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Recruiting NCT04672863

Mediterranean Diet Post-liver Transplantation

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Trial Parameters

Condition Liver Transplantation
Sponsor Mayo Clinic
Study Type INTERVENTIONAL
Phase N/A
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-01-19
Completion 2027-03-01
Interventions
Dietary Intervention

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Brief 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 Criteria

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

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