Overview
The purpose of this study is to study the effects of a structured Mediterranean dietary program on prevention of weight gain, promotion of heart health and prevention of fatty liver disease after liver transplantation.
Description
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.
Eligibility
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