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

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

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.

Study Overview

• Status: Terminated
• Conditions: Liver Transplantation; Obesity; Metabolic Syndrome X
• Intervention / Treatment: Other: Control group; Other: Mediterranean diet; Other: Protein-Sparing Modified Fast (PSMF)

Detailed Description

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
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: mohammed Eyad Yaseen Alsabbagh, MD, The Cleveland Clinic; Study Director: Naim Alkhouri, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: June 23, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 26, 2014

Study Record Updates

• Last Update Posted (Actual): March 14, 2017
• Last Update Submitted That Met QC Criteria: March 13, 2017
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Weight Loss; Diet, Reducing; Diet, Mediterranean; protein sparing modified diet
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Syndrome; Obesity; Metabolic Syndrome
• Other Study ID Numbers: PTMS-9500