Testing body weight regulation models through fasting and refeeding

Experimental Approach to Test Predictions of Body Weight Regulation Models

This study is trying to see how fasting and eating again affects body weight in people who are underweight or overweight.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: Pennington Biomedical Research Center (other)
• Locations: 1 site (Baton Rouge, Louisiana)
• Trial ID: NCT06309576 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 18-40 with either low body weight (BMI < 20 kg/m2) or obesity (BMI ≥ 30 kg/m2) who have stable weight.

Not a fit: Patients with a history of eating disorders or those outside the specified BMI range will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of body weight regulation, potentially leading to improved treatment strategies for obesity and underweight conditions.

How similar studies have performed: While the approach of testing body weight regulation models is novel, similar studies have shown promise in understanding metabolic responses to fasting.

Eligibility criteria

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 this trial is running

Baton Rouge, Louisiana

• 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

Conditions: Obesity, Underweight, Energy expenditure, Energy intake, Energy balance, Set point model, Dual-intervention point model