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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02174783
• Other study ID #: PTMS-9500
• Status: Terminated
• Phase: N/A
• First received: June 23, 2014
• Last updated: March 13, 2017
• Start date: June 2014
• Est. completion date: April 2015

Study information

• Verified date: July 2014
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplantation
• Metabolic Syndrome X
• Obesity
• Syndrome

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		6 months
Secondary	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
Secondary	Change in Hb A1c compared to baseline		6 months
Secondary	Change in HDL and LDL compared to baseline		6 months
Secondary	Change in triglyceride compared to baseline		6 months
Secondary	Change in blood pressure compared to baseline		6 months