Mediterranean Diet Post-liver Transplantation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Transplantation
• Intervention / Treatment: Behavioral: Dietary Intervention

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kymberly Watt, MD; Phone Number: 507-266-1586; Email: watt.kymberly@mayo.edu
• Study Contact Backup: Name: Mohammad Qasim Khan, M.B.B.S.; Phone Number: 507-284-3917; Email: khan.mohammadqasim@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Kymberly Watt, MD; Phone Number: 5072661586; Email: watt.kymberly@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Adult patients ≥ 18 years of age undergoing primary liver transplant
• Ascites-adjusted BMI ≥ 25 kg/m2
• Acceptable graft function (total bilirubin level < 5 mg/dL and doppler ultrasound with patent hepatic artery, hepatic veins and portal veins)

Exclusion Criteria

• Hepatocellular carcinoma (HCC) that did not fulfill Milan criteria as per explant histology
• Untreated post-transplant vascular complications or biliary strictures
• Multi-organ transplantation
• Urine protein excretion ≥2.0 g/day
• Uncontrolled diabetes mellitus (HbA1c > 10%)
• Associated medical conditions incompatible with safe participation in a nutritional intervention study, including digestive diseases with fat intolerance, neurological, psychiatric or endocrine disorders
• Active eating disorder (e.g. bulimia nervosa, anorexia nervosa)
• History of bariatric surgery
• Pregnancy or planning on pregnancy in the next year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care Group; Subjects will participate in a standardized Transplant Nutrition class between day 21-40 as per institutional protocol and will be counseled as per the Mayo Clinic standard of care vis a vis dietary intervention, standard aerobic and resistance exercise recommendations (consistent with AASLD guidelines) and other lifestyle interventions.
Experimental: Behavioral: Structured Modified Mediterranean Diet; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight gain	weight in kilograms	4 months
weight gain	weight in kilograms	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fat mass changes	InBody body composition analysis of fat mass vs lean body mass changes	4 months
fat mass changes	InBody body composition analysis of fat mass vs lean body mass changes	12 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Kymberly Watt, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2021
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Nutrition Therapy; Diet Therapy
• Other Study ID Numbers: 20-009762

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No