RecruitingNot Applicable

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

Spain212 participantsStarted 2025-12-18

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 11 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. Exclusion Criteria: * Having received a diagnosis or presenting signs or symptoms that, in the opinion of the research team, could contraindicate TRE intervention or any of the procedures included in the study. * Having been diagnosed with or having a history of metabolic (including a diagnosis of any type of diabetes mellitus), hematological, pulmonary, cardiovascular, gastrointestinal, neurological, immune, hepatic, renal, urological or psychiatric diseases that…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in weight (Kg) during the 6 months following the end of the calorie restriction intervention

Timeframe: 6 after the end of the dietary intervention - End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss).

Trial details

NCT IDNCT07315659

SponsorUniversidad de Granada

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Guillermo Sanchez-Delgado

+34 958241574 gsanchezdelgado@ugr.es

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