of Ensure Plus liquid diet for two consecutive days
You will not qualify if you...
- Eating disorders indicated by a global score ≥2.80 on the Eating Disorder Examination Questionnaire or previous diagnosis of an eating disorder
- Food insecurity (with or without hunger) for the low body weight group
- Recreational moderate-intensity physical activity ≥150 minutes/week, vigorous-intensity ≥75 minutes/week, or combination reaching ≥150 minutes/week; or professional athlete status
- Cigarette or vape smoking
- Intake of more than 14 alcoholic drinks per week
- Use of medications affecting energy intake or expenditure (e.g., semaglutide, liraglutide, exenatide, GLP-1 receptor agonists, phentermine-topiramate, naltrexone-bupropion, orlistat, metformin, SGLT2 inhibitors, pramlintide, levocarnitine, amphetamines)
- Human immunodeficiency virus, galactosemia, or lactose intolerance
- Diseases affecting energy homeostasis including endocrine disorders (hypo/hyperthyroidism, type 1 or 2 diabetes), cancer, chronic pulmonary, cardiovascular, or renal diseases
- History of inflammatory bowel disease, malabsorption syndromes, sprue, or gluten intolerance
- Moderate to severe sleep apnea defined by oxygen desaturation index >10 times/hour assessed by overnight oximetry
- Use of oral hormonal contraceptives or less than 6 months use of hormonal intrauterine device (in women)
- Adults unable to consent
- Prisoners
- Currently pregnant or breastfeeding (in women)
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Trial Site Locations
Total: 1 location
1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
Research Team
R
Rodrigo Fernandez-Verdejo, PhD
CONTACT
E
Eric Ravussin, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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