Testing Body Weight Regulation Models with Fasting-Refeeding

This study aims to understand how the human body regulates weight and fatness. Researchers are testing different ideas (models) about body weight regulation by observing how your body responds to changes in food intake. Participants will spend time in special rooms called metabolic chambers. During this time, you will follow a specific eating plan: one day of a standard diet, two days of fasting (only water), and two days where you can eat as much as you want from a liquid diet. The study will measure your body's "compensatory response" (how your body tries to prevent weight loss) to fasting. This study is for adults aged 18 to 40 who are either underweight (BMI less than 20 kg/m2) or have obesity (BMI 30 kg/m2 or greater). The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 12 participants. It is designed to test predictions of body weight regulation models.
What's involved
Participants will stay in metabolic chambers for 5 inpatient days. During this time, you will follow a specific fasting-refeeding cycle.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, compensatory response, is measured one time using data from the 5 inpatient days.

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NCT06309576

Experimental Approach to Test Predictions of Body Weight Regulation Models

Recruiting
NAAges 18–40InterventionalBasic science
Pennington Biomedical Research Center
~12 participants
Updated 2026-05-29 on ClinicalTrials.gov
What's tested:Fasting-refeeding cycle

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compensatory response
Measured over The cumulative energy balance is calculated one time using the data of 5 inpatient days
Obesity
Underweight
1 sites across 1 states
Louisiana1
  • Rodrigo Fernandez-Verdejo, PhD · PRINCIPAL_INVESTIGATOR · Pennington Biomedical Research Center
  • Eric Ravussin, PhD · PRINCIPAL_INVESTIGATOR · Pennington Biomedical Research Center
  • Dragana Lovre, MD · PRINCIPAL_INVESTIGATOR · Tulane University

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Eligibility criteria

Inclusion

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

Exclusion

Eating disorders as indicated by a global score ≥2.80 in the Eating Disorder Examination Questionnaire, or a previous diagnosis of an eating disorder
For the low body weight group, having food insecurity (with or without hunger) as assessed by the USDA
Recreational moderate-intensity physical activity ≥150 min/week, recreational vigorous-intensity physical activity ≥75 min/week, or a combination of recreational moderate-intensity and vigorous-intensity physical activity (moderate time + \[2 × vigorous time\]) ≥150 min/week as assessed by the Global Physical Activity Questionnaire, or being a professional athlete
Cigarette or vape smoking
Intake of more than 14 alcoholic drinks per week
Use of medications that may affect energy intake and/or expenditure, for example, semaglutide, liraglutide, exenatide, other GLP-1 receptor agonists, phentermine-topiramate, naltrexone-bupropion, orlistat, metformin, SGLT2 inhibitors, pramlintide, levocarnitine, amphetamines, and amphetamine-like drugs
Human immunodeficiency virus, galactosemia, and lactose intolerance
Diseases that affect energy homeostasis including endocrine such as hypo/hyperthyroidism, or type 1 or 2 diabetes; cancer; chronic pulmonary diseases; cardiovascular disease; and renal disease
History of inflammatory bowel disease (ulcerative colitis, Crohn's), malabsorption syndromes (intestinal, pancreatic), and sprue or gluten intolerance
Having moderate to severe sleep apnea defined as an oxygen desaturation index \&gt;10 times/hour assessed by overnight oximetry to be conducted on the night following the screening visit
Use of oral hormonal contraceptives or less than 6 months using a hormonal intrauterine device (in women)
Adults who are unable to consent
Prisoners
Currently pregnant or breastfeeding (in women)
  • Compensatory responseThe cumulative energy balance is calculated one time using the data of 5 inpatient days

    Cumulative energy balance during the fasting-refeeding cycle