Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty Liver Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty

Conditions
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Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Other: Dietary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: NAFLD Exclusion Criteria: pregnancy Chronic kidney disease post transplant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean Diet<br>Nutritional guidelines based on the principals of the Mediterranean Diet | Other: Dietary intervention<br>* dietary counseling based on the principals pf the dietary intervention group.<br>|
| Experimental: Paleolithic Diet<br>Nutritional guidelines based on the principals of thePaleolithic Diet | Other: Dietary intervention<br>* dietary counseling based on the principals pf the dietary intervention group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HbA1C | Blood tests for HbA1C are taken at the beginning and the end of the trial, and analyzed for changes. | 3 months | 
| Changes in Triglycerides levels | Blood tests for Triglycerides are taken at the beginning and the end of the trial, and analyzed for changes. | 3 months |