<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/NCT03293706</url>
  </required_header>
  <id_info>
    <org_study_id>BL37 Part 2</org_study_id>
    <nct_id>NCT03293706</nct_id>
  </id_info>
  <brief_title>Evaluation of Carbohydrates Part 2</brief_title>
  <official_title>Evaluation of Carbohydrates (CHO): Tolerance, Breath Hydrogen and Methane</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Nutrition</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Nutrition</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 study is single-blind with a randomized, cross-over design to evaluate gastrointestinal&#xD;
      tolerance of carbohydrate blends.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">November 15, 2017</completion_date>
  <primary_completion_date type="Actual">November 15, 2017</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Breath hydrogen</measure>
    <time_frame>0 to 7 hours</time_frame>
    <description>Assessed in exhaled gasses</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GI tolerance symptoms</measure>
    <time_frame>0 to 48 hours</time_frame>
    <description>Assessed using a subject tolerance questionnaire</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Gastro-Intestinal Tolerance</condition>
  <arm_group>
    <arm_group_label>CHO Control 1 Glucose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>25 g glucose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHO Control 2 Glucose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>25 g glucose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHO Experimental 1 Slowly Digested</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 g slowly-digested carbohydrate blend</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHO Experimental 2 Digestion Resistant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 g digestion-resistant carbohydrate blend</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHO Experimental 3 Low Sugar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 g low sugar carbohydrate blend</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHO Experimental 4 Maltodextrin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 g maltodextrin</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CHO Control 1 and 2 Glucose</intervention_name>
    <description>mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption</description>
    <arm_group_label>CHO Control 1 Glucose</arm_group_label>
    <arm_group_label>CHO Control 2 Glucose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CHO Experimental 1 Slowly Digested</intervention_name>
    <description>mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption</description>
    <arm_group_label>CHO Experimental 1 Slowly Digested</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CHO Experimental 2 Digestion Resistant</intervention_name>
    <description>mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption</description>
    <arm_group_label>CHO Experimental 2 Digestion Resistant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CHO Experimental 3 Low Sugar</intervention_name>
    <description>mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption</description>
    <arm_group_label>CHO Experimental 3 Low Sugar</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CHO Experimental 4 Maltodextrin</intervention_name>
    <description>mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption</description>
    <arm_group_label>CHO Experimental 4 Maltodextrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or non-pregnant females in good health.&#xD;
&#xD;
          -  Eligible to receive income in Canada and must demonstrate OHIP or equivalent medical&#xD;
             coverage.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject with any type of food allergy or with a known history of AIDS, hepatitis,&#xD;
             diabetes, cardio-vascular disease or GI disease.&#xD;
&#xD;
          -  Subject taking medication, or with any condition which might, in the opinion of the PI&#xD;
             either make participation dangerous to the subject or to others or affect the results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vikkie Mustad, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Abbott Nutrition</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Glycemic Index Laboratories, Inc.</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C 2N8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>December 14, 2017</last_update_submitted>
  <last_update_submitted_qc>December 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03293706
org study id: BL37 Part 2
nct id: NCT03293706
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is single-blind with a randomized, cross-over design to evaluate gastrointestinal
      tolerance of carbohydrate blends.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Participant)
measure: Breath hydrogen
time frame: 0 to 7 hours
description: Assessed in exhaled gasses
measure: GI tolerance symptoms
time frame: 0 to 48 hours
description: Assessed using a subject tolerance questionnaire
arm group label: CHO Control 1 Glucose
arm group type: Active Comparator
description: 25 g glucose
arm group label: CHO Control 2 Glucose
arm group type: Active Comparator
description: 25 g glucose
arm group label: CHO Experimental 1 Slowly Digested
arm group type: Experimental
description: 25 g slowly-digested carbohydrate blend
arm group label: CHO Experimental 2 Digestion Resistant
arm group type: Experimental
description: 25 g digestion-resistant carbohydrate blend
arm group label: CHO Experimental 3 Low Sugar
arm group type: Experimental
description: 25 g low sugar carbohydrate blend
arm group label: CHO Experimental 4 Maltodextrin
arm group type: Experimental
description: 25 g maltodextrin
intervention type: Other
intervention name: CHO Control 1 and 2 Glucose
description: mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
arm group label: CHO Control 1 Glucose
arm group label: CHO Control 2 Glucose
intervention type: Other
intervention name: CHO Experimental 1 Slowly Digested
description: mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
arm group label: CHO Experimental 1 Slowly Digested
intervention type: Other
intervention name: CHO Experimental 2 Digestion Resistant
description: mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
arm group label: CHO Experimental 2 Digestion Resistant
intervention type: Other
intervention name: CHO Experimental 3 Low Sugar
description: mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
arm group label: CHO Experimental 3 Low Sugar
intervention type: Other
intervention name: CHO Experimental 4 Maltodextrin
description: mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
arm group label: CHO Experimental 4 Maltodextrin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vikkie Mustad, PhD
role: Study Chair
affiliation: Abbott Nutrition
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: Undecided