Mediterranean Diet Post-liver Transplantation

Last updated: January 5, 2026
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Transplantation

Treatment

Dietary Intervention

Clinical Study ID

NCT04672863
20-009762
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Dietary Intervention
Phase:
Study Start date:
January 19, 2021
Estimated Completion Date:
November 30, 2027

Study 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.

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic in Rochester

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

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