<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/NCT03252704</url>
  </required_header>
  <id_info>
    <org_study_id>16AFHI</org_study_id>
    <nct_id>NCT03252704</nct_id>
  </id_info>
  <brief_title>Post-prandial Glycemic Response to Fiber in Healthy Adults</brief_title>
  <official_title>Post-prandial Glucose and Insulin Response to High-fiber Muffin Top Containing Resistant Starch in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ingredion Incorporated</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KGK Science Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ingredion Incorporated</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, double-blind, comparator controlled trial evaluated the blood glucose and&#xD;
      insulin responses in healthy adults, after consuming a high fiber or low fiber muffin top.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The fiber administered in this trial is a resistant starch type 4 derived from high-amylose&#xD;
      maize starch. This product is high in dietary fiber (70% total dietary fiber (TDF), AOAC&#xD;
      2009.01 method) and can be used in a variety of bakery applications. The objective of this&#xD;
      study was to evaluate the post-prandial blood glucose and insulin responses of healthy adults&#xD;
      (n=28) after consuming a muffin top made with resistant starch or control muffin top, in a&#xD;
      randomized, double-blind, crossover study. The muffin tops were matched for total weight,&#xD;
      total carbohydrate, sugars, protein, and fat. During each 24-hour study period, subjects&#xD;
      consumed a standard evening meal, fasted for 12 hours, and arrived at the study clinic the&#xD;
      following morning. Serum glucose, serum insulin, and capillary glucose were measured after&#xD;
      muffin top consumption. The subjects completed a seven day washout between treatments.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 31, 2016</start_date>
  <completion_date type="Actual">October 31, 2016</completion_date>
  <primary_completion_date type="Actual">October 31, 2016</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>
    <masking_description>Study products were concealed in opaque foil envelopes. The treatments were identified by alphanumeric code. The subjects and investigators did not know the identity of the treatments.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Blood glucose response</measure>
    <time_frame>0-4 hours after consumption</time_frame>
    <description>IV and capillary</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood insulin response</measure>
    <time_frame>0-4 hours after consumption</time_frame>
    <description>IV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breath hydrogen response</measure>
    <time_frame>0-24 hours after consumption</time_frame>
    <description>Expired air</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Glucose, High Blood</condition>
  <condition>Glucose, Low Blood</condition>
  <condition>Meals</condition>
  <arm_group>
    <arm_group_label>High fiber - low fiber</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment order described in arm title, resistant starch (high fiber muffin top) - conventional flour (low fiber muffin top)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low fiber - high fiber</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment order described in arm title, conventional flour (low fiber muffin top)- resistant starch (high fiber muffin top)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>resistant starch (high fiber muffin top)</intervention_name>
    <description>Muffin top contained 11 g of fiber per portion</description>
    <arm_group_label>High fiber - low fiber</arm_group_label>
    <arm_group_label>low fiber - high fiber</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>control (low fiber muffin top)</intervention_name>
    <description>Muffin top contained 1 g of fiber per portion</description>
    <arm_group_label>High fiber - low fiber</arm_group_label>
    <arm_group_label>low fiber - high fiber</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older,&#xD;
&#xD;
          -  BMI 18.0-29.9 kg/m2,&#xD;
&#xD;
          -  fasting glucose ≤ 6.0 mmol/L;&#xD;
&#xD;
          -  if female, not of childbearing potential (e.g. taking oral contraceptives, past&#xD;
             hysterectomy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosed metabolic or chronic diseases (e.g. type-2 diabetes);&#xD;
&#xD;
          -  cancer diagnosis or treatment within 5 years;&#xD;
&#xD;
          -  gastrointestinal problems;&#xD;
&#xD;
          -  bowel cleansing during prior week;&#xD;
&#xD;
          -  current medications to control blood glucose;&#xD;
&#xD;
          -  current medications to control blood cholesterol ;&#xD;
&#xD;
          -  current medications to control blood pressure;&#xD;
&#xD;
          -  smoker;&#xD;
&#xD;
          -  use of medical marijuana;&#xD;
&#xD;
          -  alcohol or drug abuse treatment in past 12 months;&#xD;
&#xD;
          -  allergy or sensitivity to study products;&#xD;
&#xD;
          -  blood donation in prior 2 months;&#xD;
&#xD;
          -  if female, currently pregnant, currently breastfeeding, or planning to become pregnant&#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>Tetyana Pelipyagina, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KGK Synergize</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>postprandial glucose insulin</keyword>
  <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/NCT03252704
org study id: 16AFHI
nct id: NCT03252704
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This randomized, double-blind, comparator controlled trial evaluated the blood glucose and
      insulin responses in healthy adults, after consuming a high fiber or low fiber muffin top.
The fiber administered in this trial is a resistant starch type 4 derived from high-amylose
      maize starch. This product is high in dietary fiber (70% total dietary fiber (TDF), AOAC
      2009.01 method) and can be used in a variety of bakery applications. The objective of this
      study was to evaluate the post-prandial blood glucose and insulin responses of healthy adults
      (n=28) after consuming a muffin top made with resistant starch or control muffin top, in a
      randomized, double-blind, crossover study. The muffin tops were matched for total weight,
      total carbohydrate, sugars, protein, and fat. During each 24-hour study period, subjects
      consumed a standard evening meal, fasted for 12 hours, and arrived at the study clinic the
      following morning. Serum glucose, serum insulin, and capillary glucose were measured after
      muffin top consumption. The subjects completed a seven day washout between treatments.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
masking description: Study products were concealed in opaque foil envelopes. The treatments were identified by alphanumeric code. The subjects and investigators did not know the identity of the treatments.
measure: Blood glucose response
time frame: 0-4 hours after consumption
description: IV and capillary
measure: Blood insulin response
time frame: 0-4 hours after consumption
description: IV
measure: Breath hydrogen response
time frame: 0-24 hours after consumption
description: Expired air
arm group label: High fiber - low fiber
arm group type: Experimental
description: Treatment order described in arm title, resistant starch (high fiber muffin top) - conventional flour (low fiber muffin top)
arm group label: low fiber - high fiber
arm group type: Experimental
description: Treatment order described in arm title, conventional flour (low fiber muffin top)- resistant starch (high fiber muffin top)
intervention type: Other
intervention name: resistant starch (high fiber muffin top)
description: Muffin top contained 11 g of fiber per portion
arm group label: High fiber - low fiber
arm group label: low fiber - high fiber
intervention type: Other
intervention name: control (low fiber muffin top)
description: Muffin top contained 1 g of fiber per portion
arm group label: High fiber - low fiber
arm group label: low fiber - high fiber
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tetyana Pelipyagina, MD
role: Principal Investigator
affiliation: KGK Synergize
responsible party type: Sponsor
sharing ipd: No