<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/NCT03300661</url>
  </required_header>
  <id_info>
    <org_study_id>Ubrescia</org_study_id>
    <nct_id>NCT03300661</nct_id>
  </id_info>
  <brief_title>Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine</brief_title>
  <acronym>SEELN</acronym>
  <official_title>Open-label, Non-Pharmacological, Intervention Cohort Study Without Control Arm, in Patients With Non Alcoholic Fatty Liver Disease and in Healthy Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi di Brescia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi di Brescia</source>
  <oversight_info>
    <has_dmc>No</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>
      The study is an open-label intervention non pharmacological Cohort Study without control arm&#xD;
      in patients with Non Alcoholic Fatty Liver Disease (NAFLD) and in healthy subjects.&#xD;
&#xD;
      The intervention in patients with NAFLD is educational, providing personalized suggestions to&#xD;
      improve diet and physical activity; the intervention in healthy subjects is educational,&#xD;
      providing general suggestions to improve diet and physical activity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2017</start_date>
  <completion_date type="Actual">May 20, 2019</completion_date>
  <primary_completion_date type="Actual">May 17, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>A single cohort of patients with NAFLD, without control group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>12 months</time_frame>
    <description>A reduction of at least 3 Kg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Mass Index (BMI) decrease</measure>
    <time_frame>12 months</time_frame>
    <description>A dicresae of at least 1Kg/m2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Waist Circumference (WC) decrease</measure>
    <time_frame>12 months</time_frame>
    <description>A decrease of at least 1.5 cm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood sugar level decrease</measure>
    <time_frame>12 months</time_frame>
    <description>A decrease of 6 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood cholesterol level decrease</measure>
    <time_frame>12 months</time_frame>
    <description>A decrease of 9 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood triglycerides level dicrease</measure>
    <time_frame>12 months</time_frame>
    <description>A decrease of 12 mg/dL</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Non Alcoholic Fatty Liver Disease</condition>
  <condition>Lifestyle</condition>
  <condition>Diet Modification</condition>
  <arm_group>
    <arm_group_label>Mediterranean Style</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Educational intervention with personalized suggestions to improve diet and physical activity</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mediterranean Style</intervention_name>
    <description>After completion of a Food Frequency Questinnaire (FFQ) and the International Physical Activity Questionnaire (IPAQ), patients enrolled in the study undergo a personalized educational intervention by a registered dietician. During the intervention the dietician advice about the main errors in diet and physical activity (by FFQ and IPAQ) and chooses three aims in diet modification and one aim in physical activity improvement. Patients adherence is assessed by the same dietician every three months, using FFQ and IPAQ, and futher supports are provided. Total intervention lenght is twelve months.</description>
    <arm_group_label>Mediterranean Style</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of Fatty Liver at ultrasonography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Breast Feeding&#xD;
&#xD;
          -  Cirrhosis or End Stage Liver Disease&#xD;
&#xD;
          -  Fatty Liver due to Hepatic Diseases other than Non Alcoholic Fatty Liver disease&#xD;
&#xD;
          -  Concomitant severe clinical condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chiara Ricci, MD. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università degli Studi di Brescia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ASST Spedali Civili Brescia</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>May 22, 2019</last_update_submitted>
  <last_update_submitted_qc>May 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi di Brescia</investigator_affiliation>
    <investigator_full_name>Chiara Ricci</investigator_full_name>
    <investigator_title>Associate Professor</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/NCT03300661
org study id: Ubrescia
nct id: NCT03300661
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is an open-label intervention non pharmacological Cohort Study without control arm
      in patients with Non Alcoholic Fatty Liver Disease (NAFLD) and in healthy subjects.

      The intervention in patients with NAFLD is educational, providing personalized suggestions to
      improve diet and physical activity; the intervention in healthy subjects is educational,
      providing general suggestions to improve diet and physical activity.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A single cohort of patients with NAFLD, without control group.
primary purpose: Treatment
masking: None (Open Label)
measure: Weight loss
time frame: 12 months
description: A reduction of at least 3 Kg
measure: Body Mass Index (BMI) decrease
time frame: 12 months
description: A dicresae of at least 1Kg/m2
measure: Waist Circumference (WC) decrease
time frame: 12 months
description: A decrease of at least 1.5 cm
measure: Blood sugar level decrease
time frame: 12 months
description: A decrease of 6 mg/dL
measure: Blood cholesterol level decrease
time frame: 12 months
description: A decrease of 9 mg/dL
measure: Blood triglycerides level dicrease
time frame: 12 months
description: A decrease of 12 mg/dL
arm group label: Mediterranean Style
arm group type: Experimental
description: Educational intervention with personalized suggestions to improve diet and physical activity
intervention type: Behavioral
intervention name: Mediterranean Style
description: After completion of a Food Frequency Questinnaire (FFQ) and the International Physical Activity Questionnaire (IPAQ), patients enrolled in the study undergo a personalized educational intervention by a registered dietician. During the intervention the dietician advice about the main errors in diet and physical activity (by FFQ and IPAQ) and chooses three aims in diet modification and one aim in physical activity improvement. Patients adherence is assessed by the same dietician every three months, using FFQ and IPAQ, and futher supports are provided. Total intervention lenght is twelve months.
arm group label: Mediterranean Style
criteria: 
gender: All
minimum age: 20 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chiara Ricci, MD. PhD
role: Principal Investigator
affiliation: Università degli Studi di Brescia
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi di Brescia
investigator full name: Chiara Ricci
investigator title: Associate Professor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: No