Mediterranean Diet Post-liver Transplantation

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04672863
• Other study ID #: 20-009762
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2021
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: Mohammad Qasim Khan, M.B.B.S.
• Phone: 507-284-3917
• Email: khan.mohammadqasim[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight gain	weight in kilograms	4 months
Primary	weight gain	weight in kilograms	12 months
Secondary	fat mass changes	InBody body composition analysis of fat mass vs lean body mass changes	4 months
Secondary	fat mass changes	InBody body composition analysis of fat mass vs lean body mass changes	12 months