<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04400864</url>
  </required_header>
  <id_info>
    <org_study_id>0122-19-rmc</org_study_id>
    <nct_id>NCT04400864</nct_id>
  </id_info>
  <brief_title>Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty Liver Disease</brief_title>
  <acronym>PALMED</acronym>
  <official_title>Mediterranean Diet Versus Paleolithic Diet for the Treatment of Non Alcohlic Fatty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hebrew University of Jerusalem</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non- alcoholic fatty liver disease (NAFLD) is one of metabolic syndrome manifestation, and&#xD;
      has become the leading cause for cirrhosis and the need for liver transplantation.&#xD;
&#xD;
      The Mediterranean diet showed in many trials its benefit in the treatment of the metabolic&#xD;
      syndrome and NAFLD. The Paleolithic Diet includes meat, fish, fruits, vegetables, nuts and&#xD;
      seeds and avoidance of processed food and most of carbohydrates. In some studies this diet&#xD;
      seemed to decrease triglycerides levels and improve insulin resistance.&#xD;
&#xD;
      The aim of this study is to evaluate the influance of the paleolithic diat for the treatment&#xD;
      of NAFLD, as shown in the Mediterranean Diet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recruitment of 60 patients with the diagnosis NAFLD from clinics in Rabin Medical center,&#xD;
      aged 18-65.&#xD;
&#xD;
      Two study groups- Mediterranean Diet and Paleolithic Diet The dietitian will assign randomly&#xD;
      for the study groups, and will assess diet adherence within 6 weeks of the trial and in its&#xD;
      end- after 3 months.&#xD;
&#xD;
      blood test for liver enzymes, lipids, crp, mda and HbA1C, will be taken at recruitment and&#xD;
      after 3 months.&#xD;
&#xD;
      Ultrasound and elastography will be tested at recruitment and after 3 months, to evaluate the&#xD;
      degree of the fatty liver, by a the same doctor who is blind to the study groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 30, 2019</start_date>
  <completion_date type="Anticipated">May 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in the severity of the fatty liver measured by ultrasound and elastography.</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in fatty liver severity score according to ultrasound wave intensity analysis- light ; moderate ; severe.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in HbA1C</measure>
    <time_frame>3 months</time_frame>
    <description>Blood tests for HbA1C are taken at the beginning and the end of the trial, and analyzed for changes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Triglycerides levels</measure>
    <time_frame>3 months</time_frame>
    <description>Blood tests for Triglycerides are taken at the beginning and the end of the trial, and analyzed for changes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Non-Alcoholic Fatty Liver Disease</condition>
  <arm_group>
    <arm_group_label>Mediterranean Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutritional guidelines based on the principals of the Mediterranean Diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paleolithic Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nutritional guidelines based on the principals of thePaleolithic Diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dietary intervention</intervention_name>
    <description>dietary counseling based on the principals pf the dietary intervention group.</description>
    <arm_group_label>Mediterranean Diet</arm_group_label>
    <arm_group_label>Paleolithic Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  NAFLD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  Chronic kidney disease&#xD;
&#xD;
          -  post transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amir Shlomai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rabin Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amir Shlomai, MD</last_name>
    <phone>03-9376753</phone>
    <email>amirsh9@clalit.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hagit Lustigman, RD</last_name>
    <phone>039376034</phone>
    <email>hagitl2@clalait.org.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petah tikva</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amir Shlomai, MD</last_name>
      <phone>03-9376753</phone>
      <email>amirsh9@clalit.org.il</email>
    </contact>
    <contact_backup>
      <last_name>Hagit Lustigman, RD</last_name>
      <phone>039376034</phone>
      <email>hagitl2@clalit.org.il</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 31, 2020</last_update_submitted>
  <last_update_submitted_qc>May 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rabin Medical Center</investigator_affiliation>
    <investigator_full_name>AMIR SHLOMAI</investigator_full_name>
    <investigator_title>Head of internal medicine department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04400864
org study id: 0122-19-rmc
nct id: NCT04400864
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes in the severity of the fatty liver measured by ultrasound and elastography.
time frame: 3 months
description: Changes in fatty liver severity score according to ultrasound wave intensity analysis- light ; moderate ; severe.
measure: Changes in HbA1C
time frame: 3 months
description: Blood tests for HbA1C are taken at the beginning and the end of the trial, and analyzed for changes.
measure: Changes in Triglycerides levels
time frame: 3 months
description: Blood tests for Triglycerides are taken at the beginning and the end of the trial, and analyzed for changes.
arm group label: Mediterranean Diet
arm group type: Experimental
description: Nutritional guidelines based on the principals of the Mediterranean Diet
arm group label: Paleolithic Diet
arm group type: Experimental
description: Nutritional guidelines based on the principals of thePaleolithic Diet
intervention type: Other
intervention name: Dietary intervention
description: dietary counseling based on the principals pf the dietary intervention group.
arm group label: Mediterranean Diet
arm group label: Paleolithic Diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amir Shlomai, MD
role: Principal Investigator
affiliation: Rabin Medical Center
last name: Amir Shlomai, MD
phone: 03-9376753
email: amirsh9@clalit.org.il
last name: Hagit Lustigman, RD
phone: 039376034
email: hagitl2@clalait.org.il
facility: 
status: Recruiting
contact: 
contact backup: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Rabin Medical Center
investigator full name: AMIR SHLOMAI
investigator title: Head of internal medicine department
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: No