Mediterranean Diet and Protein-Sparing Modified Diet for Metabolic Syndrome in Liver Transplant Recipients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02174783|
Recruitment Status : Terminated
First Posted : June 26, 2014
Last Update Posted : March 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplantation Metabolic Syndrome X Obesity||Other: Control group Other: Mediterranean diet Other: Protein-Sparing Modified Fast (PSMF)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||April 2015|
Active Comparator: Control group
Standard of care group
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.
Experimental: Mediterranean diet
Mediterranean diet for 6 months
Other: 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.
Experimental: Protein-Sparing Modified Fast (PSMF)
PSMF for 6 months
Other: 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.
- Weight loss [ Time Frame: 6 months ]
- Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: 6 months ]Investigate the safety of the mediterranean diet and PSMF in post liver transplant patients
- Change in Hb A1c compared to baseline [ Time Frame: 6 months ]
- Change in HDL and LDL compared to baseline [ Time Frame: 6 months ]
- Change in triglyceride compared to baseline [ Time Frame: 6 months ]
- Change in blood pressure compared to baseline [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02174783
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||mohammed Eyad Yaseen Alsabbagh, MD||The Cleveland Clinic|
|Study Director:||Naim Alkhouri, MD||The Cleveland Clinic|