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

Clalit Health Services

Status: Unknown

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Other: Dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04400864

0122-19-rmc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• NAFLD

Exclusion criteria

• pregnancy
• Chronic kidney disease
• post transplant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Mediterranean Diet

Experimental group

Description:

Nutritional guidelines based on the principals of the Mediterranean Diet

Treatment:

Other: Dietary intervention

Paleolithic Diet

Experimental group

Description:

Nutritional guidelines based on the principals of thePaleolithic Diet

Treatment:

Other: Dietary intervention