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Time Restricted FeedingEXTREMENCT05310721

Efficacy and Feasibility of Time-restricted Eating on Cardiometabolic Health in Adults With Overweight/Obesity

A study testing Early time-restricted eating, Late time-restricted eating and Self-selected time-restricted eating in people with Time Restricted Feeding and Obesity, Abdominal, run by Universidad de Granada at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In Spain, obesity epidemic is one of the leading contributors of chronic disease and disability. Obesity is associated with higher morbidity and all-cause mortality risk especially when fat is stored in the abdominal area (i.e., increased visceral adipose tissue, VAT). Read more about this study

Who is it for?
Ages 30 to 60 years
What is being tested?
Early time-restricted eating, Late time-restricted eating and Self-selected time-restricted eating
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
2 sitesSpain
Study dates
11 Apr 2022to 6 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

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 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Aged 30-60 years.
  • Body mass index ≥25.0 and <40 kg/m2
  • Weight stability (within 3% of screening weight) for >3 months prior to study entry.
  • Sedentary lifestyle (<150 min/week of moderate-vigorous intensity exercise) for >3 months prior to study entry.
  • Habitual eating window ≥12 hours.
  • At least one of the following metabolic impairments:
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  • High-density lipoprotein (HDL) cholesterol concentration <50 mg/dL for females and <40 mg/dL for males.
  • Low-density lipoprotein (LDL) cholesterol levels >100 mg/dL (or on medication to treat elevated LDL cholesterol levels).
  • Serum triglycerides concentration ≥150 mg/dL or on medication to treat elevated triglycerides.
  • Systolic blood pressure >130 mm Hg and/or diastolic blood pressure >85 mm Hg or already being treated with anti-hypertension medications.
  • Impaired glucose tolerance is defined as at least one of the following:
  • Fasting plasma glucose (PG) >100 mg/dL and <125 mg/dL.
  • Hemoglobin A1c between ≥5.7% and <6.5%.
  • Insulin resistance as measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA2-IR) >1.8.

Who cannot join

  • History of a major adverse cardiovascular event, clinically significant kidney, endocrine, or neurological disease, bariatric surgery, HIV/AIDS, known inflammatory and/or rheumatologic disease, cancer, or other medical condition in which fasting or exercise is contraindicated.
  • Type 1 or Type 2 diabetes.
  • Major psychiatric disorders, eating disorders, sleep disorders, or alcohol abuse.
  • Regular use of medication or compounds that may affect study outcomes (e.g., antidiabetic, steroids, beta-blockers, antibiotics, prebiotics, probiotics and symbiotics).
  • Participating in a weight loss or a weight-management program.
  • Pregnancy and lactation or planned pregnancy (within the study period).
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  • Caregiver for a dependent requiring frequent nocturnal care/sleep interruptions. Shift workers with variable hours (e.g., nocturnal). Frequent travel over time zones during the study period.
  • Fear of needles and claustrophobia to magnetic resonance imaging (MRI).
  • Being unable to understand and to accept the instructions or the study objectives and protocol.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • University of Granada

    Granada, 18011

  • Universidad Pública de Navarra

    Pamplona, Navarre, 31006

Other trials in Spain

About this study

Official title: Efficacy and Feasibility of Time-restricted Eating on Cardiometabolic Health in Adults With Overweight/Obesity: The EXTREME Study

In Spain, obesity epidemic is one of the leading contributors of chronic disease and disability. Obesity is associated with higher morbidity and all-cause mortality risk especially when fat is stored in the abdominal area (i.e., increased visceral adipose tissue, VAT). Although current approaches such as energy restriction may be effective at reducing body fat and improving cardiometabolic health, their long-term adherences are limited. Time-restricted eating (TRE; e.g., 8 hours eating: 16 hours fasting on a daily basis) is a recently emerged intermittent fasting approach with promising cardiovascular benefits. Results from pioneering pilot studies in humans are promising and suggest that simply reducing the eating time window from ≥12 to ≤8-10 hours/day improves cardiometabolic health. However, currently, there is no consensus regarding whether the TRE eating window should be aligned to the early or middle to late part of the day. The EXTREME study will investigate the efficacy and feasibility of three different 8 hours TRE schedules (i.e., early, late and self-selected) over 12 weeks on VAT (main outcome) and cardiometabolic risk factors (secondary outcomes) in adults with overweight/obesity and abdominal obesity. The final goal of the EXTREME study is to demonstrate the health benefits of a novel and pragmatic intervention for the treatment of obesity and related cardiometabolic risk factors; an approach readily adaptable to real-world practice settings, easy for clinicians to deliver, and intuitive for patients to implement and maintain in their lives.

Being tested
Early time-restricted eating, Late time-restricted eating, Self-selected time-restricted eating
Medical subject headings
Intermittent Fasting, Obesity, Abdominal, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early time-restricted eatingBehavioural

    Participants will eat ad libitum within an 8-hour early eating window starting not later than 10am. No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion

  • Late time-restricted eatingBehavioural

    Participants will eat ad libitum within an 8-hour late eating window starting not earlier than 1pm. No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion

  • Self-selected time-restricted eatingBehavioural

    Participants will self-selected an 8-hour eating window to eat ad libitum. No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion

Study groups in NCT05310721
Study groupRoleWhat they receive
Early time-restricted eatingExperimentalParticipants will eat ad libitum within an 8-hour early eating window. The first meal will be before 10 am (last meal before 18h). No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion
Receives: Behavioral: Early time-restricted eating
Late time-restricted eatingExperimentalParticipants will eat ad libitum within an 8-hour late eating window. The first meal will be at 13h or later (last meal not before 21h). No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion
Receives: Behavioral: Late time-restricted eating
Self-selected time-restricted eatingExperimentalParticipants will self-selecte an 8-hour eating window to eat ad libitum. No calorie-containing food or beverage intake will be allowed outside the 8-hour eating window. Participants will also receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion
Receives: Behavioral: Self-selected time-restricted eating
Usual-care groupNo interventionParticipants will receive standard recommendations on healthy lifestyle based on Mediterranean dietary pattern and physical activity recommendations for weight loss and health promotion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in visceral adipose tissue

    Visceral adipose tissue will be assessed by Magnetic Resonance Imaging (MRI)

    Measured: Change from baseline to 12 weeks

Secondary outcomes (37)

  1. Change in Hepatic fat content

    Hepatic fat content will be assessed by Magnetic Resonance Imaging (MRI)

    Measured: Change from baseline to 12 weeks

  2. Change in Pancreatic fat content

    Pancreatic fat content will be assessed by Magnetic Resonance Imaging (MRI)

    Measured: Change from baseline to 12 weeks

  3. Change in Intramuscular fat content

    Intramuscular fat content will be assessed by Magnetic Resonance Imaging (MRI)

    Measured: Change from baseline to 12 weeks

  4. Change in Hepatic elasticity

    Hepatic elasticity will be assessed by US elastography

    Measured: Change from baseline to 12 weeks

  5. Change in Pancreatic elasticity

    Pancreatic elasticity will be assessed by US elastography

    Measured: Change from baseline to 12 weeks

  6. Change in Fasting glucose metabolism

    Fasting blood samples will be used to analyse different biomarkers of glucose metabolism

    Measured: Change from baseline to 12 weeks

  7. Change in Fasting lipid metabolism

    Fasting blood samples will be used to analyse different biomarkers of lipid metabolism (e.g., triglycerides, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol)

    Measured: Change from baseline to 12 weeks

  8. Change in Inflammatory profile

    Fasting blood samples will be used to analyse inflammatory profile (e.g., C-reactive protein and interleukin 6)

    Measured: Change from baseline to 12 weeks

  9. Change in Hepatic profile

    Fasting blood samples will be used to analyse hepatic profile (e.g., alkaline phosphatase, bilirubin, alanine transaminase and gamma-glutamyl transferase)

    Measured: Change from baseline to 12 weeks

  10. Change in Kidney profile

    Fasting blood samples will be used to analyse kidney profile (e.g., creatinine and creatine kinase)

    Measured: Change from baseline to 12 weeks

  11. Change in Glycemia (Continuous Glucose Monitoring)

    Glycemia will be assessed by Continuous Glucose Monitoring during 2 weeks

    Measured: Change from baseline to 12 weeks

  12. Change in Body weight

    Body weight will be measured by a digital scale

    Measured: Change from baseline to 12 weeks

  13. Change in Body composition (Fat mass and fat free mass)

    Body composition will be assessed by Dual-energy X-ray Absorptiometry (DXA)

    Measured: Change from baseline to 12 weeks

  14. Change in Anthropometric measures

    Neck, hip and waist circumferences will be assessed by standard procedures

    Measured: Change from baseline to 12 weeks

  15. Change in Blood pressure

    Systolic and Diastolic blood pressure will be assessed by standard procedures

    Measured: Change from baseline to 12 weeks

  16. Change in energy intake

    Energy intake (kcal/day) will be assessed by 24h recalls

    Measured: Change from baseline to 12 weeks

  17. Change in macronutrients intake

    Macronutrients intake (g/day and percentage of energy intake) will be assessed by 24h recalls

    Measured: Change from baseline to 12 weeks

  18. Change in dietary habits

    Dietary habits will be assessed by food frequency questionnaires

    Measured: Change from baseline to 12 weeks

  19. Change in Food craving

    Food craving will be assessed by the Food Craving Inventory (FCI)

    Measured: Change from baseline to 12 weeks

  20. Change in Appetitive traits

    Appetitive traits will be assessed by the Adult Eating Behavior Questionnaire (AEBQ)

    Measured: Change from baseline to 12 weeks

  21. Change in Subjective sleep quality

    Subjective sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI)

    Measured: Change from baseline to 12 weeks

  22. Change in Objectively sleep quality

    Objectively sleep quality will be assessed by accelerometry

    Measured: Change from baseline to 12 weeks

  23. Change in Chronotype

    Chronotype will be assessed by the Munich Chronotype Questionnaire (MCTQ)

    Measured: Change from baseline to 12 weeks

  24. Change in Morning-Evening type

    Morning-Evening type will be assessed by the Morningness-Eveningness Questionnaire Self-Assessment Version.

    Measured: Change from baseline to 12 weeks

  25. Change Subjective physical activity levels

    Subjective physical activity levels will be assessed by the International Physical Activity Questionnaire short form

    Measured: Change from baseline to 12 weeks

  26. Change Objectively physical activity levels

    Objectively physical activity levels will be assessed by accelerometry

    Measured: Change from baseline to 12 weeks

  27. Change in Depression aspects

    Depression aspects will be assessed by the Beck Depression Inventory Fast Screen (BDI-FS)

    Measured: Change from baseline to 12 weeks

  28. Change in Stress aspects

    Stress aspects will be assessed by the Perceived Stress Scale (PSS)

    Measured: Change from baseline to 12 weeks

  29. Change in Anxiety aspects

    Anxiety aspects will be assessed by the State-Trait Anxiety Inventory (STAI)

    Measured: Change from baseline to 12 weeks

  30. Change in General health

    General health will be assessed by the EuroQol 5 dimensions 5 levels (EQ-5D-5L)

    Measured: Change from baseline to 12 weeks

  31. Change in Quality of life

    Quality of life will be assessed by the Rand Short Form 36 (SF-36)

    Measured: Change from baseline to 12 weeks

  32. Change in Gut microbiota composition

    DNA sequencing to determine gut microbiota composition (e.g., phylum and genera)

    Measured: Change from baseline to 12 weeks

  33. Change in Gut microbiota diversity

    DNA sequencing to determine gut microbiota diversity (e.g., beta and alpha)

    Measured: Change from baseline to 12 weeks

  34. Feasibility of recruitment

    Feasibility of recruitment (i.e., percent of response rate).

    Measured: 12 weeks

  35. Feasibility of the intervention

    Retention during the intervention (i.e., percent of attrition).

    Measured: 12 weeks

  36. Adherence to the intervention

    Adherence will be assessed by eating records

    Measured: Every day during the intervention, up to 90 days

  37. Genetic variants in Clock genes

    Genetic variantes in clock genes will be determined by Illumina sytem

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2022
  2. Study start11 Apr 2022
  3. Primary completion6 Mar 2023
  4. Study completion6 Mar 2023

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05310721
Sponsor's protocol ID
EXTREME
Acronym
EXTREME
Status last verified
Nov 2023
First submitted
17 Jan 2022
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dote-Montero M, Clavero-Jimeno A, Cortes-Martin A, Lopez-Pascual A, Merchan-Ramirez E, Camacho-Cardenosa A, Concepcion M, Oses M, Lopez-Vazquez A, Amaro-Gahete FJ, Martin-Olmedo JJ, Jurado-Fasoli L, De-la-O A, Garcia Perez PV, Galvez J, Rodriguez-Nogales A, Garcia F, Habimana CM, Vazquez MJ, Alfaro-Magallanes VM, Avila MA, Martin-Rodriguez JL, Cabeza R, Munoz-Torres M, Labayen I, Ruiz JR. Time-restricted eating, liver health, and fecal microbiota in adults with overweight or obesity: a randomized controlled trial. JHEP Rep. 2026 Jul 7:101956. doi: 10.1016/j.jhepr.2026.101956. Online ahead of print.

    PubMed 42413768

  • Camacho-Cardenosa A, Merchan-Ramirez E, Clavero-Jimeno A, De-la-O A, Romero-Noguera JM, Martin-Rodriguez JL, Munoz-Torres M, Labayen I, Ruiz JR, Dote-Montero M. Effects of an early, late, and self-selected time-restricted eating intervention on weight loss maintenance in adults with overweight or obesity: A 12-month follow-up of a randomized controlled trial. Clin Nutr. 2026 Aug;63:106706. doi: 10.1016/j.clnu.2026.106706. Epub 2026 Jun 2.

    PubMed 42302513

  • Clavero-Jimeno A, Dote-Montero M, Migueles JH, Camacho-Cardenosa A, Medrano M, Alfaro-Magallanes VM, Oses M, Carneiro-Barrera A, de Cabo R, Munoz-Torres M, Labayen I, Ruiz JR. Time-Restricted Eating and Sleep, Mood, and Quality of Life in Adults With Overweight or Obesity: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2517268. doi: 10.1001/jamanetworkopen.2025.17268.

    PubMed 40560588

  • Dote-Montero M, Clavero-Jimeno A, Merchan-Ramirez E, Oses M, Echarte J, Camacho-Cardenosa A, Concepcion M, Amaro-Gahete FJ, Alcantara JMA, Lopez-Vazquez A, Cupeiro R, Migueles JH, De-la-O A, Garcia Perez PV, Contreras-Bolivar V, Munoz-Garach A, Zugasti A, Petrina E, Alvarez de Eulate N, Goni E, Armendariz-Brugos C, Gonzalez Cejudo MT, Martin-Rodriguez JL, Idoate F, Cabeza R, Carneiro-Barrera A, de Cabo R, Munoz-Torres M, Labayen I, Ruiz JR. Effects of early, late and self-selected time-restricted eating on visceral adipose tissue and cardiometabolic health in participants with overweight or obesity: a randomized controlled trial. Nat Med. 2025 Feb;31(2):524-533. doi: 10.1038/s41591-024-03375-y. Epub 2025 Jan 7.

    PubMed 39775037

Questions about this trial

What is this clinical trial studying?

A study testing Early time-restricted eating, Late time-restricted eating and Self-selected time-restricted eating in people with Time Restricted Feeding and Obesity, Abdominal, run by Universidad de Granada at 2 sites 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 14 inclusion and 9 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: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in visceral adipose tissue (time frame: Change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05310721, which also lists 4 linked publications.

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 29 Nov 2023.

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