<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/NCT02972996</url>
  </required_header>
  <id_info>
    <org_study_id>HNS 01</org_study_id>
    <nct_id>NCT02972996</nct_id>
  </id_info>
  <brief_title>Blueberry Consumption and Type 2 Diabetes</brief_title>
  <official_title>Effects of Blueberry Consumption on Cardiometabolic Parameters in Men With Type 2 Diabetes.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albany Research Institute, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Albany Research Institute, Inc.</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>
      Lifestyle strategies that include dietary modification, such as consumption of a plant-based&#xD;
      diet, are well recognized in disease prevention and may improve type 2 diabetes. Various&#xD;
      components of a plant-based diet may contribute to its beneficial health effects, but there&#xD;
      has been keen interest in the possibility that plant polyphenols may have a role. Blueberries&#xD;
      are dietary sources of polyphenols, specifically anthocyanins. To date there are few human&#xD;
      clinical trials evaluating the beneficial health effects of blueberries in populations with&#xD;
      type 2 diabetes. The objective of the study is to determine if freeze-dried blueberries&#xD;
      compared to a blueberry placebo will improve cardiometabolic parameters in men with type 2&#xD;
      diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2017</start_date>
  <completion_date type="Actual">June 21, 2018</completion_date>
  <primary_completion_date type="Actual">June 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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>8 weeks</time_frame>
    <description>Systolic blood pressure and diastolic blood pressure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1C</measure>
    <time_frame>8 weeks</time_frame>
    <description>Hemoglobin A1C is a surrogate marker of glycemic control over the preceding 2-3 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Blueberry</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>22 g freeze-dried blueberries</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>22 g placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blueberry</intervention_name>
    <description>22 g freeze-dried whole blueberry powder</description>
    <arm_group_label>Blueberry</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>22 g placebo blueberry powder</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Ages 45 to 75 years at beginning of study&#xD;
&#xD;
          -  BMI &gt;25 kg/m2&#xD;
&#xD;
          -  HbA1C &gt; 6.5 and &lt; 9&#xD;
&#xD;
          -  Medical diagnosis of type 2 diabetes for at least 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of insulin&#xD;
&#xD;
          -  Presence of chronic kidney disease (GFR &lt; 45 mL/min), liver cirrhosis,&#xD;
             gastrointestinal disease, pancreatic disease, or malabsorption syndromes&#xD;
&#xD;
          -  Weight loss of &gt;10% of body weight over the last 6 months; routine participation in&#xD;
             heavy exercise&#xD;
&#xD;
          -  Heavy smokers (&gt;20 cigarettes per day)&#xD;
&#xD;
          -  Unable or unwilling to give informed consent or communicate with study staff&#xD;
&#xD;
          -  Other medical, psychiatric, or behavioral factors that in the judgment of the&#xD;
             Principal Investigators may interfere with study participation or the ability to&#xD;
             follow the intervention protocol&#xD;
&#xD;
          -  Allergies to blueberries or blueberry products&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Margaret M. Wilson, MS, RD, CDE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stratton V.A. Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stratton V.A. Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <results_first_submitted>October 1, 2019</results_first_submitted>
  <results_first_submitted_qc>February 17, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 19, 2022</results_first_posted>
  <last_update_submitted>February 17, 2022</last_update_submitted>
  <last_update_submitted_qc>February 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2022</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>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 6, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT02972996/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Blueberry</title>
          <description>Blueberry: 22 g freeze-dried whole blueberry powder</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo: 22 g placebo blueberry powder</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Blueberry</title>
          <description>Blueberry: 22 g freeze-dried whole blueberry powder</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo: 22 g placebo blueberry powder</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="52"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.1" spread="1.1"/>
                    <measurement group_id="B2" value="66.7" spread="1.1"/>
                    <measurement group_id="B3" value="67.0" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Blood Pressure</title>
          <units>mm Hg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Systolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="130.3" spread="21.7"/>
                    <measurement group_id="B2" value="126.2" spread="13.3"/>
                    <measurement group_id="B3" value="128.2" spread="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="73.4" spread="5.4"/>
                    <measurement group_id="B2" value="76.2" spread="7.8"/>
                    <measurement group_id="B3" value="74.8" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Blood Pressure</title>
        <description>Systolic blood pressure and diastolic blood pressure.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Blueberry</title>
            <description>Blueberry: 22 g freeze-dried whole blueberry powder</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo: 22 g placebo blueberry powder</description>
          </group>
        </group_list>
        <measure>
          <title>Blood Pressure</title>
          <description>Systolic blood pressure and diastolic blood pressure.</description>
          <units>mm Hg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125.6" spread="2.5"/>
                    <measurement group_id="O2" value="126.0" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.6" spread="1.0"/>
                    <measurement group_id="O2" value="75.1" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Values are least-squares means ± SEs (adjusted for the baseline values) from ANCOVA linear mixed model that included covariates of age, baseline (pretreatment values), BMI and weight.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.56</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemoglobin A1C</title>
        <description>Hemoglobin A1C is a surrogate marker of glycemic control over the preceding 2-3 months.</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Blueberry</title>
            <description>Blueberry: 22 g freeze-dried whole blueberry powder</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo: 22 g placebo blueberry powder</description>
          </group>
        </group_list>
        <measure>
          <title>Hemoglobin A1C</title>
          <description>Hemoglobin A1C is a surrogate marker of glycemic control over the preceding 2-3 months.</description>
          <units>percent</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" spread="0.1"/>
                    <measurement group_id="O2" value="7.5" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.03</p_value>
            <method>ANCOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Blueberry</title>
          <description>22 g freeze-dried blueberries&#xD;
Blueberry: 22 g freeze-dried whole blueberry powder</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>22 g placebo&#xD;
Placebo: 22 g placebo blueberry powder</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Margaret M. Wilson MS, RD, LD/N, CD/N, CNSC, CDE</name_or_title>
      <organization>Stratton V.A. Medical Center</organization>
      <phone>518 626-6889</phone>
      <email>margaret.wilson2@va.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02972996
org study id: HNS 01
nct id: NCT02972996
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Lifestyle strategies that include dietary modification, such as consumption of a plant-based
      diet, are well recognized in disease prevention and may improve type 2 diabetes. Various
      components of a plant-based diet may contribute to its beneficial health effects, but there
      has been keen interest in the possibility that plant polyphenols may have a role. Blueberries
      are dietary sources of polyphenols, specifically anthocyanins. To date there are few human
      clinical trials evaluating the beneficial health effects of blueberries in populations with
      type 2 diabetes. The objective of the study is to determine if freeze-dried blueberries
      compared to a blueberry placebo will improve cardiometabolic parameters in men with type 2
      diabetes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Blood Pressure
time frame: 8 weeks
description: Systolic blood pressure and diastolic blood pressure.
measure: Hemoglobin A1C
time frame: 8 weeks
description: Hemoglobin A1C is a surrogate marker of glycemic control over the preceding 2-3 months.
arm group label: Blueberry
arm group type: Experimental
description: 22 g freeze-dried blueberries
arm group label: Placebo
arm group type: Placebo Comparator
description: 22 g placebo
intervention type: Other
intervention name: Blueberry
description: 22 g freeze-dried whole blueberry powder
arm group label: Blueberry
intervention type: Other
intervention name: Placebo
description: 22 g placebo blueberry powder
arm group label: Placebo
criteria: 
gender: Male
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: No
last name: Margaret M. Wilson, MS, RD, CDE
role: Principal Investigator
affiliation: Stratton V.A. Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 