Experimental Approach to Test Predictions of Body Weight Regulation Models
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 40 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests ideas about how the body controls weight and responds to going without food. It is for men and women ages 18–40 with low body weight or obesity. Participants will fast for 2 days, then have 2 days when they can drink as much of the study meals as they want, while staying in special rooms that measure calories used.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18–40.
- Body mass index (BMI), a measure of weight compared with height, below 20 for the low-weight group or 30 or higher for the obesity group.
- For women: have never given birth and have had periods every 25–35 days for the past 6 months.
- Normal thyroid function and blood tests. Blood sugar must be below 100 mg/dL; HDL (“good”) cholesterol at least 50 mg/dL for women or 40 for men; and triglycerides (blood fats) below 150 mg/dL.
- Report that your weight has stayed within about 6.6 pounds (3 kg) over the past 6 months.
- Rate how much you like at least one Ensure Plus liquid meal flavor between 5 and 8 on a 9-point scale.
- Willing to drink only up to two assigned Ensure Plus flavors for 2 days in a row.
Who can't join
- A past eating disorder diagnosis or a score of 2.80 or higher on the study’s eating disorder survey. For the low-weight group: not having reliable access to enough food.
- Being a professional athlete or doing recreational exercise for at least 150 minutes a week at moderate effort, 75 minutes at hard effort, or a mix that reaches 150 minutes when hard-effort minutes count double.
- Smoking cigarettes, vaping, or having more than 14 alcoholic drinks a week.
- Taking medicines that may change how much you eat or how many calories you burn, including certain weight-loss drugs, diabetes drugs, and stimulants.
- HIV; galactosemia (trouble processing a sugar called galactose); lactose intolerance; or diseases affecting calorie balance, including thyroid disease, diabetes, cancer, or long-term lung, heart, blood vessel, or kidney disease.
- A history of bowel inflammation, problems absorbing nutrients, or gluten intolerance. Sleep apnea with blood oxygen drops more than 10 times an hour on the study’s overnight test.
- For women: taking birth control pills with hormones, using a hormonal IUD for less than 6 months, being pregnant, or breastfeeding.
- Unable to give consent to join the study, or being a prisoner.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 \>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)
Study sites (1)
LA
- Pennington Biomedical Research Center · Baton Rouge, LA 70808Rodrigo Fernández-Verdejo, PhD · Study contact · 225-763-2594 · rodrigo.fernandez@pbrc.eduMore trials in Baton Rouge