[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06309576":3,"trial-entities:NCT06309576":153,"trial-summary:NCT06309576":156},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":39,"secondary_outcomes":44,"sex":89,"minimum_age":90,"maximum_age":91,"healthy_volunteers":92,"eligibility_criteria":93,"std_ages":118,"locations":120,"central_contacts":135,"overall_officials":144,"references":151,"see_also_links":152},"NCT06309576","PBRC 2023-069","Experimental Approach to Test Predictions of Body Weight Regulation Models","RECRUITING","2026-12-03","2026-05","2026-05-29","2025-01-17","Pennington Biomedical Research Center","OTHER",false,"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.","Background:\n\nAlthough body weight regulation models have been proposed, experimental approaches for testing their predictions are lacking. The set point (SP) model proposes that a biologically determined fatness is defended by activating compensatory responses to prevent its change. The dual-intervention point (DIP) model proposes that there are two levels of fatness (lower and upper intervention points) within which fatness is weakly regulated. Compensatory responses would only be activated once the lower or upper intervention points are reached. In response to prolonged fasting, the SP model predicts the compensatory responses to be independent of the initial body weight. In contrast, the DIP model predicts higher responses in individuals who are closer to the lower intervention point (low body weight) compared to those who are farther away (obesity). None of these models predicts a different response in men vs. women. Our pilot and feasibility study will implement an experimental approach to test these predictions in humans by thoroughly measuring compensatory responses in energy expenditure and energy intake.\n\nDesign:\n\nTwelve individuals (3 men with low body weight and 3 with obesity; 3 women with low body weight and 3 with obesity) will be kept inpatient in metabolic chambers for 5 consecutive days and exposed to a 1-day energy balance, 2-day fasting, and 2-day ad-libitum refeeding. The primary outcome will be the extent of compensatory response, calculated as the cumulative energy balance during the 5-day inpatient period.\n\nObjectives:\n\n1. To determine the extent of compensatory response induced by a 2-day fasting followed by a 2-day ad-libitum refeeding in humans overall and among different subgroups (low body weight, obesity, men, women).\n2. To explore the timing of the compensatory responses during a 2-day fasting followed by a 2-day ad-libitum refeeding in humans.\n3. To explore potential physiological determinants of the inter-individual variability in the compensatory response induced by a 2-day fasting followed by a 2-day ad-libitum refeeding in humans.\n\nRelevance:\n\nUnderstanding how body weight is regulated in humans can help to prevent or treat obesity. In this pilot and feasibility study, the investigators propose an experimental approach to test the predictions of two body weight regulation models in response to fasting and explore potential sex differences. These preliminary data will be used to design and power future studies for testing models of body weight regulation in humans.",[18,19],"Obesity","Underweight",[21,22,23,24,25],"Energy expenditure","Energy intake","Energy balance","Set point model","Dual-intervention point model","INTERVENTIONAL","BASIC_SCIENCE",[29],"NA",{"count":31,"type":32},12,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","Fasting-refeeding cycle","Participants will be maintained in metabolic chambers and exposed to 1 day of energy balance with a standard diet, 2 days of fasting (only water), and 2 days of ad-libitum refeeding using a liquid diet provided in hydration bladders to avoid portion control.",[36],[40],{"measure":41,"description":42,"timeFrame":43},"Compensatory response","Cumulative energy balance during the fasting-refeeding cycle","The cumulative energy balance is calculated one time using the data of 5 inpatient days",[45,49,53,57,61,65,69,73,77,80,83,86],{"measure":46,"description":47,"timeFrame":48},"Timing of the compensatory response","Cumulative energy balance during different time periods of the 5-day fasting-refeeding cycle","The cumulative energy balance calculated for the following time periods along the 5-day fasting-refeeding cycle: day 1 to 2, day 1 to 3, day 1 to 4, during fasting (day 2 to 3), and during refeeding (day 4 to 5)",{"measure":50,"description":51,"timeFrame":52},"Protein balance","Protein balance (intake minus oxidation) during the fasting-refeeding cycle","Protein balance is calculated one time using the data of 5 inpatient days",{"measure":54,"description":55,"timeFrame":56},"Carbohydrate balance","Carbohydrate balance (intake minus oxidation) during the fasting-refeeding cycle","Carbohydrate balance is calculated one time using the data of 5 inpatient days",{"measure":58,"description":59,"timeFrame":60},"Lipid balance","Lipid balance (intake minus oxidation) during the fasting-refeeding cycle","Lipid balance is calculated one time using the data of 5 inpatient days",{"measure":62,"description":63,"timeFrame":64},"Overall appetite","Calculated from the results of visual analog scales that record hunger, satiety, fullness, and prospective food consumption","Overall appetite is measured 8 times per day (every 2 hours from approximately 8:00 AM) during the 5 inpatient days",{"measure":66,"description":67,"timeFrame":68},"Food preference","Measured using the Food Preference Questionnaire","Measured once a day, in the fasting state (at approximately 8:00 AM), during the 5 inpatient days",{"measure":70,"description":71,"timeFrame":72},"Physical activity","Measured with wrist-worn accelerometers","Measured continuously (i.e. for 24 hours) every day during the 5 inpatient days",{"measure":74,"description":75,"timeFrame":76},"Sleeping metabolic rate","Measured within the metabolic chamber, between 2:00 and 5:00 AM, and extrapolated to 24 hours","Measured every day during the 5 inpatient days",{"measure":78,"description":79,"timeFrame":68},"Leptin","Circulating concentrations of leptin",{"measure":81,"description":82,"timeFrame":68},"Appetite-regulating hormones","Circulating concentrations of ghrelin and insulin",{"measure":84,"description":85,"timeFrame":68},"Metabolites","Circulating concentrations of glucose, fatty acids, ketone bodies",{"measure":87,"description":88,"timeFrame":68},"Thyroid axis","Circulating concentrations of T4","ALL","18 Years","40 Years",true,{"inclusion":94,"exclusion":102,"raw_text":117},[95,96,97,98,99,100,101],"Body mass index lower than 20 kg\u002Fm2 for the low body weight group, or 30 kg\u002Fm2 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 \\\u003C100 mg\u002FdL; normal serum HDL cholesterol at \\>=50 mg\u002FdL for women and \\>=40 mg\u002FdL for men; and normal serum triglycerides at \\\u003C150 mg\u002FdL).","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",[103,104,105,106,107,108,109,110,111,112,113,114,115,116],"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\u002Fweek, recreational vigorous-intensity physical activity ≥75 min\u002Fweek, or a combination of recreational moderate-intensity and vigorous-intensity physical activity (moderate time + \\[2 × vigorous time\\]) ≥150 min\u002Fweek 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\u002For 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\u002Fhyperthyroidism, 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\u002Fhour 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)","Inclusion Criteria:\n\n* Body mass index lower than 20 kg\u002Fm2 for the low body weight group, or 30 kg\u002Fm2 or greater for the obesity group\n* 18-40 years old\n* Nulliparous and regular menstrual cycle (25-35 days) during the last six months (in women)\n* Normal thyroid function, blood count, and chemistry 15 panel (normal plasma glucose will be considered at \\\u003C100 mg\u002FdL; normal serum HDL cholesterol at \\>=50 mg\u002FdL for women and \\>=40 mg\u002FdL for men; and normal serum triglycerides at \\\u003C150 mg\u002FdL).\n* Self-reported weight stability during the last six months (±3 kg)\n* 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\n* Willing to only drink up to two assigned flavors of Ensure Plus for two consecutive days\n\nExclusion Criteria:\n\n* Eating disorders as indicated by a global score ≥2.80 in the Eating Disorder Examination Questionnaire, or a previous diagnosis of an eating disorder\n* For the low body weight group, having food insecurity (with or without hunger) as assessed by the USDA\n* Recreational moderate-intensity physical activity ≥150 min\u002Fweek, recreational vigorous-intensity physical activity ≥75 min\u002Fweek, or a combination of recreational moderate-intensity and vigorous-intensity physical activity (moderate time + \\[2 × vigorous time\\]) ≥150 min\u002Fweek as assessed by the Global Physical Activity Questionnaire, or being a professional athlete\n* Cigarette or vape smoking\n* Intake of more than 14 alcoholic drinks per week\n* Use of medications that may affect energy intake and\u002For 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\n* Human immunodeficiency virus, galactosemia, and lactose intolerance\n* Diseases that affect energy homeostasis including endocrine such as hypo\u002Fhyperthyroidism, or type 1 or 2 diabetes; cancer; chronic pulmonary diseases; cardiovascular disease; and renal disease\n* History of inflammatory bowel disease (ulcerative colitis, Crohn's), malabsorption syndromes (intestinal, pancreatic), and sprue or gluten intolerance\n* Having moderate to severe sleep apnea defined as an oxygen desaturation index \\>10 times\u002Fhour assessed by overnight oximetry to be conducted on the night following the screening visit\n* Use of oral hormonal contraceptives or less than 6 months using a hormonal intrauterine device (in women)\n* Adults who are unable to consent\n* Prisoners\n* Currently pregnant or breastfeeding (in women)",[119],"ADULT",[121],{"facility":12,"status":7,"city":122,"state":123,"zip":124,"country":125,"contacts":126,"geoPoint":132},"Baton Rouge","Louisiana","70808","United States",[127],{"name":128,"role":129,"phone":130,"email":131},"Rodrigo Fernández-Verdejo, PhD","CONTACT","225-763-2594","rodrigo.fernandez@pbrc.edu",{"lat":133,"lon":134},30.44332,-91.18747,[136,140],{"name":137,"role":129,"phone":138,"email":139},"Rodrigo Fernandez-Verdejo, PhD","2257632594","Rodrigo.Fernandez@pbrc.edu",{"name":141,"role":129,"phone":142,"email":143},"Eric Ravussin, PhD","2257633186","Eric.Ravussin@pbrc.edu",[145,147,148],{"name":137,"affiliation":12,"role":146},"PRINCIPAL_INVESTIGATOR",{"name":141,"affiliation":12,"role":146},{"name":149,"affiliation":150,"role":146},"Dragana Lovre, MD","Tulane University",[],[],{"nct_id":4,"conditions":154,"biomarkers":155},[18,19],[],{"nct_id":4,"found":92,"summary":157,"prompt_version":167},{"design":158,"status":159,"heading":160,"summary":161,"follow_up":162,"word_count":163,"commitments":164,"compensation":165,"drugs_mentioned":166},"This is an interventional study with a planned enrollment of 12 participants. It is designed to test predictions of body weight regulation models.","completed","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\u002Fm2) or have obesity (BMI 30 kg\u002Fm2 or greater). The current recruitment status is unclear.","The primary endpoint, compensatory response, is measured one time using data from the 5 inpatient days.",132,"Participants will stay in metabolic chambers for 5 inpatient days. During this time, you will follow a specific fasting-refeeding cycle.","Not stated in the trial record.",[],"v2"]