Health TrialsbyHealthPanel

Mediterranean Diet Post-liver Transplantation

ConditionLiver Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dietary Intervention

    Behavioral

    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 with study team.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Standard of Care GroupNo intervention 0 interventions
Group B: Behavioral: Structured Modified Mediterranean DietExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

weight gain

weight in kilograms

Time frame
4 months
2

weight gain

weight in kilograms

Time frame
12 months

Secondary outcomes

1

fat mass changes

InBody body composition analysis of fat mass vs lean body mass changes

Time frame
4 months
2

fat mass changes

InBody body composition analysis of fat mass vs lean body mass changes

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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