<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/NCT02245113</url>
  </required_header>
  <id_info>
    <org_study_id>R002302000</org_study_id>
    <nct_id>NCT02245113</nct_id>
  </id_info>
  <brief_title>Effects of High Oleic Palm Olein, Virgin Olive Oil and Coconut Oil Diets on Markers Selected in Malaysian</brief_title>
  <official_title>Effects of High Oleic Palm Olein (HOPO), Virgin Olive Oil (OO) and Refined Bleached and Deodorized (RBD) Coconut Oil (CO) Diets on Lipid Profile, Markers of Insulin Resistance, Inflammatory and Obesity in Overweight Subject.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Malaysia Palm Oil Board</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universiti Putra Malaysia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Medical University</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>
      This study will be comparing human body responses by the effects of diets cooked with&#xD;
      NoveLin, virgin olive oil and RBD coconut oil.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      NoveLin has high content of monounsaturate fatty acids - oleic acid (C18:1) which is the&#xD;
      predominant fatty acid and in this study NoveLin is used as cooking fat in compare with olive&#xD;
      oil. Olive oil is the world's most commonly eaten monounsaturated oil which contains 55 - 83%&#xD;
      oleic acid. Consumption of olive oil gives numerous health benefits on lowering total and LDL&#xD;
      cholesterol, reducing LDL cholesterol's, lowering blood clotting factors, and lowering blood&#xD;
      pressure. Coconut oil is the richest source of medium chain fatty acid and it has greater&#xD;
      than 90% of saturated fatty acid with dominant fatty acid of lauric acid (C12:0). RBD coconut&#xD;
      oil is used as positive control in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">June 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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in c-peptide level</measure>
    <time_frame>week 0(baseline) and week 6</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in insulin resistance's markers</measure>
    <time_frame>week 0(baseline) and week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in inflammatory markers</measure>
    <time_frame>week 0(baseline) and week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in obesity markers</measure>
    <time_frame>week 0(baseline) and week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in lipid profile</measure>
    <time_frame>week 0(baseline) and week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in physical characteristic (eg. BMI, body weight)</measure>
    <time_frame>week 0(baseline) and week 6</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Overweight</condition>
  <arm_group>
    <arm_group_label>Test Fat P</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Fat Q</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Fat R</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>diets</intervention_name>
    <description>Feeding trial for 6 weeks (week 0 - baseline). The experimental diets are comprised of 30% kcal fat, 15% kcal protein and 55% kcal carbohydrate. Each of the test fat contributes to two-thirds of total dietary fat will be compared.</description>
    <arm_group_label>Test Fat P</arm_group_label>
    <arm_group_label>Test Fat Q</arm_group_label>
    <arm_group_label>Test Fat R</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  males and females aged 20-60 years&#xD;
&#xD;
          -  BMI 23 - 27.5 kg/m2&#xD;
&#xD;
          -  free from any disease&#xD;
&#xD;
          -  not on any medication or treatment associated with reduction of CVD&#xD;
&#xD;
          -  non-smokers and non-heavy drinker or having smoking or alcoholic history&#xD;
&#xD;
          -  not pregnant or lactating&#xD;
&#xD;
          -  willing and able to comply&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  people on weight reduction therapy/program&#xD;
&#xD;
          -  people on cholesterol reduction medicatio&#xD;
&#xD;
          -  have one or more of the chronic diseases&#xD;
&#xD;
          -  people with blood clotting problem/ coagulopathy / deep vein thrombosis.&#xD;
&#xD;
          -  hypertensive persons (systolic pressure &gt; 140 mmHg, diastolic pressure &gt; 90 mmHg)&#xD;
&#xD;
          -  female who is pregnant&#xD;
&#xD;
          -  people travel to overseas during feeding.&#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, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MPOB</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lee Sin Tien, BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>UPM</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Norhaizan Md Esa, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UPM</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tony Ng Kock Wai, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IMU</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Verna Lee Kar Mun, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IMU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MPOB</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>September 2014</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 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>Overweight</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/NCT02245113
org study id: R002302000
nct id: NCT02245113
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This study will be comparing human body responses by the effects of diets cooked with
      NoveLin, virgin olive oil and RBD coconut oil.
NoveLin has high content of monounsaturate fatty acids - oleic acid (C18:1) which is the
      predominant fatty acid and in this study NoveLin is used as cooking fat in compare with olive
      oil. Olive oil is the world's most commonly eaten monounsaturated oil which contains 55 - 83%
      oleic acid. Consumption of olive oil gives numerous health benefits on lowering total and LDL
      cholesterol, reducing LDL cholesterol's, lowering blood clotting factors, and lowering blood
      pressure. Coconut oil is the richest source of medium chain fatty acid and it has greater
      than 90% of saturated fatty acid with dominant fatty acid of lauric acid (C12:0). RBD coconut
      oil is used as positive control in this study.
allocation: Randomized
intervention model: Crossover Assignment
masking: Single (Participant)
measure: change in c-peptide level
time frame: week 0(baseline) and week 6
measure: change in insulin resistance's markers
time frame: week 0(baseline) and week 6
measure: change in inflammatory markers
time frame: week 0(baseline) and week 6
measure: change in obesity markers
time frame: week 0(baseline) and week 6
measure: change in lipid profile
time frame: week 0(baseline) and week 6
measure: change in physical characteristic (eg. BMI, body weight)
time frame: week 0(baseline) and week 6
arm group label: Test Fat P
arm group type: Experimental
description: Test fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3.
arm group label: Test Fat Q
arm group type: Experimental
description: Test fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3.
arm group label: Test Fat R
arm group type: Experimental
description: Test fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3.
intervention type: Other
intervention name: diets
description: Feeding trial for 6 weeks (week 0 - baseline). The experimental diets are comprised of 30% kcal fat, 15% kcal protein and 55% kcal carbohydrate. Each of the test fat contributes to two-thirds of total dietary fat will be compared.
arm group label: Test Fat P
arm group label: Test Fat Q
arm group label: Test Fat R
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Voon Phooi Tee, PhD
role: Principal Investigator
affiliation: MPOB
last name: Lee Sin Tien, BSc
role: Principal Investigator
affiliation: UPM
last name: Norhaizan Md Esa, PhD
role: Principal Investigator
affiliation: UPM
last name: Tony Ng Kock Wai, PhD
role: Principal Investigator
affiliation: IMU
last name: Verna Lee Kar Mun, PhD
role: Principal Investigator
affiliation: IMU
facility: 
country: Malaysia
responsible party type: Sponsor
mesh term: Overweight