Obesity Morbid
Conditions
Interventions
Randomized and controlled clinical trial with a total duration of 20 weeks (12 weeks of intervention and 8 weeks of follow-up), comprising two arms: the intervention group (RC-ATR) (n=35), which will
Sponsors
Instituto de Nutrição - Universidade do Estado do Rio de Janeiro
Instituto de Nutrição - Universidade do Estado do Rio de Janeiro
Eligibility
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: Adults aged 20 years and over; of both sexes; with a body mass index (BMI) > 40 kg/m2
Exclusion criteria
Exclusion criteria: Individuals who have the following conditions that may interfere with body composition or Basal metabolic rate(BMR); pregnancy; lactation; use of illicit drugs; infectious or oncological diseases; thyroid disorders; heart, kidney, liver, or lung insufficiency; use of medications that alter energy metabolism (corticosteroids, beta-blockers, sulfonylureas, Glucagon-like Peptide-1 (GLP1) agonists, dipeptidil peptidase 4 (DPP4) inhibitors, and Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors); use of medications for obesity treatment (serotonergic, noradrenergic, and inhibitors of intestinal lipid absorption); individuals who have undergone calorie restriction (CR); have experienced a body mass modification >10% in the last six months; have undergone bariatric surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to demonstrate that, in individuals with severe obesity, caloric restriction combined with time-restricted eating promotes greater weight loss when compared to continuous caloric restriction with a difference of at least 2 kg between groups | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the changes in body composition, as determined by dual-energy X-ray absorptiometry, after 12 weeks of calorie restriction combined with a time-restricted eating strategy, followed by 8 weeks of an isocaloric diet;Evaluate the changes in energy metabolism, as determined by indirect calorimetry, after 12 weeks of calorie restriction combined with a time-restricted eating strategy, followed by 8 weeks of an isocaloric diet;Evaluate the changes in biochemical/hormonal markers after 12 weeks of calorie restriction combined with a time-restricted eating strategy followed by 8 weeks of an isocaloric diet;Evaluate the change in food consumption, assessed using a 24-hour recall, and the subjective sensation of appetite using a visual analog scale, before and after the intervention;Evaluate the adaptive thermogenesis after 12 weeks of combined calorie restriction and time-restricted eating strategy, followed by 8 weeks of an isocaloric diet | — |
Countries
Brazil
Contacts
Public ContactTatiana Campos
Universidade do Estado do Rio de Janeiro
Outcome results
None listed