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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04672863
Study type Interventional
Source Mayo Clinic
Contact Mohammad Qasim Khan, M.B.B.S.
Phone 507-284-3917
Email khan.mohammadqasim@mayo.edu
Status Recruiting
Phase N/A
Start date January 19, 2021
Completion date July 2025

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