Back to resultsMediterranean Diet and Protein-Sparing Modified Diet for Metabolic Syndrome in Liver Transplant Recipients
Primary Purpose
Liver Transplantation, Metabolic Syndrome X, Obesity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control group
Mediterranean diet
Protein-Sparing Modified Fast (PSMF)
Sponsored by
About this trial
This is an interventional treatment trial for Liver Transplantation focused on measuring Weight Loss, Diet, Mediterranean, Diet, Reducing, protein sparing modified diet
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:
- Triglyceride (TG)>150 mg/dl or specific treatment for this lipid abnormality
- HDL <40 mg/dl in females and <50 mg/dl in males or specific treatment of this lipid abnormality
- Systolic BP >130 or diastolic BP >85 mm Hg or treatment for previously diagnosed hypertension
- 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
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control group
Mediterranean diet
Protein-Sparing Modified Fast (PSMF)
Arm Description
Standard of care group
Mediterranean diet for 6 months
PSMF for 6 months
Outcomes
Primary Outcome Measures
Weight loss
Secondary Outcome Measures
Number of Participants with Serious and Non-Serious Adverse Events
Investigate the safety of the mediterranean diet and PSMF in post liver transplant patients
Change in Hb A1c compared to baseline
Change in HDL and LDL compared to baseline
Change in triglyceride compared to baseline
Change in blood pressure compared to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02174783
Brief Title
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
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Metabolic Syndrome X, Obesity
Keywords
Weight Loss, Diet, Mediterranean, Diet, Reducing, protein sparing modified diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Standard of care group
Arm Title
Mediterranean diet
Arm Type
Experimental
Arm Description
Mediterranean diet for 6 months
Arm Title
Protein-Sparing Modified Fast (PSMF)
Arm Type
Experimental
Arm Description
PSMF for 6 months
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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
Intervention Name(s)
Mediterranean diet
Intervention Description
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
Intervention Name(s)
Protein-Sparing Modified Fast (PSMF)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants with Serious and Non-Serious Adverse Events
Description
Investigate the safety of the mediterranean diet and PSMF in post liver transplant patients
Time Frame
6 months
Title
Change in Hb A1c compared to baseline
Time Frame
6 months
Title
Change in HDL and LDL compared to baseline
Time Frame
6 months
Title
Change in triglyceride compared to baseline
Time Frame
6 months
Title
Change in blood pressure compared to baseline
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
Triglyceride (TG)>150 mg/dl or specific treatment for this lipid abnormality
HDL <40 mg/dl in females and <50 mg/dl in males or specific treatment of this lipid abnormality
Systolic BP >130 or diastolic BP >85 mm Hg or treatment for previously diagnosed hypertension
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohammed Eyad Yaseen Alsabbagh, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naim Alkhouri, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Director
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
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Mediterranean Diet and Protein-Sparing Modified Diet for Metabolic Syndrome in Liver Transplant Recipients
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