<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/NCT03035981</url>
  </required_header>
  <id_info>
    <org_study_id>1405014904</org_study_id>
    <nct_id>NCT03035981</nct_id>
  </id_info>
  <brief_title>Gastric Emptying of Rice With Different Starch Properties</brief_title>
  <official_title>Assessment of Gastric Emptying and Fullness of Rice With Different Starch Properties</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>
      Glycemic carbohydrates are associated with metabolic disturbances, such as type II diabetes,&#xD;
      due to rapid digestion of starch into glucose. The specific properties of starch within these&#xD;
      foods has been studied for the purpose of slowing their digestion rate and improving related&#xD;
      physiological outcomes, such as gastric emptying rate. The current study investigated the&#xD;
      relationship among starch digestion, gastric emptying rate and satiety in white and brown&#xD;
      rice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies have indicated that starch-based foods with somewhat high amylose content have slower&#xD;
      in vitro starch digestion rates, which relate to a low glycemic response. Low glycemic&#xD;
      response is associated with delayed gastric emptying rate as well. Therefore, we hypothesized&#xD;
      that rice with a slow starch digesting property would delay gastric emptying. White and brown&#xD;
      rice with varying amylose contents were used in this study. A 13C-labeled octanoic acid&#xD;
      breath test method was used to measure gastric emptying rate, and questionnaires were used to&#xD;
      assess hunger and fullness during the testing sessions. Twelve healthy volunteers were&#xD;
      recruited to participate in a crossover design study with six rice treatments and outcome&#xD;
      measurements were gastric emptying and satiety assessments. One fermentable carbohydrate&#xD;
      (fructooligosaccharide, FOS) solution was used to validate the production of breath hydrogen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastric emptying</measure>
    <time_frame>Acute study, 4 hours after consumption of test food</time_frame>
    <description>Breath test was performed using 13C-octanoic acid mixed into test meals</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Appetitive response</measure>
    <time_frame>Acute study, 4 hours after consumption of test food</time_frame>
    <description>Fullness and hunger questionnaire was given at various time points after consumption of test foods</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Breath hydrogen</measure>
    <time_frame>Acute study, 4 hours after consumption of test food</time_frame>
    <description>Hydrogen breath test was performed following ingestion of test meals</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Appetitive Behavior</condition>
  <arm_group>
    <arm_group_label>White rice, low amylose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cooked white rice with low amylose content</description>
  </arm_group>
  <arm_group>
    <arm_group_label>White rice, high amylose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cooked white rice with high amylose content</description>
  </arm_group>
  <arm_group>
    <arm_group_label>White rice, slow</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cooked white rice with slow digesting starch</description>
  </arm_group>
  <arm_group>
    <arm_group_label>White rice, resistant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cooked white rice with resistant starch</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brown rice, low amylose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cooked brown rice with low amylose content</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brown rice, high amylose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cooked brown rice with high amylose content</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fructooligosaccharide (FOS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fermentable carbohydrate solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>White rice, low amylose</intervention_name>
    <description>White and brown rice were tested for differences in gastric emptying rate and appetitive response</description>
    <arm_group_label>White rice, low amylose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>White rice, high amylose</intervention_name>
    <description>White and brown rice were tested for differences in gastric emptying rate and appetitive response</description>
    <arm_group_label>White rice, high amylose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>White rice, slow</intervention_name>
    <description>White and brown rice were tested for differences in gastric emptying rate and appetitive response</description>
    <arm_group_label>White rice, slow</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>White rice, resistant</intervention_name>
    <description>White and brown rice were tested for differences in gastric emptying rate and appetitive response</description>
    <arm_group_label>White rice, resistant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brown rice, low amylose</intervention_name>
    <description>White and brown rice were tested for differences in gastric emptying rate and appetitive response</description>
    <arm_group_label>Brown rice, low amylose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brown rice, high amylose</intervention_name>
    <description>White and brown rice were tested for differences in gastric emptying rate and appetitive response</description>
    <arm_group_label>Brown rice, high amylose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fructooligosaccharide (FOS)</intervention_name>
    <description>White and brown rice were tested for differences in gastric emptying rate and appetitive response</description>
    <arm_group_label>Fructooligosaccharide (FOS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal body mass index (18 kg/m2 ≤ BMI ≤ 25 kg/m2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under any medication&#xD;
&#xD;
          -  History of any gastrointestinal disease or surgery&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Smoker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Purdue University</investigator_affiliation>
    <investigator_full_name>Bruce R. Hamaker</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT03035981
org study id: 1405014904
nct id: NCT03035981
lead sponsor: 
has dmc: No
Glycemic carbohydrates are associated with metabolic disturbances, such as type II diabetes,
      due to rapid digestion of starch into glucose. The specific properties of starch within these
      foods has been studied for the purpose of slowing their digestion rate and improving related
      physiological outcomes, such as gastric emptying rate. The current study investigated the
      relationship among starch digestion, gastric emptying rate and satiety in white and brown
      rice.
Studies have indicated that starch-based foods with somewhat high amylose content have slower
      in vitro starch digestion rates, which relate to a low glycemic response. Low glycemic
      response is associated with delayed gastric emptying rate as well. Therefore, we hypothesized
      that rice with a slow starch digesting property would delay gastric emptying. White and brown
      rice with varying amylose contents were used in this study. A 13C-labeled octanoic acid
      breath test method was used to measure gastric emptying rate, and questionnaires were used to
      assess hunger and fullness during the testing sessions. Twelve healthy volunteers were
      recruited to participate in a crossover design study with six rice treatments and outcome
      measurements were gastric emptying and satiety assessments. One fermentable carbohydrate
      (fructooligosaccharide, FOS) solution was used to validate the production of breath hydrogen.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Participant)
measure: Gastric emptying
time frame: Acute study, 4 hours after consumption of test food
description: Breath test was performed using 13C-octanoic acid mixed into test meals
measure: Appetitive response
time frame: Acute study, 4 hours after consumption of test food
description: Fullness and hunger questionnaire was given at various time points after consumption of test foods
measure: Breath hydrogen
time frame: Acute study, 4 hours after consumption of test food
description: Hydrogen breath test was performed following ingestion of test meals
arm group label: White rice, low amylose
arm group type: Experimental
description: Cooked white rice with low amylose content
arm group label: White rice, high amylose
arm group type: Experimental
description: Cooked white rice with high amylose content
arm group label: White rice, slow
arm group type: Experimental
description: Cooked white rice with slow digesting starch
arm group label: White rice, resistant
arm group type: Experimental
description: Cooked white rice with resistant starch
arm group label: Brown rice, low amylose
arm group type: Experimental
description: Cooked brown rice with low amylose content
arm group label: Brown rice, high amylose
arm group type: Experimental
description: Cooked brown rice with high amylose content
arm group label: Fructooligosaccharide (FOS)
arm group type: Experimental
description: Fermentable carbohydrate solution
intervention type: Other
intervention name: White rice, low amylose
description: White and brown rice were tested for differences in gastric emptying rate and appetitive response
arm group label: White rice, low amylose
intervention type: Other
intervention name: White rice, high amylose
description: White and brown rice were tested for differences in gastric emptying rate and appetitive response
arm group label: White rice, high amylose
intervention type: Other
intervention name: White rice, slow
description: White and brown rice were tested for differences in gastric emptying rate and appetitive response
arm group label: White rice, slow
intervention type: Other
intervention name: White rice, resistant
description: White and brown rice were tested for differences in gastric emptying rate and appetitive response
arm group label: White rice, resistant
intervention type: Other
intervention name: Brown rice, low amylose
description: White and brown rice were tested for differences in gastric emptying rate and appetitive response
arm group label: Brown rice, low amylose
intervention type: Other
intervention name: Brown rice, high amylose
description: White and brown rice were tested for differences in gastric emptying rate and appetitive response
arm group label: Brown rice, high amylose
intervention type: Other
intervention name: Fructooligosaccharide (FOS)
description: White and brown rice were tested for differences in gastric emptying rate and appetitive response
arm group label: Fructooligosaccharide (FOS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Purdue University
investigator full name: Bruce R. Hamaker
investigator title: Professor
sharing ipd: No