Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty Liver Disease
PALMED
1 other identifier
interventional
60
1 country
1
Brief Summary
Non- alcoholic fatty liver disease (NAFLD) is one of metabolic syndrome manifestation, and has become the leading cause for cirrhosis and the need for liver transplantation. The Mediterranean diet showed in many trials its benefit in the treatment of the metabolic syndrome and NAFLD. The Paleolithic Diet includes meat, fish, fruits, vegetables, nuts and seeds and avoidance of processed food and most of carbohydrates. In some studies this diet seemed to decrease triglycerides levels and improve insulin resistance. The aim of this study is to evaluate the influance of the paleolithic diat for the treatment of NAFLD, as shown in the Mediterranean Diet.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 30, 2019
CompletedFirst Submitted
Initial submission to the registry
May 20, 2020
CompletedFirst Posted
Study publicly available on registry
May 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedJune 4, 2020
May 1, 2020
1.3 years
May 20, 2020
May 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in the severity of the fatty liver measured by ultrasound and elastography.
Changes in fatty liver severity score according to ultrasound wave intensity analysis- light ; moderate ; severe.
3 months
Secondary Outcomes (2)
Changes in HbA1C
3 months
Changes in Triglycerides levels
3 months
Study Arms (2)
Mediterranean Diet
EXPERIMENTALNutritional guidelines based on the principals of the Mediterranean Diet
Paleolithic Diet
EXPERIMENTALNutritional guidelines based on the principals of thePaleolithic Diet
Interventions
dietary counseling based on the principals pf the dietary intervention group.
Eligibility Criteria
You may qualify if:
- NAFLD
You may not qualify if:
- pregnancy
- Chronic kidney disease
- post transplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rabin Medical Centerlead
- Hebrew University of Jerusalemcollaborator
Study Sites (1)
Rabin Medical Center
Petah Tikva, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amir Shlomai, MD
Rabin Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of internal medicine department
Study Record Dates
First Submitted
May 20, 2020
First Posted
May 26, 2020
Study Start
December 30, 2019
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
June 4, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share