Intermittent fasting may be key to keeping weight off for good
NCT ID NCT07315659
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether eating all your food within 8 hours each day (time-restricted eating) helps people with obesity keep weight off after losing it. About 212 participants will follow a calorie-restricted diet to lose 8-10% of their body weight, then be split into two groups: one eats within an 8-hour window, the other within 11 hours or more. Researchers will track weight, body composition, and health markers for 6 months after the diet ends to see which approach works better.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 212 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Physiology, Faculty of Medicine, University of Granada.
RECRUITINGGranada, Granada, 18007, Spain
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