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/NCT06021665</url>
    </required_header>
    <id_info>
      <org_study_id>20320</org_study_id>
      <nct_id>NCT06021665</nct_id>
    </id_info>
    <brief_title>A Randomized, Double-Blind, Controlled Trial to Assess the Efficacy of a Fortetropin Supplement in Improving Symptoms of Osteoarthritis</brief_title>
    <official_title>A Randomized, Double-Blind, Controlled Trial to Assess the Efficacy of a Fortetropin Supplement in Improving Symptoms of Osteoarthritis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>MYOS Corp</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Citruslabs</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>MYOS Corp</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>
        This is a hybrid, double-blind, randomized, placebo-controlled clinical trial that will last&#xD;
        12 weeks. Participants will be randomized into either the intervention product or control&#xD;
        group and will consume the test product or control daily. Participants will complete&#xD;
        study-specific and validated questionnaires at Baseline, Week 6, and Week 12, as well as&#xD;
        blood biomarker testing for a lipid panel and high-sensitivity C-reactive protein (hs-CRP) at&#xD;
        Baseline and Week 12.&#xD;
  &#xD;
        Osteoarthritis-like symptoms, such as joint pain, inflammation, and reduced mobility will be&#xD;
        evaluated at baseline and at each check-in. Likert scale responses will be examined from&#xD;
        baseline to each check-in. Participant responses on product feedback will be presented as %&#xD;
        scores. Two validated questionnaires, Western Ontario and McMaster Universities Arthritis&#xD;
        Index (WOMAC) and the Numeric Pain Rating Scale (NPRS) will also be completed at the&#xD;
        questionnaire time points. A full lipid panel and hs-CRP measurement will be completed via&#xD;
        in-person blood draws.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">June 19, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</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>Two-group, randomized controlled trial</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Both groups and the study coordinators will be blinded to the allocation.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scoring. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>The WOMAC score is a widely used questionnaire-based assessment tool designed to evaluate the symptoms and functional limitations of individuals with osteoarthritis of the knee and hip joints. Patients are asked to rate their experience on a Likert scale, usually ranging from 0 to 4 or 5, where higher values indicate greater severity of symptoms or limitations.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Numeric Pain Rating Scale (NPRS). [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>The NPRS scale is a commonly used tool for assessing and quantifying pain intensity. It's a self-report scale where individuals are asked to rate their pain on a numerical scale. The scale typically ranges from 0 to 10, with 0 representing &quot;no pain&quot; and 10 representing &quot;worst pain imaginable.&quot;</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in muscle mass perceived by participants. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Survey-based assessment (0-5 scale) of participants perception of changes in muscle mass.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in total cholesterol. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Participants will undergo blood tests to evaluate a range of parameters, including total cholesterol.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in blood triglycerides. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Participants will undergo blood tests to evaluate a range of parameters, including triglycerides.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in High-Density Lipoprotein (HDL) cholesterol. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Participants will undergo blood tests to evaluate a range of parameters, including HDL cholesterol.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Low-Density Lipoprotein (LDL) cholesterol. [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Participants will undergo blood tests to evaluate a range of parameters, including LDL cholesterol.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in high-sensitivity C-reactive protein (hs-CRP). [Baseline to Week 12]</measure>
      <time_frame>12 weeks</time_frame>
      <description>Participants will undergo blood tests to evaluate a range of parameters, including hs-CRP.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Osteoarthritis</condition>
    <arm_group>
      <arm_group_label>Fortetropin Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Fortetropin group will receive a 20cc size scoop with their product and will be instructed to mix 2 scoops of product with water or a milk of their choice daily.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The control group will receive a 50cc size scoop with their product and will be instructed to mix 2 scoops of product with water or a milk of their choice daily. The difference in scoop size is to allow for macronutrient matching of the intervention and control products.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Fortetropin supplement</intervention_name>
      <description>Test Formulation: 10g serving Calories: 64.8g Carbohydrates: 0.45g Fats: 5.5g Protein: 3.38g</description>
      <arm_group_label>Fortetropin Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Cheese protein</intervention_name>
      <description>The cheese powder will act as the control product. Cheese powder has been chosen as it matches the macronutrient content of the test product, but without the active ingredient.&#xD;
  Control Formulation: 20g serving Calories: 93g Carbohydrates: 8g Fats: 5g Protein: 3g</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Men and women aged 50-75 years of age&#xD;
  &#xD;
            -  Self-reporting osteoarthritis-like symptoms, experiencing 3 or more of the following&#xD;
               symptoms: joint pain, inflammation, reduced mobility, joint swelling, and stiffness.&#xD;
  &#xD;
            -  Non-acute osteoarthritis, must have experienced symptoms for longer than 1 year.&#xD;
  &#xD;
            -  Generally healthy and don't live with any uncontrolled chronic disease&#xD;
  &#xD;
            -  Able to eat eggs (haven't been medically advised to avoid)&#xD;
  &#xD;
            -  Willing to stop eating eggs for the 12 week study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Anyone allergic or intolerant of eggs&#xD;
  &#xD;
            -  Anyone who has been advised to avoid eggs&#xD;
  &#xD;
            -  Any pre-existing chronic conditions that would prevent participants from adhering to&#xD;
               the protocol, including oncological and psychiatric disorders.&#xD;
  &#xD;
            -  Anyone with known severe allergic reactions.&#xD;
  &#xD;
            -  Women who are pregnant, breastfeeding or attempting to become pregnant&#xD;
  &#xD;
            -  Unwilling to follow the study protocol.&#xD;
  &#xD;
            -  Subjects currently enrolled in another clinical study&#xD;
  &#xD;
            -  Subjects having finished another clinical study within the last 4 weeks before&#xD;
               inclusion&#xD;
  &#xD;
            -  Hypersensitivity, allergy, or intolerance against any compound of the test products&#xD;
               (e. g. eggs)&#xD;
  &#xD;
            -  Recent implantation of a cardiac pacemaker or other active implants&#xD;
  &#xD;
            -  History of or present liver deficiency as defined by Quick &lt; 70%&#xD;
  &#xD;
            -  History of hepatitis B, C, HIV&#xD;
  &#xD;
            -  Subjects who are scheduled to undergo any diagnostic intervention or hospitalization&#xD;
               which may cause protocol deviations&#xD;
  &#xD;
            -  Simultaneous study participation by members of the same household&#xD;
  &#xD;
            -  Any diet to lose body weight&#xD;
  &#xD;
            -  Eating disorders or vegan diet&#xD;
  &#xD;
            -  Present drug abuse or alcoholism&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Citruslabs</name>
        <address>
          <city>Santa Monica</city>
          <state>California</state>
          <zip>90404</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoarthritis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06021665
  org study id: 20320
  nct id: NCT06021665
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a hybrid, double-blind, randomized, placebo-controlled clinical trial that will last
        12 weeks. Participants will be randomized into either the intervention product or control
        group and will consume the test product or control daily. Participants will complete
        study-specific and validated questionnaires at Baseline, Week 6, and Week 12, as well as
        blood biomarker testing for a lipid panel and high-sensitivity C-reactive protein (hs-CRP) at
        Baseline and Week 12.
  
        Osteoarthritis-like symptoms, such as joint pain, inflammation, and reduced mobility will be
        evaluated at baseline and at each check-in. Likert scale responses will be examined from
        baseline to each check-in. Participant responses on product feedback will be presented as %
        scores. Two validated questionnaires, Western Ontario and McMaster Universities Arthritis
        Index (WOMAC) and the Numeric Pain Rating Scale (NPRS) will also be completed at the
        questionnaire time points. A full lipid panel and hs-CRP measurement will be completed via
        in-person blood draws.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two-group, randomized controlled trial
  primary purpose: Other
  masking: Double (Participant, Investigator)
  masking description: Both groups and the study coordinators will be blinded to the allocation.
  measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scoring. [Baseline to Week 12]
  time frame: 12 weeks
  description: The WOMAC score is a widely used questionnaire-based assessment tool designed to evaluate the symptoms and functional limitations of individuals with osteoarthritis of the knee and hip joints. Patients are asked to rate their experience on a Likert scale, usually ranging from 0 to 4 or 5, where higher values indicate greater severity of symptoms or limitations.
  measure: Change in Numeric Pain Rating Scale (NPRS). [Baseline to Week 12]
  time frame: 12 weeks
  description: The NPRS scale is a commonly used tool for assessing and quantifying pain intensity. It's a self-report scale where individuals are asked to rate their pain on a numerical scale. The scale typically ranges from 0 to 10, with 0 representing "no pain" and 10 representing "worst pain imaginable."
  measure: Changes in muscle mass perceived by participants. [Baseline to Week 12]
  time frame: 12 weeks
  description: Survey-based assessment (0-5 scale) of participants perception of changes in muscle mass.
  measure: Changes in total cholesterol. [Baseline to Week 12]
  time frame: 12 weeks
  description: Participants will undergo blood tests to evaluate a range of parameters, including total cholesterol.
  measure: Changes in blood triglycerides. [Baseline to Week 12]
  time frame: 12 weeks
  description: Participants will undergo blood tests to evaluate a range of parameters, including triglycerides.
  measure: Changes in High-Density Lipoprotein (HDL) cholesterol. [Baseline to Week 12]
  time frame: 12 weeks
  description: Participants will undergo blood tests to evaluate a range of parameters, including HDL cholesterol.
  measure: Changes in Low-Density Lipoprotein (LDL) cholesterol. [Baseline to Week 12]
  time frame: 12 weeks
  description: Participants will undergo blood tests to evaluate a range of parameters, including LDL cholesterol.
  measure: Changes in high-sensitivity C-reactive protein (hs-CRP). [Baseline to Week 12]
  time frame: 12 weeks
  description: Participants will undergo blood tests to evaluate a range of parameters, including hs-CRP.
  arm group label: Fortetropin Group
  arm group type: Experimental
  description: The Fortetropin group will receive a 20cc size scoop with their product and will be instructed to mix 2 scoops of product with water or a milk of their choice daily.
  arm group label: Control Group
  arm group type: Placebo Comparator
  description: The control group will receive a 50cc size scoop with their product and will be instructed to mix 2 scoops of product with water or a milk of their choice daily. The difference in scoop size is to allow for macronutrient matching of the intervention and control products.
  intervention type: Other
  intervention name: Fortetropin supplement
  description: Test Formulation: 10g serving Calories: 64.8g Carbohydrates: 0.45g Fats: 5.5g Protein: 3.38g
  arm group label: Fortetropin Group
  intervention type: Other
  intervention name: Cheese protein
  description: The cheese powder will act as the control product. Cheese powder has been chosen as it matches the macronutrient content of the test product, but without the active ingredient.
  Control Formulation: 20g serving Calories: 93g Carbohydrates: 8g Fats: 5g Protein: 3g
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Osteoarthritis
  sharing ipd: Undecided