Healthy Aging Through Time- Restricted Eating in Adults With Overweight/Obesity and Incipient Liver Disease: ENSATI

Summary

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.

Eligibility

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Non-menopausal women
* Alcohol abuse (CAGE score \> 2, Ewing, 1984; Malet et al. 2005)
* Change in smoking habits in the previous 6 months.
* Prevalent renal, cardiovascular, liver (excluding fatty liver), endocrine o pancreatic disease.
* Type 1 diabetes
* Type 2 diabetes with poor glucose control.
* Poorly control hypertension.
* Medical treatment affecting weight or sleep.
* Food allergies or intolerances affecting the adherence to the intervention.
* Eating disorders.
* Shift workers.
* Participants of other studies.
* Social factors affecting to the adherence to the intervention (being institutionalized, unable to ingest solid food).

Conditions2

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