Time-Restricted Eating as a Potential Strategy to Promote Weight Loss Maintenance in Patients With Obesity (REGANE)
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.
• Have a body mass index of 30-45 kg/m2.
• Have safety laboratory test results (general biochemistry and complete blood count) within the normal reference range or with abnormalities considered clinically insignificant by the medical research team and that do not require the initiation of drug treatment.
• Have sufficient venous access for the blood sampling required by the procedures described in this protocol, and not have a phobia of needles or blood.
• Maintain a usual intake window of 12 hours or longer at least 5 days a week and have a response rate greater than 85% during the self-recording carried out during the screening process.
• Willingness and ability to consume all foods provided during the outcome assessment and dietary intervention.
• Being able to understand and undergo the procedures that are part of the study, in the opinion of the research team.
• Availability to participate in the study.
• Be willing to complete the study regardless of the group to which they are assigned.