<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/NCT01706718</url>
  </required_header>
  <id_info>
    <org_study_id>10/18</org_study_id>
    <secondary_id>University of Reading</secondary_id>
    <nct_id>NCT01706718</nct_id>
  </id_info>
  <brief_title>Beetroot Enriched Bread, Blood Pressure and Vascular Function</brief_title>
  <official_title>The Effects of Beetroot Enriched Bread on Postprandial Vascular Function, Arterial Stiffness and Blood Pressure in Healthy Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Reading</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Reading</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dietary nitrate is known to lower blood pressure. Beetroot is a rich source of nitrate and&#xD;
      could therefore be an important dietary component in the management of hypertension and&#xD;
      cardiovascular disease, however consumption is relatively low. We evaluated the effects of&#xD;
      beetroot enriched bread ingestion on acute microvascular reactivity, arterial stiffness and&#xD;
      blood pressure response in healthy men.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <completion_date type="Actual">October 2010</completion_date>
  <primary_completion_date type="Actual">October 2010</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vascular reactivity</measure>
    <time_frame>Change from baseline at 2, 4 and 6 hours after bread consumption</time_frame>
    <description>Forearm blood flow by Laser Doppler Imaging with iontophoresis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arterial stiffness</measure>
    <time_frame>Change from baseline at 2, 4 and 6 hours after bread consumption</time_frame>
    <description>Pulse wave analysis (PWA) and velocity (PWV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Change from baseline at 30 minute intervals for 7 hours</time_frame>
    <description>By ambulatory blood pressure monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma nitrate</measure>
    <time_frame>Every 30 minutes for 7 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma nitrite</measure>
    <time_frame>Every 30 minutes for 7 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Control white bread</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Beetroot bread</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Bread</intervention_name>
    <arm_group_label>Beetroot bread</arm_group_label>
    <arm_group_label>Control white bread</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  A signed consent form&#xD;
&#xD;
          -  Age 18-64 years&#xD;
&#xD;
          -  Body mass index - 18.5-30 kg/m2&#xD;
&#xD;
          -  Non-smoking, healthy individuals&#xD;
&#xD;
          -  Normal blood pressure at screening (&lt; 150/90)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with anaemia&#xD;
&#xD;
          -  Sufferers of chronic illnesses&#xD;
&#xD;
          -  Individuals with food allergies&#xD;
&#xD;
          -  People with diabetes&#xD;
&#xD;
          -  People with coeliac disease&#xD;
&#xD;
          -  Women&#xD;
&#xD;
          -  Vegetarians&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Reading</name>
      <address>
        <city>Reading</city>
        <state>Berkshire</state>
        <zip>RG6 6AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Hobbs DA, Kaffa N, George TW, Methven L, Lovegrove JA. Blood pressure-lowering effects of beetroot juice and novel beetroot-enriched bread products in normotensive male subjects. Br J Nutr. 2012 Dec 14;108(11):2066-74. doi: 10.1017/S0007114512000190. Epub 2012 Mar 14.</citation>
    <PMID>22414688</PMID>
  </reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>October 12, 2012</last_update_submitted>
  <last_update_submitted_qc>October 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Reading</investigator_affiliation>
    <investigator_full_name>Julie Lovegrove</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Beetroot</keyword>
  <keyword>Blood pressure</keyword>
  <keyword>Vascular function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>January 13, 2014</submitted>
    <returned>February 22, 2014</returned>
    <submitted>March 4, 2014</submitted>
    <returned>April 9, 2014</returned>
    <submitted>July 9, 2014</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>July 28, 2014</submitted>
    <returned>August 14, 2014</returned>
  </pending_results>
  <!-- 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/NCT01706718
org study id: 10/18
secondary id: University of Reading
nct id: NCT01706718
lead sponsor: 
has dmc: Yes
Dietary nitrate is known to lower blood pressure. Beetroot is a rich source of nitrate and
      could therefore be an important dietary component in the management of hypertension and
      cardiovascular disease, however consumption is relatively low. We evaluated the effects of
      beetroot enriched bread ingestion on acute microvascular reactivity, arterial stiffness and
      blood pressure response in healthy men.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Vascular reactivity
time frame: Change from baseline at 2, 4 and 6 hours after bread consumption
description: Forearm blood flow by Laser Doppler Imaging with iontophoresis
measure: Arterial stiffness
time frame: Change from baseline at 2, 4 and 6 hours after bread consumption
description: Pulse wave analysis (PWA) and velocity (PWV)
measure: Blood pressure
time frame: Change from baseline at 30 minute intervals for 7 hours
description: By ambulatory blood pressure monitor
measure: Plasma nitrate
time frame: Every 30 minutes for 7 hours
measure: Plasma nitrite
time frame: Every 30 minutes for 7 hours
arm group label: Control white bread
arm group type: Placebo Comparator
arm group label: Beetroot bread
arm group type: Experimental
intervention type: Dietary Supplement
intervention name: Bread
arm group label: Beetroot bread
arm group label: Control white bread
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
citation: Hobbs DA, Kaffa N, George TW, Methven L, Lovegrove JA. Blood pressure-lowering effects of beetroot juice and novel beetroot-enriched bread products in normotensive male subjects. Br J Nutr. 2012 Dec 14;108(11):2066-74. doi: 10.1017/S0007114512000190. Epub 2012 Mar 14.
PMID: 22414688
responsible party type: Principal Investigator
investigator affiliation: University of Reading
investigator full name: Julie Lovegrove
investigator title: Professor
mesh term: Hypertension
submitted: January 13, 2014
returned: February 22, 2014
submitted: March 4, 2014
returned: April 9, 2014
submitted: July 9, 2014
submission canceled: Unknown
submitted: July 28, 2014
returned: August 14, 2014