<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/NCT03254082</url>
  </required_header>
  <id_info>
    <org_study_id>KSUHML10_Sorg</org_study_id>
    <nct_id>NCT03254082</nct_id>
  </id_info>
  <brief_title>Glycemic Response of Sorghum</brief_title>
  <official_title>Glycemic Response of Cooked Grains Including Sorghum</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kansas State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United Sorghum Checkoff Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kansas State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Given the interest in gluten-free foods and discovering dietary means to prevent metabolic&#xD;
      disorders, this study was designed to determine the glycemic responses of four (4) grains and&#xD;
      flours (corn, rice, wheat, and sorghum). The grain products (gruel) will be eaten by subjects&#xD;
      and blood glucose will be collected prior to and after eating over the course of two hours. A&#xD;
      dextrose solution, dosed to provide a like amount of available carbohydrate, will serve as&#xD;
      the control treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gruel was formed via a 1:9 ratio of grain (30 g) to water (270 ml) and cooked until thickened&#xD;
      by placing water and grain mixture in a beaker and placed in a hot water bath (cooked over a&#xD;
      stove/heating unit). The gruel was allowed to cool for 3-5 minutes before eating. The&#xD;
      consistency of the gruel was similar to oatmeal. Subjects had a resting blood sample&#xD;
      collected for assessment of fasting blood glucose, then ate the gruel (or control sucrose,&#xD;
      22g) that was assigned for that day -- they returned for the other gruel meals or sucrose&#xD;
      control determined by Latin Square randomization. Finger stick blood samples where then&#xD;
      collected at 30, 60, 90, and 120 minutes after eating the gruel (or sucrose) began.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">May 2011</completion_date>
  <primary_completion_date type="Actual">May 2011</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood glucose</measure>
    <time_frame>Before eating (time 0) and 30, 60, 90, and 120 minutes after eating to measure the change in blood glucose due to the different food.</time_frame>
    <description>This is an acute (over 2 hours) trial to measure blood glucose (glycemic response) to food.</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Blood Glucose</condition>
  <arm_group>
    <arm_group_label>F-1000 (fontanelle flour)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fontenel sorghum flour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sumac</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sumac sorghum flour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wheat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Wheat flour</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MMR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MMR cultivar of sorghum flour -- from MMR Genetics, a company that produces sorghum seed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sucrose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Table sugar</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Glycemic response of F-1000</intervention_name>
    <description>The intervention was to determine if different flours elicit similar or different (change from baseline) 2 hour glucose responses (e.g., similar to glycemic index) after eating.</description>
    <arm_group_label>F-1000 (fontanelle flour)</arm_group_label>
    <other_name>Fontanelle flour</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Glycemic response to sumac sorghum flour</intervention_name>
    <description>The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming sumac sorghum flour as a gruel.</description>
    <arm_group_label>Sumac</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Glycemic response to MMR sorghum flour</intervention_name>
    <description>The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming MMR sorghum flour as a gruel.</description>
    <arm_group_label>MMR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Glycemic response to wheat flour</intervention_name>
    <description>The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming wheat flour as a gruel.</description>
    <arm_group_label>Wheat</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Glycemic response to sucrose</intervention_name>
    <description>The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming sugar (dissolved in water)</description>
    <arm_group_label>Sucrose</arm_group_label>
    <other_name>sugar</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Apparently healthy with no known diseases&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known metabolic, cancer, cardiovascular disease/condition&#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>Mark Haub, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kansas State University</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 2, 2015</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kansas State University</investigator_affiliation>
    <investigator_full_name>Mark D. Haub</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>sorghum health</keyword>
  <!-- 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/NCT03254082
org study id: KSUHML10_Sorg
nct id: NCT03254082
lead sponsor: 
collaborator: 
has dmc: No
Given the interest in gluten-free foods and discovering dietary means to prevent metabolic
      disorders, this study was designed to determine the glycemic responses of four (4) grains and
      flours (corn, rice, wheat, and sorghum). The grain products (gruel) will be eaten by subjects
      and blood glucose will be collected prior to and after eating over the course of two hours. A
      dextrose solution, dosed to provide a like amount of available carbohydrate, will serve as
      the control treatment.
Gruel was formed via a 1:9 ratio of grain (30 g) to water (270 ml) and cooked until thickened
      by placing water and grain mixture in a beaker and placed in a hot water bath (cooked over a
      stove/heating unit). The gruel was allowed to cool for 3-5 minutes before eating. The
      consistency of the gruel was similar to oatmeal. Subjects had a resting blood sample
      collected for assessment of fasting blood glucose, then ate the gruel (or control sucrose,
      22g) that was assigned for that day -- they returned for the other gruel meals or sucrose
      control determined by Latin Square randomization. Finger stick blood samples where then
      collected at 30, 60, 90, and 120 minutes after eating the gruel (or sucrose) began.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Blood glucose
time frame: Before eating (time 0) and 30, 60, 90, and 120 minutes after eating to measure the change in blood glucose due to the different food.
description: This is an acute (over 2 hours) trial to measure blood glucose (glycemic response) to food.
arm group label: F-1000 (fontanelle flour)
arm group type: Experimental
description: Fontenel sorghum flour
arm group label: Sumac
arm group type: Experimental
description: Sumac sorghum flour
arm group label: Wheat
arm group type: Experimental
description: Wheat flour
arm group label: MMR
arm group type: Experimental
description: MMR cultivar of sorghum flour -- from MMR Genetics, a company that produces sorghum seed.
arm group label: Sucrose
arm group type: Active Comparator
description: Table sugar
intervention type: Other
intervention name: Glycemic response of F-1000
description: The intervention was to determine if different flours elicit similar or different (change from baseline) 2 hour glucose responses (e.g., similar to glycemic index) after eating.
arm group label: F-1000 (fontanelle flour)
other name: Fontanelle flour
intervention type: Other
intervention name: Glycemic response to sumac sorghum flour
description: The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming sumac sorghum flour as a gruel.
arm group label: Sumac
intervention type: Other
intervention name: Glycemic response to MMR sorghum flour
description: The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming MMR sorghum flour as a gruel.
arm group label: MMR
intervention type: Other
intervention name: Glycemic response to wheat flour
description: The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming wheat flour as a gruel.
arm group label: Wheat
intervention type: Other
intervention name: Glycemic response to sucrose
description: The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming sugar (dissolved in water)
arm group label: Sucrose
other name: sugar
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mark Haub, PhD
role: Principal Investigator
affiliation: Kansas State University
responsible party type: Principal Investigator
investigator affiliation: Kansas State University
investigator full name: Mark D. Haub
investigator title: Professor