Mediterranean Diet and Protein-Sparing Modified Diet for Metabolic Syndrome in Liver Transplant Recipients

The Cleveland Clinic25 enrolled

Overview

Many metabolic complications can develop after liver transplant including: diabetes, high blood pressure, obesity, heart attacks and stroke. The goal of this study is to look at the safety and effect of 2 well known and established diet regimens on the people who had a prior liver transplant and investigate whether it helps with the control of these comorbidities.

The Mediterranean diet has been shown to be effective in improving hepatic steatosis, insulin sensitivity, diabetes control and reducing cardiovascular risk in adult patients, but there is no data available for patients who underwent liver transplant. The protein-sparing modified fast (PSMF) diet has been used for years at the Cleveland Clinic to treat adult patients with obesity-related medical problems, but its safety and efficacy has not been established in liver transplant recipients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Transplantation Metabolic Syndrome X Obesity

Interventions

Control groupOTHER

Patient will be provided with basic nutrition educational materials that outline principles of a healthy diet, including: moderation, portion control, increased intakes of fruits, vegetables and whole grains and reduced intakes of saturated fat, salt and sugar. Brief education will be provided by the hepatologist without dietitian referral.

Mediterranean dietOTHER

Patient will receive verbal diet instruction from the dietitian or from the hepatologist who has received instruction from the dietitian on following the Mediterranean diet.

Protein-Sparing Modified Fast (PSMF)OTHER

Patient will be referred to the dietitian for an appointment to discuss the PSMF plan. Protein needs of 1.5 grams/kilogram will be calculated based on patient's actual body weight. Patient will receive verbal instruction from the dietitian, as well as printed materials for reference at home. Dietitian will provide a list of allowed and prohibited foods as per Cleveland Clinic's PSMF diet standards.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Adult patients \> 18 years old who had a successful liver transplant at least 1 year prior to enrollment who also have a BMI\>30 with previous failed attempts at weight loss via conventional methods. In addition to one of the following: 1. Triglyceride (TG)\>150 mg/dl or specific treatment for this lipid abnormality 2. HDL \<40 mg/dl in females and \<50 mg/dl in males or specific treatment of this lipid abnormality 3. Systolic BP \>130 or diastolic BP \>85 mm Hg or treatment for previously diagnosed hypertension 4. Fasting plasma glucose \>100 mg/dl or previously diagnosed type 12 diabetes Exclusion Criteria: * Significant behavioral issues that would interfere with compliance * Lack of readiness to change (pre-contemplation, contemplation or preparation stages) * Previous bariatric surgery * Pregnant or planning to become pregnant * History of a documented eating disorder (e.g. bulimia) * History of kidney stones

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Weight loss

Time frame: 6 months

Secondary Outcomes

Number of Participants with Serious and Non-Serious Adverse Events

Investigate the safety of the mediterranean diet and PSMF in post liver transplant patients

Time frame: 6 months

Change in Hb A1c compared to baseline

Time frame: 6 months

Change in HDL and LDL compared to baseline

Time frame: 6 months

Change in triglyceride compared to baseline

Time frame: 6 months

Change in blood pressure compared to baseline

Time frame: 6 months

Data from ClinicalTrials.gov

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