Experimental Approach to Test Predictions of Body Weight Regulation Models

Launched by PENNINGTON BIOMEDICAL RESEARCH CENTER · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how the body regulates weight and fatness, particularly in people who are underweight or obese. Researchers want to understand the body's responses to fasting and refeeding, which means participants will undergo a two-day fasting period followed by two days where they can eat freely. By measuring their energy intake and expenditure during this time, the study aims to learn how the body tries to prevent weight loss after fasting. The findings will help design future studies to better understand weight regulation.

To participate, you need to be between 18 and 40 years old and have a body mass index (BMI) either below 18.5 (underweight) or above 30 (obesity). Women must have regular menstrual cycles and normal thyroid function. If you don’t have any eating disorders and are generally healthy, you may be eligible. During the trial, you can expect to drink specific flavored meals for two days while your energy levels are monitored closely. It's important to know that certain health conditions and lifestyle factors, like smoking or extreme exercise, may exclude you from joining.

Gender

ALL

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)