Mediterranean Diet Post-liver Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dietary Intervention.
- Who it may be relevant to
- Registry conditions: Liver Transplantation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of a Structured, Modified Mediterranean Dietary Intervention After Liver Transplantation
Overview
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.
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 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.
Interventions
- 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 w
Primary outcome measures
- weight gain [Time frame: 4 months]
- weight gain [Time frame: 12 months]
Secondary outcome measures (2)
- fat mass changes [Time frame: 4 months]
- fat mass changes [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT04672863 · 20-009762