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| Name | Class |
|---|---|
| Hebrew University of Jerusalem | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean Diet | Experimental | Nutritional guidelines based on the principals of the Mediterranean Diet |
|
| Paleolithic Diet | Experimental | Nutritional guidelines based on the principals of thePaleolithic Diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary intervention | Other | dietary counseling based on the principals pf the dietary intervention group. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amir Shlomai, MD | Contact | 03-9376753 | amirsh9@clalit.org.il | |
| Hagit Lustigman, RD | Contact | 039376034 | hagitl2@clalait.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Amir Shlomai, MD | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Recruiting | Petah Tikva | Israel |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| 3 months |