Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty Liver Disease (PALMED)
Primary Purpose
Non-Alcoholic Fatty Liver Disease
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease
Eligibility Criteria
Inclusion Criteria:
- NAFLD
Exclusion Criteria:
- pregnancy
- Chronic kidney disease
- post transplant
Sites / Locations
- Rabin Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mediterranean Diet
Paleolithic Diet
Arm Description
Nutritional guidelines based on the principals of the Mediterranean Diet
Nutritional guidelines based on the principals of thePaleolithic Diet
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in HbA1C
Blood tests for HbA1C are taken at the beginning and the end of the trial, and analyzed for changes.
Changes in Triglycerides levels
Blood tests for Triglycerides are taken at the beginning and the end of the trial, and analyzed for changes.
Full Information
NCT ID
NCT04400864
First Posted
May 20, 2020
Last Updated
May 31, 2020
Sponsor
Rabin Medical Center
Collaborators
Hebrew University of Jerusalem
1. Study Identification
Unique Protocol Identification Number
NCT04400864
Brief Title
Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty Liver Disease
Acronym
PALMED
Official Title
Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 30, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
Collaborators
Hebrew University of Jerusalem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mediterranean Diet
Arm Type
Experimental
Arm Description
Nutritional guidelines based on the principals of the Mediterranean Diet
Arm Title
Paleolithic Diet
Arm Type
Experimental
Arm Description
Nutritional guidelines based on the principals of thePaleolithic Diet
Intervention Type
Other
Intervention Name(s)
Dietary intervention
Intervention Description
dietary counseling based on the principals pf the dietary intervention group.
Primary Outcome Measure Information:
Title
Changes in the severity of the fatty liver measured by ultrasound and elastography.
Description
Changes in fatty liver severity score according to ultrasound wave intensity analysis- light ; moderate ; severe.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Changes in HbA1C
Description
Blood tests for HbA1C are taken at the beginning and the end of the trial, and analyzed for changes.
Time Frame
3 months
Title
Changes in Triglycerides levels
Description
Blood tests for Triglycerides are taken at the beginning and the end of the trial, and analyzed for changes.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
NAFLD
Exclusion Criteria:
pregnancy
Chronic kidney disease
post transplant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amir Shlomai, MD
Phone
03-9376753
Email
amirsh9@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Hagit Lustigman, RD
Phone
039376034
Email
hagitl2@clalait.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Shlomai, MD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petah tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Shlomai, MD
Phone
03-9376753
Email
amirsh9@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Hagit Lustigman, RD
Phone
039376034
Email
hagitl2@clalit.org.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty Liver Disease
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