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/NCT05988099</url>
    </required_header>
    <id_info>
      <org_study_id>04-AP-MEL</org_study_id>
      <nct_id>NCT05988099</nct_id>
    </id_info>
    <brief_title>Comparison of the Effects of Standardized Chokeberry Extracts With Various Formulations on the Levels of Selected Markers Associated With Cardiovascular Disease</brief_title>
    <official_title>Comparison of the Effects of Standardized Chokeberry Extracts With Various Formulations on the Levels of Selected Markers Associated With Cardiovascular Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AronPharma Sp. z o. o.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AronPharma Sp. z o. o.</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>
        The aim of the study is to compare in a clinical condition the effect of standardized&#xD;
        chokeberry extract in different formulations and a complex preparation containing chokeberry&#xD;
        extract and other active ingredients in on the levels of selected markers associated with&#xD;
        cardiovascular diseases in people with a predisposition to the development of these diseases.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Randomized, double-blind, parallel study conducted under medical supervision on a group of 40&#xD;
        patients with known hypertension and/or hypercholesterolemia. Patients receive one of the&#xD;
        investigational products or placebo for 6 weeks. Before and after the study, the following&#xD;
        parameters are analyzed: extended lipid panel (total cholesterol (TC), triglycerides (TG),&#xD;
        low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B),&#xD;
        levels of glucose, insulin, homocysteine, markers of kidney and liver function (alanine&#xD;
        aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), blood&#xD;
        urea nitrogen (BUN), uric acid). Effects on blood pressure and anthropometric parameters are&#xD;
        also being evaluated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 20, 2023</start_date>
    <completion_date type="Actual">July 28, 2023</completion_date>
    <primary_completion_date type="Actual">July 28, 2023</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>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Extended lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B)</measure>
      <time_frame>baseline, 6 weeks</time_frame>
      <description>Comparison of lipid panel markers</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Glucose level</measure>
      <time_frame>baseline, 6 weeks</time_frame>
      <description>Comparison of glucose level</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Systolic, diatolic blood pressure</measure>
      <time_frame>baseline, 6 weeks</time_frame>
      <description>Comparison of blood pressure</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Insulin level</measure>
      <time_frame>baseline, 6 weeks</time_frame>
      <description>Comparison of insulin level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Homocysteine level</measure>
      <time_frame>baseline, 6 weeks</time_frame>
      <description>Comparison of homocysteine level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Alanine aminotransferase (ALT), aspartate aminotransferase (AST)</measure>
      <time_frame>baseline, 6 weeks</time_frame>
      <description>Comparison of ALT and AST</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Hypertension</condition>
    <condition>Hypercholesterolemia</condition>
    <arm_group>
      <arm_group_label>Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single oral dose - 2 capsules</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Chokeberry extract in liposomal formulation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Single oral dose - 2 capsules</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Chokeberry extract in traditional formulation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Single oral dose - 2 capsules</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Single oral dose - 2 capsules</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Complex product</intervention_name>
      <description>400 mg of chokeberry extract in liposomal formulation and L-arginine, vitamin E, vitamin A, folic acid, chromium</description>
      <arm_group_label>Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Chokeberry extract in liposomal formulation</intervention_name>
      <description>400 mg of chokeberry extract in liposomal formulation</description>
      <arm_group_label>Chokeberry extract in liposomal formulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Chokeberry extract in traditional formulation</intervention_name>
      <description>400 mg of chokeberry extract in traditional formulation</description>
      <arm_group_label>Chokeberry extract in traditional formulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women and men, 18-55 years old&#xD;
  &#xD;
            -  Patients with known: hypertension or hypercholesterolemia,&#xD;
  &#xD;
            -  Patients on hypotensive or hypolipemic therapy for at least 6 months prior to study&#xD;
               enrollment&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Intake of supplements containing plant extracts, polyphenols or anthocyanins,&#xD;
  &#xD;
            -  Intake of supplements with antioxidant properties,&#xD;
  &#xD;
            -  Participation in another clinical trial,&#xD;
  &#xD;
            -  Women who are pregnant, planning to become pregnant during the study, or&#xD;
               breastfeeding,&#xD;
  &#xD;
            -  Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis,&#xD;
               leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant,&#xD;
  &#xD;
            -  Patients receiving glucocorticosteroids, anti-allergic drugs, non-steroidal&#xD;
               anti-inflammatory drugs in exacerbations of chronic disease.&#xD;
  &#xD;
            -  Patients with signs of inflammation such as increased body temperature, redness,&#xD;
               swelling, pain.&#xD;
  &#xD;
            -  Patients who have not given written consent to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Centum Zdrowia Eter-Med sp. z o.o.</name>
        <address>
          <city>Gdańsk</city>
          <zip>80-822</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Hypertension</keyword>
    <keyword>Hypercholesterolemia</keyword>
    <keyword>Aronia extract</keyword>
    <keyword>Chokeberry extract</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
      <mesh_term>Cardiovascular Diseases</mesh_term>
      <mesh_term>Hypercholesterolemia</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/NCT05988099
  org study id: 04-AP-MEL
  nct id: NCT05988099
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to compare in a clinical condition the effect of standardized
        chokeberry extract in different formulations and a complex preparation containing chokeberry
        extract and other active ingredients in on the levels of selected markers associated with
        cardiovascular diseases in people with a predisposition to the development of these diseases.
  Randomized, double-blind, parallel study conducted under medical supervision on a group of 40
        patients with known hypertension and/or hypercholesterolemia. Patients receive one of the
        investigational products or placebo for 6 weeks. Before and after the study, the following
        parameters are analyzed: extended lipid panel (total cholesterol (TC), triglycerides (TG),
        low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B),
        levels of glucose, insulin, homocysteine, markers of kidney and liver function (alanine
        aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), blood
        urea nitrogen (BUN), uric acid). Effects on blood pressure and anthropometric parameters are
        also being evaluated.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Participant, Investigator)
  measure: Extended lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B)
  time frame: baseline, 6 weeks
  description: Comparison of lipid panel markers
  measure: Glucose level
  time frame: baseline, 6 weeks
  description: Comparison of glucose level
  measure: Systolic, diatolic blood pressure
  time frame: baseline, 6 weeks
  description: Comparison of blood pressure
  measure: Insulin level
  time frame: baseline, 6 weeks
  description: Comparison of insulin level
  measure: Homocysteine level
  time frame: baseline, 6 weeks
  description: Comparison of homocysteine level
  measure: Alanine aminotransferase (ALT), aspartate aminotransferase (AST)
  time frame: baseline, 6 weeks
  description: Comparison of ALT and AST
  arm group label: Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium)
  arm group type: Experimental
  description: Single oral dose - 2 capsules
  arm group label: Chokeberry extract in liposomal formulation
  arm group type: Active Comparator
  description: Single oral dose - 2 capsules
  arm group label: Chokeberry extract in traditional formulation
  arm group type: Active Comparator
  description: Single oral dose - 2 capsules
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Single oral dose - 2 capsules
  intervention type: Dietary Supplement
  intervention name: Complex product
  description: 400 mg of chokeberry extract in liposomal formulation and L-arginine, vitamin E, vitamin A, folic acid, chromium
  arm group label: Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium)
  intervention type: Dietary Supplement
  intervention name: Chokeberry extract in liposomal formulation
  description: 400 mg of chokeberry extract in liposomal formulation
  arm group label: Chokeberry extract in liposomal formulation
  intervention type: Dietary Supplement
  intervention name: Chokeberry extract in traditional formulation
  description: 400 mg of chokeberry extract in traditional formulation
  arm group label: Chokeberry extract in traditional formulation
  intervention type: Other
  intervention name: Placebo
  description: Placebo
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: No
  facility: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Hypertension
  mesh term: Cardiovascular Diseases
  mesh term: Hypercholesterolemia
  sharing ipd: No