<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/NCT01686282</url>
  </required_header>
  <id_info>
    <org_study_id>021259</org_study_id>
    <nct_id>NCT01686282</nct_id>
  </id_info>
  <brief_title>Blueberry Consumption Improves Vascular Function and Lowers Blood Pressure in Postmenopausal Women With Pre- and Stage 1-hypertension</brief_title>
  <official_title>Daily Incorporation of Blueberries Into a Diet Favorably Improves Vascular Function and Lowers Aortic Blood Pressure in Postmenopausal Women With Pre- and Stage 1-hypertension.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>U.S. Highbush Blueberry Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Florida State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiovascular disease (CVD) continues to be the leading cause of death in the U.S. Americans&#xD;
      have been more concerned about their blood cholesterol levels and dietary cholesterol intakes&#xD;
      rather than their overall cardiovascular health risk factors leading to CVD such as&#xD;
      hypertension, vascular dysfunction, inadequate consumption of fruits and vegetables and&#xD;
      physical activity. Statistics show that approximately 91% of individuals with CVD have&#xD;
      vascular dysfunction which is attributed to endothelial and autonomic dysfunction leading to&#xD;
      increased arterial stiffness.&#xD;
&#xD;
      The investigators long-term goal is to provide feasible and effective dietary ways for pre-&#xD;
      and stage 1- hypertensive individuals to normalize their blood pressure (BP), improve&#xD;
      vascular function and thereby reducing their cardiovascular risk and enhancing the quality of&#xD;
      life. Blueberries are a rich source of phenolic compounds and these compounds may play an&#xD;
      important role in promoting cardiovascular health. Considering the strong possibility that&#xD;
      phytochemicals present in blueberry work additively or synergistically, it would be ideal to&#xD;
      investigate the cardioprotective effects of blueberry as a whole. The investigators overall&#xD;
      objective to bring forth evidence that blueberry consumption will reduce BP and&#xD;
      cardiovascular risk factors including endothelial dysfunction, arterial stiffness, and&#xD;
      autonomic dysfunction in pre- and stage 1-hypertensive postmenopausal women. The&#xD;
      investigators hypothesize that blueberry supplementation will improve vascular function and&#xD;
      will lower blood pressure in postmenopausal women with pre-hypertension. The findings of this&#xD;
      study will provide a foundation for disseminating feasible, safe approaches for preventing&#xD;
      and combating hypertension at its early stage which does not require drug therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to examine the effects of 22 grams of freeze-dried blueberry&#xD;
      intake on a daily basis for eight weeks in:&#xD;
&#xD;
      The purpose of the study is to examine the effects of 22 grams of freeze-dried blueberry&#xD;
      intake on a daily basis for eight weeks on arterial function and blood pressure in&#xD;
      postmenopausal women with pre- and stage 1-hypertension. The specific aims of the study are:&#xD;
&#xD;
        1. To investigate the extent to which daily consumption of 22 g blueberry drink-mix reduces&#xD;
           blood pressure in individuals with pre- and stage 1-hypertension.&#xD;
&#xD;
        2. To determine whether daily consumption of 22 g blueberry drink-mix will improve the&#xD;
           autonomic control of blood pressure and heart rate in individuals with pre- and stage&#xD;
           1-hypertension.&#xD;
&#xD;
        3. To measure serum markers of oxidative stress to determine whether increased antioxidant&#xD;
           defense is in part responsible for blueberry's vascular protective effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>8 weeks</time_frame>
    <description>By measuring aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Autonomic Control of Blood Pressure</measure>
    <time_frame>8 weeks</time_frame>
    <description>By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomic Control of Heart Rate</measure>
    <time_frame>8 weeks</time_frame>
    <description>By measuring heart rate variability at rest and during physiological stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial Function</measure>
    <time_frame>8 week</time_frame>
    <description>By measuring markers of vascular inflammation (adiponectin, leptin, endothelin-1, angiotensin II and 8-isoprostane).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation</measure>
    <time_frame>8 weeks</time_frame>
    <description>By measuring a marker of inflammation (tumor necrosis factor-α [TNF-α]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative Stress</measure>
    <time_frame>8 weeks</time_frame>
    <description>By measuring markers of oxidative stress (superoxide dismutase [SOD], nitrate/nitrite [NOx], ET-1, angiotensin II, 8-isoprostane, MDA, and oxidized LDL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial Stiffness</measure>
    <time_frame>8 Week</time_frame>
    <description>By measuring the augmentation index and arterial stiffness at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Blood Pressure</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>8 weeks of freeze-dried blueberry powder taken in two doses of 22g each per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blueberry</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 weeks of freeze-dried blueberry powder taken in two doses of 22g each per day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Freeze-dried Blueberry Powder</intervention_name>
    <description>8 weeks of freeze-dried taken in two doses of 22g each per day.</description>
    <arm_group_label>Blueberry</arm_group_label>
    <other_name>U.S. Highbush Blueberry Council</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>8 weeks of freeze-dried taken in two doses of 22g each per day.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  40 women (1 to 10 years after natural menopause or bilateral oophorectomy) 45-65 years&#xD;
             of age.&#xD;
&#xD;
          -  Seated blood pressure ≥ 130/85 mm Hg but ≤ 160/90 mm Hg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blood pressure &gt;160/100 mmHg&#xD;
&#xD;
          -  Taking insulin&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
&#xD;
          -  Active cancer&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  Glaucoma&#xD;
&#xD;
          -  Thyroid disease&#xD;
&#xD;
          -  Kidney disease&#xD;
&#xD;
          -  Liver disease&#xD;
&#xD;
          -  Pancreatic disease&#xD;
&#xD;
          -  Enrollment in a weight loss program&#xD;
&#xD;
          -  Heavy smokers (&gt;20 cigarettes per day)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bahram H Arjmandi, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arturo Figueroa, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sarah A Johnson, PhD, RD, CSO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Department of Nutrition, Food, and Exercise Sciences, Florida State University</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>January 12, 2015</last_update_submitted>
  <last_update_submitted_qc>January 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Florida State University</investigator_affiliation>
    <investigator_full_name>Bahram Arjmandi</investigator_full_name>
    <investigator_title>Margaret A. Sitton Professor and Director of the Center for Advancing Exercise and Nutrition Research on Aging</investigator_title>
  </responsible_party>
  <keyword>Blood pressure</keyword>
  <keyword>Arterial Stiffness</keyword>
  <keyword>Blueberry Supplementation</keyword>
  <keyword>Aortic Blood Pressure</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Postmenopausal</keyword>
  <keyword>Pulse Wave Velocity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</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/NCT01686282
org study id: 021259
nct id: NCT01686282
lead sponsor: 
collaborator: 
has dmc: Yes
Cardiovascular disease (CVD) continues to be the leading cause of death in the U.S. Americans
      have been more concerned about their blood cholesterol levels and dietary cholesterol intakes
      rather than their overall cardiovascular health risk factors leading to CVD such as
      hypertension, vascular dysfunction, inadequate consumption of fruits and vegetables and
      physical activity. Statistics show that approximately 91% of individuals with CVD have
      vascular dysfunction which is attributed to endothelial and autonomic dysfunction leading to
      increased arterial stiffness.

      The investigators long-term goal is to provide feasible and effective dietary ways for pre-
      and stage 1- hypertensive individuals to normalize their blood pressure (BP), improve
      vascular function and thereby reducing their cardiovascular risk and enhancing the quality of
      life. Blueberries are a rich source of phenolic compounds and these compounds may play an
      important role in promoting cardiovascular health. Considering the strong possibility that
      phytochemicals present in blueberry work additively or synergistically, it would be ideal to
      investigate the cardioprotective effects of blueberry as a whole. The investigators overall
      objective to bring forth evidence that blueberry consumption will reduce BP and
      cardiovascular risk factors including endothelial dysfunction, arterial stiffness, and
      autonomic dysfunction in pre- and stage 1-hypertensive postmenopausal women. The
      investigators hypothesize that blueberry supplementation will improve vascular function and
      will lower blood pressure in postmenopausal women with pre-hypertension. The findings of this
      study will provide a foundation for disseminating feasible, safe approaches for preventing
      and combating hypertension at its early stage which does not require drug therapy.
The purpose of this study is to examine the effects of 22 grams of freeze-dried blueberry
      intake on a daily basis for eight weeks in:

      The purpose of the study is to examine the effects of 22 grams of freeze-dried blueberry
      intake on a daily basis for eight weeks on arterial function and blood pressure in
      postmenopausal women with pre- and stage 1-hypertension. The specific aims of the study are:

        1. To investigate the extent to which daily consumption of 22 g blueberry drink-mix reduces
           blood pressure in individuals with pre- and stage 1-hypertension.

        2. To determine whether daily consumption of 22 g blueberry drink-mix will improve the
           autonomic control of blood pressure and heart rate in individuals with pre- and stage
           1-hypertension.

        3. To measure serum markers of oxidative stress to determine whether increased antioxidant
           defense is in part responsible for blueberry's vascular protective effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Blood Pressure
time frame: 8 weeks
description: By measuring aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
measure: Autonomic Control of Blood Pressure
time frame: 8 weeks
description: By measuring blood pressure variability and baroreflex sensitivity at rest and during physiological stress.
measure: Autonomic Control of Heart Rate
time frame: 8 weeks
description: By measuring heart rate variability at rest and during physiological stress.
measure: Endothelial Function
time frame: 8 week
description: By measuring markers of vascular inflammation (adiponectin, leptin, endothelin-1, angiotensin II and 8-isoprostane).
measure: Inflammation
time frame: 8 weeks
description: By measuring a marker of inflammation (tumor necrosis factor-α [TNF-α]).
measure: Oxidative Stress
time frame: 8 weeks
description: By measuring markers of oxidative stress (superoxide dismutase [SOD], nitrate/nitrite [NOx], ET-1, angiotensin II, 8-isoprostane, MDA, and oxidized LDL).
measure: Arterial Stiffness
time frame: 8 Week
description: By measuring the augmentation index and arterial stiffness at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).
arm group label: Placebo
arm group type: Placebo Comparator
description: 8 weeks of freeze-dried blueberry powder taken in two doses of 22g each per day.
arm group label: Blueberry
arm group type: Experimental
description: 8 weeks of freeze-dried blueberry powder taken in two doses of 22g each per day.
intervention type: Dietary Supplement
intervention name: Freeze-dried Blueberry Powder
description: 8 weeks of freeze-dried taken in two doses of 22g each per day.
arm group label: Blueberry
other name: U.S. Highbush Blueberry Council
intervention type: Dietary Supplement
intervention name: Placebo
description: 8 weeks of freeze-dried taken in two doses of 22g each per day.
arm group label: Placebo
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: No
last name: Bahram H Arjmandi, PhD, RD
role: Principal Investigator
affiliation: Florida State University
last name: Arturo Figueroa, MD, PhD
role: Principal Investigator
affiliation: Florida State University
last name: Sarah A Johnson, PhD, RD, CSO
role: Principal Investigator
affiliation: Florida State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Florida State University
investigator full name: Bahram Arjmandi
investigator title: Margaret A. Sitton Professor and Director of the Center for Advancing Exercise and Nutrition Research on Aging
mesh term: Hypertension