Clinical trial NCT04672863: Mediterranean Diet Post-liver Transplantation
Official title: Effects of a Structured, Modified Mediterranean Dietary Intervention After Liver Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Transplantation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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

Primary outcomes:
measure: weight gain
timeFrame: 4 months
measure: weight gain
timeFrame: 12 months
Secondary outcomes:
measure: fat mass changes
timeFrame: 4 months
measure: fat mass changes
timeFrame: 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kymberly Watt, MD
role: PRINCIPAL_INVESTIGATOR
References: