<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/NCT03793777</url>
  </required_header>
  <id_info>
    <org_study_id>Brainport_002</org_study_id>
    <nct_id>NCT03793777</nct_id>
  </id_info>
  <brief_title>The Effect of Aronia Melanocarpa Extract on Cognitive Function</brief_title>
  <official_title>The Effect of Short-term Aronia Melanocarpa Extract Supplementation on Cognitive Function in Healthy Young Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BioActor B.V.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Maastricht University Medical Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a great interest in improving cognitive performance, including memory and attention.&#xD;
      Improved attention is desirable for a large group of people because it is linked to improved&#xD;
      performance . Students and professionals can benefit from improved attention and thus&#xD;
      performance in academic and other work environments. In addition, cognitive functioning also&#xD;
      plays an important role in sports. Various cognitive skills, including attention, reaction&#xD;
      time and motor function, have shown that they can influence sport performance. A completely&#xD;
      natural supplement with aronia melanocarpa extract could be a promising way to naturally&#xD;
      improve cognitive performance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a great interest in improving cognitive performance, including memory and attention.&#xD;
      Improved attention is desirable for a large group of people because it is linked to improved&#xD;
      performance. Students and professionals can benefit from improved attention and thus&#xD;
      performance in academic and other work environments. In addition, cognitive functioning also&#xD;
      plays an important role in sports. Various cognitive skills, including attention, reaction&#xD;
      time and motor function, have shown that they can influence sport performance. A completely&#xD;
      natural supplement with aronia melanocarpa extract could be a promising way to naturally&#xD;
      improve cognitive performance. The product in this study is aronia melanocarpa which contains&#xD;
      polyphenols. A limited number of clinical studies have already been carried out to see the&#xD;
      effect of similar products on cognitive functioning. However, these studies have often been&#xD;
      done in older study populations or over a longer period of time. In this study, in healthy&#xD;
      adolescents (ages between the 18-35 and with a BMI between 18.5 and 30), the investigators&#xD;
      want to test the short term (7 days) effect of aronia melanocarpa extract on cognitive&#xD;
      functioning. The investigators will also test the effect of supplementation on the&#xD;
      particpant's mood, vascular function, blood biomarkers, retinal vasculature, and subjective&#xD;
      cognition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2020</start_date>
  <completion_date type="Actual">April 29, 2021</completion_date>
  <primary_completion_date type="Actual">April 29, 2021</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>
    <intervention_model_description>Cross-over study with 2 intervention conditions</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>block randomization</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>After 7 days of supplementation</time_frame>
    <description>CANTAB</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>After 7 days of supplementation</time_frame>
    <description>VAMS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers in blood and saliva</measure>
    <time_frame>After 7 days of supplementation</time_frame>
    <description>BDNF &amp; cortisol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular function</measure>
    <time_frame>After 7 days of supplementation</time_frame>
    <description>SBP &amp; DBP, PWA &amp; PWV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microvasculature</measure>
    <time_frame>After 7 days of supplementation</time_frame>
    <description>Fundus photography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective cognition</measure>
    <time_frame>After 7 days of supplementation</time_frame>
    <description>Cognitive Failures Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Cognitive Function</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>microcrystalline cellulose supplementation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aronia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>aronia melanocarpa supplementation</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Aronia</intervention_name>
    <description>daily supplementation</description>
    <arm_group_label>Aronia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>daily supplementation</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy young adults: ages between 18 and 35&#xD;
&#xD;
          -  BM between 18.5-30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current use of (antioxidant) dietary supplements and not willing to quit for the&#xD;
             duration of the study duration&#xD;
&#xD;
          -  Pre-existing or history of neurological illness&#xD;
&#xD;
          -  High blood pressure (&gt;140 systolic and/or &gt;90 diastolic mmHg)&#xD;
&#xD;
          -  Use of medication that might have influence on endpoints (e.g. antidepressant)&#xD;
&#xD;
          -  Known pregnancy or lactation&#xD;
&#xD;
          -  Food allergy to the study product&#xD;
&#xD;
          -  Administration of investigational drugs or participation in any scientific&#xD;
             intervention study which may interfere with this study, to be decided by the principle&#xD;
             investigator, in the 180 days prior to the study&#xD;
&#xD;
          -  Abuse of products (&gt; 20 alcoholic consumptions per week and drug usage)&#xD;
&#xD;
          -  Participation in a scientific intervention study which may interfere with this study&#xD;
             in the 180 days prior to this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jogchum Plat, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maastricht University</name>
      <address>
        <city>Maastricht</city>
        <state>Limburg</state>
        <zip>6229ET</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>September 3, 2021</last_update_submitted>
  <last_update_submitted_qc>September 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>supplementation</keyword>
  <keyword>cognition</keyword>
  <keyword>cognitive function</keyword>
  <keyword>vascular function</keyword>
  <keyword>microvasculature</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/NCT03793777
org study id: Brainport_002
nct id: NCT03793777
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
There is a great interest in improving cognitive performance, including memory and attention.
      Improved attention is desirable for a large group of people because it is linked to improved
      performance . Students and professionals can benefit from improved attention and thus
      performance in academic and other work environments. In addition, cognitive functioning also
      plays an important role in sports. Various cognitive skills, including attention, reaction
      time and motor function, have shown that they can influence sport performance. A completely
      natural supplement with aronia melanocarpa extract could be a promising way to naturally
      improve cognitive performance.
There is a great interest in improving cognitive performance, including memory and attention.
      Improved attention is desirable for a large group of people because it is linked to improved
      performance. Students and professionals can benefit from improved attention and thus
      performance in academic and other work environments. In addition, cognitive functioning also
      plays an important role in sports. Various cognitive skills, including attention, reaction
      time and motor function, have shown that they can influence sport performance. A completely
      natural supplement with aronia melanocarpa extract could be a promising way to naturally
      improve cognitive performance. The product in this study is aronia melanocarpa which contains
      polyphenols. A limited number of clinical studies have already been carried out to see the
      effect of similar products on cognitive functioning. However, these studies have often been
      done in older study populations or over a longer period of time. In this study, in healthy
      adolescents (ages between the 18-35 and with a BMI between 18.5 and 30), the investigators
      want to test the short term (7 days) effect of aronia melanocarpa extract on cognitive
      functioning. The investigators will also test the effect of supplementation on the
      particpant's mood, vascular function, blood biomarkers, retinal vasculature, and subjective
      cognition.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Cross-over study with 2 intervention conditions
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: block randomization
measure: Cognitive function
time frame: After 7 days of supplementation
description: CANTAB
measure: Mood
time frame: After 7 days of supplementation
description: VAMS
measure: Biomarkers in blood and saliva
time frame: After 7 days of supplementation
description: BDNF & cortisol
measure: Vascular function
time frame: After 7 days of supplementation
description: SBP & DBP, PWA & PWV
measure: Microvasculature
time frame: After 7 days of supplementation
description: Fundus photography
measure: Subjective cognition
time frame: After 7 days of supplementation
description: Cognitive Failures Questionnaire
arm group label: placebo
arm group type: Placebo Comparator
description: microcrystalline cellulose supplementation
arm group label: Aronia
arm group type: Experimental
description: aronia melanocarpa supplementation
intervention type: Dietary Supplement
intervention name: Aronia
description: daily supplementation
arm group label: Aronia
intervention type: Dietary Supplement
intervention name: Placebo
description: daily supplementation
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jogchum Plat, Prof
role: Principal Investigator
affiliation: Maastricht University
facility: 
country: Netherlands
responsible party type: Sponsor
sharing ipd: No