Impact of time-restricted eating and Mediterranean diet on liver health
Immunometabolic Effects of Time Restricted Eating in Non-alcoholic Fatty Liver Disease
This study is testing if following an 8-hour eating schedule along with a Mediterranean diet can help adults with non-alcoholic fatty liver disease improve their liver health and metabolism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University College Dublin Academic / other |
| Locations | 1 site (Dublin, Leinster) |
| Trial ID | NCT05968378 on ClinicalTrials.gov |
What this trial studies
This study assesses the effects of an 8-hour time-restricted eating schedule combined with a Mediterranean diet on metabolism and inflammation in adults suffering from non-alcoholic fatty liver disease (NAFLD). NAFLD is a leading cause of chronic liver disease globally, often linked to obesity and metabolic inflammation. The study aims to explore how dietary changes can influence liver fat accumulation and immune responses, potentially improving metabolic health. Participants will receive standard healthy eating advice alongside the intervention to evaluate its effectiveness.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-65 with obesity and liver fat accumulation but without significant liver fibrosis or other major health issues.
Not a fit: Patients with uncontrolled diabetes, cardiovascular events, or significant renal or psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved liver health and reduced inflammation for patients with non-alcoholic fatty liver disease.
How similar studies have performed: Previous studies have shown promising results with dietary interventions similar to this approach, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females * Age 18-65 years, from all ethnic groups, capable of providing informed consent to participate * Obesity (body mass index \>30kg/m\^2) and of stable body weight (±3% for ≥3 months) * Fasting blood glucose \<7.0 mmol/L and HbA1c \<6.5%. * Liver fat \>10% (CAP score \>238 dB/m) and no fibrosis (liver stiffness score 2-7 kPa) as assessed by liver elastography (FibroScan) Exclusion Criteria: * Impaired renal function * Abnormal hematocrit * History of cardiovascular events * Uncontrolled hypertension * Type 2 diabetes * Medications or supplements known to affect glucose or lipid metabolism * Active inflammatory, autoimmune, infectious, gastrointestinal, or malignant disease * Uncontrolled neurological or psychiatric disease * Iron deficiency anemia, (hemoglobin \< 12g/dl men, \< 11g/dl women) * Fatty acid supplements and consumers of high doses of anti- antioxidant vitamins (A, C, E, b-carotene)
Where this trial is running
Dublin, Leinster
- University College Dublin — Dublin, Leinster, Ireland (Recruiting)
Study contacts
- Study coordinator: Helen M Roche, Professor
- Email: helen.roche@ucd.ie
- Phone: +353017164031
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.