RECRUITING

Experimental Approach to Test Predictions of Body Weight Regulation Models

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Experimental Approach to Test Predictions of Body Weight Regulation Models

Quick Facts

Study Start:2024-11-26

Study Completion:2025-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06309576

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Rodrigo Fernandez-Verdejo, PhD

CONTACT

2257632594

Rodrigo.Fernandez@pbrc.edu

Eric Ravussin, PhD

CONTACT

2257633186

Eric.Ravussin@pbrc.edu

Principal Investigator

Rodrigo Fernandez-Verdejo, PhD

PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Eric Ravussin, PhD

PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Dragana Lovre, MD

PRINCIPAL_INVESTIGATOR

Tulane University

Study Locations (Sites)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808

United States

Collaborators and Investigators

Sponsor: Pennington Biomedical Research Center

Rodrigo Fernandez-Verdejo, PhD, PRINCIPAL_INVESTIGATOR, Pennington Biomedical Research Center
Eric Ravussin, PhD, PRINCIPAL_INVESTIGATOR, Pennington Biomedical Research Center
Dragana Lovre, MD, PRINCIPAL_INVESTIGATOR, Tulane University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-26

Study Completion Date2025-11

Study Record Updates

Study Start Date2024-11-26

Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

Energy expenditure
Energy intake
Energy balance
Set point model
Dual-intervention point model

Additional Relevant MeSH Terms

Obesity
Underweight