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

Not Applicable

Terminated

• Conditions: Obesity; Metabolic Syndrome X; Liver Transplantation
• Interventions: Other: Protein-Sparing Modified Fast (PSMF); Other: Mediterranean diet; Other: Control group

• Registration Number: NCT02174783
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-06-24
• Study First Posted: 2014-06-26
• Status Verified: 2014-07
• Primary Completion: 2015-01
• Study Completion: 2015-04
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protein-Sparing Modified Fast (PSMF)	Protein-Sparing Modified Fast (PSMF)	PSMF for 6 months
Mediterranean diet	Mediterranean diet	Mediterranean diet for 6 months
Control group	Control group	Standard of care group

Primary Outcome Measures

Name	Time	Method
Weight loss	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States