<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/NCT03236259</url>
  </required_header>
  <id_info>
    <org_study_id>Brainport-001</org_study_id>
    <nct_id>NCT03236259</nct_id>
  </id_info>
  <brief_title>The Effect of Berry Extract Administration on Cognitive Health</brief_title>
  <official_title>The Effect of Berry Extract Administration on Cognitive Health</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effects of daily supplementation of Brainport&#xD;
      for a period of 6 months on cognitive health.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Actual">August 21, 2018</completion_date>
  <primary_completion_date type="Actual">August 21, 2018</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognition</measure>
    <time_frame>6 months</time_frame>
    <description>test attention with STROOP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognition</measure>
    <time_frame>6 months</time_frame>
    <description>Test concentration with 'cijferdoorstreep test'</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognition</measure>
    <time_frame>6 months</time_frame>
    <description>Test psychomotor speed with grooved pegboard</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>vascular structure</measure>
    <time_frame>6 months</time_frame>
    <description>measure vascular structure with ultrasound.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>6 months</time_frame>
    <description>Test mood with visual analogue mood scale. 8 emotions are scored on a 1-10 scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver function</measure>
    <time_frame>6 months</time_frame>
    <description>analysis of alkaline phosphatase, alanine aminotransferase, aspartaat aminotransferase, bilirubine, gamma-glutamyltransferase to determine liver function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>flavo-enzyme</measure>
    <time_frame>6 months</time_frame>
    <description>monoamine oxidase B analysis</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Cognitive Impairment</condition>
  <condition>Overweight and Obesity</condition>
  <arm_group>
    <arm_group_label>Brainport high dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Brainport low dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Maltodextrin</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Brainport high dose</intervention_name>
    <description>berry extract, high dose. Daily ingestion of capsule</description>
    <arm_group_label>Brainport high dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Brainport low dose</intervention_name>
    <description>Berry extract, low dose. Daily ingestion of capsule</description>
    <arm_group_label>Brainport low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Maltodextrin. Daily ingestion of capsule</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy individuals&#xD;
&#xD;
          -  Age between 40 and 60 years&#xD;
&#xD;
          -  BMI 25 - 35 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic,&#xD;
             hematological/immunologic, HEENT (head, ears, eyes, nose, throat).&#xD;
             Dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine,&#xD;
             neurological diseases, allergy, major surgery and /or laboratory assessments that&#xD;
             might limit participation in or completion of the study protocol.&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Use of medication that might have influence on endpoints (hypertension medication)&#xD;
&#xD;
          -  Administration of investigational drugs or participation in any scientific&#xD;
             intervention study which may interfere with this study in the 180 days prior to the&#xD;
             study&#xD;
&#xD;
          -  Use of antibiotics in the 30 days prior to the start of the study&#xD;
&#xD;
          -  Use of antioxidants, minerals and vitamin supplements available in pharmacies,&#xD;
             drugstores, food markets or in alternative medicine&#xD;
&#xD;
          -  Pregnancy, lactation&#xD;
&#xD;
          -  Abuse of products (&gt; 20 alcoholic consumptions per week and drugs)&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Weight gain or loss (&gt; 3 kg in previous 3 months)&#xD;
&#xD;
          -  High physical activity (&gt;4.5 hours of running/week)&#xD;
&#xD;
          -  History of any side effects towards intake of berries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>February 23, 2021</last_update_submitted>
  <last_update_submitted_qc>February 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- 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/NCT03236259
org study id: Brainport-001
nct id: NCT03236259
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the effects of daily supplementation of Brainport
      for a period of 6 months on cognitive health.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Cognition
time frame: 6 months
description: test attention with STROOP
measure: Cognition
time frame: 6 months
description: Test concentration with 'cijferdoorstreep test'
measure: Cognition
time frame: 6 months
description: Test psychomotor speed with grooved pegboard
measure: vascular structure
time frame: 6 months
description: measure vascular structure with ultrasound.
measure: Mood
time frame: 6 months
description: Test mood with visual analogue mood scale. 8 emotions are scored on a 1-10 scale.
measure: Blood pressure
time frame: 6 months
measure: Liver function
time frame: 6 months
description: analysis of alkaline phosphatase, alanine aminotransferase, aspartaat aminotransferase, bilirubine, gamma-glutamyltransferase to determine liver function.
measure: flavo-enzyme
time frame: 6 months
description: monoamine oxidase B analysis
arm group label: Brainport high dose
arm group type: Active Comparator
arm group label: Brainport low dose
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
description: Maltodextrin
intervention type: Dietary Supplement
intervention name: Brainport high dose
description: berry extract, high dose. Daily ingestion of capsule
arm group label: Brainport high dose
intervention type: Dietary Supplement
intervention name: Brainport low dose
description: Berry extract, low dose. Daily ingestion of capsule
arm group label: Brainport low dose
intervention type: Dietary Supplement
intervention name: Placebo
description: Maltodextrin. Daily ingestion of capsule
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Overweight