xml: <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/NCT05995002</url>
    </required_header>
    <id_info>
      <org_study_id>43004233</org_study_id>
      <nct_id>NCT05995002</nct_id>
    </id_info>
    <brief_title>Anthocyanin Intake on Cardiometabolic Biomarkers</brief_title>
    <official_title>Effects of Increasing Anthocyanin Intake on Cardiometabolic Biomarkers in Patients With Coronary Artery Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shahid Beheshti University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Shahid Beheshti University of Medical Sciences</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Shahid Beheshti University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Flavonoids are one of the main groups of polyphenols. Anthocyanins, which are a subgroup of&#xD;
        the flavonoid family, are found in a number of fruits and some vegetables. In epidemiological&#xD;
        studies, high dietary intake of polyphenols has been associated with improvement of some&#xD;
        cardiometabolic risk factors in high-risk individuals. Furthermore, in controlled studies,&#xD;
        consumption of polyphenol-rich food sources or anthocyanin extract supplementation has&#xD;
        improved some cardiometabolic factors. In the present study, the effect of diet enriched with&#xD;
        anthocyanin-rich food sources on cardiometabolic factors will be studied in coronary artery&#xD;
        disease patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is an unblinded randomized controlled clinical trial. In this study, among the&#xD;
        patients referred to Shahid Modares Hospital (Tehran, IRAN), those who are willing to&#xD;
        participate and have inclusion criteria will be recruited. Inclusion criteria are coronary&#xD;
        heart disease with recent coronary angiography, age range of 30-75 years. Exclusion criteria&#xD;
        are end-stage renal disease, patients undergoing chemotherapy or radiotherapy, patients with&#xD;
        inflammatory bowel syndrome, patients being treated with glucocorticoid drugs or antibiotics.&#xD;
        Patients are randomly assigned to one of two study groups, including the control group and&#xD;
        the group consuming food sources rich in anthocyanin in the diet. The duration of the study&#xD;
        will be 8 weeks. In the control group, a general recommendation related to a healthy diet&#xD;
        such as reducing the intake of saturated fats, sodium, and simple sugars, is provided. In the&#xD;
        anthocyanin-rich diet group, the weekly food plan aims to increase the consumption of&#xD;
        anthocyanin-rich sources such as berries, black grapes (or currants), cherries, strawberries,&#xD;
        pomegranates, and red onions. The patients' drug regimen will not change during the study.&#xD;
        Patients are asked not to use over-the-counter herbal medicines and nutritional supplements&#xD;
        during the study. At the beginning and end of the study, blood,&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 21, 2023</start_date>
    <completion_date type="Anticipated">April 27, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 19, 2024</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Plasma inflammatory factors concentration</measure>
      <time_frame>8 weeks</time_frame>
      <description>fasting plasma concentration of C-reactive protein and IL-6</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Plasma concentration of insulin</measure>
      <time_frame>8 weeks</time_frame>
      <description>Fasting plasma concentration of insulin</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma levels of lipids and lipoproteins</measure>
      <time_frame>8 weeks</time_frame>
      <description>Fasting plasma levels of triglycerides, HDL-cholesterol, and LDL-cholesterol</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Coronary Artery Stenosis</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Conventional drug treatment with a general recommendation for a healthy diet.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Anthocyanin-rich diet group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Conventional drug treatment with a weekly food plan aims to increase the consumption of anthocyanin-rich sources</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Anthocyanin-rich diet</intervention_name>
      <description>A weekly food plan aims to increase the consumption of anthocyanin-rich sources such as berries, black grapes (or currants), cherries, strawberries, pomegranates, and red onions.</description>
      <arm_group_label>Anthocyanin-rich diet group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  coronary heart disease with recent coronary angiography&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  End-stage renal disease,&#xD;
  &#xD;
            -  Patients undergoing chemotherapy or radiotherapy,&#xD;
  &#xD;
            -  Patients with inflammatory bowel syndrome&#xD;
  &#xD;
            -  Patients being treated with glucocorticoid drugs or antibiotics.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Javad Nasrollahzadeh, PhD</last_name>
      <phone>+98212277424</phone>
      <email>jnasrollahzadeh@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shahid Modares Hospital</name>
        <address>
          <city>Tehran</city>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sogand Tavakoli</last_name>
        <phone>+98 9121792248</phone>
      </contact>
    </location>
    <location_countries>
      <country>Iran, Islamic Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shahid Beheshti University of Medical Sciences</investigator_affiliation>
      <investigator_full_name>Javad Nasrollahzadeh</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>Coronary Stenosis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995002
  org study id: 43004233
  nct id: NCT05995002
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Flavonoids are one of the main groups of polyphenols. Anthocyanins, which are a subgroup of
        the flavonoid family, are found in a number of fruits and some vegetables. In epidemiological
        studies, high dietary intake of polyphenols has been associated with improvement of some
        cardiometabolic risk factors in high-risk individuals. Furthermore, in controlled studies,
        consumption of polyphenol-rich food sources or anthocyanin extract supplementation has
        improved some cardiometabolic factors. In the present study, the effect of diet enriched with
        anthocyanin-rich food sources on cardiometabolic factors will be studied in coronary artery
        disease patients.
  This study is an unblinded randomized controlled clinical trial. In this study, among the
        patients referred to Shahid Modares Hospital (Tehran, IRAN), those who are willing to
        participate and have inclusion criteria will be recruited. Inclusion criteria are coronary
        heart disease with recent coronary angiography, age range of 30-75 years. Exclusion criteria
        are end-stage renal disease, patients undergoing chemotherapy or radiotherapy, patients with
        inflammatory bowel syndrome, patients being treated with glucocorticoid drugs or antibiotics.
        Patients are randomly assigned to one of two study groups, including the control group and
        the group consuming food sources rich in anthocyanin in the diet. The duration of the study
        will be 8 weeks. In the control group, a general recommendation related to a healthy diet
        such as reducing the intake of saturated fats, sodium, and simple sugars, is provided. In the
        anthocyanin-rich diet group, the weekly food plan aims to increase the consumption of
        anthocyanin-rich sources such as berries, black grapes (or currants), cherries, strawberries,
        pomegranates, and red onions. The patients' drug regimen will not change during the study.
        Patients are asked not to use over-the-counter herbal medicines and nutritional supplements
        during the study. At the beginning and end of the study, blood,
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Plasma inflammatory factors concentration
  time frame: 8 weeks
  description: fasting plasma concentration of C-reactive protein and IL-6
  measure: Plasma concentration of insulin
  time frame: 8 weeks
  description: Fasting plasma concentration of insulin
  measure: Plasma levels of lipids and lipoproteins
  time frame: 8 weeks
  description: Fasting plasma levels of triglycerides, HDL-cholesterol, and LDL-cholesterol
  arm group label: Control
  arm group type: No Intervention
  description: Conventional drug treatment with a general recommendation for a healthy diet.
  arm group label: Anthocyanin-rich diet group
  arm group type: Experimental
  description: Conventional drug treatment with a weekly food plan aims to increase the consumption of anthocyanin-rich sources
  intervention type: Other
  intervention name: Anthocyanin-rich diet
  description: A weekly food plan aims to increase the consumption of anthocyanin-rich sources such as berries, black grapes (or currants), cherries, strawberries, pomegranates, and red onions.
  arm group label: Anthocyanin-rich diet group
  criteria: 
  gender: All
  minimum age: 30 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Javad Nasrollahzadeh, PhD
  phone: +98212277424
  email: jnasrollahzadeh@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Iran, Islamic Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Shahid Beheshti University of Medical Sciences
  investigator full name: Javad Nasrollahzadeh
  investigator title: Associate Professor
  mesh term: Coronary Stenosis
  sharing ipd: No