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Search / Trial NCT04672863

Mediterranean Diet Post-liver Transplantation

Launched by MAYO CLINIC · Dec 14, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how a Mediterranean diet can help patients after they have had a liver transplant. The Mediterranean diet is rich in fruits, vegetables, whole grains, and healthy fats, and the study aims to see if following this diet can help prevent weight gain, promote heart health, and reduce the risk of fatty liver disease in these patients.

To be eligible for this study, participants need to be adults aged 18 or older who are about to undergo their first liver transplant and have a body mass index (BMI) of 25 or higher. However, individuals with certain health issues, like uncontrolled diabetes or active eating disorders, cannot participate. Those who join the study can expect to follow a structured eating plan based on Mediterranean foods and will be monitored for how this diet affects their health after the transplant. This trial is important because it could provide valuable insights into how diet can play a role in recovery and long-term health after liver transplantation.

Gender

ALL

Eligibility criteria

  • 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

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Rochester, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

Kymberly Watt, MD

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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