ObesityREGANENCT07315659
Time-Restricted Eating as a Potential Strategy to Promote Weight Loss Maintenance in Patients With Obesity
A study testing Calorie restriction (Dietary intervention), Regular eating window and Time-restricted eating in people with Obesity, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- Calorie restriction (Dietary intervention), Regular eating window and Time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 212 participants
- Where
- 1 siteSpain
- Study dates
- 18 Dec 2025to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Department of Physiology, Faculty of Medicine, University of Granada.
Granada, Granada, 18007
Guillermo Sanchez-Delgado, +34 958241574, gsanchezdelgado@ugr.es
About this study
Official title: 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 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
- Obesity
- Being tested
- Calorie restriction (Dietary intervention), Regular eating window, Time-restricted eating
- Keywords
- Obesity, Calorie restriction, Intermittent Fasting, Weight loss, Weight loss maintenance, Weight regain, Time-restricted eating, Diet
- Medical subject headings
- Obesity, Intermittent Fasting, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calorie restriction (Dietary intervention)Behavioural
Calorie restriction intervention consisting on a meal plan designed to induce an 8-10% weight loss over a 12-16 week period.
Regular eating windowBehavioural
Receiving instructions to maintain their regular eating window (11h/d or more) both during the 12-16 weeks of calorie restriction and the 12 months following its completion.
Time-restricted eatingBehavioural
Receiving instructions to confine all daily meals to a period of 8 hours or less (at least 6 days a week) both during the 12-16 weeks of calorie restriction and the 12 months following its completion.
| Study group | Role | What they receive |
|---|---|---|
| Time-restricted eating (eating within 8 hours/day or less) | Experimental | Participants in the time-restricted eating group will be instructed to concentrate all daily meals to 8 hours or less Receives: Behavioral: Calorie restriction (Dietary intervention); Behavioral: Time-restricted eating |
| Regular eating window (eating within 11 hours/day or more) | Sham comparator | Participants in the regular eating group will be instructed to spread all daily meals within a of 11 hours or more. Receives: Behavioral: Calorie restriction (Dietary intervention); Behavioral: Regular eating window |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight (Kg) during the 6 months following the end of the calorie restriction intervention
Measured: 6 after the end of the dietary intervention - End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss).
Secondary outcomes (58)
Weight (Kg)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention
Waist circumference (cm)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Hip Circumference (cm)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Fat mass (kg) by DXA
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Fat free mass (kg) by DXA
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Fat mass (kg) by Bioimpendaciometry
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Fat free mass (kg) by Bioimpendaciometry
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Body Mass Index (kg/m2)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Resting Energy Expenditure (kcal/day) measured by indirect calorimetry
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Posprandial Energy Expenditure (kcal/day) measured by indirect calorimetry
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Fasting nutrient utilization rates (g/min) measured by indirect calorimetry and protein excretion
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Postprandial nutrient utilization rates (g/min) measured by indirect calorimetry and protein excretion
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Energy Intake (kcal) in an Ad-Libitum Meal Test
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Energy efficiency (W/KJ) while cycling, assessed by indirect calorimetry
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Maximal fat oxidation (g/min) by indirect calorimetry
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Physical activity (counts/day) measured by accelerometry
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 after the end of dietary intervention.
Sedentary time (min/day) measured by accelerometry
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention
Habitual food consumption collected by a food frecuency questionnaire
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Serum Total Cholesterol (mg/dl)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum LDL cholesterol (mg/dl)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum HDL cholesterol (mg/dl)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum triglycerides (mg/dl)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum glucose (mg/dl)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum insulin (U/ml)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum hemoglobin A1c (mmol/mol)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum thyrotropin (µU/mL)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum Alanine Transaminase (U/L)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention
Serum Aspartate Transaminase (U/L)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum gamma-glutamyl transferase (U/L)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum C-reactive protein (mg/dL)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Craving Control measured using the Control of Eating Weekly Questionnaire (CoEQ)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Positive Mood measured using the Control of Eating Weekly Questionnaire (CoEQ)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Craving for Sweet Foods measured using the Control of Eating Weekly Questionnaire (CoEQ)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Craving for Savory Foods measured using the Control of Eating Weekly Questionnaire (CoEQ)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Fasting appetite-related sensations measured using "Visual Analogue Scales (VAS)"
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Meal-induced changes in appetite-related sensations measured using "Visual Analogue Scales (VAS)" in response to a meal
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Fasting Liking and Wanting measured using Leeds Food Preference Questionnaire
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Liking and Wanting in response to a meal measured using Leeds Food Preference Questionnaire
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Meal-induced changes in serum glucose concentration (mg/dL) in response to a standardized meal
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Meal-induced changes in serum insulin concentration (U/ml) in response to a standardized meal
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Cognitive restriction of food intake measured using the "Three-Factor Eating Questionnaire"
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Food disinhibition measured using the "Three-Factor Eating Questionnaire"
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Subjective hunger measured using the "Three-Factor Eating Questionnaire"
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Binge eating behavior measured using the "Binge Eating Questionnaire"
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Sleep time (min) measured by accelerometry
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Handgrip strength (kg) measured using a dynamometer
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Functional mobility measured by "Timed Up and Go (TUG)" test
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Walking speed (m/s) measured by a gait speed test
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Independence in activities of daily living (ADL) measured by "Barthel Index"
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention
Food cravings measured using the "Food Craving Inventory" questionnaire
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention
Carbohydrate intake (g/day) collected through three 24-hour recalls
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Fat intake (g/day) collected through three 24-hour recalls
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Protein intake (g/day) collected through three 24-hour recalls
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Fiber intake (g/day) collected through three 24-hour recalls
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Changes in appetite-related sensations measured using "Visual Analogue Scales (VAS)" in response to a submaximal stress test
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Resting heart rate variability
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Resting Systolic blood pressure (mmHg)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Resting Diastolic blood pressure (mmHg)
Measured: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start18 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinico Universitario San Cecilio, University Hospital Virgen de las Nieves
- Responsible party
- Principal investigator, Guillermo Sanchez Delgado, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315659
- Sponsor's protocol ID
- GSD-2024-003
- Acronym
- REGANE
- Status last verified
- May 2026
- First submitted
- 18 Dec 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-Restricted Eating as a Potential Strategy to Promote Weight Loss Maintenance in Patients With Obesity (REGANE)
- ClinicalTrials.gov ID
- NCT07315659
- Acronym / sponsor ID
- REGANE / GSD-2024-003
- Conditions
- Obesity
- Keywords
- Obesity, Calorie restriction, Intermittent Fasting, Weight loss, Weight loss maintenance, Weight regain, Time-restricted eating, Diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- Hospital Clinico Universitario San Cecilio, University Hospital Virgen de las Nieves
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-restricted eating (eating within 8 hours/day or less) | Experimental | Behavioral: Calorie restriction (Dietary intervention), Behavioral: Time-restricted eatingParticipants in the time-restricted eating group will be instructed to concentrate all daily meals to 8 hours or less |
| Regular eating window (eating within 11 hours/day or more) | Sham comparator | Behavioral: Calorie restriction (Dietary intervention), Behavioral: Regular eating windowParticipants in the regular eating group will be instructed to spread all daily meals within a of 11 hours or more. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calorie restriction (Dietary intervention)Calorie restriction intervention consisting on a meal plan designed to induce an 8-10% weight loss over a 12-16 week period. | Behavioural | Regular eating window (eating within 11 hours/day or more), Time-restricted eating (eating within 8 hours/day or less) |
| Regular eating windowReceiving instructions to maintain their regular eating window (11h/d or more) both during the 12-16 weeks of calorie restriction and the 12 months following its completion. | Behavioural | Regular eating window (eating within 11 hours/day or more) |
| Time-restricted eatingReceiving instructions to confine all daily meals to a period of 8 hours or less (at least 6 days a week) both during the 12-16 weeks of calorie restriction and the 12 months following its completion. | Behavioural | Time-restricted eating (eating within 8 hours/day or less) |
Primary outcome
Change in weight (Kg) during the 6 months following the end of the calorie restriction intervention
Time frame: 6 after the end of the dietary intervention - End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss).
58 secondary outcomes
Weight (Kg)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention
Waist circumference (cm)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Hip Circumference (cm)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Fat mass (kg) by DXA
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Fat free mass (kg) by DXA
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Fat mass (kg) by Bioimpendaciometry
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Fat free mass (kg) by Bioimpendaciometry
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Body Mass Index (kg/m2)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Resting Energy Expenditure (kcal/day) measured by indirect calorimetry
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Posprandial Energy Expenditure (kcal/day) measured by indirect calorimetry
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Fasting nutrient utilization rates (g/min) measured by indirect calorimetry and protein excretion
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Postprandial nutrient utilization rates (g/min) measured by indirect calorimetry and protein excretion
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Energy Intake (kcal) in an Ad-Libitum Meal Test
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Energy efficiency (W/KJ) while cycling, assessed by indirect calorimetry
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Maximal fat oxidation (g/min) by indirect calorimetry
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Physical activity (counts/day) measured by accelerometry
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 after the end of dietary intervention.
Sedentary time (min/day) measured by accelerometry
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention
Habitual food consumption collected by a food frecuency questionnaire
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Serum Total Cholesterol (mg/dl)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum LDL cholesterol (mg/dl)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum HDL cholesterol (mg/dl)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum triglycerides (mg/dl)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum glucose (mg/dl)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum insulin (U/ml)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum hemoglobin A1c (mmol/mol)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum thyrotropin (µU/mL)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum Alanine Transaminase (U/L)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention
Serum Aspartate Transaminase (U/L)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum gamma-glutamyl transferase (U/L)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Serum C-reactive protein (mg/dL)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Craving Control measured using the Control of Eating Weekly Questionnaire (CoEQ)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Positive Mood measured using the Control of Eating Weekly Questionnaire (CoEQ)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Craving for Sweet Foods measured using the Control of Eating Weekly Questionnaire (CoEQ)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Craving for Savory Foods measured using the Control of Eating Weekly Questionnaire (CoEQ)
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Fasting appetite-related sensations measured using "Visual Analogue Scales (VAS)"
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Meal-induced changes in appetite-related sensations measured using "Visual Analogue Scales (VAS)" in response to a meal
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Fasting Liking and Wanting measured using Leeds Food Preference Questionnaire
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 1, 3, 6, 12, 18, 24 and 36 months after the end of dietary intervention.
Liking and Wanting in response to a meal measured using Leeds Food Preference Questionnaire
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Meal-induced changes in serum glucose concentration (mg/dL) in response to a standardized meal
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Meal-induced changes in serum insulin concentration (U/ml) in response to a standardized meal
Time frame: Baseline; End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss); 6 months after the end of dietary intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calorie restriction (Dietary intervention), Regular eating window and Time-restricted eating in people with Obesity, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillermo Sanchez-Delgado (+34 958241574, gsanchezdelgado@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (Kg) during the 6 months following the end of the calorie restriction intervention (time frame: 6 after the end of the dietary intervention - End of dietary intervention (Week 12/16, depending on achievement of 8-10% weight loss).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.