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

NCT ID: NCT04400864

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-30
• Study Completion Date: 2021-05-01

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.

Conditions

Non-Alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mediterranean Diet

Nutritional guidelines based on the principals of the Mediterranean Diet

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: OTHER

dietary counseling based on the principals pf the dietary intervention group.

Paleolithic Diet

Nutritional guidelines based on the principals of thePaleolithic Diet

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: OTHER

dietary counseling based on the principals pf the dietary intervention group.

Interventions

Dietary intervention

dietary counseling based on the principals pf the dietary intervention group.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• NAFLD

Exclusion Criteria

• pregnancy
• Chronic kidney disease
• post transplant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hebrew University of Jerusalem

OTHER

Sponsor Role: collaborator

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

AMIR SHLOMAI

Head of internal medicine department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amir Shlomai, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

Rabin Medical Center

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Amir Shlomai, MD

Role: CONTACT

amirsh9@clalit.org.il

03-9376753

Hagit Lustigman, RD

Role: CONTACT

hagitl2@clalait.org.il

039376034

Facility Contacts

Amir Shlomai, MD

Role: primary

amirsh9@clalit.org.il

03-9376753

Hagit Lustigman, RD

Role: backup

hagitl2@clalit.org.il

039376034

Other Identifiers

0122-19-rmc

Identifier Type: -

Identifier Source: org_study_id