<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/NCT03796286</url>
  </required_header>
  <id_info>
    <org_study_id>MB-1805</org_study_id>
    <nct_id>NCT03796286</nct_id>
  </id_info>
  <brief_title>A Randomized, Crossover Study to Assess the Effects of Dietary Fiber-containing Bars on Glucose and Insulin Responses</brief_title>
  <official_title>A Randomized, Crossover Study to Assess the Effects of Dietary Fiber-containing Bars on Postprandial Glucose and Insulin Responses.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Midwest Center for Metabolic and Cardiovascular Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ingredion Incorporated</agency>
      <agency_class>Industry</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>
      This randomized, crossover study will include four clinic visits: one screening (day -7) and&#xD;
      three test visits (days 0, 2, 4). The objective of this study is to assess the effects of&#xD;
      dietary fiber-containing bars, at two doses of fiber, compared to a control product, on&#xD;
      postprandial glucose and insulin responses in healthy adult men and women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2018</start_date>
  <completion_date type="Actual">February 27, 2019</completion_date>
  <primary_completion_date type="Actual">February 27, 2019</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>
    <intervention_model_description>Randomized, controlled, three-treatment, crossover trial with one screening/baseline visit and three test visits. At each testing visit, the study product (a bar) will be consumed with water.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The study site will be provided pre-packaged, sealed containers of control (a bar with no fiber) and active study products (a bar with 10 grams of fiber and a bar with 20 grams of fiber). Each product container will be labeled with the lot number, expiration date, and blinded product code.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the incremental area under the curve for capillary glucose.</measure>
    <time_frame>Up to 120 minutes - measured at each treatment visit</time_frame>
    <description>Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for capillary glucose.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the incremental area under the curve for venous glucose.</measure>
    <time_frame>Up to 120 minutes - measured at each treatment visit</time_frame>
    <description>Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous glucose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the incremental area under the curve for venous insulin.</measure>
    <time_frame>Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous glucose.</time_frame>
    <description>Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous insulin.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Blood Glucose</condition>
  <condition>Insulin Sensitivity</condition>
  <condition>Dietary Fiber</condition>
  <arm_group>
    <arm_group_label>Control bar (0 g fiber)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Each subject will be randomly assigned to consume a control sports bar-type product (0 grams of fiber) at one treatment visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium-fiber bar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will be randomly assigned to consume sports bar-type product (containing 10 grams of fiber) at one treatment visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-fiber bar</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each subject will be randomly assigned to consume sports bar-type product (containing 20 grams of fiber) at one treatment visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medium-fiber bar</intervention_name>
    <description>Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.</description>
    <arm_group_label>Medium-fiber bar</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-fiber bar</intervention_name>
    <description>Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.</description>
    <arm_group_label>High-fiber bar</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control bar (0 g fiber)</intervention_name>
    <description>Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.</description>
    <arm_group_label>Control bar (0 g fiber)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, 18-65 y of age, inclusive.&#xD;
&#xD;
          -  Subject has a body mass index of 18.5 to 32.0 kg/m, inclusive.&#xD;
&#xD;
          -  Subject is judged by the Investigator to be in generally good health on the basis of&#xD;
             medical history and screening measurements.&#xD;
&#xD;
          -  Subject is willing to consume the study products as described in the protocol.&#xD;
&#xD;
          -  Subject is willing to maintain usual diet and activity patterns throughout the study.&#xD;
&#xD;
          -  Subject has no plans to change smoking or other nicotine use during the study period.&#xD;
&#xD;
          -  Subject is willing and able to attend all clinic visits.&#xD;
&#xD;
          -  Subject has a vein access scale score of 7-10.&#xD;
&#xD;
          -  Subject understands the study procedures and signs forms documenting informed consent&#xD;
             to participate in the study and authorization for release of relevant protected health&#xD;
             information to the study Investigator and is willing to complete study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individual has a clinically significant gastrointestinal, endocrine (including Type 1&#xD;
             and Type 2 diabetes mellitus), cardiovascular, renal, hepatic, pulmonary, pancreatic,&#xD;
             neurologic, or biliary disorder.&#xD;
&#xD;
          -  Subject has pre-diabetes (fasting capillary glucose between 100 and 125 mg/dL) at&#xD;
             screening. One re-test on a separate day will be allowed for subjects with no known&#xD;
             history of pre-diabetes or diabetes who have a capillary glucose of 100 - 110 mg/dL at&#xD;
             screening (visit 1).&#xD;
&#xD;
          -  Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or&#xD;
             diastolic blood pressure ≥100 mm Hg) at screening.&#xD;
&#xD;
          -  Individual has a history of cancer in the prior 2 years, except for non-melanoma skin&#xD;
             cancer.&#xD;
&#xD;
          -  Individual has extreme dietary habits (e.g., Atkins, vegan).&#xD;
&#xD;
          -  Individual has had weight change of ±4.5 kg (10 lbs) in the previous 3 months.&#xD;
&#xD;
          -  Individual has a known allergy, sensitivity, or intolerance to any ingredients in the&#xD;
             study products.&#xD;
&#xD;
          -  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;
          -  Individual has been exposed to any non-registered drug product within 30 days of&#xD;
             screening.&#xD;
&#xD;
          -  Individual has a condition the Investigator believes would interfere with his or her&#xD;
             ability to provide informed consent or comply with the study protocol, or which might&#xD;
             confound the interpretation of the study results or put the person at undue risk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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 and Consulting LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MB Clinical Research</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33487</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Clinical Trials</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>July 23, 2019</last_update_submitted>
  <last_update_submitted_qc>July 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postprandial glucose</keyword>
  <keyword>Meal tolerance test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
  </condition_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/NCT03796286
org study id: MB-1805
nct id: NCT03796286
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized, crossover study will include four clinic visits: one screening (day -7) and
      three test visits (days 0, 2, 4). The objective of this study is to assess the effects of
      dietary fiber-containing bars, at two doses of fiber, compared to a control product, on
      postprandial glucose and insulin responses in healthy adult men and women.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized, controlled, three-treatment, crossover trial with one screening/baseline visit and three test visits. At each testing visit, the study product (a bar) will be consumed with water.
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The study site will be provided pre-packaged, sealed containers of control (a bar with no fiber) and active study products (a bar with 10 grams of fiber and a bar with 20 grams of fiber). Each product container will be labeled with the lot number, expiration date, and blinded product code.
measure: Change in the incremental area under the curve for capillary glucose.
time frame: Up to 120 minutes - measured at each treatment visit
description: Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for capillary glucose.
measure: Change in the incremental area under the curve for venous glucose.
time frame: Up to 120 minutes - measured at each treatment visit
description: Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous glucose.
measure: Change in the incremental area under the curve for venous insulin.
time frame: Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous glucose.
description: Differences between the dietary fiber and control conditions following a breakfast meal tolerance test (MTT) completed at visits 2, 3, and 4 in the incremental AUC (iAUC) from pre-breakfast intake to 2 hours post breakfast intake for venous insulin.
arm group label: Control bar (0 g fiber)
arm group type: Placebo Comparator
description: Each subject will be randomly assigned to consume a control sports bar-type product (0 grams of fiber) at one treatment visit.
arm group label: Medium-fiber bar
arm group type: Experimental
description: Each subject will be randomly assigned to consume sports bar-type product (containing 10 grams of fiber) at one treatment visit.
arm group label: High-fiber bar
arm group type: Experimental
description: Each subject will be randomly assigned to consume sports bar-type product (containing 20 grams of fiber) at one treatment visit.
intervention type: Other
intervention name: Medium-fiber bar
description: Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.
arm group label: Medium-fiber bar
intervention type: Other
intervention name: High-fiber bar
description: Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.
arm group label: High-fiber bar
intervention type: Other
intervention name: Control bar (0 g fiber)
description: Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.
arm group label: Control bar (0 g fiber)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kevin Maki, PhD
role: Study Director
affiliation: MB Clinical Research and Consulting LLC
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Insulin Resistance
sharing ipd: No