NCT06395246

Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs

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: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Institut Investigacio Sanitaria Pere Virgili · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Active Comparator: Continuous calorie restriction	Individualized continuous calorie restriction diet based on healthy Mediterranean diet recommendations aiming to achieve at least a 5% weight loss at the end of the intervention
BEHAVIORAL	eTRE	early (morning) time-restricted eating pluss individualized continuous calorie restriction diet based on healthy Mediterranean diet recommendations aiming to achieve at least a 5% weight loss at the end of the intervention

Timeline

• Start date: 2024-05-20
• Primary completion: 2025-05-30
• Completion: 2025-12-20
• First posted: 2024-05-02
• Last updated: 2024-10-04

Locations

1 site across 1 country: Spain