Mediterranean Diet Post-liver Transplantation

Study Overview
=================
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.

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.

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

Conditions
-----------------
Liver Transplantation

Intervention / Treatment
-----------------
* Behavioral: Dietary Intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care Group<br>Subjects will participate in a standardized Transplant Nutrition class between day 21-40 as per institutional protocol and will be counseled as per the Mayo Clinic standard of care vis a vis dietary intervention, standard aerobic and resistance exercise recommendations (consistent with AASLD guidelines) and other lifestyle interventions. | |
| Experimental: Behavioral: Structured Modified Mediterranean Diet<br>Subjects will participate in a one-on-one counselling session with a dietician, as opposed to attending the standardized Transplant Nutrition class. Counselling will be provided on the elements of the modified Mediterranean diet which emphasizes consumption of fruits, vegetables, whole grains, beans and nuts, in addition to low salt, moderate amounts of lean protein (primarily fish and poultry) in addition to low to moderate quantities of monounsaturated fats. | Behavioral: Dietary Intervention<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight gain | weight in kilograms | 4 months | 
| weight gain | weight in kilograms | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fat mass changes | InBody body composition analysis of fat mass vs lean body mass changes | 4 months | 
| fat mass changes | InBody body composition analysis of fat mass vs lean body mass changes | 12 months |