Mediterranean Diet Post-liver Transplantation
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.
| Condition(s) | Liver Transplantation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Mayo Clinic |
| Locations | Rochester, Minnesota, United States |
| Start date | 2021-01-19 |
| NCT ID | NCT04672863 |
| Official listing | https://clinicaltrials.gov/study/NCT04672863 |