<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/NCT03806829</url>
  </required_header>
  <id_info>
    <org_study_id>ETHSHE1376</org_study_id>
    <nct_id>NCT03806829</nct_id>
  </id_info>
  <brief_title>The Acute Effects of Commercially Available Drinks on the Endothelial Function of Humans Following a High-fat Meal</brief_title>
  <official_title>Pilot Study: The Acute Effects of Commercially Available Drinks on the Endothelial Function of Humans Following a High-fat Meal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of the Highlands and Islands</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of the Highlands and Islands</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>
      High fat diets are associated with impaired endothelial function and increased cardiovascular&#xD;
      disease risk amongst our population. These negative effects are likely caused by triglyceride&#xD;
      induced suppression of nitric oxide, which is produced from the endothelium, and/or an&#xD;
      increase in oxidative stress.&#xD;
&#xD;
      Interestingly, previous studies have found that some beverages that are high in polyphenols&#xD;
      and antioxidants may suppress the impairment in endothelial function observed following high&#xD;
      fat meals/diets. Typically, these studies have investigated the ingestion of red wine, orange&#xD;
      juice or green tea on outcome measures (typically flow mediated dilatation (FMD) of the&#xD;
      brachial artery). Despite this previous research, no study has compared the effects of&#xD;
      different beverages on endothelial outcomes following a high-fat meal within the same&#xD;
      participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2018</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Endothelial (dys)function</measure>
    <time_frame>2 hours post-prandial</time_frame>
    <description>Assessed via flow mediated dilatation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma Nitrite</measure>
    <time_frame>2 hours post-prandial</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma antioxidant capacity</measure>
    <time_frame>2 hours post-prandial</time_frame>
    <description>Plasma oxygen radical absorbance capacity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma ox-LDL</measure>
    <time_frame>2 hours post-prandial</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Endothelial Dysfunction</condition>
  <arm_group>
    <arm_group_label>Water + Meal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>250 ml Water and a high calorie, high fat meal (&gt;900 kcal, 50g fat)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Red Wine + Meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>250 ml Red Wine and a high calorie, high fat meal (&gt;900 kcal, 50g fat)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Green Tea + Meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>250 ml Green Tea and a high calorie, high fat meal (&gt;900 kcal, 50g fat)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orange Juice + Meal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>250 ml Orange Juice and a high calorie, high fat meal (&gt;900 kcal, 50g fat)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Water</intervention_name>
    <description>250 ml</description>
    <arm_group_label>Water + Meal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Red Wine</intervention_name>
    <description>250 ml</description>
    <arm_group_label>Red Wine + Meal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Green Tea</intervention_name>
    <description>250 ml</description>
    <arm_group_label>Green Tea + Meal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Orange Juice</intervention_name>
    <description>250 ml</description>
    <arm_group_label>Orange Juice + Meal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females to be postmenopausal and not on hormone replacement therapy&#xD;
&#xD;
          -  25 &gt; BMI &lt; 35&#xD;
&#xD;
          -  Sedentary to light activity lifestyle.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cardiovascular disease (Hypertension, Atherosclerosis, endothelial issues&#xD;
             etc).&#xD;
&#xD;
          -  History of diabetes (Type 1 or type 2)&#xD;
&#xD;
          -  Vegan or with food allergies or intolerances.&#xD;
&#xD;
          -  Taking any antioxidants over the counter (Vit C, E or polyphenol supplements)&#xD;
&#xD;
          -  Taking prescription medication for hypertension.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ian Megson, Megson</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of the Highlands and Islands</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of the Highlands and Islands</name>
      <address>
        <city>Inverness</city>
        <zip>IV2 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>antioxidants</keyword>
  <keyword>polyphenols</keyword>
  <keyword>flow-mediated dilatation</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03806829
org study id: ETHSHE1376
nct id: NCT03806829
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
High fat diets are associated with impaired endothelial function and increased cardiovascular
      disease risk amongst our population. These negative effects are likely caused by triglyceride
      induced suppression of nitric oxide, which is produced from the endothelium, and/or an
      increase in oxidative stress.

      Interestingly, previous studies have found that some beverages that are high in polyphenols
      and antioxidants may suppress the impairment in endothelial function observed following high
      fat meals/diets. Typically, these studies have investigated the ingestion of red wine, orange
      juice or green tea on outcome measures (typically flow mediated dilatation (FMD) of the
      brachial artery). Despite this previous research, no study has compared the effects of
      different beverages on endothelial outcomes following a high-fat meal within the same
      participants.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Endothelial (dys)function
time frame: 2 hours post-prandial
description: Assessed via flow mediated dilatation
measure: Plasma Nitrite
time frame: 2 hours post-prandial
measure: Plasma antioxidant capacity
time frame: 2 hours post-prandial
description: Plasma oxygen radical absorbance capacity
measure: Plasma ox-LDL
time frame: 2 hours post-prandial
arm group label: Water + Meal
arm group type: Active Comparator
description: 250 ml Water and a high calorie, high fat meal (>900 kcal, 50g fat)
arm group label: Red Wine + Meal
arm group type: Experimental
description: 250 ml Red Wine and a high calorie, high fat meal (>900 kcal, 50g fat)
arm group label: Green Tea + Meal
arm group type: Experimental
description: 250 ml Green Tea and a high calorie, high fat meal (>900 kcal, 50g fat)
arm group label: Orange Juice + Meal
arm group type: Experimental
description: 250 ml Orange Juice and a high calorie, high fat meal (>900 kcal, 50g fat)
intervention type: Other
intervention name: Water
description: 250 ml
arm group label: Water + Meal
intervention type: Other
intervention name: Red Wine
description: 250 ml
arm group label: Red Wine + Meal
intervention type: Other
intervention name: Green Tea
description: 250 ml
arm group label: Green Tea + Meal
intervention type: Other
intervention name: Orange Juice
description: 250 ml
arm group label: Orange Juice + Meal
criteria: 
gender: All
minimum age: 50 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ian Megson, Megson
role: Principal Investigator
affiliation: University of the Highlands and Islands
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No