Clinical Trial

Time-Restricted Eating as a Potential Strategy to Promote Weight Loss Maintenance in Patients With Obesity

Study acronym: REGANE
Recruiting
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Summary
While body weight reduction can be achieved through various interventions in people living with obesity, most patients regain a substantial proportion of the lost weight within the following months. There is a lack of effective interventions to prevent this regain, making weight regain one of the most pressing challenges in obesity management. The goal of this clinical trial is to determine whether adhering to time-restricted eating (TRE; a form of intermittent fasting) during and after a dietary weight loss intervention, promotes weight maintenance to a greater extent than consuming all daily meals within 11 hours or more. Additionally, the study will address other questions, such as whether TRE improves body composition, insulin sensitivity, and cardiometabolic risk factors; whether the TRE intervention produces effects on different components of energy balance or related behaviors; and whether prior exposure to the TRE intervention influences eating window duration and weight change over the subsequent 24 months. The study will compare participants who concentrate all their food intake within 8 hours or less with those who consume all their daily meals within 11 hours or more. All participants will follow a calorie-restricted diet designed to induce an 8-10% weight loss over 12-16 weeks and will be followed for several months after the weight loss intervention.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-12-18; most recent amendment 2026-05-09.
Trial Details
NCT Number NCT07315659
Lead Sponsor Universidad de Granada
Collaborators: Hospital Clinico Universitario San Cecilio, University Hospital Virgen de las Nieves
Conditions Obesity
Enrollment 212 participants
Start Date 2025-12-18
Primary Completion 2027-12 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-05-12