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

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

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.

Study Overview

• Status: Unknown
• Conditions: Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: Dietary intervention

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amir Shlomai, MD; Phone Number: 03-9376753; Email: amirsh9@clalit.org.il
• Study Contact Backup: Name: Hagit Lustigman, RD; Phone Number: 039376034; Email: hagitl2@clalait.org.il

Study Locations

• Israel
  • Petah tikva, Israel
    • Recruiting
    • Rabin Medical Center
    • Contact: Amir Shlomai, MD; Phone Number: 03-9376753; Email: amirsh9@clalit.org.il
    • Contact: Hagit Lustigman, RD; Phone Number: 039376034; Email: hagitl2@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• NAFLD

Exclusion Criteria:

• pregnancy
• Chronic kidney disease
• post transplant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mediterranean Diet; Nutritional guidelines based on the principals of the Mediterranean Diet	Other: Dietary intervention; dietary counseling based on the principals pf the dietary intervention group.
Experimental: Paleolithic Diet; Nutritional guidelines based on the principals of thePaleolithic Diet	Other: Dietary intervention; dietary counseling based on the principals pf the dietary intervention group.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: Hebrew University of Jerusalem
• Investigators: Principal Investigator: Amir Shlomai, MD, Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2019
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: May 31, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 0122-19-rmc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No