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

Launched by IMDEA FOOD · May 18, 2023

Keywords

ClinConnect Summary

**Clinical Trial Summary: Healthy Aging Through Time-Restricted Eating (ENSATI)**

This clinical trial, called ENSATI, is exploring how a specific eating pattern called time-restricted eating (TRE) can help adults who are overweight or have early signs of liver disease. The goal is to see if TRE, which involves eating within a limited time frame each day, can improve aspects of aging compared to traditional calorie-restricted diets and regular eating habits. Researchers want to find out if TRE is easy to stick with over six months, and how it affects things like metabolism (how our bodies process food), sleep patterns, mood, memory, and overall quality of life.

To participate in this study, adults aged 20 to 25 who have a body mass index (BMI) between 27 and 35 and a diagnosis of fatty liver disease might be eligible. Participants will be assigned to one of three groups: one will follow an unrestricted Mediterranean diet, another will have a reduced-calorie Mediterranean diet, and the last group will follow the Mediterranean diet but with TRE. The study will last for six months, and then researchers will check in with participants for an additional six months to see how well they maintained the changes. This trial is currently recruiting, and it's a chance for individuals to contribute to research that could improve health and aging.

Gender

ALL

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).