<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/NCT03020485</url>
  </required_header>
  <id_info>
    <org_study_id>2014/01008</org_study_id>
    <nct_id>NCT03020485</nct_id>
  </id_info>
  <brief_title>The Glycaemic Effect of Isomaltulose Consumption in Healthy Participants</brief_title>
  <official_title>The Glycaemic Effect of Isomaltulose Consumption in Healthy Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Nutrition Research Centre, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinical Nutrition Research Centre, Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to determine the glycaemic effect of isomaltulose and sucrose&#xD;
      in Chinese, Indian, Malay, and Caucasian individuals. The current study will provide&#xD;
      important information on the potential health benefits of isomaltulose consumption in Asian&#xD;
      population. It will also reveal how the three main ethnicities in Singapore respond to&#xD;
      isomaltulose and whether the response differs from the Caucasians.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the present study is to investigate the glycaemic effect of isomaltulose in&#xD;
      Chinese, Indians, Malays and Caucasians. This will be a single intervention. Up to fifty&#xD;
      participants, consisting of at least ten Chinese, ten Malays, ten Indians, and ten Caucasians&#xD;
      completed data sets, aged between 21 and 40 years will be recruited from the general public&#xD;
      in Singapore. Participants will be asked to attend two test sessions for this study.&#xD;
      Participants will consume either a sucrose drink or an isomaltulose drink (each containing 50&#xD;
      g of available carbohydrate).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in post prandial Blood glucose for 180 minutes period</measure>
    <time_frame>180 minutes</time_frame>
    <description>Blood glucose obtained through finger pricks using Hemocue Glucose Analyser</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Isomaltulose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50g of isomaltulose dissolved in 250ml of water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sucrose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50g of sucrose dissolved in 250ml of water</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Isomaltulose</intervention_name>
    <description>Isomaltulose is a disaccharide made up of one molecule glucose and fructose with a (α1-6) linkage.</description>
    <arm_group_label>Isomaltulose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sucrose</intervention_name>
    <description>Sucrose is normal table sugar</description>
    <arm_group_label>Sucrose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chinese, Indian, Malay or Caucasian ethnic origin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People with major chronic disease such as heart disease, cancer or diabetes mellitus&#xD;
&#xD;
          -  Individuals with food intolerances or allergies to isomaltulose or sucrose&#xD;
&#xD;
          -  Individuals who are taking insulin or drugs known to affect glucose metabolism and&#xD;
             body fat distribution&#xD;
&#xD;
          -  People with a major medical or surgical event requiring hospitalization within the&#xD;
             preceding 3 months&#xD;
&#xD;
          -  Individuals with the presence of disease or drugs which influence digestion and&#xD;
             absorption of nutrients&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melvin Leow, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Nutrition Research Centre</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinical Nutrition Research Centre, Singapore</investigator_affiliation>
    <investigator_full_name>Melvin Leow</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT03020485
org study id: 2014/01008
nct id: NCT03020485
lead sponsor: 
has dmc: No
The objective of this study is to determine the glycaemic effect of isomaltulose and sucrose
      in Chinese, Indian, Malay, and Caucasian individuals. The current study will provide
      important information on the potential health benefits of isomaltulose consumption in Asian
      population. It will also reveal how the three main ethnicities in Singapore respond to
      isomaltulose and whether the response differs from the Caucasians.
The objective of the present study is to investigate the glycaemic effect of isomaltulose in
      Chinese, Indians, Malays and Caucasians. This will be a single intervention. Up to fifty
      participants, consisting of at least ten Chinese, ten Malays, ten Indians, and ten Caucasians
      completed data sets, aged between 21 and 40 years will be recruited from the general public
      in Singapore. Participants will be asked to attend two test sessions for this study.
      Participants will consume either a sucrose drink or an isomaltulose drink (each containing 50
      g of available carbohydrate).
allocation: Randomized
intervention model: Crossover Assignment
masking: Single (Participant)
measure: Change in post prandial Blood glucose for 180 minutes period
time frame: 180 minutes
description: Blood glucose obtained through finger pricks using Hemocue Glucose Analyser
arm group label: Isomaltulose
arm group type: Experimental
description: 50g of isomaltulose dissolved in 250ml of water
arm group label: Sucrose
arm group type: Experimental
description: 50g of sucrose dissolved in 250ml of water
intervention type: Other
intervention name: Isomaltulose
description: Isomaltulose is a disaccharide made up of one molecule glucose and fructose with a (α1-6) linkage.
arm group label: Isomaltulose
intervention type: Other
intervention name: Sucrose
description: Sucrose is normal table sugar
arm group label: Sucrose
criteria: 
gender: All
minimum age: 21 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Melvin Leow, MD
role: Principal Investigator
affiliation: Clinical Nutrition Research Centre
responsible party type: Principal Investigator
investigator affiliation: Clinical Nutrition Research Centre, Singapore
investigator full name: Melvin Leow
investigator title: Principal Investigator
sharing ipd: No