<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/NCT03248115</url>
  </required_header>
  <id_info>
    <org_study_id>HNR6480</org_study_id>
    <nct_id>NCT03248115</nct_id>
  </id_info>
  <brief_title>Bioavailability of Green Tea and Coffee Polyphenols</brief_title>
  <acronym>POBAS</acronym>
  <official_title>Bioavailability of Green Tea and Coffee Polyphenols in Healthy Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MRC Human Nutrition Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MRC Human Nutrition Research</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is little information on the dietary intake, absorption, metabolism and bioavailability&#xD;
      (degree to which a substance becomes available to the target tissues upon administration) of&#xD;
      polyphenols (natural substances present in a variety of foods) in human participants.&#xD;
&#xD;
      This study assessed the bioavailability in healthy participants of polyphenols from 2&#xD;
      supplements containing green tea and green coffee extracts.&#xD;
&#xD;
      Eleven participants were recruited and their habitual diet was assessed to estimate&#xD;
      polyphenol intake. After completing a 24-hour urine collection, participants were given six&#xD;
      green tea extract and three green coffee extract tablets, which they took daily for a period&#xD;
      of 8 weeks. No tablets were taken during the last 4 weeks of the study. Further 24-hour&#xD;
      urines were collected at 2, 4, 8 and 12 weeks.&#xD;
&#xD;
      Participants were required to attend HNR (medical laboratory) the day after each 24hour urine&#xD;
      collection. At these visits, they were asked to bring along their urine collections,&#xD;
      completed documents (urine collection sheet, checklist for tablet intake/side effects) and&#xD;
      any remaining supplements, which were used to assess tablet compliance.&#xD;
&#xD;
      The investigators identified and quantified the amount of polyphenols in the supplement&#xD;
      tablets as well as the amount of polyphenols and their metabolites in urine. The&#xD;
      investigators then evaluated polyphenol bioavailability from the relationship between their&#xD;
      dietary intake and urinary output.&#xD;
&#xD;
      Evidence from this research could inform future intervention studies by providing data on the&#xD;
      bioavailability of green tea and coffee polyphenols, and on the individual differences&#xD;
      related to phenolic intake.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2013</start_date>
  <completion_date type="Actual">October 18, 2013</completion_date>
  <primary_completion_date type="Actual">October 18, 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline phenolic metabolites in urine at 2 weeks</measure>
    <time_frame>Week 0 -before supplementation- and week 2</time_frame>
    <description>Assessment of the profile of metabolites coming from green tea and green coffee phytochemicals in urine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline phenolic metabolites in urine at 4 weeks</measure>
    <time_frame>Week 0 -before supplementation- and week 4</time_frame>
    <description>Assessment of the profile of metabolites coming from green tea and green coffee</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline phenolic metabolites in urine at 8 weeks</measure>
    <time_frame>Week 0 -before supplementation- and week 8</time_frame>
    <description>Assessment of the profile of metabolites coming from green tea and green coffee</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline phenolic metabolites in urine at 12 weeks</measure>
    <time_frame>Week 0 -before supplementation- and week 12 -4 weeks after finishing the supplementation period-</time_frame>
    <description>Assessment of the profile of metabolites coming from green tea and green coffee</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phenolic compounds in tablets</measure>
    <time_frame>Through study completion, an average of 3 months</time_frame>
    <description>Quantification of the tablet polyphenol content</description>
  </secondary_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>Diet, Food, and Nutrition</condition>
  <condition>Dietary Supplements</condition>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Green tea and green coffee extract tablets</intervention_name>
    <description>Tablets: participants were required to take 6 green tea and 3 green coffee extract tablets daily for a period of 8 weeks. No tablets were taken during the last 4 weeks of the study. Randomly chosen tablets were analysed to quantify their polyphenol content.&#xD;
Urine collections: Several urine collections were required during the supplementation period in order have sufficient time points to estimate the plateau of the concentration of green tea and coffee polyphenols excreted in the urine to then be able to determine their bioavailability. There was a total of five 24-hour urine collections (at week 0 -before supplementation-, 2, 4, 8, and 12 -4 weeks after finishing the supplementation period).&#xD;
Completion of study documents: Participants were provided with urine collection sheets, polyphenol questionnaires, checklists to record polyphenol tablet intake, and detailed instructions.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men and women.&#xD;
&#xD;
          -  18-45 years of age.&#xD;
&#xD;
          -  BMI between 18.5 and 24.9 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking.&#xD;
&#xD;
          -  Allergy or intolerance to intervention supplements.&#xD;
&#xD;
          -  Chronic, acute or active inflammatory conditions, haematological disorders, or any&#xD;
             other systemic illness of renal, hepatic or gastrointestinal origin.&#xD;
&#xD;
          -  Major surgical operations in the gastrointestinal tract or medical treatment for&#xD;
             gastrointestinal problems.&#xD;
&#xD;
          -  Active cancer or diagnosis of malignancy within the last five years.&#xD;
&#xD;
          -  Pregnant, lactating, contemplating pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Virginia Tomatis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MRC HNR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MRC HNR Elsie Widdowson Laboratory</name>
      <address>
        <city>Cambridge</city>
        <zip>CB1 9NL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>MRC Human Nutrition Research</investigator_affiliation>
    <investigator_full_name>Virginia Tomatis</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>polyphenols</keyword>
  <keyword>green tea catechins</keyword>
  <keyword>coffee caffeoylquinic acids</keyword>
  <keyword>metabolism</keyword>
  <keyword>inter-individual variability</keyword>
  <keyword>colonic microbiota</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/NCT03248115
org study id: HNR6480
nct id: NCT03248115
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
There is little information on the dietary intake, absorption, metabolism and bioavailability
      (degree to which a substance becomes available to the target tissues upon administration) of
      polyphenols (natural substances present in a variety of foods) in human participants.

      This study assessed the bioavailability in healthy participants of polyphenols from 2
      supplements containing green tea and green coffee extracts.

      Eleven participants were recruited and their habitual diet was assessed to estimate
      polyphenol intake. After completing a 24-hour urine collection, participants were given six
      green tea extract and three green coffee extract tablets, which they took daily for a period
      of 8 weeks. No tablets were taken during the last 4 weeks of the study. Further 24-hour
      urines were collected at 2, 4, 8 and 12 weeks.

      Participants were required to attend HNR (medical laboratory) the day after each 24hour urine
      collection. At these visits, they were asked to bring along their urine collections,
      completed documents (urine collection sheet, checklist for tablet intake/side effects) and
      any remaining supplements, which were used to assess tablet compliance.

      The investigators identified and quantified the amount of polyphenols in the supplement
      tablets as well as the amount of polyphenols and their metabolites in urine. The
      investigators then evaluated polyphenol bioavailability from the relationship between their
      dietary intake and urinary output.

      Evidence from this research could inform future intervention studies by providing data on the
      bioavailability of green tea and coffee polyphenols, and on the individual differences
      related to phenolic intake.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change from baseline phenolic metabolites in urine at 2 weeks
time frame: Week 0 -before supplementation- and week 2
description: Assessment of the profile of metabolites coming from green tea and green coffee phytochemicals in urine
measure: Change from baseline phenolic metabolites in urine at 4 weeks
time frame: Week 0 -before supplementation- and week 4
description: Assessment of the profile of metabolites coming from green tea and green coffee
measure: Change from baseline phenolic metabolites in urine at 8 weeks
time frame: Week 0 -before supplementation- and week 8
description: Assessment of the profile of metabolites coming from green tea and green coffee
measure: Change from baseline phenolic metabolites in urine at 12 weeks
time frame: Week 0 -before supplementation- and week 12 -4 weeks after finishing the supplementation period-
description: Assessment of the profile of metabolites coming from green tea and green coffee
measure: Phenolic compounds in tablets
time frame: Through study completion, an average of 3 months
description: Quantification of the tablet polyphenol content
intervention type: Dietary Supplement
intervention name: Green tea and green coffee extract tablets
description: Tablets: participants were required to take 6 green tea and 3 green coffee extract tablets daily for a period of 8 weeks. No tablets were taken during the last 4 weeks of the study. Randomly chosen tablets were analysed to quantify their polyphenol content.
Urine collections: Several urine collections were required during the supplementation period in order have sufficient time points to estimate the plateau of the concentration of green tea and coffee polyphenols excreted in the urine to then be able to determine their bioavailability. There was a total of five 24-hour urine collections (at week 0 -before supplementation-, 2, 4, 8, and 12 -4 weeks after finishing the supplementation period).
Completion of study documents: Participants were provided with urine collection sheets, polyphenol questionnaires, checklists to record polyphenol tablet intake, and detailed instructions.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Virginia Tomatis, PhD
role: Principal Investigator
affiliation: MRC HNR
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: MRC Human Nutrition Research
investigator full name: Virginia Tomatis
investigator title: Principal Investigator
sharing ipd: No