Testing body weight regulation models through fasting and refeeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to experimentally test predictions of body weight regulation models, specifically the set point and dual-intervention point models, in humans. Participants with low body weight or obesity will undergo a fasting-refeeding cycle while their energy intake and expenditure are meticulously measured in metabolic chambers. The study will involve twelve individuals, balanced by gender and body weight category, who will be monitored over five days to assess their compensatory responses to fasting. The findings will help inform future research on body weight regulation mechanisms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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)

Where it's running

• Pennington Biomedical Research Center
  Baton Rouge, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Rodrigo Fernandez-Verdejo, PhD — Pennington Biomedical Research Center
• Study coordinator: Rodrigo Fernandez-Verdejo, PhD
• Email: Rodrigo.Fernandez@pbrc.edu
• Phone: 2257632594

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.