<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/NCT02259153</url>
  </required_header>
  <id_info>
    <org_study_id>CEICA;PI13-00106</org_study_id>
    <nct_id>NCT02259153</nct_id>
  </id_info>
  <brief_title>Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis</brief_title>
  <official_title>A Randomized Study to Assess the Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Aragones de Ciencias de la Salud</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Aragones de Ciencias de la Salud</source>
  <brief_summary>
    <textblock>
      The objective of the study is to assess the effect of two diets with different fat&#xD;
      composition on cholesterol metabolism. The study was a randomized cross-over trial where&#xD;
      volunteers follow two study periods with different types of meat (lean and fat red meat)&#xD;
      separately by a ten days wash-out period. At the beginning of the study and after the study&#xD;
      periods the following parameters are determined: anthropometric (weight, waist, circumference&#xD;
      and body mass index), blood pressure, dietary (72-hours dietary registry) and exercise&#xD;
      assessments and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL&#xD;
      cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferring, ferritin, uric acid,&#xD;
      glucose, HbA1c and insulin). Serum concentration of non cholesterol sterols (sitosterol,&#xD;
      campesterol, stigmasterol, desmosterol and lanosterol) and oxysterols&#xD;
      (24S-hydroxycholesterol, 27-hydroxycholesterol and 7α-hydroxycholestenone) were measured by&#xD;
      High Performance Liquid Chromatography tandem Mass Spectrometry in these subjects throughout&#xD;
      along the study in order to demonstrate the effect of different red meat on the hepatic&#xD;
      metabolism of cholesterol.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in lipid profile</measure>
    <time_frame>Baseline and after 10 days of intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in non cholesterol sterols and oxysterols serum concentrations</measure>
    <time_frame>Baseline and after 10 days of intervention</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Lipid Metabolism Disorders</condition>
  <condition>Sterols</condition>
  <condition>Diet, High-Fat</condition>
  <condition>Cholesterol</condition>
  <condition>Fatty Acids</condition>
  <condition>Hyperlipidemias</condition>
  <arm_group>
    <arm_group_label>Lean red meat diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants were given 350 g per day of lean red meat to incorporate to their usual diet for ten days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fat red meat diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants were given 350 g per day of fat red meat to incorporate to their usual diet for ten days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Changes in cholesterol metabolism</intervention_name>
    <arm_group_label>Fat red meat diet</arm_group_label>
    <arm_group_label>Lean red meat diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lean red meat diet</intervention_name>
    <arm_group_label>Lean red meat diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fat red meat diet</intervention_name>
    <arm_group_label>Fat red meat diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normolipemic healthy subjects defined by levels of LDL cholesterol and triglycerides&#xD;
             below the 90th percentile adjusted for age and sex.&#xD;
&#xD;
          -  Diet and stable lifestyle with controllable feeding.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or intention of pregnancy during the study.&#xD;
&#xD;
          -  Lipid lowering drugs in the last 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernando Civeira, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lucía Baila-Rueda, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)</affiliation>
  </overall_official>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 1, 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>Instituto Aragones de Ciencias de la Salud</investigator_affiliation>
    <investigator_full_name>Fernando Civeira</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Lipids</keyword>
  <keyword>Non Cholesterol Sterols</keyword>
  <keyword>Oxysterols</keyword>
  <keyword>Cholesterol Metabolism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlipidemias</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Lipid Metabolism Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT02259153
org study id: CEICA;PI13-00106
nct id: NCT02259153
lead sponsor: 
The objective of the study is to assess the effect of two diets with different fat
      composition on cholesterol metabolism. The study was a randomized cross-over trial where
      volunteers follow two study periods with different types of meat (lean and fat red meat)
      separately by a ten days wash-out period. At the beginning of the study and after the study
      periods the following parameters are determined: anthropometric (weight, waist, circumference
      and body mass index), blood pressure, dietary (72-hours dietary registry) and exercise
      assessments and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL
      cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferring, ferritin, uric acid,
      glucose, HbA1c and insulin). Serum concentration of non cholesterol sterols (sitosterol,
      campesterol, stigmasterol, desmosterol and lanosterol) and oxysterols
      (24S-hydroxycholesterol, 27-hydroxycholesterol and 7α-hydroxycholestenone) were measured by
      High Performance Liquid Chromatography tandem Mass Spectrometry in these subjects throughout
      along the study in order to demonstrate the effect of different red meat on the hepatic
      metabolism of cholesterol.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Changes in lipid profile
time frame: Baseline and after 10 days of intervention
measure: Changes in non cholesterol sterols and oxysterols serum concentrations
time frame: Baseline and after 10 days of intervention
arm group label: Lean red meat diet
arm group type: Active Comparator
description: Participants were given 350 g per day of lean red meat to incorporate to their usual diet for ten days.
arm group label: Fat red meat diet
arm group type: Active Comparator
description: Participants were given 350 g per day of fat red meat to incorporate to their usual diet for ten days.
intervention type: Behavioral
intervention name: Changes in cholesterol metabolism
arm group label: Fat red meat diet
arm group label: Lean red meat diet
intervention type: Other
intervention name: Lean red meat diet
arm group label: Lean red meat diet
intervention type: Other
intervention name: Fat red meat diet
arm group label: Fat red meat diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fernando Civeira, MD, PhD
role: Principal Investigator
affiliation: Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
last name: Lucía Baila-Rueda, MSc
role: Principal Investigator
affiliation: Unidad de Lípidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain)
responsible party type: Principal Investigator
investigator affiliation: Instituto Aragones de Ciencias de la Salud
investigator full name: Fernando Civeira
investigator title: Professor
mesh term: Hyperlipidemias
mesh term: Metabolic Diseases
mesh term: Lipid Metabolism Disorders