<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/NCT02234648</url>
  </required_header>
  <id_info>
    <org_study_id>NUKK1</org_study_id>
    <nct_id>NCT02234648</nct_id>
  </id_info>
  <brief_title>To Investigate the Effect of Tart Montmorency Cherry Juice (Prunus Cerasus) on Vascular Function.</brief_title>
  <official_title>Investigate the Effect of Tart Montmorency Cherry Juice (Prunus Cerasus) on Vascular Function.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northumbria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northumbria University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Given the global health issues associated with poor cardiovascular function, interventions&#xD;
      that help reduce the severity, with emphasis on prevention would not only have economic&#xD;
      implications, but would also improve health, wellbeing and quality of life. Research provides&#xD;
      evidence that consumption of a diet high in plant foods and rich is polyphenols is associated&#xD;
      with a reduction in the incidence of cardiovascular disease (Hung et al 2004). Tart&#xD;
      Montmorency cherries have been shown to be high in numerous phytochemicals (Wang et al 1999;&#xD;
      Seeram et al 2001). Several of these compounds, are known to be vasoactive and improve blood&#xD;
      vessel function by increasing bioavailability of vasodilators (Mudnic et al 2012), reducing&#xD;
      vasoconstrictors (Broncel et al 2010), decreasing platelet aggregation (Hubbart et al 2006)&#xD;
      and increasing blood vessel dilation (Schroeter et al 2006). Impaired function of the lining&#xD;
      of blood vessels (endothelial dysfunction) has been linked to increased risk of&#xD;
      cardiovascular disease. However, the bioavailability of all the compounds in Tart Montmorency&#xD;
      Cherry Juice and their efficacy with respect to vascular function has not been fully&#xD;
      determined. This study will examine the influence of tart Montmorency cherry juice on&#xD;
      cardiovascular function, specifically arterial stiffness by pulse wave velocity and blood&#xD;
      flow in the microcirculation by laser Doppler imaging. This study will also examine digital&#xD;
      volume pulse and pulse wave analysis. These data will provide information on the ability of&#xD;
      TMCJ to affect blood flow and vascular function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants provided blood samples immediately before supplementation and sequentially 8h&#xD;
      post ingestion. Additionally, vascular measurements including laser Doppler imaging (LDI),&#xD;
      pulse wave analysis (PWA), pulse wave velocity (PWV), digital volume pulse (DVP) and blood&#xD;
      pressure (BP) were performed with the participant in a supine position. LDI, PWV, PWA, and&#xD;
      DVP were measured at 1, 2, 3, 5 and 8h intervals. BP was performed at hourly intervals. All&#xD;
      vascular measurements took place on the non - cannulated arm. No additional food or fluid was&#xD;
      provided during the study period except for low-nitrate mineral water. Following a minimum of&#xD;
      two weeks washout, the participants were required to return to the laboratory to repeat the&#xD;
      procedure with the other intervention drink.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in microvasculature blood flow</measure>
    <time_frame>0,1,2,3,5 and 8 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in arterial stiffness</measure>
    <time_frame>0,1,2,3,5 and 8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood pressure</measure>
    <time_frame>0,1,2,3,4,5,6,7 and 8 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The PLA supplement consisted of a commercially available, less than 5% fruit, cordial (Protein - Trace, Carbohydrate 260 mg•mL-1, Sodium 0.02 mg•mL-1, Fibre-Trace and Anthocyanins-Trace for colour), mixed with water, whey protein isolate (Arla Foods Ltd., Leeds, UK) and maltodextrin (MyProtein Ltd., Northwich, UK) until matched for carbohydrate and calorie content of the MC.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>60mL tart Montmorency cherry juice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One bolus of 60mL of tart Montmorency cherry (MC) juice mixed with 100mL of water. Independent analysis of MC (Atlas Biosciences, 2010) provided the following compositional data; Fat 0.028 mg•mL-1, Protein 31.47 mg•mL-1, Carbohydrate 669.4 mg•mL-1, Cholesterol &lt; 0.01 mg•mL-1, Sodium 0.691 mg•mL-1, Calcium 0.137 mg•mL-1 and Iron 0.026 mg•mL-1. Additionally, according to the manufacturers guidelines (Cherry Active, Hanworth, UK),</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>60mL tart Montmorency cherry juice</intervention_name>
    <description>One bolus of 60mL of tart Montmorency concentrate mixed with 100mL of water.</description>
    <arm_group_label>60mL tart Montmorency cherry juice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>One bolus of less than 5% fruit cordial mixed with water, maltodextrin and whey protein isolate to match for carbohydrate and calorie content of the juice.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>less than 5% &quot;Kia Ora&quot; mixed fruit squash</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Those with blood pressure below 140/90&#xD;
&#xD;
          -  Males&#xD;
&#xD;
          -  Aged 21 - 55y&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with blood pressure above 140/90&#xD;
&#xD;
          -  Taken other medication/ supplements.&#xD;
&#xD;
          -  Those aged &gt;21 or &lt;55.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Glyn Howatson</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northumbria University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northumbria University</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE1 8ST</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>April 13, 2015</last_update_submitted>
  <last_update_submitted_qc>April 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northumbria University</investigator_affiliation>
    <investigator_full_name>Glyn Howatson</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Vascular Function</keyword>
  <keyword>tart Montmorency cherries</keyword>
  <keyword>Arterial Stiffness</keyword>
  <keyword>Blood Flow</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/NCT02234648
org study id: NUKK1
nct id: NCT02234648
lead sponsor: 
has dmc: Yes
Given the global health issues associated with poor cardiovascular function, interventions
      that help reduce the severity, with emphasis on prevention would not only have economic
      implications, but would also improve health, wellbeing and quality of life. Research provides
      evidence that consumption of a diet high in plant foods and rich is polyphenols is associated
      with a reduction in the incidence of cardiovascular disease (Hung et al 2004). Tart
      Montmorency cherries have been shown to be high in numerous phytochemicals (Wang et al 1999;
      Seeram et al 2001). Several of these compounds, are known to be vasoactive and improve blood
      vessel function by increasing bioavailability of vasodilators (Mudnic et al 2012), reducing
      vasoconstrictors (Broncel et al 2010), decreasing platelet aggregation (Hubbart et al 2006)
      and increasing blood vessel dilation (Schroeter et al 2006). Impaired function of the lining
      of blood vessels (endothelial dysfunction) has been linked to increased risk of
      cardiovascular disease. However, the bioavailability of all the compounds in Tart Montmorency
      Cherry Juice and their efficacy with respect to vascular function has not been fully
      determined. This study will examine the influence of tart Montmorency cherry juice on
      cardiovascular function, specifically arterial stiffness by pulse wave velocity and blood
      flow in the microcirculation by laser Doppler imaging. This study will also examine digital
      volume pulse and pulse wave analysis. These data will provide information on the ability of
      TMCJ to affect blood flow and vascular function.
Participants provided blood samples immediately before supplementation and sequentially 8h
      post ingestion. Additionally, vascular measurements including laser Doppler imaging (LDI),
      pulse wave analysis (PWA), pulse wave velocity (PWV), digital volume pulse (DVP) and blood
      pressure (BP) were performed with the participant in a supine position. LDI, PWV, PWA, and
      DVP were measured at 1, 2, 3, 5 and 8h intervals. BP was performed at hourly intervals. All
      vascular measurements took place on the non - cannulated arm. No additional food or fluid was
      provided during the study period except for low-nitrate mineral water. Following a minimum of
      two weeks washout, the participants were required to return to the laboratory to repeat the
      procedure with the other intervention drink.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Changes in microvasculature blood flow
time frame: 0,1,2,3,5 and 8 hours
measure: Changes in arterial stiffness
time frame: 0,1,2,3,5 and 8 hours
measure: Changes in blood pressure
time frame: 0,1,2,3,4,5,6,7 and 8 hours
arm group label: Placebo
arm group type: Placebo Comparator
description: The PLA supplement consisted of a commercially available, less than 5% fruit, cordial (Protein - Trace, Carbohydrate 260 mg•mL-1, Sodium 0.02 mg•mL-1, Fibre-Trace and Anthocyanins-Trace for colour), mixed with water, whey protein isolate (Arla Foods Ltd., Leeds, UK) and maltodextrin (MyProtein Ltd., Northwich, UK) until matched for carbohydrate and calorie content of the MC.
arm group label: 60mL tart Montmorency cherry juice
arm group type: Active Comparator
description: One bolus of 60mL of tart Montmorency cherry (MC) juice mixed with 100mL of water. Independent analysis of MC (Atlas Biosciences, 2010) provided the following compositional data; Fat 0.028 mg•mL-1, Protein 31.47 mg•mL-1, Carbohydrate 669.4 mg•mL-1, Cholesterol < 0.01 mg•mL-1, Sodium 0.691 mg•mL-1, Calcium 0.137 mg•mL-1 and Iron 0.026 mg•mL-1. Additionally, according to the manufacturers guidelines (Cherry Active, Hanworth, UK),
intervention type: Dietary Supplement
intervention name: 60mL tart Montmorency cherry juice
description: One bolus of 60mL of tart Montmorency concentrate mixed with 100mL of water.
arm group label: 60mL tart Montmorency cherry juice
intervention type: Other
intervention name: Placebo
description: One bolus of less than 5% fruit cordial mixed with water, maltodextrin and whey protein isolate to match for carbohydrate and calorie content of the juice.
arm group label: Placebo
other name: less than 5% "Kia Ora" mixed fruit squash
criteria: 
gender: Male
minimum age: 21 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Glyn Howatson
role: Principal Investigator
affiliation: Northumbria University
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Northumbria University
investigator full name: Glyn Howatson
investigator title: Dr.
mesh term: Hypertension