RecruitingNot ApplicableNCT04672863

Mediterranean Diet Post-liver Transplantation

Effects of a Structured, Modified Mediterranean Dietary Intervention After Liver Transplantation

Sponsor

Mayo Clinic

Enrollment

80 participants

Start Date

Jan 19, 2021

Study Type

INTERVENTIONAL

Conditions

Liver Transplantation

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria9

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

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Interventions

BEHAVIORALDietary Intervention

Modified Mediterranean diet approved by the Nutrition Team at the Transplant Center and it emphasizes consumption of fruits, vegetables, whole grains, beans and nuts, in addition to low salt (2-2.4g/day), moderate amounts of lean protein (primarily fish and poultry) in addition to low to moderate quantities of monounsaturated fats. The modifications to the traditional Mediterranean diet are: no alcohol consumption and fewer added fats. In addition, close scheduled followup on diet and progress with study team.