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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Safety and Efficacy of Mediterranean Diet and Protein-Sparing Modified Diet on Obesity and Metabolic Syndrome in Liver Transplant Recipients: A Randomized Clinical Trial

Conditions
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Liver Transplantation, Metabolic Syndrome X, Obesity

Intervention / Treatment
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* Other: Control group
* Other: Mediterranean diet
* Other: Protein-Sparing Modified Fast (PSMF)


Participation Criteria
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Eligibility Criteria
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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: Triglyceride (TG)>150 mg/dl or specific treatment for this lipid abnormality HDL <40 mg/dl in females and <50 mg/dl in males or specific treatment of this lipid abnormality Systolic BP >130 or diastolic BP >85 mm Hg or treatment for previously diagnosed hypertension 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Standard of care group | Other: Control group<br>* 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.<br>|
| Experimental: Mediterranean diet<br>Mediterranean diet for 6 months | Other: Mediterranean diet<br>* 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.<br>|
| Experimental: Protein-Sparing Modified Fast (PSMF)<br>PSMF for 6 months | Other: Protein-Sparing Modified Fast (PSMF)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Serious and Non-Serious Adverse Events | Investigate the safety of the mediterranean diet and PSMF in post liver transplant patients | 6 months | 
| Change in Hb A1c compared to baseline |  | 6 months | 
| Change in HDL and LDL compared to baseline |  | 6 months | 
| Change in triglyceride compared to baseline |  | 6 months | 
| Change in blood pressure compared to baseline |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss, Diet, Mediterranean, Diet, Reducing, protein sparing modified diet