<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/NCT02259244</url>
  </required_header>
  <id_info>
    <org_study_id>006-0000000-3521</org_study_id>
    <nct_id>NCT02259244</nct_id>
  </id_info>
  <brief_title>Effect of Mediterranean and Hypolipemic Reduction Diet in Obese Patients</brief_title>
  <official_title>Effect of the Mediterranean Diet and Hypolipemic Reduction Diet in Combination With Exercise in Obese Croatian Population- 1-year Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zagreb</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital Dubrava</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Zagreb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the combined effect of physical activity and&#xD;
      adherence to Mediterranean diet or Hypolipemic Reduction diet on parameters of oxidative&#xD;
      stress in obese patients enrolled in the weight management reduction program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2008</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxidative stress</measure>
    <time_frame>The outcome measure is studied at baseline, 1 and 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body weight (kg)</measure>
    <time_frame>The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist circumference (cm)</measure>
    <time_frame>The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting glycemia</measure>
    <time_frame>The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid profile (HLD, LDL, TC,)</measure>
    <time_frame>The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urate</measure>
    <time_frame>The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure (mmHg)</measure>
    <time_frame>The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity level</measure>
    <time_frame>The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months</time_frame>
    <description>IPAQ-SF for record on physical activity during 7 last 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months</time_frame>
    <description>SF-36 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary intakes</measure>
    <time_frame>The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months</time_frame>
    <description>Food Frequency Questionnaire 7-day food diary</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">124</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Mediterranean diet+physical activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mediterranean diet based on 1573 kcal/day with the goal of consumption of 30 ml/day of olive oil, 56g/week of nuts, 3-4 servings/week of fish, 3 servings/day of fruits, 2-3 servings/day of vegetables, 3 servings/week legumes and white meat instead of red meat</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hypolipemic reduction diet+physical activity</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hypolipemic reduction diet based on 1287 kcal/day with the goal of consumption of 3 servings/day of fruits, 2-3 servings/day of vegetables, 3 servings/week legumes and white meat instead of red meat, non-fat or low-fat dairy products</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight reduction program</intervention_name>
    <arm_group_label>Hypolipemic reduction diet+physical activity</arm_group_label>
    <arm_group_label>Mediterranean diet+physical activity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI ≥ 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  newly diagnosed diabetes, hypertension or cardiovascular disease&#xD;
&#xD;
          -  change in antihypertensive therapy and antidiabetic therapy in the period of 3 months&#xD;
             prior to the commencement of the study&#xD;
&#xD;
          -  insulin therapy&#xD;
&#xD;
          -  alcohol consumption &gt;500 g of alcohol/week in the last year&#xD;
&#xD;
          -  pregnancy or breast feeding&#xD;
&#xD;
          -  use of drugs affecting weight control (eg. weight loss medication or systemic&#xD;
             glucocorticoids)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>October 3, 2014</last_update_submitted>
  <last_update_submitted_qc>October 3, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Zagreb</investigator_affiliation>
    <investigator_full_name>Prof. dr. sc. Velimir Božikov</investigator_full_name>
    <investigator_title>Head of the Department of Endocrinology, Diabetes and Metabolism Disorders, Dubrava University Hospital</investigator_title>
  </responsible_party>
  <!-- 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/NCT02259244
org study id: 006-0000000-3521
nct id: NCT02259244
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the combined effect of physical activity and
      adherence to Mediterranean diet or Hypolipemic Reduction diet on parameters of oxidative
      stress in obese patients enrolled in the weight management reduction program.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: Oxidative stress
time frame: The outcome measure is studied at baseline, 1 and 12 months
measure: Body weight (kg)
time frame: The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months
measure: Waist circumference (cm)
time frame: The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months
measure: Fasting glycemia
time frame: The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months
measure: Lipid profile (HLD, LDL, TC,)
time frame: The outcome measure is studied at baseline, 1 week, 1 month, 3, 6 and 12 months
measure: Urate
time frame: The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months
measure: Blood pressure (mmHg)
time frame: The outcome measure is studied at baseline, at 1 week, 1 month, 3, 6 and 12 months
measure: Physical activity level
time frame: The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months
description: IPAQ-SF for record on physical activity during 7 last 7 days.
measure: Quality of life
time frame: The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months
description: SF-36 questionnaire
measure: Dietary intakes
time frame: The outcome measure is studied at baseline, at 1 month, 3, 6 and 12 months
description: Food Frequency Questionnaire 7-day food diary
arm group label: Mediterranean diet+physical activity
arm group type: Experimental
description: Mediterranean diet based on 1573 kcal/day with the goal of consumption of 30 ml/day of olive oil, 56g/week of nuts, 3-4 servings/week of fish, 3 servings/day of fruits, 2-3 servings/day of vegetables, 3 servings/week legumes and white meat instead of red meat
arm group label: Hypolipemic reduction diet+physical activity
arm group type: Active Comparator
description: Hypolipemic reduction diet based on 1287 kcal/day with the goal of consumption of 3 servings/day of fruits, 2-3 servings/day of vegetables, 3 servings/week legumes and white meat instead of red meat, non-fat or low-fat dairy products
intervention type: Behavioral
intervention name: Weight reduction program
arm group label: Hypolipemic reduction diet+physical activity
arm group label: Mediterranean diet+physical activity
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Zagreb
investigator full name: Prof. dr. sc. Velimir Božikov
investigator title: Head of the Department of Endocrinology, Diabetes and Metabolism Disorders, Dubrava University Hospital