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RecruitingNCT07315659REGANEUpdated May 12, 2026

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

An interventional study of Calorie restriction (Dietary intervention) and Regular eating window in Obesity, sponsored by Universidad de Granada. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
212
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity

Keywords

  • Obesity
  • Calorie restriction
  • Intermittent Fasting
  • Weight loss
  • Weight loss maintenance
  • Weight regain
  • Time-restricted eating
  • Diet
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 212 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Universidad de Granada is the lead sponsor of 246 studies on the registry; 43 are open to participants now.

Browse Universidad de Granada studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Have a 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

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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
212 participants (estimated)

Study arms

  • Experimental
    Time-restricted eating (eating within 8 hours/day or less)

    Participants in the time-restricted eating group will be instructed to concentrate all daily meals to 8 hours or less

    Behavioral: Calorie restriction (Dietary intervention) · Behavioral: Time-restricted eating

  • Sham comparator
    Regular eating window (eating within 11 hours/day or more)

    Participants in the regular eating group will be instructed to spread all daily meals within a of 11 hours or more.

    Behavioral: Calorie restriction (Dietary intervention) · Behavioral: Regular eating window

Interventions

  • BehavioralCalorie 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.

  • BehavioralRegular eating window

    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.

  • BehavioralTime-restricted eating

    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.

06

What researchers measure

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. Cognitive restriction of food intake measured using the "Three-Factor Eating 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.

  42. Food disinhibition measured using the "Three-Factor Eating 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.

  43. Subjective hunger measured using the "Three-Factor Eating 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.

  44. Binge eating behavior measured using the "Binge Eating 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.

  45. Sleep time (min) 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.

  46. Handgrip strength (kg) measured using a dynamometer

    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.

  47. Functional mobility measured by "Timed Up and Go (TUG)" 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.

  48. Walking speed (m/s) measured by a gait speed 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.

  49. Independence in activities of daily living (ADL) measured by "Barthel Index"

    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

  50. Food cravings measured using the "Food Craving Inventory" 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

  51. Carbohydrate intake (g/day) collected through three 24-hour recalls

    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.

  52. Fat intake (g/day) collected through three 24-hour recalls

    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.

  53. Protein intake (g/day) collected through three 24-hour recalls

    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.

  54. Fiber intake (g/day) collected through three 24-hour recalls

    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.

  55. Changes in appetite-related sensations measured using "Visual Analogue Scales (VAS)" in response to a submaximal stress 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.

  56. Resting heart rate variability

    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.

  57. Resting Systolic blood pressure (mmHg)

    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.

  58. Resting Diastolic blood pressure (mmHg)

    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.

07

Study locations

1 of 1 sites recruiting
  • Department of Physiology, Faculty of Medicine, University of Granada.
    Granada, Granada 18007, Spain
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Dec 2027, 24 months after the start.

Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 24 months is close to that.

Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2025
First posted
Jan 2, 2026
StartActual
Dec 18, 2025
Primary completionEst.
Dec 2027
CompletionEst.
Jun 2030
Last update
May 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07315659
Lead sponsor
Universidad de Granada
Collaborators
Hospital Clinico Universitario San Cecilio, University Hospital Virgen de las Nieves
Responsible party
Guillermo Sanchez Delgado (Ramon y Cajal Researcher (Tenure-track position), Universidad de Granada) — Principal investigator
First posted
Jan 2, 2026
Start date
Dec 18, 2025
Primary completion
Dec 2027 (estimated)
Completion
Jun 2030 (estimated)
Last update
May 12, 2026

Study contacts

Guillermo Sanchez-Delgado
Contact
gsanchezdelgado@ugr.es
+34 958241574

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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