Effects of Caloric Restriction combined with intermittent fasting on metabolism and body composition of individuals with Severe Obesity

Not Applicable

Recruiting

• Conditions: Obesity Morbid; C18.654.726.750.500

• Registration Number: RBR-45fpgqh
• Lead Sponsor: Instituto de Nutrição - Universidade do Estado do Rio de Janeiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-01
• Last Update Posted: 22 August 2023
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Adults aged 20 years and over; of both sexes; with a body mass index (BMI) > 40 kg/m2

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, GLP1 agonists, DPP4 inhibitors, and 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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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