Effect of continuous energy restriction with probiotics on intestinal bacterial composition and its relationship with resting energy expenditure and adaptive thermogenesis in men with obesity: a randomized, double-blind, placebo-controlled clinical trial

• Grant number: 25/16276-2
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: September 01, 2025
• End date: June 30, 2026
• Field of knowledge: Health Sciences - Nutrition
• Principal Investigator: Marcus Vinicius Lucio dos Santos Quaresma
• Grantee: Catarina Bortoloto França Ferracini
• Host Institution: Campus Ipiranga. Centro Universitário São Camilo (CUSP). União Social Camiliana (USC). São Paulo , SP, Brazil

Abstract

The global prevalence of obesity has been increasing in recent years. Its pathophysiology is multifactorial, with the most frequently attributed cause being the imbalance between caloric intake and energy expenditure (EE). However, recent evidence suggests that the gut microbiota (GM) is a contributing factor to the development of obesity, as it modulates energy metabolism. Therefore, proposing strategies capable of promoting its modulation may be relevant for the prevention and/or treatment of obesity. The aim of the present study is to evaluate the effect of probiotic supplementation associated with caloric restriction and the potential impact of GM on resting energy expenditure (REE) and adaptive thermogenesis (AT) in adult men living with obesity. This is a randomized, double-blind, placebo-controlled clinical trial with two parallel groups of young adults with class I obesity. The sample consisted of 40 participants for the assessment of REE and AT. The intervention period lasted 12 weeks, with probiotic or placebo supplementation combined with caloric restriction. All assessments were performed at baseline, and after 4, 8, and 12 weeks. Statistical analysis was conducted according to the behavior of the data, using parametric and nonparametric tests when appropriate. As this is a secondary study, the data assessed indicated that there was no attenuation of AT; however, the impact of GM on the metabolic response was not evaluated, thus making this study necessary to clarify the potential impact of GM.