Experimental Approach to Test Predictions of Body Weight Regulation Models
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorPennington Biomedical Research Center
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Fasting-refeeding cycle
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Pennington Biomedical Research Center
Lead sponsor
Tulane University
Collaborator
Source ClinicalTrials.gov