<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/NCT02985580</url>
  </required_header>
  <id_info>
    <org_study_id>1314/134617</org_study_id>
    <nct_id>NCT02985580</nct_id>
  </id_info>
  <brief_title>Effects of Blueberry Juice Consumption on Cognitive Function in Healthy Older People</brief_title>
  <official_title>Effects of Blueberry Juice Consumption on Brain Activation and Perfusion in Healthy Older People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Exeter</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Exeter</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Blueberries are rich in flavonoids that possess antioxidant and anti-inflammatory properties,&#xD;
      which in rodent models are neuro-protective. The risk of developing dementia is reduced in&#xD;
      people habitually consuming high flavonoid intakes, but data from human intervention studies&#xD;
      is sparse. We therefore investigated whether 12 weeks of blueberry concentrate&#xD;
      supplementation improved cognitive function in healthy elderly via increased brain activation&#xD;
      and perfusion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brain perfusion</measure>
    <time_frame>Change from baseline to 12 weeks dietary supplementation</time_frame>
    <description>MRI - arterial spin labelling</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brain activation</measure>
    <time_frame>Change from baseline to 12 weeks dietary supplementation</time_frame>
    <description>fMRI whilst performing modified Stroop task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function tests</measure>
    <time_frame>Change from baseline to 12 weeks dietary supplementation</time_frame>
    <description>Cogstate battery of tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood biomarkers of inflammation</measure>
    <time_frame>Change from baseline to 12 weeks dietary supplementation</time_frame>
    <description>CRP, IL6,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood biomarkers of oxidative stress</measure>
    <time_frame>Change from baseline to 12 weeks dietary supplementation</time_frame>
    <description>protein carbonyls, glutathione</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood biomarkers of neurogenesis</measure>
    <time_frame>Change from baseline to 12 weeks dietary supplementation</time_frame>
    <description>BDNF</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Cognitive Aging</condition>
  <arm_group>
    <arm_group_label>Blueberry</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Blueberry concentrate consumed daily for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo concentrate consumed daily for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Blueberry</intervention_name>
    <arm_group_label>Blueberry</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 60-80y&#xD;
&#xD;
          -  Addenbrooke's Cognitive Examination III questionnaire &gt; 88&#xD;
&#xD;
          -  Consuming 5 or less portions of fruit per day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Addenbrooke's Cognitive Examination III questionnaire &lt; 88 Contraindications for MRI&#xD;
        Consuming more than 5 portions of fruit per day&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joanna Bowtell, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Exeter</affiliation>
  </overall_official>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02985580
org study id: 1314/134617
nct id: NCT02985580
lead sponsor: 
has dmc: No
Blueberries are rich in flavonoids that possess antioxidant and anti-inflammatory properties,
      which in rodent models are neuro-protective. The risk of developing dementia is reduced in
      people habitually consuming high flavonoid intakes, but data from human intervention studies
      is sparse. We therefore investigated whether 12 weeks of blueberry concentrate
      supplementation improved cognitive function in healthy elderly via increased brain activation
      and perfusion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Brain perfusion
time frame: Change from baseline to 12 weeks dietary supplementation
description: MRI - arterial spin labelling
measure: Brain activation
time frame: Change from baseline to 12 weeks dietary supplementation
description: fMRI whilst performing modified Stroop task
measure: Cognitive function tests
time frame: Change from baseline to 12 weeks dietary supplementation
description: Cogstate battery of tests
measure: Blood biomarkers of inflammation
time frame: Change from baseline to 12 weeks dietary supplementation
description: CRP, IL6,
measure: Blood biomarkers of oxidative stress
time frame: Change from baseline to 12 weeks dietary supplementation
description: protein carbonyls, glutathione
measure: Blood biomarkers of neurogenesis
time frame: Change from baseline to 12 weeks dietary supplementation
description: BDNF
arm group label: Blueberry
arm group type: Active Comparator
description: Blueberry concentrate consumed daily for 12 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo concentrate consumed daily for 12 weeks.
intervention type: Dietary Supplement
intervention name: Blueberry
arm group label: Blueberry
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joanna Bowtell, PhD
role: Principal Investigator
affiliation: University of Exeter
responsible party type: Sponsor
sharing ipd: No