Mediterranean Diet Post-liver Transplantation

This study is looking at whether a modified Mediterranean diet can help prevent weight gain and improve heart health after a liver transplant. Researchers want to see if this diet can also prevent fatty liver disease. You might be able to join if you are an adult (18 or older) who has recently had a liver transplant, have a certain body mass index (BMI) of 25 or higher, and good liver function. The study will measure weight gain at 4 and 12 months to see if the diet is successful. The current status of this study is unclear.

Study design
This is a randomized study, meaning participants are randomly assigned to either follow the modified Mediterranean diet or receive standard care. It plans to enroll 80 participants.
What's involved
All patients will be followed for 12 months. The record does not specify the number of visits, procedures, or tests.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after starting the study.

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NCT04672863

Mediterranean Diet Post-liver Transplantation

Recruiting
NAAges 18+InterventionalSupportive care
Mayo Clinic
~80 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:Dietary Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
weight gain
Measured over 4 months
+1 more outcome measured
Liver Transplantation
1 sites across 1 states
Minnesota1
  • Kymberly Watt, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

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

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
  • weight gain4 months

    weight in kilograms

  • weight gain12 months

    weight in kilograms