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/NCT06012669</url>
    </required_header>
    <id_info>
      <org_study_id>MB-2305</org_study_id>
      <nct_id>NCT06012669</nct_id>
    </id_info>
    <brief_title>Effects of Lactoferrin at Two Doses vs. Active Control on Markers of Immune Function</brief_title>
    <official_title>A Randomized, Double-blind, Controlled, Parallel-arm Trial to Assess the Effects of Lactoferrin at Two Doses vs. Active Control on Markers of Immune Function in Healthy Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Midwest Center for Metabolic and Cardiovascular Research</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Helaina</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Midwest Center for Metabolic and Cardiovascular Research</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 purpose of this study is to evaluate the impact of 28-day supplementation with human&#xD;
        recombinant lactoferrin at two doses, compared to an active control product formulated with&#xD;
        bovine lactoferrin, on indicators of immunity in healthy males and females.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Samples will be retained for possible analyses such as lactoferrin absorption, distribution,&#xD;
        metabolism, and excretion (ADME) and gut microbiota.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 10, 2024</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>Other</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Antibodies</measure>
      <time_frame>0, 8 weeks</time_frame>
      <description>Change from baseline in anti-lactoferrin antibodies</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Markers of Immune Function</measure>
      <time_frame>0, 4 weeks, 8 weeks, 12 weeks</time_frame>
      <description>Change from baseline in markers of Immune Function (such as biomarkers of inflammation)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Markers of Immune Function</measure>
      <time_frame>0, 8 weeks</time_frame>
      <description>Change from baseline in markers of Immune Function (such as T-cell responses to lactoferrin and related peptides)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Immune Health</condition>
    <arm_group>
      <arm_group_label>Low Dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>0.34 g Recombinant Human Lactoferrin</description>
    </arm_group>
    <arm_group>
      <arm_group_label>High Dose</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>3.4 g Recombinant Human Lactoferrin</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Active Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>3.4 g Bovine Lactoferrin</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>High dose Human Lactoferrin</intervention_name>
      <description>Dietary Supplement and Food Ingredient</description>
      <arm_group_label>High Dose</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Low dose Human Lactoferrin</intervention_name>
      <description>Dietary Supplement and Food Ingredient</description>
      <arm_group_label>Low Dose</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Active Control Bovine Lactoferrin</intervention_name>
      <description>Dietary Supplement and Food Ingredient</description>
      <arm_group_label>Active Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Individual is male or premenopausal female (approximately half males and half&#xD;
               females), 18 to 45 years of age, inclusive.&#xD;
  &#xD;
            2. Individual has a BMI of ≥18.50 and &lt;30.00 kg/m2.&#xD;
  &#xD;
            3. Individual is judged to be in good health based on medical history and routine&#xD;
               laboratory tests.&#xD;
  &#xD;
            4. Individual agrees to abstain from alcohol consumption and vigorous physical activity&#xD;
               for at least 24 h prior to all test visits. According to the World Health Organization&#xD;
               (WHO), vigorous physical activity may include running, fast cycling, fast swimming, or&#xD;
               moving heavy objects.&#xD;
  &#xD;
            5. Individual understands the study procedures, and is willing to complete them, and&#xD;
               signs forms documenting informed consent to participate in the study and authorization&#xD;
               for release of relevant protected health information to the study Investigator.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Individual is unwilling to avoid consumption of all dietary supplements (other than&#xD;
               provided study products and multivitamin/mineral/calcium supplements) within 14 days&#xD;
               of visit (day 0) and throughout the study period.&#xD;
  &#xD;
            2. Individual is a chronic user of nicotine products.&#xD;
  &#xD;
            3. Individual has a score &lt;7 on the Vein Access Scale.&#xD;
  &#xD;
            4. Individual has a positive test for illicit drugs on the urine drug screen.&#xD;
  &#xD;
            5. Individual has a clinically significant medical condition that, in the opinion of the&#xD;
               Investigator, could interfere with the interpretation of the study results.&#xD;
  &#xD;
            6. Individual has an autoimmune disorder (e.g., type 1 diabetes, rheumatoid arthritis,&#xD;
               Graves disease, multiple sclerosis, lupus, etc.).&#xD;
  &#xD;
            7. Individual has a gastrointestinal condition that would potentially interfere with&#xD;
               absorption of the study product (e.g., inflammatory bowel disease, celiac disease,&#xD;
               history of gastric bypass surgery, chronic gastritis).&#xD;
  &#xD;
            8. Individual has used medication or over-the-counter products (including herbal and&#xD;
               dietary supplements) that, in the opinion of the investigator, could interfere with&#xD;
               the absorption and metabolism of lactoferrin or affect inflammatory or immune function&#xD;
               markers including, but not limited to, aspirin, anti-inflammatories, antacids,&#xD;
               histamine 2 receptor antagonists, laxatives, stool softeners, and proton-pump&#xD;
               inhibitors.&#xD;
  &#xD;
            9. Individual has had a weight change of ±4.5 kg (10 lbs.) in the previous 3 months.&#xD;
  &#xD;
           10. Individual has extreme dietary habits (e.g., Atkins, vegan, very low carbohydrate&#xD;
               diet).&#xD;
  &#xD;
           11. Individual has history of bariatric surgery, is currently taking a weight loss drug,&#xD;
               or is actively attempting to lose or gain body weight.&#xD;
  &#xD;
           12. Individual has an active infection or signs/symptoms of an infection. Test visits will&#xD;
               be rescheduled to allow the subject to be symptom-free of any type of systemic&#xD;
               infection for at least five days.&#xD;
  &#xD;
           13. Individual has recent use of antibiotics (within 7 days of visit 2, day 0) and&#xD;
               throughout the study period. The test days will be rescheduled to allow the subject to&#xD;
               wash out the antibiotic for at least 7 days.&#xD;
  &#xD;
           14. Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or&#xD;
               diastolic blood pressure ≥100 mm Hg) at screening.&#xD;
  &#xD;
           15. Individual has a history of cancer in the prior 2 years, except non-melanoma skin&#xD;
               cancer or carcinoma in situ of the cervix.&#xD;
  &#xD;
           16. Individual has an allergy or sensitivity to any components of the study products.&#xD;
  &#xD;
           17. Individual has an allergy or sensitivity to yeast.&#xD;
  &#xD;
           18. Individual is a female who is pregnant, planning to be pregnant during the study&#xD;
               period, lactating, or is of childbearing potential and is unwilling to commit to the&#xD;
               use of a medically approved form of contraception throughout the study period.&#xD;
  &#xD;
           19. Individual has been exposed to any non-registered drug product within 30 days of the&#xD;
               screening visit.&#xD;
  &#xD;
           20. Individual has a current or recent history (past 12 months of screening) or strong&#xD;
               potential for illicit drug or excessive alcohol intake defined as &gt;14 drinks per week&#xD;
               (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).&#xD;
  &#xD;
           21. Individual has a condition the Investigator believes would interfere with&#xD;
               his/her/their ability to provide informed consent, comply with the study protocol,&#xD;
               which might confound the interpretation of the study results or put the person at&#xD;
               undue risk.&#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>Kevin Maki, PhD</last_name>
      <role>Study Director</role>
      <affiliation>MB Clinical Research &amp; Consulting, LLC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Caryn Adams, MPH</last_name>
      <phone>8123449432</phone>
      <email>cwolfe@mbclinicalresearch.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Liana Guarneiri, PhD</last_name>
      <phone>4235967708</phone>
      <email>lguarneiri@mbclinicalresearch.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</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>Lactoferrin</mesh_term>
    </intervention_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/NCT06012669
  org study id: MB-2305
  nct id: NCT06012669
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the impact of 28-day supplementation with human
        recombinant lactoferrin at two doses, compared to an active control product formulated with
        bovine lactoferrin, on indicators of immunity in healthy males and females.
  Samples will be retained for possible analyses such as lactoferrin absorption, distribution,
        metabolism, and excretion (ADME) and gut microbiota.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Antibodies
  time frame: 0, 8 weeks
  description: Change from baseline in anti-lactoferrin antibodies
  measure: Markers of Immune Function
  time frame: 0, 4 weeks, 8 weeks, 12 weeks
  description: Change from baseline in markers of Immune Function (such as biomarkers of inflammation)
  measure: Markers of Immune Function
  time frame: 0, 8 weeks
  description: Change from baseline in markers of Immune Function (such as T-cell responses to lactoferrin and related peptides)
  arm group label: Low Dose
  arm group type: Experimental
  description: 0.34 g Recombinant Human Lactoferrin
  arm group label: High Dose
  arm group type: Experimental
  description: 3.4 g Recombinant Human Lactoferrin
  arm group label: Active Control
  arm group type: Active Comparator
  description: 3.4 g Bovine Lactoferrin
  intervention type: Dietary Supplement
  intervention name: High dose Human Lactoferrin
  description: Dietary Supplement and Food Ingredient
  arm group label: High Dose
  intervention type: Dietary Supplement
  intervention name: Low dose Human Lactoferrin
  description: Dietary Supplement and Food Ingredient
  arm group label: Low Dose
  intervention type: Dietary Supplement
  intervention name: Active Control Bovine Lactoferrin
  description: Dietary Supplement and Food Ingredient
  arm group label: Active Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kevin Maki, PhD
  role: Study Director
  affiliation: MB Clinical Research & Consulting, LLC
  last name: Caryn Adams, MPH
  phone: 8123449432
  email: cwolfe@mbclinicalresearch.com
  last name: Liana Guarneiri, PhD
  phone: 4235967708
  email: lguarneiri@mbclinicalresearch.com
  responsible party type: Sponsor
  mesh term: Lactoferrin
  sharing ipd: No