Mediterranean Diet Post-liver Transplantation

Study Hypotheses

• A modified Mediterranean diet after liver transplantation results in weight loss, improvement of insulin sensitivity, lipid profiles, blood pressure, BMI, and waist circumference in patients who adhere to the program.
• A modified Mediterranean diet after liver transplantation results in relative improvement in cardiovascular outcomes in patients who adhere to the program when compared to standard of care.
• A modified Mediterranean diet after liver transplantation results in relative improvement in 10-year ASCVD risk in patients who adhere to the program when compared to standard of care.
• A modified Mediterranean diet after liver transplantation decreases the risk of development of NAFLD/NASH/NASH fibrosis in patients who adhere to the program.

Study Design:

• Single-center, prospective, randomized interventional trial
• All eligible post-liver transplant patients during the enrollment period will be invited to participate in the trial.
• All enrolled patients will be randomized to the Dietary Intervention (DI) arm or the Standard of Care (SOC) arm.
• All patients will be followed for 12 months.

Inclusion criteria

• Adult patients ≥ 18 years of age undergoing primary liver transplant
• Ascites-adjusted BMI ≥ 25 kg/m2
• Acceptable graft function (total bilirubin level < 5 mg/dL and doppler ultrasound with patent hepatic artery, hepatic veins and portal veins)

Exclusion criteria

• Hepatocellular carcinoma (HCC) that did not fulfill Milan criteria as per explant histology
• Untreated post-transplant vascular complications or biliary strictures
• Multi-organ transplantation
• Urine protein excretion ≥2.0 g/day
• Uncontrolled diabetes mellitus (HbA1c > 10%)
• Associated medical conditions incompatible with safe participation in a nutritional intervention study, including digestive diseases with fat intolerance, neurological, psychiatric or endocrine disorders
• Active eating disorder (e.g. bulimia nervosa, anorexia nervosa)
• History of bariatric surgery
• Pregnancy or planning on pregnancy in the next year