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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
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.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
RECRUITINGweight gain
weight in kilograms
Time frame: 4 months
weight gain
weight in kilograms
Time frame: 12 months
fat mass changes
InBody body composition analysis of fat mass vs lean body mass changes
Time frame: 4 months
fat mass changes
InBody body composition analysis of fat mass vs lean body mass changes
Time frame: 12 months
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