Time-restricted eating to help people with obesity keep weight off
Time-Restricted Eating as a Potential Strategy to Promote Weight Loss Maintenance in Patients With Obesity (REGANE)
This project will test whether limiting daily eating to a shorter time window helps adults with obesity keep weight off better than eating over 11 hours or more.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 212 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universidad de Granada Academic / other |
| Locations | 1 site (Granada, Granada) |
| Trial ID | NCT07315659 on ClinicalTrials.gov |
What this trial studies
Adults with obesity (BMI 30–45 kg/m2) will complete a calorie-restricted weight loss phase and then be assigned to either a time-restricted eating schedule or to continue consuming daily meals over an 11-hour or longer window. The trial compares weight maintenance between groups while measuring body composition, insulin sensitivity, and cardiometabolic risk factors. Researchers will monitor components of energy balance and related behaviors using self-recording, provided meals during outcome assessments, and blood sampling. The protocol also examines whether prior exposure to time-restricted eating affects later eating-window duration and subsequent weight change.
Who should consider this trial
Good fit: Adults with BMI 30–45 kg/m2 who currently have an eating window of 11 hours or longer at least five days per week, can provide blood samples, are willing to eat the provided foods, and are available for follow-up are ideal candidates.
Not a fit: People with BMI outside the 30–45 range, those already practicing a shorter eating window, individuals unwilling to follow the dietary or blood-sampling requirements, or those with medical conditions requiring treatment are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, time-restricted eating could help people with obesity maintain weight loss and improve metabolic health.
How similar studies have performed: Short-term trials of time-restricted eating have shown modest improvements in weight and metabolic markers, but long-term evidence for preventing weight regain is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 could interfere with the study results or compliance with the protocol. * Having undergone any surgical procedure that, in the opinion of the research team, could alter energy metabolism or digestive function during the course of the study. * Taking drugs or supplements that are likely to alter body weight or appetite. * Have experienced weight loss of more than 10% in the last two years, or more than 5% in the last 6 months, unless all the weight lost has been regained. * Follow unconventional eating patterns, such as vegan or fasting diets, or be unable to tolerate the foods provided during the study. * Being pregnant or planning to become pregnant within the next two years. * Being in the postpartum phase (within 12 months of giving birth) or breastfeeding. * Being in the perimenopausal stage, defined as meeting the criteria of irregular menstrual cycles, hormonal changes indicative of perimenopause, or the presence of menopausal symptoms. * Participating in a nutritional intervention or treatment or having done so during the previous 3 months. * Having been diagnosed with or showing signs or risk factors for the development of an eating disorder. * Experiencing frequent interruptions in the sleep-wake cycle. * Having clinically significant gastric emptying abnormalities, a current diagnosis of any form of diabetes, blood pressure greater than 160/90 mm Hg, or heart rate below 50 or above 100 beats per minute (sitting), with or without stable doses of antihypertensive medication. * Have an active or untreated malignant disease or be in remission from a clinically significant malignant disease for less than five years prior to the time of evaluation. * Having a history of drug or alcohol abuse or testing positive for drugs, unless due to medication prescribed by a healthcare professional. * Smoking, vaping, or regular use of tobacco products, unless there have been periods of at least 24 consecutive hours without consumption during the last 4 weeks. * Regular consumption of caffeine in excess of the equivalent of 3 espressos per day (225 mg/day). * Being a direct relative or cohabitant of research team personnel. * Any other condition that, in the opinion of the research team, makes participation in the study inadvisable.
Where this trial is running
Granada, Granada
- Department of Physiology, Faculty of Medicine, University of Granada. — Granada, Granada, Spain (Recruiting)
Study contacts
- Study coordinator: Guillermo Sanchez-Delgado
- Email: gsanchezdelgado@ugr.es
- Phone: +34 958241574
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.