Mediterranean Diet Post-liver Transplantation

Not Applicable

Recruiting

• Conditions: Liver Transplantation
• Interventions: Behavioral: Dietary Intervention

• Registration Number: NCT04672863
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-17
• Study Start: 2021-01-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-12
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral: Structured Modified Mediterranean Diet	Dietary Intervention	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.

Primary Outcome Measures

Name	Time	Method
weight gain	12 months	weight in kilograms

Secondary Outcome Measures

Name	Time	Method
fat mass changes	12 months	InBody body composition analysis of fat mass vs lean body mass changes

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States