<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/NCT02187913</url>
  </required_header>
  <id_info>
    <org_study_id>1406014929</org_study_id>
    <nct_id>NCT02187913</nct_id>
  </id_info>
  <brief_title>Effects of Resistant Starch in a Baked Snack Bar on a Post-prandial Glycemic and Insulinemic Response</brief_title>
  <official_title>Effects of Resistant Starch in a Baked Snack Bar on a Post-prandial Glycemic and Insulinemic Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Purdue University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Purdue University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  About two-thirds of adults in the United States are overweight or obese which can cause&#xD;
           adverse health consequences for those individuals. Post-prandial hyperglycemia is one of&#xD;
           these possible consequences and is associated with a higher risk for Type 2 Diabetes.&#xD;
           Controlling hyperglycemia is important in the prevention of the onset of diabetes and&#xD;
           obesity. Resistant starch is a dietary carbohydrate which is not completely digested in&#xD;
           the gut and produces energy for the body to use. The investigators are interested in&#xD;
           assessing the effects of resistant starch on postprandial blood glucose and insulin&#xD;
           concentrations.&#xD;
&#xD;
        -  Aim: To assess the effects of a resistant starch on post-prandial blood glucose and&#xD;
           insulin concentrations.&#xD;
&#xD;
        -  Hypothesis: A baked snack bar with a resistant starch will blunt and sustain the&#xD;
           post-prandial rise in blood glucose and insulin concentrations compared to a baked snack&#xD;
           bar with maltodextrin (an easily digested carbohydrate).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Anticipated">December 2014</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>resistant starch effects</measure>
    <time_frame>2 weeks</time_frame>
    <description>effects of resistant starch consumption of area under the curve of blood serum glucose, insulin, and hydrogen breath testing</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Hyperglycemia, Diabetes, and Obesity</condition>
  <arm_group>
    <arm_group_label>Resistant starch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The test snack bar consumed has the resistant starch</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The control bar uses maltodextrin rather than the resistant starch.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Resistant starch</intervention_name>
    <description>Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a snack bar containing resistant starch. The test snack bar will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the snack bar will be consumed four hours later.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Resistant starch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Thirty healthy men and women (aged 18-29y) will be recruited from the greater&#xD;
             Lafayette, IN region with the expectation that ≥20 subjects will complete the study.&#xD;
             Subjects must weigh &gt;110 pounds, with a BMI between 20.0 and 29.9.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Weight change &gt; 3kg in the past 3 months&#xD;
&#xD;
          -  Exercising vigorously over the past 3 months as well as no exercise 3 days prior to&#xD;
             testing day&#xD;
&#xD;
          -  Intestinal disorders including lipid mal-absorption or lactose intolerance&#xD;
&#xD;
          -  Abnormal liver or kidney function tests; fasting blood glucose &gt;100mg/dL&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Drinking more than 2 alcoholic drinks per day&#xD;
&#xD;
          -  Taking lipid-lowering medications or dietary supplements affecting plasma cholesterol&#xD;
             concentration.&#xD;
&#xD;
          -  Subjects must not be pregnant or lactating.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Purdue University</name>
      <address>
        <city>West Lafayette</city>
        <state>Indiana</state>
        <zip>47907</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jan K Green</last_name>
      <phone>765-494-6342</phone>
      <email>jkgreen@purdue.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Purdue University</investigator_affiliation>
    <investigator_full_name>Wayne Campbell</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>September 8, 2015</submitted>
    <returned>October 8, 2015</returned>
    <submitted>October 19, 2015</submitted>
    <returned>November 18, 2015</returned>
    <submitted>December 30, 2015</submitted>
    <returned>February 1, 2016</returned>
    <submitted>February 10, 2016</submitted>
    <returned>March 8, 2016</returned>
    <submitted>September 8, 2016</submitted>
    <returned>October 26, 2016</returned>
    <submitted>April 5, 2018</submitted>
    <returned>November 2, 2018</returned>
    <submitted>March 19, 2019</submitted>
    <returned>June 18, 2019</returned>
    <submitted>July 16, 2020</submitted>
    <returned>July 31, 2020</returned>
  </pending_results>
  <!-- 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/NCT02187913
org study id: 1406014929
nct id: NCT02187913
lead sponsor: 
has dmc: No
-  About two-thirds of adults in the United States are overweight or obese which can cause
           adverse health consequences for those individuals. Post-prandial hyperglycemia is one of
           these possible consequences and is associated with a higher risk for Type 2 Diabetes.
           Controlling hyperglycemia is important in the prevention of the onset of diabetes and
           obesity. Resistant starch is a dietary carbohydrate which is not completely digested in
           the gut and produces energy for the body to use. The investigators are interested in
           assessing the effects of resistant starch on postprandial blood glucose and insulin
           concentrations.

        -  Aim: To assess the effects of a resistant starch on post-prandial blood glucose and
           insulin concentrations.

        -  Hypothesis: A baked snack bar with a resistant starch will blunt and sustain the
           post-prandial rise in blood glucose and insulin concentrations compared to a baked snack
           bar with maltodextrin (an easily digested carbohydrate).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: resistant starch effects
time frame: 2 weeks
description: effects of resistant starch consumption of area under the curve of blood serum glucose, insulin, and hydrogen breath testing
arm group label: Resistant starch
arm group type: Experimental
description: The test snack bar consumed has the resistant starch
arm group label: Control
arm group type: Experimental
description: The control bar uses maltodextrin rather than the resistant starch.
intervention type: Dietary Supplement
intervention name: Resistant starch
description: Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a snack bar containing resistant starch. The test snack bar will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the snack bar will be consumed four hours later.
arm group label: Control
arm group label: Resistant starch
criteria: 
gender: All
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Purdue University
investigator full name: Wayne Campbell
investigator title: Professor
mesh term: Hyperglycemia
submitted: September 8, 2015
returned: October 8, 2015
submitted: October 19, 2015
returned: November 18, 2015
submitted: December 30, 2015
returned: February 1, 2016
submitted: February 10, 2016
returned: March 8, 2016
submitted: September 8, 2016
returned: October 26, 2016
submitted: April 5, 2018
returned: November 2, 2018
submitted: March 19, 2019
returned: June 18, 2019
submitted: July 16, 2020
returned: July 31, 2020