<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/NCT04421950</url>
  </required_header>
  <id_info>
    <org_study_id>260493</org_study_id>
    <nct_id>NCT04421950</nct_id>
  </id_info>
  <brief_title>The Blueberry Study</brief_title>
  <official_title>Plasma and Urine Profiles of Blueberry Derived Polyphenols After a Short Term Intervention With Blueberry in Children With Typical Low Fruit and Vegetable Consumption.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arkansas Children's Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arkansas Children's Hospital Research Institute</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>
      This is a research study about the effects of blueberries on the health of children who do&#xD;
      not eat much fruits and vegetables. By doing this study, we hope to find out what nutrients&#xD;
      from blueberries appear in the blood and urine of the child&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double blinded randomized control trial aiming to characterize the profile of&#xD;
      polyphenol-derived metabolites in plasma and urine for children ages 11-12 years supplemented&#xD;
      short term with wild blueberry powder. The study will assess if a short-term supplementation&#xD;
      (5 days) with wild blueberry powder impacts immune responses as well as markers for&#xD;
      cardiovascular and bone health. Up to 44 children will be recruited. The participants will&#xD;
      attend three visits at Arkansas Children's Nutrition Center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 23, 2021</start_date>
  <completion_date type="Anticipated">December 18, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 18, 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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Double blinded randomized control</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma and urine levels of blueberry derived polyphenols and their metabolites</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>Blood will be collected twice following an overnight fast. Twelve-hour urine will be collected twice by participants at home. Plasma and urine samples will be analyzed using mass spectrometry to identify blueberry-derived polyphenols and their levels</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number and percentage of lymphocytes cluster of differentiation 4 (CD4), lymphocytes cluster of differentiation 8 (CD8) and natural killer (NK) cells</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>Mitogen stimulated blood will be stained with combinations of fluorochrome-labeled antibodies and analyzed by flow cytometry. Absolute and relative number of CD4, lymphocytes CD8 and natural killer (NK) will be compared between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T-lymphocyte responsiveness to immune stressors</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>Blood will be collected following an overnight fast after 5 days on the intervention. Whole blood will be cultured and cells stressed with E. coli lipopolysaccharide (LPS) to induce cytokine release from immune cells. Cytokines will be assayed using electrochemiluminescence based detection platform with multiplexed immunoassays, and their levels compared between study groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial function by brachial artery flow mediated dilation</measure>
    <time_frame>up to 2 weeks</time_frame>
    <description>Endothelial-dependent flow-mediated vasodilation of the brachial artery will be measured using high resolution ultrasound at enrollment and after 5 days on the intervention. This technology uses sound waves (ultrasound) to visualize the diameter of the brachial artery. A baseline image of the brachial artery will be recorded at rest. A blood pressure cuff will be placed around the lower arm and the cuff will be inflated to 50 mmHg above systolic pressure for 5 minutes, followed by rapid deflation of the cuff. The diameter of the brachial artery will be measured from ultrasound images captured throughout the 8 minute recording protocol. The percent change in the brachial artery will be compared between and within groups.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Wild Blueberry Supplement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 grams of wild blueberry powder per day in foods items provided to them</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo supplement</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Food items will be provided to them without the wild blueberry power.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Wild blueberry containing foods</intervention_name>
    <description>Foods that contain wild blueberry supplement to deliver up to 30 grams of blueberry powder</description>
    <arm_group_label>Wild Blueberry Supplement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo containing foods</intervention_name>
    <description>Foods that do not contain the blueberry powder but a placebo</description>
    <arm_group_label>Placebo supplement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eats &lt;1.5 cup of fruit and &lt;2.0 cup of vegetables per day&#xD;
&#xD;
          -  Boys or girls&#xD;
&#xD;
          -  All ethnicities&#xD;
&#xD;
          -  All BMIs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to blueberries&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  Chronic kidney disease&#xD;
&#xD;
          -  Hormonal disease&#xD;
&#xD;
          -  Autoimmune disease&#xD;
&#xD;
          -  Bleeding disorders&#xD;
&#xD;
          -  Chronic infections&#xD;
&#xD;
          -  Type 2 and Type 1 diabetes mellitus&#xD;
&#xD;
          -  Attention deficit hyperactivity disorder&#xD;
&#xD;
          -  Opposition defiant disorder&#xD;
&#xD;
          -  Autistic spectrum disorder&#xD;
&#xD;
          -  Pre-existing medical conditions or medications as determined by the investigators to&#xD;
             affect the outcomes of interest&#xD;
&#xD;
          -  If the participants/parents perceive barriers with adhering to low-polyphenol meals&#xD;
&#xD;
          -  Parent or child refusal to stop nutritional supplements&#xD;
&#xD;
          -  Parent or child refusal to have blood drawn&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arkansas Children's Nutrition Center</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>March 2, 2023</last_update_submitted>
  <last_update_submitted_qc>March 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04421950
org study id: 260493
nct id: NCT04421950
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a research study about the effects of blueberries on the health of children who do
      not eat much fruits and vegetables. By doing this study, we hope to find out what nutrients
      from blueberries appear in the blood and urine of the child
This is a double blinded randomized control trial aiming to characterize the profile of
      polyphenol-derived metabolites in plasma and urine for children ages 11-12 years supplemented
      short term with wild blueberry powder. The study will assess if a short-term supplementation
      (5 days) with wild blueberry powder impacts immune responses as well as markers for
      cardiovascular and bone health. Up to 44 children will be recruited. The participants will
      attend three visits at Arkansas Children's Nutrition Center.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
masking description: Double blinded randomized control
measure: Plasma and urine levels of blueberry derived polyphenols and their metabolites
time frame: up to 2 weeks
description: Blood will be collected twice following an overnight fast. Twelve-hour urine will be collected twice by participants at home. Plasma and urine samples will be analyzed using mass spectrometry to identify blueberry-derived polyphenols and their levels
measure: Number and percentage of lymphocytes cluster of differentiation 4 (CD4), lymphocytes cluster of differentiation 8 (CD8) and natural killer (NK) cells
time frame: up to 2 weeks
description: Mitogen stimulated blood will be stained with combinations of fluorochrome-labeled antibodies and analyzed by flow cytometry. Absolute and relative number of CD4, lymphocytes CD8 and natural killer (NK) will be compared between groups.
measure: T-lymphocyte responsiveness to immune stressors
time frame: up to 2 weeks
description: Blood will be collected following an overnight fast after 5 days on the intervention. Whole blood will be cultured and cells stressed with E. coli lipopolysaccharide (LPS) to induce cytokine release from immune cells. Cytokines will be assayed using electrochemiluminescence based detection platform with multiplexed immunoassays, and their levels compared between study groups.
measure: Endothelial function by brachial artery flow mediated dilation
time frame: up to 2 weeks
description: Endothelial-dependent flow-mediated vasodilation of the brachial artery will be measured using high resolution ultrasound at enrollment and after 5 days on the intervention. This technology uses sound waves (ultrasound) to visualize the diameter of the brachial artery. A baseline image of the brachial artery will be recorded at rest. A blood pressure cuff will be placed around the lower arm and the cuff will be inflated to 50 mmHg above systolic pressure for 5 minutes, followed by rapid deflation of the cuff. The diameter of the brachial artery will be measured from ultrasound images captured throughout the 8 minute recording protocol. The percent change in the brachial artery will be compared between and within groups.
arm group label: Wild Blueberry Supplement
arm group type: Active Comparator
description: 30 grams of wild blueberry powder per day in foods items provided to them
arm group label: Placebo supplement
arm group type: Placebo Comparator
description: Food items will be provided to them without the wild blueberry power.
intervention type: Dietary Supplement
intervention name: Wild blueberry containing foods
description: Foods that contain wild blueberry supplement to deliver up to 30 grams of blueberry powder
arm group label: Wild Blueberry Supplement
intervention type: Dietary Supplement
intervention name: Placebo containing foods
description: Foods that do not contain the blueberry powder but a placebo
arm group label: Placebo supplement
criteria: 
gender: All
minimum age: 11 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor