Non-Alcoholic Fatty Liver Disease
Conditions
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.
Interventions
OTHERDietary intervention
dietary counseling based on the principals pf the dietary intervention group.
Sponsors
Hebrew University of Jerusalem
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* NAFLD
Exclusion criteria
* pregnancy * Chronic kidney disease * post transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the severity of the fatty liver measured by ultrasound and elastography. | 3 months | Changes in fatty liver severity score according to ultrasound wave intensity analysis- light ; moderate ; severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HbA1C | 3 months | Blood tests for HbA1C are taken at the beginning and the end of the trial, and analyzed for changes. |
| Changes in Triglycerides levels | 3 months | Blood tests for Triglycerides are taken at the beginning and the end of the trial, and analyzed for changes. |
Countries
Israel
Contacts
Primary ContactAmir Shlomai, MD
Backup ContactHagit Lustigman, RD
Outcome results
None listed