<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/NCT02256332</url>
  </required_header>
  <id_info>
    <org_study_id>FDS-NAA-1633</org_study_id>
    <nct_id>NCT02256332</nct_id>
  </id_info>
  <brief_title>Plant-based Ingredient on Post Prandial Glucose in Type II Diabetes</brief_title>
  <official_title>Effect of Plant-based Ingredient on Post Prandial Glucose in Untreated Type II Diabetes Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unilever R&amp;D</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unilever R&amp;D</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Effects of a plant based ingredient on blood glucose in Type II diabetes patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed to determine the extend to which a plant based ingredient in a food&#xD;
      format affects blood glucose responses in untreated Type II diabetes patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">July 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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post prandial blood glucose positive incremental area under the curve</measure>
    <time_frame>120 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post prandial insulin area under the curve</measure>
    <time_frame>120 minutes</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Post prandial blood glucose positive incremental area under the curve</measure>
    <time_frame>180 and 240 minutes</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Post prandial insulin area under the curve</measure>
    <time_frame>180 and 240 minutes</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Glucose levels in urine</measure>
    <time_frame>240 minutes</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Intestinal discomfort</measure>
    <time_frame>240 minutes</time_frame>
    <description>Intestinal discomfort will be evaluated by a paper and pen questionnaire in the subject's native language directed to intestinal symptoms (nausea, flatulence, bloating and abdominal pain).</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Low dose plant based ingredient</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reference food with low dose of plant based ingredient</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose plant based ingredient</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reference food with high dose of plant based ingredient</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference food format</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Reference food without plant-based ingredient</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Low dose plant based ingredient</intervention_name>
    <description>Reference food with low dose of plant based ingredient</description>
    <arm_group_label>Low dose plant based ingredient</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>High dose plant based ingredient</intervention_name>
    <description>Reference food with high dose of plant based ingredient</description>
    <arm_group_label>High dose plant based ingredient</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Reference food format</intervention_name>
    <description>Reference food without plant-based ingredient</description>
    <arm_group_label>Reference food format</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female volunteers with confirmed Type II diabetes not treated with&#xD;
             pharmaceutical-based glucose lowering treatment for past three months (controlled&#xD;
             solely through diet and exercise);&#xD;
&#xD;
          -  Age ≥ 20 and ≤ 65 year at screening;&#xD;
&#xD;
          -  Body Mass Index (BMI) between ≥18 and ≤ 32 kg/m2;&#xD;
&#xD;
          -  HbA1c ≥48 mmol/mol and ≤53 mmol/mol (≥ 6.5% and ≤ 7.0%). At discretion of the study&#xD;
             physician, subjects with HbA1c &gt;53 mmol/mol and &lt;58 mmol/mol (&gt;7.0% and &lt; 7.5%)&#xD;
             controlled solely through diet and exercise are also allowed to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being an employee of Unilever or research site;&#xD;
&#xD;
          -  Chronic smokers, tobacco chewers and drinkers;&#xD;
&#xD;
          -  No medication, including vitamins and tonics, except for cholesterol, as determined by&#xD;
             the physician;&#xD;
&#xD;
          -  Reported weight loss/gain ≥ 10% of body weight in the 6 months preceding screening;&#xD;
&#xD;
          -  Allergy to any food or cosmetics;&#xD;
&#xD;
          -  If female, not being pregnant or planning pregnancy during the study period;&#xD;
&#xD;
          -  If female, lactating or has been lactating for 6 weeks before pre-study investigation&#xD;
             and/or during the study period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Ketul Modi, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lambda Therapeutics Research Ltd (LTRL)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dr Shrikant V Deshpande</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA</name>
      <address>
        <city>Thane</city>
        <state>Maharashtra</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lambda Therapeutics Research Ttd (LTRL)</name>
      <address>
        <city>Ahemdabad</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>September 21, 2015</last_update_submitted>
  <last_update_submitted_qc>September 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT02256332
org study id: FDS-NAA-1633
nct id: NCT02256332
lead sponsor: 
has dmc: No
Effects of a plant based ingredient on blood glucose in Type II diabetes patients.
The study is designed to determine the extend to which a plant based ingredient in a food
      format affects blood glucose responses in untreated Type II diabetes patients.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Post prandial blood glucose positive incremental area under the curve
time frame: 120 minutes
measure: Post prandial insulin area under the curve
time frame: 120 minutes
measure: Post prandial blood glucose positive incremental area under the curve
time frame: 180 and 240 minutes
measure: Post prandial insulin area under the curve
time frame: 180 and 240 minutes
measure: Glucose levels in urine
time frame: 240 minutes
measure: Intestinal discomfort
time frame: 240 minutes
description: Intestinal discomfort will be evaluated by a paper and pen questionnaire in the subject's native language directed to intestinal symptoms (nausea, flatulence, bloating and abdominal pain).
arm group label: Low dose plant based ingredient
arm group type: Active Comparator
description: Reference food with low dose of plant based ingredient
arm group label: High dose plant based ingredient
arm group type: Active Comparator
description: Reference food with high dose of plant based ingredient
arm group label: Reference food format
arm group type: Placebo Comparator
description: Reference food without plant-based ingredient
intervention type: Dietary Supplement
intervention name: Low dose plant based ingredient
description: Reference food with low dose of plant based ingredient
arm group label: Low dose plant based ingredient
intervention type: Dietary Supplement
intervention name: High dose plant based ingredient
description: Reference food with high dose of plant based ingredient
arm group label: High dose plant based ingredient
intervention type: Dietary Supplement
intervention name: Reference food format
description: Reference food without plant-based ingredient
arm group label: Reference food format
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Dr Ketul Modi, MBBS
role: Principal Investigator
affiliation: Lambda Therapeutics Research Ltd (LTRL)
last name: Dr Shrikant V Deshpande
role: Principal Investigator
affiliation: Ashirwad Hospital and Research Centre, THANE , MAHARASHTRA
facility: 
facility: 
country: India
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2