<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/NCT02218528</url>
  </required_header>
  <id_info>
    <org_study_id>FDS-NAA-1716</org_study_id>
    <nct_id>NCT02218528</nct_id>
  </id_info>
  <brief_title>Effect of a Plant-based Ingredient on Glucose Response</brief_title>
  <official_title>An Exploratory Study of a Plant-based Ingredient for Reducing the Post-prandial Blood Glucose Response in Healthy Indian Adults, When Administered With a Meal</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>
      The study is designed to determine the extent to which a plant-based ingredient is able to&#xD;
      modulate blood glucose response when administered with a meal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Positive incremental post-prandial blood glucose area unde the curve</measure>
    <time_frame>120 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive incremental post-prandial blood glucose area under the curve</measure>
    <time_frame>180 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-prandial insulin response</measure>
    <time_frame>120 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-prandial insulin response</measure>
    <time_frame>180 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of gastric emptying rate</measure>
    <time_frame>10 hours</time_frame>
    <description>GE50% (time to empty 50% of the gastric content) will be determined with paracetamol</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cmax</measure>
    <time_frame>120 minutes</time_frame>
    <description>peak plasma glucose</description>
  </other_outcome>
  <other_outcome>
    <measure>Cmax-baseline corrected</measure>
    <time_frame>120 minutes</time_frame>
    <description>peak plasma glucose - baseline plasma glucose</description>
  </other_outcome>
  <other_outcome>
    <measure>Tmax</measure>
    <time_frame>120 minutes</time_frame>
    <description>peak time plasma glucose</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Starchy meal</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>No Plant-based ingredient added to a starchy meal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose added to starchy meal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Plant-based ingredient in low dose added to starchy meal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Starchy meal and side dish</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>No Plant-based ingredient added to starchy meal and side dish</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose added to starchy meal and side dish</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Plant-based ingredient in low dose added to starchy meal and side dish</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium dose added to starchy meal and side dish</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Plant-based ingredient in medium dose added to starchy meal and side dish</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose added to starchy meal and side dish</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Plant-based ingredient in high dose added to starchy meal and side dish</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Plant-based ingredient</intervention_name>
    <arm_group_label>High dose added to starchy meal and side dish</arm_group_label>
    <arm_group_label>Low dose added to starchy meal</arm_group_label>
    <arm_group_label>Low dose added to starchy meal and side dish</arm_group_label>
    <arm_group_label>Medium dose added to starchy meal and side dish</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>No Plant-based ingredient</intervention_name>
    <arm_group_label>Starchy meal</arm_group_label>
    <arm_group_label>Starchy meal and side dish</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males and females, age at start of the study ≥ 18 and ≤ 50 years;&#xD;
&#xD;
          -  Apparently healthy: no medical conditions which might affect the study measurements,&#xD;
             as judged by study physician and/or measured by questionnaire, and/or assessed by&#xD;
             haematology, blood chemistry and urinalysis;&#xD;
&#xD;
          -  Fasting blood glucose value of subjects is ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110&#xD;
             mg/dl) at screening;&#xD;
&#xD;
          -  Haemoglobin level within clinically acceptable range (for male 12 to 17 gm/dL and for&#xD;
             females 11 to 15 gm/dL; both inclusive) as judged by the research physician;&#xD;
&#xD;
          -  Body mass index (BMI) ≥ 18,0 and ≤ 25,0 kg/m2;&#xD;
&#xD;
          -  Agreeing to be informed about medically relevant personal test-results by study&#xD;
             physician;&#xD;
&#xD;
          -  Willing to comply to study protocol during study;&#xD;
&#xD;
          -  Willing to refrain from drinking of alcohol on and one day before the blood&#xD;
             withdrawal;&#xD;
&#xD;
          -  Accessible veins on arms as determined by examination at screening;&#xD;
&#xD;
          -  Being literate;&#xD;
&#xD;
          -  HbA1C ≤ 6.5 % (48 mmol/mol).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any history of diabetes, hyper- (or hypo-) glycemia or other disorder of glucose&#xD;
             metabolism;&#xD;
&#xD;
          -  Any history of gastro-intestinal disorders (including frequent diarrhoea for example);&#xD;
&#xD;
          -  Blood donation in the past 2 months;&#xD;
&#xD;
          -  Reported participation in another nutritional or biomedical trial 3 months before the&#xD;
             pre-study examination or during the study;&#xD;
&#xD;
          -  Reported participation in night shift work two weeks prior to pre-study investigation&#xD;
             or during the study. Night work is defined as working between 23.00 PM and 6.00 AM;&#xD;
&#xD;
          -  Reported intense sporting activities &gt; 10h/w;&#xD;
&#xD;
          -  Consumption of ≥120 ml of alcoholic drinks for males and females in a typical week;&#xD;
&#xD;
          -  Drug abuse as indicated by urine analysis;&#xD;
&#xD;
          -  Chronic smokers, tobacco chewers and drinkers;&#xD;
&#xD;
          -  Use of any medication, including supplements and traditional medicine;&#xD;
&#xD;
          -  Reported dietary habits, such as a medically prescribed/slimming diet;&#xD;
&#xD;
          -  Not being used to eat breakfast;&#xD;
&#xD;
          -  Reported weight loss/gain (&gt;10%) in the last six month before the study;&#xD;
&#xD;
          -  Being an employee of Unilever or CRO;&#xD;
&#xD;
          -  Allergy or intolerance to food products and aversion to food products provided during&#xD;
             the study;&#xD;
&#xD;
          -  If female: pregnant or will be planning pregnancy during the study period;&#xD;
&#xD;
          -  If female: lactating or has been lactating in the 6 weeks before pre-study&#xD;
             investigation and/or during the study period.&#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>
  <overall_official>
    <last_name>Dr. Ketul Modi, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lambda Therapeutics Research Ltd (LTRL)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lambda Therapeutics Research Ltd (LTRL)</name>
      <address>
        <city>Ahmedabad</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>February 17, 2015</last_update_submitted>
  <last_update_submitted_qc>February 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>subjects</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/NCT02218528
org study id: FDS-NAA-1716
nct id: NCT02218528
lead sponsor: 
has dmc: No
The study is designed to determine the extent to which a plant-based ingredient is able to
      modulate blood glucose response when administered with a meal.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Positive incremental post-prandial blood glucose area unde the curve
time frame: 120 minutes
measure: Positive incremental post-prandial blood glucose area under the curve
time frame: 180 minutes
measure: Post-prandial insulin response
time frame: 120 minutes
measure: Post-prandial insulin response
time frame: 180 minutes
measure: Assessment of gastric emptying rate
time frame: 10 hours
description: GE50% (time to empty 50% of the gastric content) will be determined with paracetamol
measure: Cmax
time frame: 120 minutes
description: peak plasma glucose
measure: Cmax-baseline corrected
time frame: 120 minutes
description: peak plasma glucose - baseline plasma glucose
measure: Tmax
time frame: 120 minutes
description: peak time plasma glucose
arm group label: Starchy meal
arm group type: Placebo Comparator
description: No Plant-based ingredient added to a starchy meal
arm group label: Low dose added to starchy meal
arm group type: Active Comparator
description: Plant-based ingredient in low dose added to starchy meal
arm group label: Starchy meal and side dish
arm group type: Placebo Comparator
description: No Plant-based ingredient added to starchy meal and side dish
arm group label: Low dose added to starchy meal and side dish
arm group type: Active Comparator
description: Plant-based ingredient in low dose added to starchy meal and side dish
arm group label: Medium dose added to starchy meal and side dish
arm group type: Active Comparator
description: Plant-based ingredient in medium dose added to starchy meal and side dish
arm group label: High dose added to starchy meal and side dish
arm group type: Active Comparator
description: Plant-based ingredient in high dose added to starchy meal and side dish
intervention type: Dietary Supplement
intervention name: Plant-based ingredient
arm group label: High dose added to starchy meal and side dish
arm group label: Low dose added to starchy meal
arm group label: Low dose added to starchy meal and side dish
arm group label: Medium dose added to starchy meal and side dish
intervention type: Dietary Supplement
intervention name: No Plant-based ingredient
arm group label: Starchy meal
arm group label: Starchy meal and side dish
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Ketul Modi, MBBS
role: Principal Investigator
affiliation: Lambda Therapeutics Research Ltd (LTRL)
facility: 
country: India
responsible party type: Sponsor