Clinical trial NCT02174783: Mediterranean Diet and Protein-Sparing Modified Diet for Metabolic Syndrome in Liver Transplant Recipients
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Transplantation
Metabolic Syndrome X
Obesity
Keywords: Weight Loss
Diet, Mediterranean
Diet, Reducing
protein sparing modified diet
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weight loss
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: 6 months
measure: Change in Hb A1c compared to baseline
timeFrame: 6 months
measure: Change in HDL and LDL compared to baseline
timeFrame: 6 months
measure: Change in triglyceride compared to baseline
timeFrame: 6 months
measure: Change in blood pressure compared to baseline
timeFrame: 6 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: mohammed Eyad Yaseen Alsabbagh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Naim Alkhouri, MD
role: STUDY_DIRECTOR
References: