NCT07315659

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 212 (estimated)
• Sponsor: Universidad de Granada · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 12 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 12 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.

Conditions

• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Calorie restriction (Dietary intervention)	Calorie restriction intervention consisting on a meal plan designed to induce an 8-10% weight loss over a 12-16 week period.
BEHAVIORAL	Regular eating window	Receiving instructions to maintain their regular eating window (12h/d or more) both during the 12-16 weeks of calorie restriction and the 12 months following its completion.
BEHAVIORAL	Time-restricted eating	Receiving instructions to confine all daily meals to a period of 8 hours or less (at least 6 days a week) both during the 12-16 weeks of calorie restriction and the 12 months following its completion.

Timeline

• Start date: 2025-12-18
• Primary completion: 2027-12-01
• Completion: 2030-06-01
• First posted: 2026-01-02
• Last updated: 2026-01-07

Locations

1 site across 1 country: Spain