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Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs

NCT06395246 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-04

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Institut Investigacio Sanitaria Pere Virgili

    lead OTHER

Principal Investigators

  • Juan José Vendrell Ortega, Professor · Instituto de Investigación Sanitaria Pere Virgili (IISPV)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2025-05-30
Completion
2025-12-20

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06395246 on ClinicalTrials.gov