Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-24 @ 1:43 PM
NCT ID:
NCT05880095
Eligibility Criteria:
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
70 Years
Study:
NCT05880095
Study Brief:
Protocol Section:
NCT05880095