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

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.

Conditions

• Obesity

Interventions

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 (11h/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.

Sponsors & Collaborators

• Hospital Clinico Universitario San Cecilio

  collaborator OTHER

• University Hospital Virgen de las Nieves

  collaborator OTHER

• Universidad de Granada

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-18

Primary Completion

2027-12-31

Completion

2030-06-30

Countries

• Spain

Study Locations