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

NCT ID: NCT02174783

Last Updated: 2017-03-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-04-30

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.

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.

Conditions

Liver Transplantation; Metabolic Syndrome X; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Standard of care group

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

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 diet

Mediterranean diet for 6 months

Group Type: EXPERIMENTAL

Mediterranean diet

Intervention Type: OTHER

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)

PSMF for 6 months

Group Type: EXPERIMENTAL

Protein-Sparing Modified Fast (PSMF)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

mohammed Eyad Yaseen Alsabbagh, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Naim Alkhouri, MD

Role: STUDY_DIRECTOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

PTMS-9500

Identifier Type: -

Identifier Source: org_study_id