Effects of Time-restricted Hypocaloric Diet in Patients With NAFLD
Non-Alcoholic Fatty Liver Disease
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Time-Restricted Feeding, Mediterranean Diet
Eligibility Criteria
Inclusion Criteria: Body Mass Index >25 kg/m2 Liver steatosis with Magnetic Resonance Elastography (MRE) Exclusion Criteria: Other chronic liver diseases Alcohol consumption >20 g/day (female) and >30 g/day (male) Medications that cause liver disease or secondary NAFLD (e.g. tamoxifen, corticosteroids, Methotrexate, tetracycline, estrogens, valproic acid) Changes in body weight ± 3 % in the last 3 months Patients following a hypocaloric diet program and/or time-restricted feeding and/or other intermittent fasting protocols Unstable glucose-lowering medications in the last 6 months Body weight lowering medications and/or history of bariatric surgery Statins and/ or other fat-reducing medications if not taken in steady dosage for at least 3 months Uncontrolled type 2 diabetes mellitus defined as HbA1c value > 9.0% or insulin depending type 1 and 2 diabetes mellitus Pregnancy Lactation Immunologic or inflammatory diseases Depression and other psychiatric diseases Patients working in shifts Cancer
Sites / Locations
- Laiko General Hospital of Athens
- Agricultural University of AthensRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Early Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet
Late Time-Restricted Feeding Plus Hypocaloric Mediterranean Diet
Hypocaloric Mediterranean Diet Without Time Restriction In Feeding
Early 14:10 time-restricted feeding plus hypocaloric Mediterranean diet
Late 14:10 time-restricted feeding plus hypocaloric Mediterranean diet
Hypocaloric Mediterranean diet without time restriction in feeding