<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/NCT02984345</url>
  </required_header>
  <id_info>
    <org_study_id>660065600</org_study_id>
    <nct_id>NCT02984345</nct_id>
  </id_info>
  <brief_title>Does the Ingestion of Mycoprotein Elicit an Optimal Anabolic Response in Resting and Exercised Skeletal Muscle?</brief_title>
  <acronym>ARM</acronym>
  <official_title>Does the Ingestion of Mycoprotein Elicit an Optimal Anabolic Response in Resting and Exercised Skeletal Muscle?</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>
      The present study will seek to quantify the muscle protein synthetic response to mycoprotein&#xD;
      feeding, comparing it to milk protein as a gold standard and heavily researched positive&#xD;
      control&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 26, 2017</start_date>
  <completion_date type="Anticipated">May 2022</completion_date>
  <primary_completion_date type="Actual">May 1, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle fractional synthetic rate (muscle protein synthesis)</measure>
    <time_frame>7.5 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma amino acid concentration</measure>
    <time_frame>7.5 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum insulin concentration</measure>
    <time_frame>7.5 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Molecular markers of muscle anabolism</measure>
    <time_frame>7.5 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Mycoprotein beverage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Milk protein beverage</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mycoprotein beverage</intervention_name>
    <description>Mycoprotein protein beverage</description>
    <arm_group_label>Mycoprotein beverage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Milk protein beverage</intervention_name>
    <description>Milk protein beverage</description>
    <arm_group_label>Milk protein beverage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • BMI between 18 and 30 -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)&#xD;
&#xD;
          -  Any diagnosed cardiovascular disease or hypertension.&#xD;
&#xD;
          -  Elevated blood pressure at the time of screening (e.g. blood pressure of ≥140/90mmHg).&#xD;
&#xD;
          -  Chronic use of any prescribed or over the counter pharmaceuticals.&#xD;
&#xD;
          -  A personal or family history of epilepsy, seizures or schizophrenia.&#xD;
&#xD;
          -  Anyone with previous motor disorders.&#xD;
&#xD;
          -  An allergy to mycoprotein / Quorn, penicillin, or milk.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Exeter, Sports &amp; Health Sciences, College of Life &amp; Environmental Sciences</name>
      <address>
        <city>Exeter</city>
        <state>Devon</state>
        <zip>EX1 2LU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2021</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>May 25, 2021</last_update_submitted>
  <last_update_submitted_qc>May 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caseins</mesh_term>
  </intervention_browse>
  <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/NCT02984345
org study id: 660065600
nct id: NCT02984345
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study will seek to quantify the muscle protein synthetic response to mycoprotein
      feeding, comparing it to milk protein as a gold standard and heavily researched positive
      control
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Muscle fractional synthetic rate (muscle protein synthesis)
time frame: 7.5 hours
measure: Plasma amino acid concentration
time frame: 7.5 hours
measure: Serum insulin concentration
time frame: 7.5 hours
measure: Molecular markers of muscle anabolism
time frame: 7.5 hours
arm group label: Mycoprotein beverage
arm group type: Active Comparator
arm group label: Milk protein beverage
arm group type: Placebo Comparator
intervention type: Other
intervention name: Mycoprotein beverage
description: Mycoprotein protein beverage
arm group label: Mycoprotein beverage
intervention type: Other
intervention name: Milk protein beverage
description: Milk protein beverage
arm group label: Milk protein beverage
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Caseins
sharing ipd: No