Status:
RECRUITING
Mediterranean Diet Post-liver Transplantation
Lead Sponsor:
Mayo Clinic
Conditions:
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 live...
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 i...
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
Exclusion
Key Trial Info
Start Date :
January 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04672863
Start Date
January 19 2021
End Date
November 1 2027
Last Update
January 7 2026
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905