NCT05880095Completed
Healthy Aging Through Time- Restricted Eating in Adults With Overweight/Obesity and Incipient Liver Disease: ENSATI
Healthy Aging Through Time- Restricted Eating in Adults With Overweight/Obesity and Incipient Liver Disease: the ENSATI Study
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate the effect of a time-restricted eating (TRE) regimen on hallmarks of aging, in comparison with traditional caloric restriction and an unrestricted diet in adults with overweight/obesity. Investigators aim to assess: 1. If TRE is sustainable over 6-months. 2. If TRE positively affects metabolism and body composition 3. If TRE improves circadian rhythm/sleep. 4. If TRE benefits cognitive function, mood and quality of life (QoL). 5. If these beneficial effects are associated with changes in molecular hallmarks of aging. Participants will be randomly allocated to: * an unrestricted Mediterranean diet group (MedD) * a energy-reduced Mediterranean diet group (MedD\_RC) * or to an unrestricted Mediterranean diet with TRE group (MedD\_TRE) Intervention will be maintained for 6 months, and there will be an additional 6-months period of follow-up to assess the maintenance of the intervention without supervision. Changes from baseline in phenotypic and molecular hallmarks of aging, including: chronobiology, quality of life, cognition, metabolism and epigenetics among groups over the follow-up will be analyzed.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 176 (actual)
- First submitted
- 16 Mar 2023
- Start date
- 5 Jul 2023
- Primary completion date
- 15 Mar 2026
- Lead sponsor
- IMDEA Food
- Diseases
- Obesity
- NCT number
- NCT05880095
What you commit to
- Study type: Interventional
- Participants enrolled: 176
- From 5 Jul 2023 to the primary completion date, 15 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change in smoking habits in the previous 6 months.
Other illness
- Prevalent renal, cardiovascular, liver (excluding fatty liver), endocrine o pancreatic disease.
- Type 1 diabetes
- Poorly control hypertension.
- Food allergies or intolerances affecting the adherence to the intervention.
- Eating disorders.
Lab values
- Type 2 diabetes with poor glucose control.
Other
- Non-menopausal women
- Alcohol abuse (CAGE score \> 2, Ewing, 1984; Malet et al. 2005)
- Medical treatment affecting weight or sleep.
- Shift workers.
- Participants of other studies.
- Social factors affecting to the adherence to the intervention (being institutionalized, unable to ingest solid food).
Who the study is looking for
- BMI: 27-35 Kg/m2
- Prevalent fatty liver disease (FLI \> 59 or echography screening) EASL, Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease, 2016.
- Habitual daily eating window ≥ 14 h
- Regular sleeping patterns (7 ± 2 sleeping hours every day)
- Stable weight during the last 3 months (weight changes ≤ 4 Kg)
- Not considering changes in thei physical activity in the following 6 months
- Not being under a weight-loss program or medication.
Age in the registry: 55 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IMDEA Food Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.