Back to Trials
NCT04672863NARecruiting

Mediterranean Diet Post-liver Transplantation

Mayo Clinic

Start Date

1/19/2021

Completion Date

11/1/2027

Summary

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.

Detailed 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 Criteria

Age Range: 18 years to No maximum

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

Interventions

BEHAVIORAL

Dietary Intervention

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Liver Transplantation

Locations

Mayo Clinic in Rochester

Rochester, Minnesota 55905

United States