NCT04672863

Mediterranean Diet Post-liver Transplantation

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
BEHAVIORAL	Dietary Intervention	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.

Timeline

• Start date: 2021-01-19
• Primary completion: 2027-03-01
• Completion: 2027-11-01
• First posted: 2020-12-17
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States