<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/NCT01720511</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 12002</org_study_id>
    <nct_id>NCT01720511</nct_id>
  </id_info>
  <brief_title>Pilot Study of the Effect of Purple Rice on Glucose Tolerance, Serum Lipids and Inflammation</brief_title>
  <official_title>Pilot Study of the Effect of Purple Rice on Glucose Tolerance, Serum Lipids and Inflammation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study to demonstrate the effect of purple rice on post-prandial glucose and&#xD;
      insulin. The purple color is due, like red wine grapes, mainly to the anthocyanins. The&#xD;
      safety and tolerability of purple rice is similar to white or brown rice, but contains the&#xD;
      purple elements common to other foods like grapes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a study that will have 1 screening visit and 9 study visits. Subjects will come to&#xD;
      the screening visit for blood chemistry, health questionnaire and speak to the coordinator.&#xD;
      Each subject passing inclusion/exclusion will go on to eat purple rice for 4 weeks and brown&#xD;
      rice for 4 weeks. The 4-week feeding periods will be balanced and assigned randomly. The&#xD;
      subjects will report to the metabolic kitchen to pick up their supply of 14 frozen rice&#xD;
      dishes each week in a container and return the empty containers as a measure of compliance.&#xD;
      At the end of each 4-week feeding period, subjects will come to the inpatient unit fasting&#xD;
      from 9pm the prior night except for water. Subjects will have an intravenous line placed and&#xD;
      fasting blood will be drawn for chemistry. Subjects will then be given glucose to drink and&#xD;
      blood will be drawn from then IV line for glucose and insulin at time listed in the consent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glucose Tolerance</measure>
    <time_frame>10 weeks</time_frame>
    <description>Subjects will have an Intravenous line placed and fasting blood will be drawn. Subjects will then be given glucose to drink and blood will be drawn from an IV line for glucose and insulin.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Lipids</measure>
    <time_frame>10 weeks</time_frame>
    <description>Subjects will have an Intravenous line placed and fasting blood will be drawn for a chemistry-15 panel and High-sensitivity C-reaction Protein. Subjects will then be given 75 grams of glucose to drink and blood will be drawn from an IV line for glucose and insulin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation measured by highly sensitive C-reative protein test</measure>
    <time_frame>10 weeks</time_frame>
    <description>A high-sensitivity CRP (hs-CRP), that can be done in the lab using a blood test.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Type 2 Diabetic</condition>
  <arm_group>
    <arm_group_label>Purple Rice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twice a day given purple rice with 5mg of resveratrol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brown RIce</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Plain Purple rice given twice a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Purple Rice</intervention_name>
    <description>Incorporate one cup of purple rice into dishes to be consumed at lunch and dinner each day for 4 weeks (equivalent of 4 ounces of uncooked rice/day).</description>
    <arm_group_label>Purple Rice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Brown Rice</intervention_name>
    <description>Incorporate one cup of brown rice into dishes to be consumed at lunch and dinner each day for 4 weeks (equivalent of 4 ounces of uncooked rice/day).</description>
    <arm_group_label>Brown RIce</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Generally healthy male or female with a fasting glucose between 100 mg/mL and 126&#xD;
             mg/dL or with type 2 diabetes controlled on diet without diabetes medications.&#xD;
&#xD;
          -  Eighteen years of age or older.&#xD;
&#xD;
          -  Hemoglobin A1c(HgbA1c) less than 7%.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or nursing.&#xD;
&#xD;
          -  Taking a medication for diabetes (e.g. Metformin), a medication known to affect blood&#xD;
             sugar (e.g. glucocorticoids), an anti-inflammatory medication (e.g. aspiring) or&#xD;
             triglycerides (e.g. fibrates).&#xD;
&#xD;
          -  Any chronic medication that has not had a stable dose for 1 month or longer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>December 17, 2015</last_update_submitted>
  <last_update_submitted_qc>December 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Frank Greenway</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <!-- 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/NCT01720511
org study id: PBRC 12002
nct id: NCT01720511
lead sponsor: 
has dmc: No
This is a pilot study to demonstrate the effect of purple rice on post-prandial glucose and
      insulin. The purple color is due, like red wine grapes, mainly to the anthocyanins. The
      safety and tolerability of purple rice is similar to white or brown rice, but contains the
      purple elements common to other foods like grapes.
This is a study that will have 1 screening visit and 9 study visits. Subjects will come to
      the screening visit for blood chemistry, health questionnaire and speak to the coordinator.
      Each subject passing inclusion/exclusion will go on to eat purple rice for 4 weeks and brown
      rice for 4 weeks. The 4-week feeding periods will be balanced and assigned randomly. The
      subjects will report to the metabolic kitchen to pick up their supply of 14 frozen rice
      dishes each week in a container and return the empty containers as a measure of compliance.
      At the end of each 4-week feeding period, subjects will come to the inpatient unit fasting
      from 9pm the prior night except for water. Subjects will have an intravenous line placed and
      fasting blood will be drawn for chemistry. Subjects will then be given glucose to drink and
      blood will be drawn from then IV line for glucose and insulin at time listed in the consent.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Glucose Tolerance
time frame: 10 weeks
description: Subjects will have an Intravenous line placed and fasting blood will be drawn. Subjects will then be given glucose to drink and blood will be drawn from an IV line for glucose and insulin.
measure: Serum Lipids
time frame: 10 weeks
description: Subjects will have an Intravenous line placed and fasting blood will be drawn for a chemistry-15 panel and High-sensitivity C-reaction Protein. Subjects will then be given 75 grams of glucose to drink and blood will be drawn from an IV line for glucose and insulin.
measure: Inflammation measured by highly sensitive C-reative protein test
time frame: 10 weeks
description: A high-sensitivity CRP (hs-CRP), that can be done in the lab using a blood test.
arm group label: Purple Rice
arm group type: Experimental
description: Twice a day given purple rice with 5mg of resveratrol.
arm group label: Brown RIce
arm group type: Active Comparator
description: Plain Purple rice given twice a day
intervention type: Dietary Supplement
intervention name: Purple Rice
description: Incorporate one cup of purple rice into dishes to be consumed at lunch and dinner each day for 4 weeks (equivalent of 4 ounces of uncooked rice/day).
arm group label: Purple Rice
intervention type: Dietary Supplement
intervention name: Brown Rice
description: Incorporate one cup of brown rice into dishes to be consumed at lunch and dinner each day for 4 weeks (equivalent of 4 ounces of uncooked rice/day).
arm group label: Brown RIce
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Frank Greenway
investigator title: Principal Investigator
mesh term: Inflammation