<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/NCT04415112</url>
  </required_header>
  <id_info>
    <org_study_id>2017-234</org_study_id>
    <nct_id>NCT04415112</nct_id>
  </id_info>
  <brief_title>Mediterranean Diet Treatment for NAFLD</brief_title>
  <official_title>Effectiveness of a Mediterranean Diet to Treat Non-Alcoholic Fatty Liver Disease in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Antalya Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Antalya Training and Research Hospital</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>
      Treatment for Nonalcoholic Fatty Liver Disease (NAFLD) is through lifestyle modification&#xD;
      consisting of caloric restriction and exercise, with an emphasis on weight loss.&#xD;
      Unfortunately, the success and longevity of lifestyle changes that focus on weight loss, are&#xD;
      poor in children. The dietary recommendation of calorie restriction alone may not be optimal&#xD;
      in a pediatric population for multiple reasons including changes in hormonal milieu, growth&#xD;
      velocity, and decreased bone mineral density that occur with significant weight loss.&#xD;
      Mediterranean Diet (MD) is based on the high intake of extra virgin olive oil, vegetables,&#xD;
      fruits, cereals, nuts and legumes; moderate intakes of fish and other meats, dairy products&#xD;
      and red wine and low intakes of eggs and sweets. So, it provides a large amount of&#xD;
      monounsaturated fatty acids, polyunsaturated fatty acids, vegetable proteins, fibre and&#xD;
      antioxidants; and low amounts of sugar, cholesterol and saturated fats. It offers a lot of&#xD;
      choice in food selection, and well tolerated, and many people can adhere to it over the long&#xD;
      term. The investigators aimed to evaluate the effects of a MD vs. low fat diet on changes in&#xD;
      hepatic steatosis, aminotransferases, and anthropometric measurements among obese children&#xD;
      with NAFLD&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-alcoholic fatty liver disease (NAFLD) is a disease caused by abnormal lipid accumulation&#xD;
      in the liver without alcohol intake or other organic causes. NAFLD covers a range of liver&#xD;
      diseases ranging from simple oil infiltration to non-alcoholic steatohepatitis (NASH),&#xD;
      fibrosis and cirrhosis. The most important risk factor in the development of NAFLD is insulin&#xD;
      resistance due to obesity. Insulin resistance increases hepatic steatosis and accumulation of&#xD;
      hepatic fatty acids by increasing peripheral lipolysis and the entry of fatty acids into the&#xD;
      liver. In parallel with the increased prevalence of childhood obesity, the occurrence of&#xD;
      NAFLD is increasing among children. The risk that the NAFLD can turn into chronic liver&#xD;
      disease increases the importance of the disease even more when children become adults&#xD;
      Mediterranean Diet (MD) has gained popularity in scientific literature because it is one of&#xD;
      the healthiest diets in the world.This diet is based on the high intake of extra virgin olive&#xD;
      oil, vegetables, fruits, cereals, nuts and legumes; moderate intakes of fish and other meats,&#xD;
      dairy products and red wine and low intakes of eggs and sweets. So, it provides a large&#xD;
      amount of monounsaturated fatty acids, polyunsaturated fatty acids, vegetable proteins, fibre&#xD;
      and antioxidants; and low amounts of sugar, cholesterol and saturated fats. MD is&#xD;
      characterized as low-carbohydrate (40% of calories) and in contrast to low-fat diets, the MD&#xD;
      includes fat as 40% of the diet. It offers a lot of choice in food selection, and well&#xD;
      tolerated, and many people can adhere to it over the long term. There are a limited number of&#xD;
      studies investigating the effectiveness of the MD in NAFLD treatment in different countries.&#xD;
      However, there are no studies in the treatment of children with NAFLD in Turkey. The primary&#xD;
      aims to this study is to evaluate the effects of a MD vs. low fat diet on changes in hepatic&#xD;
      steatosis, aminotransferases, and anthropometric measurements among obese children with NAFLD&#xD;
      in Turkey. The secondary aim to this study is to evaluate the effects of the both diets in&#xD;
      insulin resistance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>
    <intervention_model_description>The study design was a single-blinded randomized, parallel assignment clinical trial of children with NAFLD was conducted. Participants were randomized in a 1:1 fashion to either 12-weeks of a Mediterranean diet or a low fat diet.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The study design was single blind and the participants did not know what diet they had taken.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Non-alcoholic Fatty Liver Disease Ultrasonography Score</measure>
    <time_frame>12 weeks</time_frame>
    <description>A semiquantitative score to measure Non-alcoholic Fatty Liver Disease will be used. Degrees of steatosis range from 0 (no steatosis) to 3 (severe steatosis), according to Hamaguchi score, which used a 6-point scoring system based on liver brightness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effects of the both diets in insulin resistance</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in Homeostatic Model Assessment of Insulin Resistance from baseline to 12-week post Mediterranean diet and low fat diet intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effects of the both diets in capillary blood glucose</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in fasting capillary blood glucose (mg/dL) from baseline to 12-week post Mediterranean diet and low fat diet intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effects of the both diets in fasting insulin levels</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes in fasting insulin (μU/mL) levels from baseline to 12-week post Mediterranean diet and low fat diet intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Mediterranean Diet</condition>
  <arm_group>
    <arm_group_label>Mediterranean Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The MD diet is rich in plant based foods including vegetables, whole cereal and fruit with the main added fat being extra virgin olive oil. In addition, the diet emphasises, while consumption of legumes, nuts and fish is high, consumption of red meat and home-made desserts is low, and consumption of fermented milk and poultry is moderate. The MD diet had a target macronutrient composition of 35-40% fat (with &lt;10% of energy as saturated fat), 40-44% carbohydrate and 20% protein.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Fat Diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Low Fat diet had a target macronutrient composition of 55% of energy from carbohydrate, 20-25% from fat (with &lt;10% of energy as saturated fat) and 20-25% from protein. Nutrition education focused on choosing foods containing ≤3 grams of fat/serving, limiting added fats, and using low-fat meal preparation strategies. Parents were instructed to offer their children ample amounts of grains, vegetables, fruits, lean meats, low-fat dairy products and limit high-fat foods</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mediterranean Diet</intervention_name>
    <description>A list of foods high consumption of vegetables, fruits, non-refined cereals, legumes and potatoes, moderate consumption of fish and poultry and low consumption of full fat dairies, red meat and its products and homemade sweets.</description>
    <arm_group_label>Mediterranean Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Low Fat Diet</intervention_name>
    <description>These children are forbidden to eat high-fat foods such as fried foods, butter, cream cheese, while foods such as fruits, vegetables (starchy and non-starch), cereals, poultry, lean meat and low-fat dairy products are allowed.</description>
    <arm_group_label>Low Fat Diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of NAFLD&#xD;
&#xD;
          -  Body mass index z-score &gt;85th percentile&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary causes of NAFLD (eg. medication induced)&#xD;
&#xD;
          -  Use of weight loss medications&#xD;
&#xD;
          -  Diabetes Mellitus&#xD;
&#xD;
          -  Other causes of fatty liver disease (eg. Wilson disease, alpha-1 antitrypsin&#xD;
             deficiency, auto-immune hepatitis, and viral hepatitis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulas E Akbulut</last_name>
    <role>Study Chair</role>
    <affiliation>Antalya Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ulas Emre Akbulut</name>
      <address>
        <city>Antalya</city>
        <zip>07100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Properzi C, O'Sullivan TA, Sherriff JL, Ching HL, Jeffrey GP, Buckley RF, Tibballs J, MacQuillan GC, Garas G, Adams LA. Ad Libitum Mediterranean and Low-Fat Diets Both Significantly Reduce Hepatic Steatosis: A Randomized Controlled Trial. Hepatology. 2018 Nov;68(5):1741-1754. doi: 10.1002/hep.30076. Epub 2018 Oct 14.</citation>
    <PMID>29729189</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 30, 2020</last_update_submitted>
  <last_update_submitted_qc>May 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non Alcoholic Fatty Liver Disease</keyword>
  <keyword>Mediterranean Diet</keyword>
  <keyword>Low Fat Diet</keyword>
  <keyword>Children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04415112
org study id: 2017-234
nct id: NCT04415112
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Treatment for Nonalcoholic Fatty Liver Disease (NAFLD) is through lifestyle modification
      consisting of caloric restriction and exercise, with an emphasis on weight loss.
      Unfortunately, the success and longevity of lifestyle changes that focus on weight loss, are
      poor in children. The dietary recommendation of calorie restriction alone may not be optimal
      in a pediatric population for multiple reasons including changes in hormonal milieu, growth
      velocity, and decreased bone mineral density that occur with significant weight loss.
      Mediterranean Diet (MD) is based on the high intake of extra virgin olive oil, vegetables,
      fruits, cereals, nuts and legumes; moderate intakes of fish and other meats, dairy products
      and red wine and low intakes of eggs and sweets. So, it provides a large amount of
      monounsaturated fatty acids, polyunsaturated fatty acids, vegetable proteins, fibre and
      antioxidants; and low amounts of sugar, cholesterol and saturated fats. It offers a lot of
      choice in food selection, and well tolerated, and many people can adhere to it over the long
      term. The investigators aimed to evaluate the effects of a MD vs. low fat diet on changes in
      hepatic steatosis, aminotransferases, and anthropometric measurements among obese children
      with NAFLD
Non-alcoholic fatty liver disease (NAFLD) is a disease caused by abnormal lipid accumulation
      in the liver without alcohol intake or other organic causes. NAFLD covers a range of liver
      diseases ranging from simple oil infiltration to non-alcoholic steatohepatitis (NASH),
      fibrosis and cirrhosis. The most important risk factor in the development of NAFLD is insulin
      resistance due to obesity. Insulin resistance increases hepatic steatosis and accumulation of
      hepatic fatty acids by increasing peripheral lipolysis and the entry of fatty acids into the
      liver. In parallel with the increased prevalence of childhood obesity, the occurrence of
      NAFLD is increasing among children. The risk that the NAFLD can turn into chronic liver
      disease increases the importance of the disease even more when children become adults
      Mediterranean Diet (MD) has gained popularity in scientific literature because it is one of
      the healthiest diets in the world.This diet is based on the high intake of extra virgin olive
      oil, vegetables, fruits, cereals, nuts and legumes; moderate intakes of fish and other meats,
      dairy products and red wine and low intakes of eggs and sweets. So, it provides a large
      amount of monounsaturated fatty acids, polyunsaturated fatty acids, vegetable proteins, fibre
      and antioxidants; and low amounts of sugar, cholesterol and saturated fats. MD is
      characterized as low-carbohydrate (40% of calories) and in contrast to low-fat diets, the MD
      includes fat as 40% of the diet. It offers a lot of choice in food selection, and well
      tolerated, and many people can adhere to it over the long term. There are a limited number of
      studies investigating the effectiveness of the MD in NAFLD treatment in different countries.
      However, there are no studies in the treatment of children with NAFLD in Turkey. The primary
      aims to this study is to evaluate the effects of a MD vs. low fat diet on changes in hepatic
      steatosis, aminotransferases, and anthropometric measurements among obese children with NAFLD
      in Turkey. The secondary aim to this study is to evaluate the effects of the both diets in
      insulin resistance.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study design was a single-blinded randomized, parallel assignment clinical trial of children with NAFLD was conducted. Participants were randomized in a 1:1 fashion to either 12-weeks of a Mediterranean diet or a low fat diet.
primary purpose: Other
masking: Single (Participant)
masking description: The study design was single blind and the participants did not know what diet they had taken.
measure: Non-alcoholic Fatty Liver Disease Ultrasonography Score
time frame: 12 weeks
description: A semiquantitative score to measure Non-alcoholic Fatty Liver Disease will be used. Degrees of steatosis range from 0 (no steatosis) to 3 (severe steatosis), according to Hamaguchi score, which used a 6-point scoring system based on liver brightness.
measure: Evaluate the effects of the both diets in insulin resistance
time frame: 12 weeks
description: Changes in Homeostatic Model Assessment of Insulin Resistance from baseline to 12-week post Mediterranean diet and low fat diet intervention
measure: Evaluate the effects of the both diets in capillary blood glucose
time frame: 12 weeks
description: Changes in fasting capillary blood glucose (mg/dL) from baseline to 12-week post Mediterranean diet and low fat diet intervention
measure: Evaluate the effects of the both diets in fasting insulin levels
time frame: 12 weeks
description: Changes in fasting insulin (μU/mL) levels from baseline to 12-week post Mediterranean diet and low fat diet intervention
arm group label: Mediterranean Diet
arm group type: Active Comparator
description: The MD diet is rich in plant based foods including vegetables, whole cereal and fruit with the main added fat being extra virgin olive oil. In addition, the diet emphasises, while consumption of legumes, nuts and fish is high, consumption of red meat and home-made desserts is low, and consumption of fermented milk and poultry is moderate. The MD diet had a target macronutrient composition of 35-40% fat (with <10% of energy as saturated fat), 40-44% carbohydrate and 20% protein.
arm group label: Low Fat Diet
arm group type: Active Comparator
description: The Low Fat diet had a target macronutrient composition of 55% of energy from carbohydrate, 20-25% from fat (with <10% of energy as saturated fat) and 20-25% from protein. Nutrition education focused on choosing foods containing ≤3 grams of fat/serving, limiting added fats, and using low-fat meal preparation strategies. Parents were instructed to offer their children ample amounts of grains, vegetables, fruits, lean meats, low-fat dairy products and limit high-fat foods
intervention type: Behavioral
intervention name: Mediterranean Diet
description: A list of foods high consumption of vegetables, fruits, non-refined cereals, legumes and potatoes, moderate consumption of fish and poultry and low consumption of full fat dairies, red meat and its products and homemade sweets.
arm group label: Mediterranean Diet
intervention type: Behavioral
intervention name: Low Fat Diet
description: These children are forbidden to eat high-fat foods such as fried foods, butter, cream cheese, while foods such as fruits, vegetables (starchy and non-starch), cereals, poultry, lean meat and low-fat dairy products are allowed.
arm group label: Low Fat Diet
criteria: 
gender: All
minimum age: 9 Years
maximum age: 17 Years
healthy volunteers: No
last name: Ulas E Akbulut
role: Study Chair
affiliation: Antalya Training and Research Hospital
facility: 
country: Turkey
citation: Properzi C, O'Sullivan TA, Sherriff JL, Ching HL, Jeffrey GP, Buckley RF, Tibballs J, MacQuillan GC, Garas G, Adams LA. Ad Libitum Mediterranean and Low-Fat Diets Both Significantly Reduce Hepatic Steatosis: A Randomized Controlled Trial. Hepatology. 2018 Nov;68(5):1741-1754. doi: 10.1002/hep.30076. Epub 2018 Oct 14.
PMID: 29729189
responsible party type: Sponsor
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: No