<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/NCT02231502</url>
  </required_header>
  <id_info>
    <org_study_id>14/EE/0070</org_study_id>
    <nct_id>NCT02231502</nct_id>
  </id_info>
  <brief_title>Innovation in Food Production Techniques to Improve Bioactive Content</brief_title>
  <acronym>ENRICH</acronym>
  <official_title>Optimising Vegetable Based Convenience Food Production to Retain Compounds Found in Vegetables</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of East Anglia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quadram Institute Bioscience</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>PepsiCo Global R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of East Anglia</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to establish to what extent innovations in food production&#xD;
      techniques may facilitate retention of bioactive compounds in healthy individuals.&#xD;
&#xD;
      The study has a single-blinded (outcome assessor), cross-over design; wherein, the plasma&#xD;
      concentration and urinary excretion levels of a range of bioactive compounds will be assessed&#xD;
      over a 24 hour period following intake of either a vegetable based convenience food, or a&#xD;
      minimally processed meal containing the same vegetable materials.&#xD;
&#xD;
      To do this, 20 healthy volunteers will attend two assessment days (and a follow-up assessment&#xD;
      at +24hr) and will provide blood and urine samples, which will be collected at biologically&#xD;
      relevant times over the 24 hour period. In this cross-over study, each meal will be eaten on&#xD;
      separate days, with a wash-out period of at least 1 week between assessments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">January 2015</completion_date>
  <primary_completion_date type="Anticipated">December 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>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>24hr excretion of bioactive compounds</measure>
    <time_frame>24h</time_frame>
    <description>A range of bioactive compounds found in vegetables, and their metabolites, will be assessed in blood and/or urine samples collected over a 24 hour period.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Bioavailability</condition>
  <arm_group>
    <arm_group_label>Vegetable-based convenience food</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One time ingestion of a vegetable-based convenience product. Dietary restrictions will be observed (i.e. avoidance of some vegetables) for 3 days prior to the bioavailability assessment (a list of foods to avoid will be provided).&#xD;
At least 7 days wash-out between each assessment visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vegetable meal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One time ingestion of a minimally processed vegetable meal. Dietary restrictions will be observed (i.e. avoidance of some vegetables) for 3 days prior to the bioavailability assessment (a list of foods to avoid will be provided).&#xD;
At least 7 days wash-out between each assessment visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vegetable-based convenience food</intervention_name>
    <arm_group_label>Vegetable-based convenience food</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vegetable meal</intervention_name>
    <arm_group_label>Vegetable meal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women&#xD;
&#xD;
          -  ≥ 18 years old&#xD;
&#xD;
          -  Successful biochemical, haematological and urinalysis assessment at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current smokers, or ex-smokers ceasing &lt; 3 months ago&#xD;
&#xD;
          -  Pregnant women, or those currently breast feeding&#xD;
&#xD;
          -  Subjects with existing or significant past medical history of medical conditions&#xD;
             likely to affect the study measures i.e. diabetes, hepatic, renal, digestive or cancer&#xD;
             (excluding Basal-cell carcinoma) - to be judged by the study clinical advisor.&#xD;
&#xD;
          -  Those unprepared to adhere to dietary restrictions for 3d preceding and during each&#xD;
             assessment day.&#xD;
&#xD;
          -  Parallel participation in another research project involving dietary intervention&#xD;
             and/or sampling of biological fluids/material.&#xD;
&#xD;
          -  Those on therapeutic diets or having experienced substantial weight loss (to be judged&#xD;
             by clinical advisor) within 3 month of screening&#xD;
&#xD;
          -  Taking dietary supplements containing flavonoids, isothiocyanates or carotenes&#xD;
             (including multivitamins) (and unwilling to cease intake during, and 1 month preceding&#xD;
             the trial) or unwilling to maintain existing intake of other supplements.&#xD;
&#xD;
          -  Prescribed medications likely to affect ADME (absorption, distribution, metabolism,&#xD;
             and excretion); medications to be assessed for suitability by the clinical advisor.&#xD;
&#xD;
          -  Clinical advisor judged: abnormal biochemical, haematological or urinary results or&#xD;
             measurements considered to be counter indicative for the study: including kidney and&#xD;
             liver function, fasting glucose (especially if indicative of diabetes), lipid&#xD;
             abnormalities, full blood count.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aedin Cassidy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of East Anglia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Norwich Medical School</name>
      <address>
        <city>Norwich</city>
        <state>Norfolk</state>
        <zip>NR4 7TJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>November 10, 2014</last_update_submitted>
  <last_update_submitted_qc>November 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bioavailability in healthy individuals</keyword>
  <!-- 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/NCT02231502
org study id: 14/EE/0070
nct id: NCT02231502
lead sponsor: 
collaborator: 
collaborator: 
The purpose of this study is to establish to what extent innovations in food production
      techniques may facilitate retention of bioactive compounds in healthy individuals.

      The study has a single-blinded (outcome assessor), cross-over design; wherein, the plasma
      concentration and urinary excretion levels of a range of bioactive compounds will be assessed
      over a 24 hour period following intake of either a vegetable based convenience food, or a
      minimally processed meal containing the same vegetable materials.

      To do this, 20 healthy volunteers will attend two assessment days (and a follow-up assessment
      at +24hr) and will provide blood and urine samples, which will be collected at biologically
      relevant times over the 24 hour period. In this cross-over study, each meal will be eaten on
      separate days, with a wash-out period of at least 1 week between assessments.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: 24hr excretion of bioactive compounds
time frame: 24h
description: A range of bioactive compounds found in vegetables, and their metabolites, will be assessed in blood and/or urine samples collected over a 24 hour period.
arm group label: Vegetable-based convenience food
arm group type: Experimental
description: One time ingestion of a vegetable-based convenience product. Dietary restrictions will be observed (i.e. avoidance of some vegetables) for 3 days prior to the bioavailability assessment (a list of foods to avoid will be provided).
At least 7 days wash-out between each assessment visit.
arm group label: Vegetable meal
arm group type: Active Comparator
description: One time ingestion of a minimally processed vegetable meal. Dietary restrictions will be observed (i.e. avoidance of some vegetables) for 3 days prior to the bioavailability assessment (a list of foods to avoid will be provided).
At least 7 days wash-out between each assessment visit.
intervention type: Other
intervention name: Vegetable-based convenience food
arm group label: Vegetable-based convenience food
intervention type: Other
intervention name: Vegetable meal
arm group label: Vegetable meal
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aedin Cassidy, PhD
role: Principal Investigator
affiliation: University of East Anglia
facility: 
country: United Kingdom
responsible party type: Sponsor