<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/NCT03041961</url>
  </required_header>
  <id_info>
    <org_study_id>Aronia FMD</org_study_id>
    <nct_id>NCT03041961</nct_id>
  </id_info>
  <brief_title>Aronia Berry Consumption on Vascular Function</brief_title>
  <official_title>Effects of Aronia Berry (Chokeberry) Extract on Vascular Function in Healthy Men: a 3 Month Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Naturex-Dbs</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>No</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>
      There is an increasing interest in the effects of various food derived polyphenols on&#xD;
      vascular function. Arguably the most well-established vascular benefits are attributed to&#xD;
      flavanols from cocoa beans and this has been supported by a successful health claim through&#xD;
      the European Food Safely Authority in 2012. Berry fruits are another rich source of&#xD;
      polyphenols that have vasoactive properties, and there is a growing body of research&#xD;
      exploring these effects in various berries (blueberries, cranberries, strawberries) and other&#xD;
      fruit products with similar polyphenol composition. A key (poly)phenol in berries and other&#xD;
      fruits believed to provide much of the benefit is anthocyanins. When given as an isolated&#xD;
      extract, 320 mg anthocyanins have been found to improve blood vessel function both acutely&#xD;
      and in response to chronic consumption over 12 weeks.&#xD;
&#xD;
      Aronia berries are a native North American berry with high naturally occurring anthocyanins&#xD;
      among other polyphenols. Based on their polyphenol composition, there is growing interest in&#xD;
      the potential for Aronia berries to elicit health promoting cardio-metabolic effects.&#xD;
      Specifically, Aronia berry extracts, which provide a concentrated source of polyphenols, may&#xD;
      improve blood vessel function.&#xD;
&#xD;
      Thus, the primary focus of this project is to evaluate the effects of Aronia berry extracts&#xD;
      of differing polyphenol dose on vascular endothelial function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2017</start_date>
  <completion_date type="Actual">July 20, 2017</completion_date>
  <primary_completion_date type="Actual">July 20, 2017</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>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Flow-mediated dilation</measure>
    <time_frame>Baseline 0 and 2 hours and 12 weeks 0 and 2 hours</time_frame>
    <description>Change form Baseline Endothelial function at 12 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pulse wave velocity</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Measured by SphygmoCor 0 and 2 hours postconsumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Automatical measurements 0 and 2 hours postconsumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood measurements- Blood lipids</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Cholesterol, HDL, LDL, triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood measurements</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Haematology (White blood cell count, red blood cell count, Haemoglobin, hematocrit, platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils, reticulocytes, eosinophils</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood measurements-Electrolytes</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Urea, Creatinine, uric acid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood measurements</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Liver values (bilirubin, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyltranspeptidase, total protein, albumine, alkaline phosphatase)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood measurements -Glucose</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Plasma aronia berry (poly)phenol metabolites</measure>
    <time_frame>Baseline 0 and 2 hours and 12 weeks 0 and 2 hours</time_frame>
    <description>Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption</description>
  </other_outcome>
  <other_outcome>
    <measure>Microbiome analysis</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Stool sample collection (Umnigene gut collection kit)</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Healthy Young Men</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Formulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aronia full spectrum</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Formulation of an aronia full spectrum ingredient in a 1-hard capsule regimen (500 mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aronia extract</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Formulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Aronia full spectrum</intervention_name>
    <description>Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)</description>
    <arm_group_label>Aronia full spectrum</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Aronia extract</intervention_name>
    <description>Powdered extract obtained from aronia berries (Aronia melanocarpa)</description>
    <arm_group_label>Aronia extract</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men aged 18-45 years old&#xD;
&#xD;
          -  Subjects are willing to maintain their normal eating/drinking habits and exercise&#xD;
             habits to avoid changes in body weight over the duration of the study&#xD;
&#xD;
          -  Are able to understand the nature of the study&#xD;
&#xD;
          -  Able to give signed written informed consent&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Manifest cardiovascular disease including coronary artery disease, cerebrovascular&#xD;
             disease and peripheral artery disease&#xD;
&#xD;
          -  Hypertensive, as defined as SBP superior or equal to 140 mmHg or DBP superior or equal&#xD;
             to 90 mmHg&#xD;
&#xD;
          -  Obese participants, defined as BMI superior or equal to 30&#xD;
&#xD;
          -  Diabetes mellitus and metabolic syndrome&#xD;
&#xD;
          -  Acute inflammation&#xD;
&#xD;
          -  Terminal renal failure&#xD;
&#xD;
          -  Malignancies&#xD;
&#xD;
          -  Abnormal heart rhythm (lower or higher than 60-100 bpm)&#xD;
&#xD;
          -  Allergies to berries or other significant food allergy.&#xD;
&#xD;
          -  Subjects under medication or on vitamin/dietary supplements.&#xD;
&#xD;
          -  Subjects who have lost more than 10% of their weight in the past 6 months or are&#xD;
             currently in a diet&#xD;
&#xD;
          -  Subjects who reported participant in another study within one month before the study&#xD;
             start&#xD;
&#xD;
          -  Subjects who smoke an irregular amount of cigarettes per day&#xD;
&#xD;
          -  Unable to swallow the capsule&#xD;
&#xD;
          -  Any reason or condition that in the judgment of the clinical investigator(s) may put&#xD;
             the subject at unacceptable risk or that may preclude the subject from understanding&#xD;
             or complying with the study's requirements.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Life Sciences and Medecine</name>
      <address>
        <city>London</city>
        <state>Central London</state>
        <zip>SE1 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>July 2, 2019</last_update_submitted>
  <last_update_submitted_qc>July 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King's College London</investigator_affiliation>
    <investigator_full_name>Dr Ana Rodriguez-Mateos</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Vascular function</keyword>
  <keyword>Endothelial function</keyword>
  <keyword>(Poly)phenols</keyword>
  <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/NCT03041961
org study id: Aronia FMD
nct id: NCT03041961
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There is an increasing interest in the effects of various food derived polyphenols on
      vascular function. Arguably the most well-established vascular benefits are attributed to
      flavanols from cocoa beans and this has been supported by a successful health claim through
      the European Food Safely Authority in 2012. Berry fruits are another rich source of
      polyphenols that have vasoactive properties, and there is a growing body of research
      exploring these effects in various berries (blueberries, cranberries, strawberries) and other
      fruit products with similar polyphenol composition. A key (poly)phenol in berries and other
      fruits believed to provide much of the benefit is anthocyanins. When given as an isolated
      extract, 320 mg anthocyanins have been found to improve blood vessel function both acutely
      and in response to chronic consumption over 12 weeks.

      Aronia berries are a native North American berry with high naturally occurring anthocyanins
      among other polyphenols. Based on their polyphenol composition, there is growing interest in
      the potential for Aronia berries to elicit health promoting cardio-metabolic effects.
      Specifically, Aronia berry extracts, which provide a concentrated source of polyphenols, may
      improve blood vessel function.

      Thus, the primary focus of this project is to evaluate the effects of Aronia berry extracts
      of differing polyphenol dose on vascular endothelial function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Flow-mediated dilation
time frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
description: Change form Baseline Endothelial function at 12 weeks
measure: Pulse wave velocity
time frame: Baseline and 12 weeks
description: Measured by SphygmoCor 0 and 2 hours postconsumption
measure: Blood pressure
time frame: Baseline and 12 weeks
description: Automatical measurements 0 and 2 hours postconsumption
measure: Blood measurements- Blood lipids
time frame: Baseline and 12 weeks
description: Cholesterol, HDL, LDL, triglycerides
measure: Blood measurements
time frame: Baseline and 12 weeks
description: Haematology (White blood cell count, red blood cell count, Haemoglobin, hematocrit, platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils, reticulocytes, eosinophils
measure: Blood measurements-Electrolytes
time frame: Baseline and 12 weeks
description: Urea, Creatinine, uric acid
measure: Blood measurements
time frame: Baseline and 12 weeks
description: Liver values (bilirubin, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyltranspeptidase, total protein, albumine, alkaline phosphatase)
measure: Blood measurements -Glucose
time frame: Baseline and 12 weeks
measure: Plasma aronia berry (poly)phenol metabolites
time frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
description: Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption
measure: Microbiome analysis
time frame: Baseline and 12 weeks
description: Stool sample collection (Umnigene gut collection kit)
arm group label: Placebo
arm group type: Placebo Comparator
description: Formulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg)
arm group label: Aronia full spectrum
arm group type: Active Comparator
description: Formulation of an aronia full spectrum ingredient in a 1-hard capsule regimen (500 mg)
arm group label: Aronia extract
arm group type: Active Comparator
description: Formulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg)
intervention type: Dietary Supplement
intervention name: Placebo
description: Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.
arm group label: Placebo
intervention type: Dietary Supplement
intervention name: Aronia full spectrum
description: Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)
arm group label: Aronia full spectrum
intervention type: Dietary Supplement
intervention name: Aronia extract
description: Powdered extract obtained from aronia berries (Aronia melanocarpa)
arm group label: Aronia extract
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: King's College London
investigator full name: Dr Ana Rodriguez-Mateos
investigator title: Principal investigator
sharing ipd: No