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

• ClinicalTrials.gov Identifier: NCT02174783
• Recruitment Status: Terminated
• First Posted: June 26, 2014
• Last Update Posted: March 14, 2017
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): The Cleveland Clinic

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Liver Transplantation; Metabolic Syndrome X; Obesity	Other: Control group; Other: Mediterranean diet; Other: Protein-Sparing Modified Fast (PSMF)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: June 2014
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: April 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Weight loss [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: 6 months ]
   Investigate the safety of the mediterranean diet and PSMF in post liver transplant patients
2. Change in Hb A1c compared to baseline [ Time Frame: 6 months ]
3. Change in HDL and LDL compared to baseline [ Time Frame: 6 months ]
4. Change in triglyceride compared to baseline [ Time Frame: 6 months ]
5. Change in blood pressure compared to baseline [ Time Frame: 6 months ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

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

More Information

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT02174783
• Other Study ID Numbers: PTMS-9500
• First Posted: June 26, 2014
• Last Update Posted: March 14, 2017
• Last Verified: July 2014

Keywords provided by The Cleveland Clinic:

Weight Loss; Diet, Mediterranean; Diet, Reducing; protein sparing modified diet

Additional relevant MeSH terms:

Obesity; Metabolic Syndrome; Syndrome; Disease; Pathologic Processes; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases