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

Non-Alcoholic Fatty Liver Disease Clinical Trial

— PALMED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04400864
• Other study ID #: 0122-19-rmc
• Status: Recruiting
• Phase: N/A
• Start date: December 30, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: May 2020
• Source: Rabin Medical Center
• Contact: Amir Shlomai, MD
• Phone: 03-9376753
• Email: amirsh9[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• NAFLD

Exclusion Criteria:

• pregnancy

• Chronic kidney disease

• post transplant

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Other:
• Dietary intervention
dietary counseling based on the principals pf the dietary intervention group.

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in HbA1C	Blood tests for HbA1C are taken at the beginning and the end of the trial, and analyzed for changes.	3 months
Secondary	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