<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/NCT02192047</url>
  </required_header>
  <id_info>
    <org_study_id>PD 174/13</org_study_id>
    <nct_id>NCT02192047</nct_id>
  </id_info>
  <brief_title>Chronic Effects of Natural and Interesterified Fats Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)</brief_title>
  <official_title>Chronic Effects of Natural Palm-based Margarine and Interesterified Palm- and Soy-based Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)</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>
      The investigators hypothesized that there will be a significant difference between the&#xD;
      effects of trans-free palm-, interesterified palm- and interesterified soybean oil blend on&#xD;
      cardiovascular disease, inflammation, insulin resistance and obesity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Human volunteers will be conditioned for a 8 wk intervention on 3 different test diets&#xD;
      providing 30 % energy as fat, 15% energy as protein and 55% energy as carbohydrate according&#xD;
      to parallel designed sequences. The test fats used for this study are palm oil, chemically&#xD;
      interesterified palm oil and chemically interesterified fully hydrogenated soybean oil and&#xD;
      soft oil blend in the form of margarine. Volunteers will be restricted to follow the dietary&#xD;
      guidelines throughout the study. Blood collection sessions will held before and after every&#xD;
      diet intervention. Outcome measures of the study are serum lipid profile, markers of&#xD;
      inflammation, markers of obesity and insulin resistance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 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>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in serum C-peptide level of subject</measure>
    <time_frame>up to 8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in serum lipid profile</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in markers of inflammation</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in markers of obesity</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in markers of insulin resistance</measure>
    <time_frame>up to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral Glucose tolerance test (OGTT)</measure>
    <time_frame>Baseline, month-2</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>palm olein margarine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IE palm olein margarine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IE soybean oil-based margarine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Palm Olein</intervention_name>
    <description>8 weeks</description>
    <arm_group_label>palm olein margarine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IE Palm olein</intervention_name>
    <description>8 weeks</description>
    <arm_group_label>IE palm olein margarine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IE soybean oil-based</intervention_name>
    <description>8 weeks</description>
    <arm_group_label>IE soybean oil-based margarine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult males and females, aged 20-60 yr&#xD;
&#xD;
          -  Staff and students of International Medical University, IMU/ Staff of Malaysian Palm&#xD;
             Oil Board, MPOB to facilitate centralized consumption of the test fats/snacks&#xD;
&#xD;
          -  BMI 21 - 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnomal liver function test (elevated transaminases- alanine aminotransferase,ALT;&#xD;
             aspartate aminotransferase,AST))/ abnormal kidney function test (elevated plasma&#xD;
             creatinine)&#xD;
&#xD;
          -  History of type 2 diabetes mellitus, cancer, stomach ulcers, drug abuse or alcoholism&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  On lipid/blood pressure- lowering medication/supplements&#xD;
&#xD;
          -  Blood pressure&gt;140/90 mmHg&#xD;
&#xD;
          -  Fasting total cholesterol &gt; 6.5 mmol/L&#xD;
&#xD;
          -  Fasting TAG &gt; 2.0 mmol/L&#xD;
&#xD;
          -  Candidates who are going abroad during the planned schedule for the dietary&#xD;
             intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 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>MPOB</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ng Yen Teng, BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>IMU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Putra Malaysia</name>
      <address>
        <city>Serdang</city>
        <state>Selangor</state>
        <zip>43400</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</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>Cardiovascular Diseases</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Insulin Resistance</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/NCT02192047
org study id: PD 174/13
nct id: NCT02192047
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The investigators hypothesized that there will be a significant difference between the
      effects of trans-free palm-, interesterified palm- and interesterified soybean oil blend on
      cardiovascular disease, inflammation, insulin resistance and obesity.
Human volunteers will be conditioned for a 8 wk intervention on 3 different test diets
      providing 30 % energy as fat, 15% energy as protein and 55% energy as carbohydrate according
      to parallel designed sequences. The test fats used for this study are palm oil, chemically
      interesterified palm oil and chemically interesterified fully hydrogenated soybean oil and
      soft oil blend in the form of margarine. Volunteers will be restricted to follow the dietary
      guidelines throughout the study. Blood collection sessions will held before and after every
      diet intervention. Outcome measures of the study are serum lipid profile, markers of
      inflammation, markers of obesity and insulin resistance.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in serum C-peptide level of subject
time frame: up to 8 weeks
measure: Change in serum lipid profile
time frame: up to 8 weeks
measure: Change in markers of inflammation
time frame: up to 8 weeks
measure: Change in markers of obesity
time frame: up to 8 weeks
measure: Change in markers of insulin resistance
time frame: up to 8 weeks
measure: Oral Glucose tolerance test (OGTT)
time frame: Baseline, month-2
arm group label: palm olein margarine
arm group type: Experimental
description: 8 weeks
arm group label: IE palm olein margarine
arm group type: Experimental
description: 8 weeks
arm group label: IE soybean oil-based margarine
arm group type: Experimental
description: 8 weeks
intervention type: Other
intervention name: Palm Olein
description: 8 weeks
arm group label: palm olein margarine
intervention type: Other
intervention name: IE Palm olein
description: 8 weeks
arm group label: IE palm olein margarine
intervention type: Other
intervention name: IE soybean oil-based
description: 8 weeks
arm group label: IE soybean oil-based margarine
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Voon Phooi Tee, Ph.D
role: Principal Investigator
affiliation: MPOB
last name: Ng Yen Teng, BSc
role: Principal Investigator
affiliation: IMU
facility: 
country: Malaysia
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Overweight
mesh term: Insulin Resistance