<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/NCT01729793</url>
  </required_header>
  <id_info>
    <org_study_id>NEC-001</org_study_id>
    <nct_id>NCT01729793</nct_id>
  </id_info>
  <brief_title>Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Investigate the Efficacy of Digestive Enzymes on Inflammation After a Meal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Enzyme Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Enzyme Company</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to assess the efficacy of Digestive Enzyme Blend #2, a&#xD;
      digestive enzyme dietary supplement product, on markers indicative of inflammation after a&#xD;
      meal. The markers will be assessed by blood levels tumor necrosis factor alpha (TNF-alpha),&#xD;
      interleukin-1 beta (IL-1beta), interleukin-6 (IL-6), and high sensitivity C-reactive protein&#xD;
      (hsCRP) at times 0, 45 minutes, 2 hours and 4 hours post-meal. A full complete blood count&#xD;
      (CBC)and an erythrocyte sedimentation rate (ESR) blood test will also be conducted at times 0&#xD;
      and 4 hours post-meal. In addition, a questionaire on Gastrointestinal symptoms will be&#xD;
      administered 4 hours post-meal. The study hypothesis is that some or all of these potential&#xD;
      markers of inflammation will increase following the meal, and the amount of increase in&#xD;
      inflammation will be attenuated when a digestive enzyme is consumed with the meal compared to&#xD;
      the placebo. In addition, it is hypothesized that levels of gastric discomfort as assessed by&#xD;
      the questionaire will be reduced with the digestive enzyme compared to the placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the study is to assess the efficacy of Digestive Enzyme Blend #2, a&#xD;
      digestive enzyme dietary supplement product, on markers indicative of inflammation after a&#xD;
      meal. The study design is a randomized, double-blind, placebo-controlled, cross-over type&#xD;
      study. The markers will be assessed by blood levels TNF-alpha, IL-1beta, IL-6, and hsCRP at&#xD;
      times 0, 45 minutes, 2 hours and 4 hours post-meal. A full blood CBC panel and an ESR blood&#xD;
      test will also be conducted at times 0 and 4 hours post-meal. In addition, a questionaire on&#xD;
      Gastrointestinal symptoms will be administered 4 hours post-meal. The study hypothesis is&#xD;
      that some or all of these potential markers of inflammation will increase following the meal,&#xD;
      and the amount of increase in inflammation will be attenuated when a digestive enzyme is&#xD;
      consumed with the meal compared to the placebo. In addition, it is hypothesized that levels&#xD;
      of gastric discomfort as assessed by the questionaire will be reduced with the digestive&#xD;
      enzyme compared to the placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">December 2012</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>TNF-alpha blood level change from time 0</measure>
    <time_frame>0, 45 minutes, 2 hours and 4 hours</time_frame>
    <description>Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IL-1beta blood level change from time 0</measure>
    <time_frame>0, 45 minutes, 2 hours and 4 hours</time_frame>
    <description>Aliquots will be taken at time 0 (pre-meal) and the remainder post-meal.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IL-6 Blood Level change from time 0</measure>
    <time_frame>0, 45 minutes, 2 hours, 4 hours</time_frame>
    <description>Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>hsCRP Blood Level change from time 0</measure>
    <time_frame>0, 45 minutes, 2 hours, 4 hours</time_frame>
    <description>Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CBC Panel change from time 0</measure>
    <time_frame>0, 4 hours</time_frame>
    <description>Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ESR blood test change from time 0</measure>
    <time_frame>0, 4 hours</time_frame>
    <description>Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionaire: Gastrointestinal Symptoms</measure>
    <time_frame>4 hours</time_frame>
    <description>The questionaire to assess gastrointestinal symptoms associated with gastrointestinal disturbances will be administered.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Post Prandial Inflammation Markers</condition>
  <arm_group>
    <arm_group_label>Digestive Enzyme #2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A proprietary blend of dietary supplement enzymes in a capsule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Capsule identical to active arm containing only microcrystalline cellulose</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Digestive Enzyme #2</intervention_name>
    <description>Contains dietary supplement proteases, lipases and carbohydrases</description>
    <arm_group_label>Digestive Enzyme #2</arm_group_label>
    <other_name>NEC formula #C372</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Capsule containing microcrystalline cellulose</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>NEC formula #C373</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. If female, not of child bearing potential. Defined as females who have had a&#xD;
             hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural&#xD;
             or surgical with &gt;1 year since last menstruation). OR Female subject of childbearing&#xD;
             potential must agree to use a medically approved method of birth control and have a&#xD;
             negative urine pregnancy test result.&#xD;
&#xD;
          2. Healthy as determined by laboratory results, medical history and physical exam&#xD;
&#xD;
          3. Agrees to comply with study protocols&#xD;
&#xD;
          4. Has given voluntary, written, informed consent to participate in the study -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who are pregnant, breastfeeding, or planning to become pregnant during the&#xD;
             course of the trial.&#xD;
&#xD;
          2. Gastrointestinal lesions/ulcer, diabetes, or any condition requiring the use of&#xD;
             prescribed medications for treatment&#xD;
&#xD;
          3. Immunocompromised individuals such as subjects that have undergone organ&#xD;
             transplantation or subjects diagnosed with human immunodeficiency virus (HIV)&#xD;
&#xD;
          4. History of or current diagnosis of any cancer (except for successfully treated basal&#xD;
             cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer&#xD;
             in full remission more than 5 years after diagnosis are acceptable.&#xD;
&#xD;
          5. History of bleeding disorders, or significant blood loss in the past 3 months&#xD;
&#xD;
          6. Use of blood thinning medications.&#xD;
&#xD;
          7. Use of anti-inflammatory medications, including over-the-counter pain relievers within&#xD;
             the past 14 days.&#xD;
&#xD;
          8. Use of prescription medication (other than birth control), vitamins, minerals or other&#xD;
             natural health products within the past 3 days. .&#xD;
&#xD;
          9. Alcohol use &gt;2 standard alcoholic drinks per day and/or alcohol or drug abuse within&#xD;
             the past year&#xD;
&#xD;
         10. Allergy or sensitivity to study supplement ingredients, study meal ingredients or&#xD;
             allergy or sensitivity to yeasts or molds/fungi.&#xD;
&#xD;
         11. Participation in a clinical research trial within 30 days prior to randomization&#xD;
&#xD;
         12. Individuals who are cognitively impaired and/or who are unable to give informed&#xD;
             consent&#xD;
&#xD;
         13. Use of fish oil supplements within 10 days of randomization and during the trial&#xD;
&#xD;
         14. Any other condition which in the Investigator's opinion may adversely affect the&#xD;
             subject's ability to complete the study or its measures or which may pose significant&#xD;
             risk to the subject&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dale Wilson, MD</last_name>
    <role>Study Director</role>
    <affiliation>KGK Synergize</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KGK Synergize Inc.</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>November 26, 2012</last_update_submitted>
  <last_update_submitted_qc>November 26, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 27, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TNFalpha</keyword>
  <keyword>IL6</keyword>
  <keyword>postprandial</keyword>
  <keyword>digestive</keyword>
  <keyword>inflammation</keyword>
  <keyword>IL1beta</keyword>
  <keyword>CRP</keyword>
  <keyword>CBC</keyword>
  <keyword>ESR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <!-- 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/NCT01729793
org study id: NEC-001
nct id: NCT01729793
lead sponsor: 
has dmc: Yes
The primary objective of the study is to assess the efficacy of Digestive Enzyme Blend #2, a
      digestive enzyme dietary supplement product, on markers indicative of inflammation after a
      meal. The markers will be assessed by blood levels tumor necrosis factor alpha (TNF-alpha),
      interleukin-1 beta (IL-1beta), interleukin-6 (IL-6), and high sensitivity C-reactive protein
      (hsCRP) at times 0, 45 minutes, 2 hours and 4 hours post-meal. A full complete blood count
      (CBC)and an erythrocyte sedimentation rate (ESR) blood test will also be conducted at times 0
      and 4 hours post-meal. In addition, a questionaire on Gastrointestinal symptoms will be
      administered 4 hours post-meal. The study hypothesis is that some or all of these potential
      markers of inflammation will increase following the meal, and the amount of increase in
      inflammation will be attenuated when a digestive enzyme is consumed with the meal compared to
      the placebo. In addition, it is hypothesized that levels of gastric discomfort as assessed by
      the questionaire will be reduced with the digestive enzyme compared to the placebo.
The primary objective of the study is to assess the efficacy of Digestive Enzyme Blend #2, a
      digestive enzyme dietary supplement product, on markers indicative of inflammation after a
      meal. The study design is a randomized, double-blind, placebo-controlled, cross-over type
      study. The markers will be assessed by blood levels TNF-alpha, IL-1beta, IL-6, and hsCRP at
      times 0, 45 minutes, 2 hours and 4 hours post-meal. A full blood CBC panel and an ESR blood
      test will also be conducted at times 0 and 4 hours post-meal. In addition, a questionaire on
      Gastrointestinal symptoms will be administered 4 hours post-meal. The study hypothesis is
      that some or all of these potential markers of inflammation will increase following the meal,
      and the amount of increase in inflammation will be attenuated when a digestive enzyme is
      consumed with the meal compared to the placebo. In addition, it is hypothesized that levels
      of gastric discomfort as assessed by the questionaire will be reduced with the digestive
      enzyme compared to the placebo.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: TNF-alpha blood level change from time 0
time frame: 0, 45 minutes, 2 hours and 4 hours
description: Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
measure: IL-1beta blood level change from time 0
time frame: 0, 45 minutes, 2 hours and 4 hours
description: Aliquots will be taken at time 0 (pre-meal) and the remainder post-meal.
measure: IL-6 Blood Level change from time 0
time frame: 0, 45 minutes, 2 hours, 4 hours
description: Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
measure: hsCRP Blood Level change from time 0
time frame: 0, 45 minutes, 2 hours, 4 hours
description: Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
measure: CBC Panel change from time 0
time frame: 0, 4 hours
description: Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
measure: ESR blood test change from time 0
time frame: 0, 4 hours
description: Aliquots will be taken at time 0 (pre-meal), and the remainder post-meal
measure: Questionaire: Gastrointestinal Symptoms
time frame: 4 hours
description: The questionaire to assess gastrointestinal symptoms associated with gastrointestinal disturbances will be administered.
arm group label: Digestive Enzyme #2
arm group type: Active Comparator
description: A proprietary blend of dietary supplement enzymes in a capsule
arm group label: Placebo
arm group type: Placebo Comparator
description: Capsule identical to active arm containing only microcrystalline cellulose
intervention type: Dietary Supplement
intervention name: Digestive Enzyme #2
description: Contains dietary supplement proteases, lipases and carbohydrases
arm group label: Digestive Enzyme #2
other name: NEC formula #C372
intervention type: Other
intervention name: Placebo
description: Capsule containing microcrystalline cellulose
arm group label: Placebo
other name: NEC formula #C373
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dale Wilson, MD
role: Study Director
affiliation: KGK Synergize
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Inflammation