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Clinical Trial 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.


Clinical Trial Description

Recruitment of 60 patients with the diagnosis NAFLD from clinics in Rabin Medical center, aged 18-65.

Two study groups- Mediterranean Diet and Paleolithic Diet The dietitian will assign randomly for the study groups, and will assess diet adherence within 6 weeks of the trial and in its end- after 3 months.

blood test for liver enzymes, lipids, crp, mda and HbA1C, will be taken at recruitment and after 3 months.

Ultrasound and elastography will be tested at recruitment and after 3 months, to evaluate the degree of the fatty liver, by a the same doctor who is blind to the study groups. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04400864
Study type Interventional
Source Rabin Medical Center
Contact Amir Shlomai, MD
Phone 03-9376753
Email amirsh9@clalit.org.il
Status Recruiting
Phase N/A
Start date December 30, 2019
Completion date May 1, 2021

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