Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Liver Transplantation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT04672863
Collaborators
Not Provided
Investigators
Principal Investigator: Kymberly Watt, MD Mayo Clinic