<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/NCT04486664</url>
  </required_header>
  <id_info>
    <org_study_id>3-2020-0030</org_study_id>
    <nct_id>NCT04486664</nct_id>
  </id_info>
  <brief_title>Effect of Mediterranean Diet in Dyslipidemic Patients</brief_title>
  <official_title>Effect of Mediterranean Diet on Metabolic Parameters and Microbiome in Dyslipidemic Patients: Randomized Crossover Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gangnam Severance Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gangnam Severance Hospital</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>
      The purpose of this randomized cross-over clinical trial is to examine the effects of&#xD;
      Mediterranean diet based intervention on inflammation, metabolic risk and microbiome in&#xD;
      patients with dyslipidemia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 24, 2020</start_date>
  <completion_date type="Anticipated">April 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2020</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body weight</measure>
    <time_frame>baseline, 4 weeks, 10 weeks</time_frame>
    <description>body weight (kg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fat mass</measure>
    <time_frame>baseline, 4 weeks, 10 weeks</time_frame>
    <description>fat mass (kg) measured by bioelectrical impedance analyzer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in muscle mass</measure>
    <time_frame>baseline, 4 weeks, 10 weeks</time_frame>
    <description>muscle mass (kg) measured by bioelectrical impedance analyzer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in leukocyte count</measure>
    <time_frame>baseline, 4 weeks, 10 weeks</time_frame>
    <description>leukocyte count (/μL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in C-reactive protein</measure>
    <time_frame>baseline, 4 weeks, 10 weeks</time_frame>
    <description>C-reactive protein (mg/L)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in fasting glucose</measure>
    <time_frame>baseline, 4 weeks, 10 weeks</time_frame>
    <description>fasting glucose (mg/dL)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in insulin</measure>
    <time_frame>baseline, 4 weeks, 10 weeks</time_frame>
    <description>insulin (mcIU/mL)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in triglyceride</measure>
    <time_frame>baseline, 4 weeks, 10 weeks</time_frame>
    <description>triglyceride (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in high-density lipoprotein cholesterol (HDL-cholesterol)</measure>
    <time_frame>baseline, 4 weeks, 10 weeks</time_frame>
    <description>HDL-cholesterol (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in low-density lipoprotein cholesterol (LDL-cholesterol)</measure>
    <time_frame>baseline, 4 weeks, 10 weeks</time_frame>
    <description>LDL-cholesterol (mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in gut microbiome</measure>
    <time_frame>baseline, 4 weeks, 10 weeks</time_frame>
    <description>Gut microbiome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in metabolomic response</measure>
    <time_frame>baseline, 4 weeks, 10 weeks</time_frame>
    <description>metabolomic profile of lipid metabolism</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Dyslipidemias</condition>
  <arm_group>
    <arm_group_label>Mediterranean diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mediterranean diet twice per day for four weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional diet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Conventional diet for four weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mediterranean Diet</intervention_name>
    <description>Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.</description>
    <arm_group_label>Conventional diet</arm_group_label>
    <arm_group_label>Mediterranean diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  One or more of this criteria (total cholesterol ≥ 200mg/dl, LDL- cholesterol ≥130&#xD;
             mg/dL, triglyceride ≥ 200mg/dl)&#xD;
&#xD;
          -  If woman of child bearing potential, agree to use effective contraception throughout&#xD;
             the study period and 30 days after discontinuation of study drug&#xD;
&#xD;
          -  Able to speak and read Korean&#xD;
&#xD;
          -  Able to comply with all required study procedures and schedule&#xD;
&#xD;
          -  Willing and able to give written informed consent&#xD;
&#xD;
          -  Participants who are not participating in other clinical trials.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with cancer treatment&#xD;
&#xD;
          -  Participants with uncontrolled hypertension (systolic blood pressure (SBP) &gt;180 mmHg,&#xD;
             or diastolic blood pressure (DBP) &gt;120 mmHg)&#xD;
&#xD;
          -  Participants with uncontrolled diabetes or fasting glucose ≥ 200mg/dl)&#xD;
&#xD;
          -  Participants with hepatic disease (aspartate aminotransferase (AST)/alanine&#xD;
             aminotransferase (ALT) &gt;3 x institutional upper limit of normal) or renal disease&#xD;
             (serum creatinine &gt;2.0 mg/dL)&#xD;
&#xD;
          -  Participants with significant cardiovascular disease (ischemic heart disease or&#xD;
             stroke)&#xD;
&#xD;
          -  Participants who are taking lipid-lowering medications.&#xD;
&#xD;
          -  Participants who are taking other clinical trial medications.&#xD;
&#xD;
          -  Participants with acute infectious disease such as pneumonia, acute gastroenteritis,&#xD;
             and urinary tract infection.&#xD;
&#xD;
          -  Vegetarian (does not eat red meat, poultry or fish)&#xD;
&#xD;
          -  Participants with food allergy (sea food, fish, nuts, egg, meat, tomato, wheat, or&#xD;
             soybean)&#xD;
&#xD;
          -  Participants who are not able to eat more than 10 mediterranean meal in a row.&#xD;
&#xD;
          -  Any condition which in the opinion of the investigator makes the subject unsuitable&#xD;
             for inclusion in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ji Won Lee, MD.PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gangnam Severance Hospital, Yonsei University College of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ji Won Lee, MD.PhD</last_name>
    <phone>82-2-2019-3480</phone>
    <email>indi5645@yuhs.ac</email>
  </overall_contact>
  <location>
    <facility>
      <name>Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ji-Won Lee</last_name>
      <phone>82-2-2019-4601</phone>
      <email>indi5645@yuhs.ac</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gangnam Severance Hospital</investigator_affiliation>
    <investigator_full_name>Ji-Won Lee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>dyslipidemia</keyword>
  <keyword>mediterranean diet</keyword>
  <keyword>microbiome</keyword>
  <keyword>inflammation</keyword>
  <keyword>metabolic risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslipidemias</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/NCT04486664
org study id: 3-2020-0030
nct id: NCT04486664
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this randomized cross-over clinical trial is to examine the effects of
      Mediterranean diet based intervention on inflammation, metabolic risk and microbiome in
      patients with dyslipidemia.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in body weight
time frame: baseline, 4 weeks, 10 weeks
description: body weight (kg)
measure: Change in fat mass
time frame: baseline, 4 weeks, 10 weeks
description: fat mass (kg) measured by bioelectrical impedance analyzer
measure: Change in muscle mass
time frame: baseline, 4 weeks, 10 weeks
description: muscle mass (kg) measured by bioelectrical impedance analyzer
measure: Change in leukocyte count
time frame: baseline, 4 weeks, 10 weeks
description: leukocyte count (/μL)
measure: Change in C-reactive protein
time frame: baseline, 4 weeks, 10 weeks
description: C-reactive protein (mg/L)
measure: Change in fasting glucose
time frame: baseline, 4 weeks, 10 weeks
description: fasting glucose (mg/dL)
measure: Change in insulin
time frame: baseline, 4 weeks, 10 weeks
description: insulin (mcIU/mL)
measure: Change in triglyceride
time frame: baseline, 4 weeks, 10 weeks
description: triglyceride (mg/dL)
measure: Change in high-density lipoprotein cholesterol (HDL-cholesterol)
time frame: baseline, 4 weeks, 10 weeks
description: HDL-cholesterol (mg/dL)
measure: Change in low-density lipoprotein cholesterol (LDL-cholesterol)
time frame: baseline, 4 weeks, 10 weeks
description: LDL-cholesterol (mg/dL)
measure: Change in gut microbiome
time frame: baseline, 4 weeks, 10 weeks
description: Gut microbiome
measure: Change in metabolomic response
time frame: baseline, 4 weeks, 10 weeks
description: metabolomic profile of lipid metabolism
arm group label: Mediterranean diet
arm group type: Experimental
description: Mediterranean diet twice per day for four weeks
arm group label: Conventional diet
arm group type: Placebo Comparator
description: Conventional diet for four weeks
intervention type: Behavioral
intervention name: Mediterranean Diet
description: Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.
arm group label: Conventional diet
arm group label: Mediterranean diet
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ji Won Lee, MD.PhD
role: Principal Investigator
affiliation: Gangnam Severance Hospital, Yonsei University College of Medicine
last name: Ji Won Lee, MD.PhD
phone: 82-2-2019-3480
email: indi5645@yuhs.ac
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Gangnam Severance Hospital
investigator full name: Ji-Won Lee
investigator title: Professor
mesh term: Dyslipidemias
sharing ipd: No