<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/NCT03840746</url>
  </required_header>
  <id_info>
    <org_study_id>BB/M027724/1-3</org_study_id>
    <nct_id>NCT03840746</nct_id>
  </id_info>
  <brief_title>Interactions Between Fibre and Polyphenols on Colonic Phenolic Acid Production and Biomarkers of Health ( 6 Weeks)</brief_title>
  <official_title>6 Week Feeding Study of Interactions Between Fibre and Polyphenols Sources on Colonic Phenolic Acid Production and Biomarkers of Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Scottish Universities Environmental Research Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Glasgow</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The investigators have studied the acute interactions of polyphenols and NDC in a single meal&#xD;
      in a human study containing tomatoes, lovage &amp; onions, with and without inulin. The&#xD;
      investigators now wish to study the longer-term interactions of these foods over 6 weeks as&#xD;
      well as their impact on biomarkers of human health, the gut microbiome, human proteome and&#xD;
      markers of risk of chronic disease. This may allow better targeted evaluation of foods which&#xD;
      influence health through the gut microbiome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Polyphenol rich plant foods have been associated with several health benefits but their&#xD;
      bioavailability is generally low. The majority of plant polyphenols are poorly absorbed in&#xD;
      the small intestine and enter the colon where the colonic microbiota metabolise them to&#xD;
      release a range of phenolic acids, which are now thought to be the main bioactive components&#xD;
      related to the reduction in disease risk. Very little is known about the impact of other&#xD;
      constituents of the diet on the metabolism and bacterial catabolism of these polyphenols.&#xD;
&#xD;
      Colonic bacteria are key agents in the release of the bioactive molecules from polyphenols&#xD;
      but also ferment non-digestible carbohydrates (NDC) such as inulin to short chain fatty&#xD;
      acids. It is likely that there are key interactions in the colonic bacterial metabolism of&#xD;
      NDC and phenolics. The investigators hypothesize that combination of polyphenolics (in&#xD;
      onions, tomatoes and lovage) with inulin (NDC) will increase the urinary output of bioactive&#xD;
      phenolic acids over a 6 week feeding trial and impact on biomarkers of cardiometabolic&#xD;
      health.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 11, 2018</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">July 30, 2019</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>Parallel Assignment</intervention_model>
    <intervention_model_description>This intervention study will be carried out using a parallel design, with three arms (foods containing polyphenol+NDC, foods with polyphenol alone, and habitual diet control)</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>soups in plain tins and labelled A or B. Code held by person not part of study team.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline of total amount of phenolic acids (umoles/24 hours) in urine (3 wk)</measure>
    <time_frame>3 weeks</time_frame>
    <description>Profile and amounts of phenolic acids in urine derived from the colonic bacterial metabolism of polyphenols</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline of total amount of phenolic acids (umoles/24 hours) in urine (6 wk)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Profile and amounts of phenolic acids in urine derived from the colonic bacterial metabolism of polyphenols</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Habitual diet</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>participants remain on their habitual diet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tomato, onion and lovage soup (TOL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One tin of soup containing Tomato onion and lovage daily for 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TOL soup with inulin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One tin of Tomato, onion and lovage soup with added inulin for 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tomato, onion and lovage soup (TOL)</intervention_name>
    <description>Soup</description>
    <arm_group_label>Tomato, onion and lovage soup (TOL)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TOL soup with inulin</intervention_name>
    <description>Soup</description>
    <arm_group_label>TOL soup with inulin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Generally healthy&#xD;
&#xD;
          -  BMI&gt;=25&#xD;
&#xD;
          -  Not on antibiotics within 3 months of starting of study&#xD;
&#xD;
          -  No medication likely to influence gut function, colonic bacterial activity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Antibiotics&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Glasgow</name>
      <address>
        <city>Glasgow</city>
        <state>Scotland</state>
        <zip>G31 2ER</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>March 24, 2023</last_update_submitted>
  <last_update_submitted_qc>March 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Glasgow</investigator_affiliation>
    <investigator_full_name>Christine Edwards</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>self-reported healthy adults</keyword>
  <keyword>age 40-70</keyword>
  <keyword>BMI &gt; 25</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/46/NCT03840746/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03840746
org study id: BB/M027724/1-3
nct id: NCT03840746
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators have studied the acute interactions of polyphenols and NDC in a single meal
      in a human study containing tomatoes, lovage & onions, with and without inulin. The
      investigators now wish to study the longer-term interactions of these foods over 6 weeks as
      well as their impact on biomarkers of human health, the gut microbiome, human proteome and
      markers of risk of chronic disease. This may allow better targeted evaluation of foods which
      influence health through the gut microbiome.
Polyphenol rich plant foods have been associated with several health benefits but their
      bioavailability is generally low. The majority of plant polyphenols are poorly absorbed in
      the small intestine and enter the colon where the colonic microbiota metabolise them to
      release a range of phenolic acids, which are now thought to be the main bioactive components
      related to the reduction in disease risk. Very little is known about the impact of other
      constituents of the diet on the metabolism and bacterial catabolism of these polyphenols.

      Colonic bacteria are key agents in the release of the bioactive molecules from polyphenols
      but also ferment non-digestible carbohydrates (NDC) such as inulin to short chain fatty
      acids. It is likely that there are key interactions in the colonic bacterial metabolism of
      NDC and phenolics. The investigators hypothesize that combination of polyphenolics (in
      onions, tomatoes and lovage) with inulin (NDC) will increase the urinary output of bioactive
      phenolic acids over a 6 week feeding trial and impact on biomarkers of cardiometabolic
      health.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This intervention study will be carried out using a parallel design, with three arms (foods containing polyphenol+NDC, foods with polyphenol alone, and habitual diet control)
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: soups in plain tins and labelled A or B. Code held by person not part of study team.
measure: Change from baseline of total amount of phenolic acids (umoles/24 hours) in urine (3 wk)
time frame: 3 weeks
description: Profile and amounts of phenolic acids in urine derived from the colonic bacterial metabolism of polyphenols
measure: Change from baseline of total amount of phenolic acids (umoles/24 hours) in urine (6 wk)
time frame: 6 weeks
description: Profile and amounts of phenolic acids in urine derived from the colonic bacterial metabolism of polyphenols
arm group label: Habitual diet
arm group type: No Intervention
description: participants remain on their habitual diet
arm group label: Tomato, onion and lovage soup (TOL)
arm group type: Experimental
description: One tin of soup containing Tomato onion and lovage daily for 6 weeks
arm group label: TOL soup with inulin
arm group type: Experimental
description: One tin of Tomato, onion and lovage soup with added inulin for 6 weeks
intervention type: Other
intervention name: Tomato, onion and lovage soup (TOL)
description: Soup
arm group label: Tomato, onion and lovage soup (TOL)
intervention type: Other
intervention name: TOL soup with inulin
description: Soup
arm group label: TOL soup with inulin
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Glasgow
investigator full name: Christine Edwards
investigator title: Professor
sharing ipd: No
provided document: 