Mediterranean Diet Post-liver Transplantation

Liver Transplantation Clinical Trial

Official title: Effects of a Structured, Modified Mediterranean Dietary Intervention After Liver Transplantation

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Liver Transplantation

• 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