Actively Recruiting
Time-Restricted Eating as a Potential Strategy to Promote Weight Loss Maintenance in Patients With Obesity
Led by Universidad de Granada · Updated on 2026-05-12
212
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
Sponsors
U
Universidad de Granada
Lead Sponsor
H
Hospital Clinico Universitario San Cecilio
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Time-Restricted Eating as a Potential Strategy to Promote Weight Loss Maintenance in Patients With Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a body mass index of 30-45 kg/m2.
- Have safety laboratory test results within normal ranges or clinically insignificant abnormalities not requiring drug treatment.
- Have sufficient venous access for blood sampling and no phobia of needles or blood.
- Maintain a usual eating window of 11 hours or longer at least 5 days a week with a response rate greater than 85% during screening self-recording.
- Willingness and ability to consume all foods provided during the study.
- Ability to understand and undergo the study procedures as judged by the research team.
- Availability to participate in the study.
- Willingness to complete the study regardless of assigned group.
You will not qualify if you...
- Have any diagnosis or symptoms that contraindicate time-restricted eating or study procedures as judged by the research team.
- History or diagnosis of metabolic (including diabetes), hematological, pulmonary, cardiovascular, gastrointestinal, neurological, immune, hepatic, renal, urological, or psychiatric diseases that could affect study results or protocol compliance.
- Underwent any surgery that could alter energy metabolism or digestive function during the study.
- Taking drugs or supplements likely to affect body weight or appetite.
- Lost more than 10% body weight in last 2 years or more than 5% in last 6 months unless fully regained.
- Follow unconventional diets such as vegan or fasting diets or cannot tolerate the study foods.
- Pregnant, planning pregnancy within 2 years, postpartum within 12 months, or breastfeeding.
- In perimenopausal stage with irregular cycles, hormonal changes, or menopausal symptoms.
- Participated in nutritional interventions or treatments within previous 3 months.
- Diagnosed with or at risk for eating disorders.
- Experience frequent sleep-wake cycle interruptions.
- Have clinically significant gastric emptying abnormalities, current diabetes diagnosis, blood pressure over 160/90 mm Hg, or resting heart rate below 50 or above 100 bpm.
- Have active or untreated malignant disease or remission less than 5 years.
- History of drug or alcohol abuse or positive drug test unless prescribed.
- Smoking, vaping, or regular tobacco use without periods of at least 24 hours abstinence in last 4 weeks.
- Consume caffeine above 225 mg/day.
- Direct relative or cohabitant of research team personnel.
- Any other condition making participation inadvisable as judged by the research team.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Physiology, Faculty of Medicine, University of Granada.
Granada, Granada, Spain, 18007
Actively Recruiting
Research Team
G
Guillermo Sanchez-Delgado
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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