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

NeuroTherapia, Inc.

Status: Terminated

Conditions: Liver Transplantation; Obesity; Metabolic Syndrome X

Treatments: Other: Mediterranean diet; Other: Protein-Sparing Modified Fast (PSMF); Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT02174783

PTMS-9500

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Control group

Active Comparator group

Description:

Standard of care group

Treatment:

Other: Control group

Mediterranean diet

Experimental group

Description:

Mediterranean diet for 6 months

Treatment:

Other: Mediterranean diet

Protein-Sparing Modified Fast (PSMF)

Experimental group

Description:

PSMF for 6 months

Treatment:

Other: Protein-Sparing Modified Fast (PSMF)