<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/NCT01685879</url>
  </required_header>
  <id_info>
    <org_study_id>HARice</org_study_id>
    <secondary_id>Project HAW00262H</secondary_id>
    <nct_id>NCT01685879</nct_id>
  </id_info>
  <brief_title>Glycemic Response to High Amylose Rice</brief_title>
  <official_title>Glycemic Response to High Amylose Rice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Hawaii</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Hawaii</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Certain types of rice have more dietary fiber than others. This type of rice is known a &quot;high&#xD;
      amylose rice.&quot; This study hypothesizes that high-amylose rice, will decrease blood glucose&#xD;
      and insulin responses after consumption compared to conventional rice in healthy adults, ages&#xD;
      18-40. Eighteen healthy men and women will participate in this study. This study will&#xD;
      determine how high blood glucose and insulin values rise after eating a portion of rice. This&#xD;
      study will also evaluate hunger ratings after consuming rice. The results of this study will&#xD;
      help researchers better understand how diet can influence diabetes management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study to assess glucose response in humans to a rice sample prepared with&#xD;
      high amylose rice (high amylose rice 1 and high amylose rice 2), compared to conventional&#xD;
      rice and a glucose test beverage.&#xD;
&#xD;
      Study Design: The proposed study is a randomized single-blind crossover design with repeated&#xD;
      measures using human subjects (clinical study).&#xD;
&#xD;
      Treatment: The amount of resistant starch, a type of dietary fiber, is greater for high&#xD;
      amylose varieties of rice than conventional varieties of rice. High amylose rice is&#xD;
      commercially produced in Louisiana and Arkansas, USA. This specific rice has been bred to&#xD;
      contain more amylose than ordinary (conventional) rice. This food is not genetically&#xD;
      modified.&#xD;
&#xD;
      Brief Methods: Study subjects (men and women) aged 18-40 years old will be recruited from the&#xD;
      UH-Manoa campus and Honolulu area via flyers. Interested individuals will be screened by&#xD;
      telephone for initial eligibility (nonsmoker, non-vegetarian, habitual breakfast eater, able&#xD;
      to fast for 12 hours, available 7:00am-10:00 am on weekdays, willing to participate in&#xD;
      study). Based on the initial phone screening, eligible study subjects will attend an&#xD;
      enrollment visit to complete the consent form, obtain study materials, and confirm health&#xD;
      status and eligibility based on subject inclusion and exclusion criteria. Individuals who do&#xD;
      not meet study eligibility will have all records destroyed. 18 healthy subjects (9 men and 9&#xD;
      women) will attend 4 morning study visits at the RMATRIX CRC at The Queens Medical Center.&#xD;
      Subjects will complete a 24-hour food record for the 24 hours prior to the study visit.&#xD;
      Subjects will be fasted for 12 hours at the time of the study visit. Upon arrival, subjects&#xD;
      will have an IV inserted for serial blood draws, fasting blood samples will be obtained (time&#xD;
      = 0). Subjects will then be presented one of four treatments in random order: high amylose&#xD;
      rice-1, high amylose rice-2, conventional rice or glucose beverage. Subjects will be&#xD;
      instructed to consume the sample or beverage within 15 minutes. Blood samples will be taken&#xD;
      at 15, 30, 45, 60, 90, and 120 minutes. Subjects will complete an appetite survey after each&#xD;
      blood draw. Upon completion of the study visit, subjects will be offered a snack and juice&#xD;
      and monitored for safety.&#xD;
&#xD;
      Study staff: A graduate research assistant in the Nutrition graduate program will coordinate&#xD;
      the clinical study. Undergraduate research assistants will assist with study visits. All&#xD;
      students will be working under Dr. Stewart's supervision. All study staff will complete UHM&#xD;
      biosafety training, UMH blood borne pathogens training, and UMH or NIH human subjects&#xD;
      training.&#xD;
&#xD;
      Clinical Support: The study will be supported by nursing staff from the RMATRIX PCR to&#xD;
      perform IV catheter insertion, collect serial blood samples and monitor for adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Glucose response</measure>
    <time_frame>120 minutes</time_frame>
    <description>Evaluated changes in blood glucose after consuming a bolus of carbohydrate from rice or a standard glucose beverage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insulin Response</measure>
    <time_frame>120 minutes</time_frame>
    <description>Measure insulin concentrations after consuming a bolus of carbohydrate from rice or standard glucose beverage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appetite Response</measure>
    <time_frame>120 minutes</time_frame>
    <description>Measure appetite after consuming a bolus of carbohydrate from rice or standard glucose beverage.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Diabetes Treatment (Pilot Study)</condition>
  <arm_group>
    <arm_group_label>High Amylose Rice 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test rice with high dietary fiber content</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Amylose Rice 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test rice with high dietary fiber content</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Rice</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Rice portion that contains 50 g carbohydrate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucose beverage</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Glucose beverage with 50 g carbohydrate</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rice</intervention_name>
    <description>Rice portion containing 50 g total carbohydrate</description>
    <arm_group_label>High Amylose Rice 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rice</intervention_name>
    <description>Rice portion that provides 50 g total carbohydrate.</description>
    <arm_group_label>High Amylose Rice 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rice</intervention_name>
    <description>Rice portion that provides 50 g total carbohydrate.</description>
    <arm_group_label>Control Rice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Glucose Beverage</intervention_name>
    <description>Glucose beverage that provides 50 g total carbohydrate.</description>
    <arm_group_label>Glucose beverage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gender: male or female&#xD;
&#xD;
               -  Age 18-40 years old&#xD;
&#xD;
               -  In good general health&#xD;
&#xD;
               -  Habitual breakfast eater&#xD;
&#xD;
               -  Able to fast for 12 hours&#xD;
&#xD;
               -  Available 7:00am-9:30am on weekdays&#xD;
&#xD;
               -  Willing to participate in study and complete 4 study visits within a 6-week&#xD;
                  period&#xD;
&#xD;
               -  Capable of giving informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current smoker&#xD;
&#xD;
          -  BMI &gt; 30 kg/m2&#xD;
&#xD;
          -  Current use of medications that alter appetite (antidepressants, antibiotics, weight&#xD;
             loss medications, or appetite suppressants)&#xD;
&#xD;
          -  Current use of medications to control blood glucose, insulin or insulin receptors&#xD;
&#xD;
          -  History of pre-diabetes, diabetes, hyperglycemia, hyperinsulinemia, gastrointestinal&#xD;
             disease or surgery, or eating disorders&#xD;
&#xD;
          -  Food allergy of any kind&#xD;
&#xD;
          -  Vegetarian&#xD;
&#xD;
          -  For females, pregnancy (current or within past 6 months) or lack of a regular&#xD;
             menstrual cycle.&#xD;
&#xD;
          -  History of bleeding or clotting disorders (e.g. hemophilia, thrombocytopenia, Vitamin&#xD;
             K deficiency, liver failure)&#xD;
&#xD;
          -  Current use of medications or supplements that may interfere with clotting and prolong&#xD;
             bleeding time (e.g. aspirin, NSAIDS, coumadin, other anticoagulant therapy, herbal&#xD;
             supplements including, but not limited to curcumin and flavonoids)&#xD;
&#xD;
          -  Problems with vascular access or difficulty tolerating blood draws&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Stewart, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Hawaii at Manoa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Hawaii at Manoa</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>August 28, 2014</last_update_submitted>
  <last_update_submitted_qc>August 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Hawaii</investigator_affiliation>
    <investigator_full_name>Maria Stewart</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>postprandial glycemic response</keyword>
  <keyword>postprandial insulin response</keyword>
  <keyword>rice</keyword>
  <keyword>appetite</keyword>
  <keyword>hunger</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/NCT01685879
org study id: HARice
secondary id: Project HAW00262H
nct id: NCT01685879
lead sponsor: 
has dmc: No
Certain types of rice have more dietary fiber than others. This type of rice is known a "high
      amylose rice." This study hypothesizes that high-amylose rice, will decrease blood glucose
      and insulin responses after consumption compared to conventional rice in healthy adults, ages
      18-40. Eighteen healthy men and women will participate in this study. This study will
      determine how high blood glucose and insulin values rise after eating a portion of rice. This
      study will also evaluate hunger ratings after consuming rice. The results of this study will
      help researchers better understand how diet can influence diabetes management.
This is a pilot study to assess glucose response in humans to a rice sample prepared with
      high amylose rice (high amylose rice 1 and high amylose rice 2), compared to conventional
      rice and a glucose test beverage.

      Study Design: The proposed study is a randomized single-blind crossover design with repeated
      measures using human subjects (clinical study).

      Treatment: The amount of resistant starch, a type of dietary fiber, is greater for high
      amylose varieties of rice than conventional varieties of rice. High amylose rice is
      commercially produced in Louisiana and Arkansas, USA. This specific rice has been bred to
      contain more amylose than ordinary (conventional) rice. This food is not genetically
      modified.

      Brief Methods: Study subjects (men and women) aged 18-40 years old will be recruited from the
      UH-Manoa campus and Honolulu area via flyers. Interested individuals will be screened by
      telephone for initial eligibility (nonsmoker, non-vegetarian, habitual breakfast eater, able
      to fast for 12 hours, available 7:00am-10:00 am on weekdays, willing to participate in
      study). Based on the initial phone screening, eligible study subjects will attend an
      enrollment visit to complete the consent form, obtain study materials, and confirm health
      status and eligibility based on subject inclusion and exclusion criteria. Individuals who do
      not meet study eligibility will have all records destroyed. 18 healthy subjects (9 men and 9
      women) will attend 4 morning study visits at the RMATRIX CRC at The Queens Medical Center.
      Subjects will complete a 24-hour food record for the 24 hours prior to the study visit.
      Subjects will be fasted for 12 hours at the time of the study visit. Upon arrival, subjects
      will have an IV inserted for serial blood draws, fasting blood samples will be obtained (time
      = 0). Subjects will then be presented one of four treatments in random order: high amylose
      rice-1, high amylose rice-2, conventional rice or glucose beverage. Subjects will be
      instructed to consume the sample or beverage within 15 minutes. Blood samples will be taken
      at 15, 30, 45, 60, 90, and 120 minutes. Subjects will complete an appetite survey after each
      blood draw. Upon completion of the study visit, subjects will be offered a snack and juice
      and monitored for safety.

      Study staff: A graduate research assistant in the Nutrition graduate program will coordinate
      the clinical study. Undergraduate research assistants will assist with study visits. All
      students will be working under Dr. Stewart's supervision. All study staff will complete UHM
      biosafety training, UMH blood borne pathogens training, and UMH or NIH human subjects
      training.

      Clinical Support: The study will be supported by nursing staff from the RMATRIX PCR to
      perform IV catheter insertion, collect serial blood samples and monitor for adverse events.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Blood Glucose response
time frame: 120 minutes
description: Evaluated changes in blood glucose after consuming a bolus of carbohydrate from rice or a standard glucose beverage.
measure: Insulin Response
time frame: 120 minutes
description: Measure insulin concentrations after consuming a bolus of carbohydrate from rice or standard glucose beverage.
measure: Appetite Response
time frame: 120 minutes
description: Measure appetite after consuming a bolus of carbohydrate from rice or standard glucose beverage.
arm group label: High Amylose Rice 1
arm group type: Experimental
description: Test rice with high dietary fiber content
arm group label: High Amylose Rice 2
arm group type: Experimental
description: Test rice with high dietary fiber content
arm group label: Control Rice
arm group type: Placebo Comparator
description: Rice portion that contains 50 g carbohydrate.
arm group label: Glucose beverage
arm group type: Placebo Comparator
description: Glucose beverage with 50 g carbohydrate
intervention type: Other
intervention name: Rice
description: Rice portion containing 50 g total carbohydrate
arm group label: High Amylose Rice 1
intervention type: Other
intervention name: Rice
description: Rice portion that provides 50 g total carbohydrate.
arm group label: High Amylose Rice 2
intervention type: Other
intervention name: Rice
description: Rice portion that provides 50 g total carbohydrate.
arm group label: Control Rice
intervention type: Other
intervention name: Glucose Beverage
description: Glucose beverage that provides 50 g total carbohydrate.
arm group label: Glucose beverage
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maria Stewart, PhD
role: Principal Investigator
affiliation: University of Hawaii at Manoa
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Hawaii
investigator full name: Maria Stewart
investigator title: Assistant Professor