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

Not Applicable

• Conditions: Non-Alcoholic Fatty Liver Disease
• Interventions: Other: Dietary intervention

• Registration Number: NCT04400864
• Lead Sponsor: Rabin Medical Center

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.

Detailed 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 Timeline

• Study Start: 2019-12-30
• Status Verified: 2020-05
• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-26
• Last Update Submitted: 2020-05-31
• Last Update Posted: 2020-06-04
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• NAFLD

Exclusion Criteria

• pregnancy
• Chronic kidney disease
• post transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mediterranean Diet	Dietary intervention	Nutritional guidelines based on the principals of the Mediterranean Diet
Paleolithic Diet	Dietary intervention	Nutritional guidelines based on the principals of thePaleolithic Diet

Primary Outcome Measures

Name	Time	Method
Changes in the severity of the fatty liver measured by ultrasound and elastography.	3 months	Changes in fatty liver severity score according to ultrasound wave intensity analysis- light ; moderate ; severe.

Secondary Outcome Measures

Name	Time	Method
Changes in HbA1C	3 months	Blood tests for HbA1C are taken at the beginning and the end of the trial, and analyzed for changes.
Changes in Triglycerides levels	3 months	Blood tests for Triglycerides are taken at the beginning and the end of the trial, and analyzed for changes.

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah tikva, Israel