<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/NCT02972463</url>
  </required_header>
  <id_info>
    <org_study_id>IGYNRPD-150001-RPD01</org_study_id>
    <nct_id>NCT02972463</nct_id>
  </id_info>
  <brief_title>The Influence of IgY Max on Inflammatory Markers and the Gut Microbiome</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Parallel Dose Ranging Study on the Influence of IgY Max on Inflammatory Markers and the Gut Microbiome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Igy Nutrition, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nutrasource Pharmaceutical and Nutraceutical Services, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Igy Nutrition, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the optimal dose of IgY as assessed by changes in&#xD;
      the inflammatory marker, C-reactive protein and investigate the effect of IgY on the gut&#xD;
      microbiome as assessed by 16s RNA sequencing of fecal samples.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 13, 2017</start_date>
  <completion_date type="Actual">January 12, 2018</completion_date>
  <primary_completion_date type="Actual">January 12, 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>2 weeks and 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal Symptoms</measure>
    <time_frame>2, 4, 8 and 12 weeks</time_frame>
    <description>Total Gastrointestinal Quality of Life Index (GIQLI) score</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Intestinal microbiome</measure>
    <time_frame>12 weeks</time_frame>
    <description>As measured by microbial abundance by 16S RNA sequencing of feces</description>
  </other_outcome>
  <other_outcome>
    <measure>Stool frequency</measure>
    <time_frame>12 weeks</time_frame>
    <description>Self-reported number of movements daily averaged over each week</description>
  </other_outcome>
  <other_outcome>
    <measure>Stool consistency</measure>
    <time_frame>12 weeks</time_frame>
    <description>Bristol Stool Scale, self-reported per bowel movement and averaging over each week</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse events</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of subjects with a treatment emergent adverse effect</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>9 maltodextrin capsules, once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IgY Max Low-Dose (1g IgY Max)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 Immunoglobulin Y capsules and 7 maltodextrin capsules, once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IgY Max Mid-Dose (2g IgY Max)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 Immunoglobulin Y capsules and 5 maltodextrin capsules, once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IgY Max High-Dose (4.5g IgY Max)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>9 Immunoglobulin Y capsules, once daily for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Immunoglobulin Y</intervention_name>
    <arm_group_label>IgY Max High-Dose (4.5g IgY Max)</arm_group_label>
    <arm_group_label>IgY Max Low-Dose (1g IgY Max)</arm_group_label>
    <arm_group_label>IgY Max Mid-Dose (2g IgY Max)</arm_group_label>
    <other_name>IgY Max</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Maltodextrin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female adults aged 18 - 60 (inclusive)&#xD;
&#xD;
          -  Self-reported complaints of minor gastrointestinal symptoms (i.e. occasional gas,&#xD;
             bloating, etc.)&#xD;
&#xD;
          -  Non-smoker, or ex-smoker ≥6 months&#xD;
&#xD;
          -  Body mass index 25.0- 34.9kg/m2 (inclusive)&#xD;
&#xD;
          -  Female subjects of childbearing potential [i.e. not surgically sterilized or&#xD;
             post-menopausal (greater than one year since last menses)] must have negative urine&#xD;
             pregnancy test and must be using an effective birth control method&#xD;
&#xD;
          -  Willing to avoid alcohol consumption for 24 h prior to every clinic visit&#xD;
&#xD;
          -  Willing to maintain their regimens of medications and supplements known to alter GI&#xD;
             function (including, but not limited to, iron supplements, calcium, and&#xD;
             anti-depressants)&#xD;
&#xD;
          -  Willing to maintain a stable body weight, activity level and dietary pattern except&#xD;
             for use of the study products, as directed&#xD;
&#xD;
          -  Willing and able to provide informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or lactation, or subject unwilling to take appropriate contraceptives for&#xD;
             the duration of the study&#xD;
&#xD;
          -  Use of prescription non-steroidal anti-inflammatory drugs (or daily use of over the&#xD;
             counter non-steroidal anti-inflammatory drugs &gt;1month), steroids, corticosteroids, or&#xD;
             any other prescription anti-inflammatory drugs within 3 months prior to visit 1&#xD;
&#xD;
          -  Unstable use (i.e. initiation or change in dose) of antihypertensive medications or&#xD;
             thyroid hormone replacement medications within 3 months prior to visit 1&#xD;
&#xD;
          -  Use of any weight-loss programs or weight-loss medications (prescription or over-the&#xD;
             counter) including, but not limited to, lipase inhibitors, within 3 months prior to&#xD;
             visit&#xD;
&#xD;
          -  Use of over the counter or prescription laxatives or stool softeners within 1 month&#xD;
             prior to baseline (V2)&#xD;
&#xD;
          -  Use of antibiotics (other than topical) within 2 months prior to baseline (V2)&#xD;
&#xD;
          -  Use of prebiotic supplements (e.g. fructans and galacto-oligosaccharides (FOS, GOS),&#xD;
             psyllium, fiber, inulin) or probiotic supplements (i.e. live microorganisms) within 4&#xD;
             weeks of baseline (V2) and consumption of foods fortified with prebiotics (e.g.&#xD;
             inulin) or probiotics within 2 weeks of baseline (V2)&#xD;
&#xD;
          -  History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g.&#xD;
             warfarin)&#xD;
&#xD;
          -  Individuals with achlorhydria&#xD;
&#xD;
          -  Presence of major diseases such as diabetes, gastrointestinal disease, cardiovascular&#xD;
             disease, pancreatic, renal, or liver disease&#xD;
&#xD;
          -  Chronic diarrhea or constipation, irritable bowel syndrome, or inflammatory bowel&#xD;
             disease&#xD;
&#xD;
          -  Abdominal or gastrointestinal surgery within the previous 12 months or planned&#xD;
             abdominal or gastrointestinal surgery in the next 4 months&#xD;
&#xD;
          -  Recent gastrointestinal food-borne illness (within 1 month prior to visit 1)&#xD;
&#xD;
          -  History of neurological disease (e.g. Parkinson's disease, stroke, traumatic brain&#xD;
             injury, etc.)&#xD;
&#xD;
          -  History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the&#xD;
             past 5 years&#xD;
&#xD;
          -  Uncontrolled hypertension defined as a seated resting systolic blood pressure ≥140&#xD;
             mmHg and/or diastolic blood pressure ≥90 mmHg&#xD;
&#xD;
          -  Abnormal laboratory test results of clinical significance, including, but not limited&#xD;
             to ALT or AST ≥1.5X the upper limit of normal at screening (visit 1)&#xD;
&#xD;
          -  Presence or history (past 6 months) of alcohol or drug abuse; alcohol use of &gt;2&#xD;
             standard alcoholic drinks per day&#xD;
&#xD;
          -  Extreme dietary habits (e.g. vegan or very low carbohydrate diets)&#xD;
&#xD;
          -  Subject has a known allergy or intolerance to the test products or placebo&#xD;
&#xD;
          -  Subject is unwilling or unable to abide by the requirements of the protocol&#xD;
&#xD;
          -  Any condition that would interfere with the subject's ability to comply with study&#xD;
             instructions, might confound the interpretation of the study, or put the subject at&#xD;
             risk&#xD;
&#xD;
          -  Subject has taken an investigational health product or has participated in a research&#xD;
             study within 30 days prior to first study visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nutrasource</name>
      <address>
        <city>Guelph</city>
        <state>Ontario</state>
        <zip>N1G 0B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>September 4, 2018</last_update_submitted>
  <last_update_submitted_qc>September 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastrointestinal</keyword>
  <keyword>Microbiome</keyword>
  <keyword>Inflammation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Immunoglobulins, Intravenous</mesh_term>
    <mesh_term>Antibodies</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/NCT02972463
org study id: IGYNRPD-150001-RPD01
nct id: NCT02972463
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the optimal dose of IgY as assessed by changes in
      the inflammatory marker, C-reactive protein and investigate the effect of IgY on the gut
      microbiome as assessed by 16s RNA sequencing of fecal samples.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: C-reactive protein
time frame: 12 weeks
measure: C-reactive protein
time frame: 2 weeks and 4 weeks
measure: Gastrointestinal Symptoms
time frame: 2, 4, 8 and 12 weeks
description: Total Gastrointestinal Quality of Life Index (GIQLI) score
measure: Intestinal microbiome
time frame: 12 weeks
description: As measured by microbial abundance by 16S RNA sequencing of feces
measure: Stool frequency
time frame: 12 weeks
description: Self-reported number of movements daily averaged over each week
measure: Stool consistency
time frame: 12 weeks
description: Bristol Stool Scale, self-reported per bowel movement and averaging over each week
measure: Adverse events
time frame: 12 weeks
description: Number of subjects with a treatment emergent adverse effect
arm group label: Placebo
arm group type: Placebo Comparator
description: 9 maltodextrin capsules, once daily for 12 weeks
arm group label: IgY Max Low-Dose (1g IgY Max)
arm group type: Experimental
description: 2 Immunoglobulin Y capsules and 7 maltodextrin capsules, once daily for 12 weeks
arm group label: IgY Max Mid-Dose (2g IgY Max)
arm group type: Experimental
description: 4 Immunoglobulin Y capsules and 5 maltodextrin capsules, once daily for 12 weeks
arm group label: IgY Max High-Dose (4.5g IgY Max)
arm group type: Experimental
description: 9 Immunoglobulin Y capsules, once daily for 12 weeks
intervention type: Dietary Supplement
intervention name: Immunoglobulin Y
arm group label: IgY Max High-Dose (4.5g IgY Max)
arm group label: IgY Max Low-Dose (1g IgY Max)
arm group label: IgY Max Mid-Dose (2g IgY Max)
other name: IgY Max
intervention type: Other
intervention name: Placebo
arm group label: Placebo
other name: Maltodextrin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Immunoglobulins
mesh term: Immunoglobulins, Intravenous
mesh term: Antibodies
sharing ipd: No