Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs — TREV  

Obesity Clinical Trial

Official title: The Usefulness of Circulating Microvesicles (Host and Bacterial) in Regulating Metabolic Homeostasis in Obesity Randomized Study of Parallel Arms in Obese Patients Undergoing Caloric Restriction Diet vs. Early Time-restricted Eating

Status Not yet recruiting

Clinical Trial Summary

The main aim of the present study is to evaluate the effectiveness of two dietary protocols: Daily Caloric Restriction (DCR) and Early Time-Restricted Feeding + DCR (eTRE) on metabolic homeostasis and the influence of circulating extracellular vesicles (EVs) as inter-organ communication elements in obese patients.

Clinical Trial Description

The specific objectives are:

1. To assess the effect of two dietary protocols on weight loss and metabolic benefits in non-morbidly obese subjects.

2. Influence of both protocols on energy signaling metabolites and the dynamics of enteroendocrine hormones.

3. Define the "digital footprint" of EVs as inter-organ communication elements influencing metabolic status in obese subjects.

The study design comprises a randomized parallel-arm design (n=40) with consecutive 1:1 allocation to a calorie restriction protocol for a healthy Mediterranean diet under Daily Caloric Restriction (DCR) (n=20) or an eTRE protocol (n=20) for 12 weeks. Clinical and analytical variables, adherence, satiety, chronotype, and brown fat content will be determined before and at the end of the follow-up. Derivatives of intestinal microbiota, short-chain fatty acids, bile acids, and circulating metabolites derived from host intermediary metabolism will be assessed through metabolomics. Glucagon-like peptide 1 (GLP1) and gastric inhibitory polypeptide (GIP) dynamics after a standard meal test. Metagenomics. Bioenergetic analysis of PBMC by SeaHorse. Total EV miRNA profile. Isolation of host and bacterial EVs. Characterization of the protein cargo of host and bacterial EVs. ;

Related Conditions & MeSH terms

• Obesity

• NCT number: NCT06395246
• Study type: Interventional
• Source: Institut Investigacio Sanitaria Pere Virgili
• Contact: Juan José Vendrell Ortega, Professor
• Phone: +34 619672912
• Email: jvortega2002@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2024
• Completion date: December 20, 2024