<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/NCT02984358</url>
  </required_header>
  <id_info>
    <org_study_id>660065613</org_study_id>
    <nct_id>NCT02984358</nct_id>
  </id_info>
  <brief_title>Chronic Mycoprotein Consumption and Nucleotide Content in Metabolic Health</brief_title>
  <acronym>MYTH</acronym>
  <official_title>Effect of Chronic Mycoprotein Consumption, and of Its Nucleotide Content, in Uric Acid Concentrations and Other Markers of Metabolic Health in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Exeter</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Exeter</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>
      Compare chronic (one week) of a 'normal' meat diet with one week of mycoprotein consumption,&#xD;
      with or without a reduced nucleotide content, on markers of metabolic health, such as uric&#xD;
      acid concentrations, blood glucose control and blood lipid profiles.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum uric acid concentrations</measure>
    <time_frame>Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glycaemia and serum insulin - insulin sensitivity (oral glucose tolerance test)</measure>
    <time_frame>Measured at baseline and after 1 week intervention (day 8)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-6</measure>
    <time_frame>Measured at baseline and after 1 week intervention (day 8)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24 h blood glucose homeostasis - measured using a Dexcom CGMS</measure>
    <time_frame>Measured 5 days at baseline (habitual data) and 5 days during the intervention (days 3 - 7)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolomics (using Nuclear Magnetic Resonance - NMR)</measure>
    <time_frame>Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Animal protein based diet</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Seven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by animal products (meat and fish).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-nucleotide mycoprotein based diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Seven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by nucleotide-depleted mycoprotein products (commercial Quorn products).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-nucleotide mycoprotein based diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Seven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by nucleotide-rich mycoprotein products.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Animal protein based diet</intervention_name>
    <arm_group_label>Animal protein based diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low-nucleotide mycoprotein based diet</intervention_name>
    <arm_group_label>Low-nucleotide mycoprotein based diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-nucleotide mycoprotein based diet</intervention_name>
    <arm_group_label>High-nucleotide mycoprotein based diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI between 18 and 30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  On medication (except contraception)&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Diagnosed with any metabolic or cardiovascular conditions&#xD;
&#xD;
          -  BMI &lt; 18 or &gt; 30&#xD;
&#xD;
          -  Dietary restrictions (vegetarians/vegans, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>June 13, 2018</last_update_submitted>
  <last_update_submitted_qc>June 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02984358
org study id: 660065613
nct id: NCT02984358
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Compare chronic (one week) of a 'normal' meat diet with one week of mycoprotein consumption,
      with or without a reduced nucleotide content, on markers of metabolic health, such as uric
      acid concentrations, blood glucose control and blood lipid profiles.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Serum uric acid concentrations
time frame: Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)
measure: Glycaemia and serum insulin - insulin sensitivity (oral glucose tolerance test)
time frame: Measured at baseline and after 1 week intervention (day 8)
measure: IL-6
time frame: Measured at baseline and after 1 week intervention (day 8)
measure: 24 h blood glucose homeostasis - measured using a Dexcom CGMS
time frame: Measured 5 days at baseline (habitual data) and 5 days during the intervention (days 3 - 7)
measure: Metabolomics (using Nuclear Magnetic Resonance - NMR)
time frame: Measured at baseline; days 2, 4 and 6 of the intervention; and after the 1 week intervention (day 8)
arm group label: Animal protein based diet
arm group type: Placebo Comparator
description: Seven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by animal products (meat and fish).
arm group label: Low-nucleotide mycoprotein based diet
arm group type: Active Comparator
description: Seven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by nucleotide-depleted mycoprotein products (commercial Quorn products).
arm group label: High-nucleotide mycoprotein based diet
arm group type: Active Comparator
description: Seven day fully controlled normocaloric diet (1.2 g/ kg body weight of protein per day), with the main protein source at the two main meals (lunch and dinner) being provided by nucleotide-rich mycoprotein products.
intervention type: Other
intervention name: Animal protein based diet
arm group label: Animal protein based diet
intervention type: Other
intervention name: Low-nucleotide mycoprotein based diet
arm group label: Low-nucleotide mycoprotein based diet
intervention type: Other
intervention name: High-nucleotide mycoprotein based diet
arm group label: High-nucleotide mycoprotein based diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: No