Healthy aging through time-restricted eating for adults with overweight and liver disease
Healthy Aging Through Time- Restricted Eating in Adults With Overweight/Obesity and Incipient Liver Disease: the ENSATI Study
NA · IMDEA Food · NCT05880095
This study is testing if a time-restricted eating plan can help adults with overweight and early liver disease feel better and improve their health compared to different types of Mediterranean diets.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 175 (estimated) |
| Ages | 55 Years to 70 Years |
| Sex | All |
| Sponsor | IMDEA Food (other) |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05880095 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of a time-restricted eating (TRE) regimen on biological aging markers in adults with overweight or obesity and incipient liver disease. Participants will be randomly assigned to one of three groups: an unrestricted Mediterranean diet, an energy-reduced Mediterranean diet, or a Mediterranean diet with TRE. The study aims to assess the sustainability of TRE over six months, its impact on metabolism, body composition, circadian rhythms, cognitive function, mood, and quality of life. Additionally, the trial will explore the molecular changes associated with these potential benefits.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with a BMI between 27-35 and prevalent fatty liver disease.
Not a fit: Patients with type 1 diabetes, poorly controlled type 2 diabetes, or significant cardiovascular or renal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary approach to promote healthy aging and improve overall well-being in adults with overweight and liver disease.
How similar studies have performed: Previous studies have shown promising results for time-restricted eating in improving health outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Madrid
- IMDEA Food — Madrid, Spain (RECRUITING)
Study contacts
- Study coordinator: Lidia D Daimiel Ruiz, PhD
- Email: lidia.daimiel@alimentacion.imdea.org
- Phone: 917278100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Biological Aging, Clinical trial, Time-restricted eating, Healthy aging, Epigenetics, Obesity, Precision nutrition, Autophagy