xml: <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/NCT06025292</url>
    </required_header>
    <id_info>
      <org_study_id>276210</org_study_id>
      <nct_id>NCT06025292</nct_id>
    </id_info>
    <brief_title>Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults</brief_title>
    <acronym>PORK</acronym>
    <official_title>Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Arkansas</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The National Pork Board</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Arkansas</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>
        We will be directly comparing a high-quality protein diet composed primarily of lean pork&#xD;
        loin (PORK) to a lower-quality plant-based protein diet (PLANT) in individuals with&#xD;
        prediabetes on muscle and whole-body protein turnover and glucose regulation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2025</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>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Whole Body Protein Balance</measure>
      <time_frame>24 hours</time_frame>
      <description>Volume of net protein protein produced per unit of time</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Pre Diabetes</condition>
    <arm_group>
      <arm_group_label>High Quality Protein Intake -Pork</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Meal patterns will mimic a standard American diet (50% carbohydrate, 15% protein, 35% fat), providing an isonitrogenous 0.8 g/kg/d protein, and meeting individual estimated daily energy requirements. We have chosen 0.8 g/kg/d as it is the recommend dietary allowance for protein in the US. This arm's protein source will be from lean pork.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Low Quality Protein Intake- Plant</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Meal patterns will mimic a standard American diet (50% carbohydrate, 15% protein, 35% fat), providing an isonitrogenous 0.8 g/kg/d protein, and meeting individual estimated daily energy requirements. We have chosen 0.8 g/kg/d as it is the recommend dietary allowance for protein in the US. This arm's protein source will be from plant based protein (ie impossible burger, black bean burger, soy, etc).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Lean Pork vs Plant Based</intervention_name>
      <description>Participants will eat pre prepared study meals for three days that have either protein sourced from lean pork or plant sources.</description>
      <arm_group_label>High Quality Protein Intake -Pork</arm_group_label>
      <arm_group_label>Low Quality Protein Intake- Plant</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Males and females ages 40-60 years. 2. BMI &lt;35 kg/m2. 3. Capable of providing&#xD;
               informed consent. 4. COVID-19 negative and/or asymptomatic. 5. Willing to abstain from&#xD;
               drinking alcohol or consuming marijuana and CBD products during the 4-day study meal&#xD;
               period 6. HbA1: 5.7-6.4%&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Subject who does not/will not eat animal protein sources. 2. Body mass index &lt;20&#xD;
               kg/m2 or &gt;35 kg/m2. 3. Hemoglobin &lt;10g/dL at screening. 4. Platelets &lt;150,000/uL at&#xD;
               screening. 5. History of chemotherapy or radiation therapy for cancer in the 6 months&#xD;
               prior to enrollment.&#xD;
  &#xD;
               6. History of gastrointestinal bypass/reduction surgery. 7. Pregnant or lactating&#xD;
               individuals. 8. History of a chronic inflammatory disease (e.g. Lupus, Crohn's&#xD;
               disease) 9. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH,&#xD;
               IGF-I) therapy.&#xD;
  &#xD;
               10. Currently using prescription blood thinning medications. 11. Currently using&#xD;
               corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).&#xD;
  &#xD;
               12. Unable or unwilling to suspend aspirin use for 7 days prior to Visit 3. 13.&#xD;
               Unwilling to avoid using protein or amino-acid supplements during participation.&#xD;
  &#xD;
               14. Unwilling to fast overnight. 15. Unwilling to avoid alcohol, marijuana and CBD&#xD;
               products for the four study days.&#xD;
  &#xD;
               16. Participating in &gt;200 minutes/week of vigorous exercise and/or &gt;4 days/week of&#xD;
               resistance training.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>David Church, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Arkansas</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>David Church, PhD</last_name>
      <phone>501-526-5769</phone>
      <email>dchurch@uams.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Amanda Gwin, PA-C</last_name>
      <phone>5018380096</phone>
      <email>algwin@uams.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>plant based</keyword>
    <keyword>protein sources</keyword>
    <keyword>lean pork</keyword>
    <keyword>muscle protein synthesis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prediabetic State</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06025292
  org study id: 276210
  nct id: NCT06025292
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  We will be directly comparing a high-quality protein diet composed primarily of lean pork
        loin (PORK) to a lower-quality plant-based protein diet (PLANT) in individuals with
        prediabetes on muscle and whole-body protein turnover and glucose regulation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Whole Body Protein Balance
  time frame: 24 hours
  description: Volume of net protein protein produced per unit of time
  arm group label: High Quality Protein Intake -Pork
  arm group type: Active Comparator
  description: Meal patterns will mimic a standard American diet (50% carbohydrate, 15% protein, 35% fat), providing an isonitrogenous 0.8 g/kg/d protein, and meeting individual estimated daily energy requirements. We have chosen 0.8 g/kg/d as it is the recommend dietary allowance for protein in the US. This arm's protein source will be from lean pork.
  arm group label: Low Quality Protein Intake- Plant
  arm group type: Active Comparator
  description: Meal patterns will mimic a standard American diet (50% carbohydrate, 15% protein, 35% fat), providing an isonitrogenous 0.8 g/kg/d protein, and meeting individual estimated daily energy requirements. We have chosen 0.8 g/kg/d as it is the recommend dietary allowance for protein in the US. This arm's protein source will be from plant based protein (ie impossible burger, black bean burger, soy, etc).
  intervention type: Other
  intervention name: Lean Pork vs Plant Based
  description: Participants will eat pre prepared study meals for three days that have either protein sourced from lean pork or plant sources.
  arm group label: High Quality Protein Intake -Pork
  arm group label: Low Quality Protein Intake- Plant
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: David Church, PhD
  role: Principal Investigator
  affiliation: University of Arkansas
  last name: David Church, PhD
  phone: 501-526-5769
  email: dchurch@uams.edu
  last name: Amanda Gwin, PA-C
  phone: 5018380096
  email: algwin@uams.edu
  responsible party type: Sponsor
  mesh term: Prediabetic State
  sharing ipd: No