<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/NCT02194673</url>
  </required_header>
  <id_info>
    <org_study_id>AH 00112</org_study_id>
    <nct_id>NCT02194673</nct_id>
  </id_info>
  <brief_title>Acute Effects of Natural and Interesterified Fats-margarine on Lipemic and Insulinemic Response</brief_title>
  <official_title>Acute Effects of Natural and Interesterified Fats-formulated Margarine on Lipemic and Insulinemic Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Malaysia Palm Oil Board</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>International Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universiti Putra Malaysia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Malaysia Palm Oil Board</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Interesterified (IE) fat blends will respond differently in terms of postprandial lipemia and&#xD;
      insulinemic responses compare to a trans free palm margarine (TFPM).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study was to investigate whether IE-fat blends behave differently on&#xD;
      postprandial serum lipid, insulin, C-peptide and glucose concentration compare to TFPM. A&#xD;
      randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and&#xD;
      conducted on 10 males and 10 females adults. During postprandial challenge day, each subject&#xD;
      received an a test muffin incorporated with test margarine. Blood samples were collected at&#xD;
      half-hourly intervals until 4 hr by using cannulation technique.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in serum triglycerides level of subjects as a measure of postprandial triglycerides response</measure>
    <time_frame>Baseline, 4 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the level of plasma insulin, c-peptide and serum glucose as a measure of postprandial insulinemic response</measure>
    <time_frame>Baseline, 4 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Trans free palm margarine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One high fat muffin will be serves together with a glass of low fat milk shake.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interesterified palm based margarine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One high fat muffin will be serves together with a glass of low fat milk shake.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IE soybean oil-based margarine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One high fat muffin will be serves together with a glass of low fat milk shake.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Trans free palm margarine</intervention_name>
    <description>A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.</description>
    <arm_group_label>IE soybean oil-based margarine</arm_group_label>
    <arm_group_label>Interesterified palm based margarine</arm_group_label>
    <arm_group_label>Trans free palm margarine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interesterified Palm based margarine</intervention_name>
    <description>A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.</description>
    <arm_group_label>IE soybean oil-based margarine</arm_group_label>
    <arm_group_label>Interesterified palm based margarine</arm_group_label>
    <arm_group_label>Trans free palm margarine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IE Soybean oil-based margarine</intervention_name>
    <description>A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.</description>
    <arm_group_label>IE soybean oil-based margarine</arm_group_label>
    <arm_group_label>Interesterified palm based margarine</arm_group_label>
    <arm_group_label>Trans free palm margarine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index (BMI) between 18.5 and 24.9&#xD;
&#xD;
          -  &lt;130mmHg for systolic pressure and &lt;80 mmHg for diastolic pressure&#xD;
&#xD;
          -  Blood glucose level in the range of 3.9 to 5.5 mmol/L&#xD;
&#xD;
          -  Total cholesterol less than 5.17 mmol/L&#xD;
&#xD;
          -  No use of tobacco and no consumption of alcohol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suffer from chronic disease&#xD;
&#xD;
          -  Metabolic syndrome&#xD;
&#xD;
          -  Consuming any medical prescriptions&#xD;
&#xD;
          -  People with blood clotting problem&#xD;
&#xD;
          -  Women who are pregnant&#xD;
&#xD;
          -  Hypertensive person&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Voon Phooi Tee, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malaysia Palm Oil Board</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MalaysiaPOB</name>
      <address>
        <city>Kajang</city>
        <state>Selangor</state>
        <zip>43000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 16, 2014</last_update_submitted>
  <last_update_submitted_qc>July 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02194673
org study id: AH 00112
nct id: NCT02194673
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Interesterified (IE) fat blends will respond differently in terms of postprandial lipemia and
      insulinemic responses compare to a trans free palm margarine (TFPM).
The objective of this study was to investigate whether IE-fat blends behave differently on
      postprandial serum lipid, insulin, C-peptide and glucose concentration compare to TFPM. A
      randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and
      conducted on 10 males and 10 females adults. During postprandial challenge day, each subject
      received an a test muffin incorporated with test margarine. Blood samples were collected at
      half-hourly intervals until 4 hr by using cannulation technique.
allocation: Randomized
intervention model: Crossover Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in serum triglycerides level of subjects as a measure of postprandial triglycerides response
time frame: Baseline, 4 hours
measure: Change in the level of plasma insulin, c-peptide and serum glucose as a measure of postprandial insulinemic response
time frame: Baseline, 4 hours
arm group label: Trans free palm margarine
arm group type: Experimental
description: One high fat muffin will be serves together with a glass of low fat milk shake.
arm group label: Interesterified palm based margarine
arm group type: Experimental
description: One high fat muffin will be serves together with a glass of low fat milk shake.
arm group label: IE soybean oil-based margarine
arm group type: Experimental
description: One high fat muffin will be serves together with a glass of low fat milk shake.
intervention type: Other
intervention name: Trans free palm margarine
description: A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
arm group label: IE soybean oil-based margarine
arm group label: Interesterified palm based margarine
arm group label: Trans free palm margarine
intervention type: Other
intervention name: Interesterified Palm based margarine
description: A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
arm group label: IE soybean oil-based margarine
arm group label: Interesterified palm based margarine
arm group label: Trans free palm margarine
intervention type: Other
intervention name: IE Soybean oil-based margarine
description: A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
arm group label: IE soybean oil-based margarine
arm group label: Interesterified palm based margarine
arm group label: Trans free palm margarine
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Voon Phooi Tee, Ph.D
role: Principal Investigator
affiliation: Malaysia Palm Oil Board
facility: 
country: Malaysia
responsible party type: Sponsor