<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/NCT01665482</url>
  </required_header>
  <id_info>
    <org_study_id>PD155/11</org_study_id>
    <nct_id>NCT01665482</nct_id>
  </id_info>
  <brief_title>Effects of Dietary Fats on Cardiovascular Health and Insulin Sensitivity in Subjects With Abdominal Obesity</brief_title>
  <official_title>Effects of Dietary Fats on Cardiovascular Health and Insulin Sensitivity in Subjects With Abdominal Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Malaysia Palm Oil Board</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Malaya</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>
      Rationale: It is well established that increased intake of saturated fatty acids (SFA) is&#xD;
      associated with incidence of cardiovascular heart disease (CHD). This effect is mediated by&#xD;
      dietary saturated fat's impact on fasting plasma cholesterol levels. Research is needed to&#xD;
      clarify the association between dietary fatty acids and metabolic risk markers beyond lipid&#xD;
      profile. World Health Organisation (WHO) has recommended reduced intake of SFA with energy&#xD;
      replacement from monounsaturated fatty acids (MUFA) or carbohydrates (CARB). However, limited&#xD;
      evidence is available on the effects of dietary fatty acids on insulin sensitivity and&#xD;
      secretion. The current study is designed to investigate the effects of SFA versus MUFA versus&#xD;
      CARB on insulinemic response and lipid metabolism in healthy individuals with central&#xD;
      obesity.&#xD;
&#xD;
      Study design: A randomized, crossover, single blind design study was carried out. The&#xD;
      subjects consumed controlled diets for 6 weeks each. They were provided 3 meals per day&#xD;
      during weekdays in which SFA, MUFA and CARB diet was assigned to them randomly. Protein&#xD;
      content was standardised at 14% energy. The SFA and MUFA diets each provided 31.5% energy&#xD;
      intake from fat, with 69% of the total fats replaced by test fats (approximately 49 g/d based&#xD;
      on a 2000 kcal basic diet). Each individual fatty acid provided approximately 7% of the total&#xD;
      energy intake. The CARB diet provided approximately 34 g/day experimental fat based on a 2000&#xD;
      kcal basic diet. The CARB diet replaced 7 % energy of carbohydrate from total fat with the&#xD;
      exchange from oleic acid (C18:1).&#xD;
&#xD;
      Hypothesis: Changing energy from dietary fat (SFA and MUFA) to carbohydrate will influence&#xD;
      insulin sensitivity, endothelial and vascular function, pro-inflammatory markers and lipid&#xD;
      metabolism differently in individuals with metabolic syndrome. SFA (palm olein) may be&#xD;
      comparable with MUFA (high oleic sunflower oil) with regards to its effects on insulin&#xD;
      sensitivity, endothelial and vascular function and inflammation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">July 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interleukin-6</measure>
    <time_frame>Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>C-peptide</measure>
    <time_frame>Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>hsCRP</measure>
    <time_frame>Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Inflammation</condition>
  <condition>Insulin Sensitivity</condition>
  <arm_group>
    <arm_group_label>Saturated fat rich diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Monounsaturated fat rich diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Carbohydrate/ Low fat diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>A 2000 kcal test meal</intervention_name>
    <arm_group_label>Monounsaturated fat rich diet</arm_group_label>
    <arm_group_label>Saturated fat rich diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate</intervention_name>
    <arm_group_label>Carbohydrate/ Low fat diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Abdominally obese males and females (waist circumference &gt; 90 cm for male, &gt; 80 cm for&#xD;
             female),&#xD;
&#xD;
          2. Age 20-60 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a medical history of cardiovascular disease, diabetes, dyslipidemia;&#xD;
&#xD;
          -  current use of antihypertensive or lipid lowering medication;&#xD;
&#xD;
          -  plasma cholesterol &gt; 6.5 mmol/L, TAG &gt; 4.5 mmol/L;&#xD;
&#xD;
          -  alcohol intake exceeding a moderate intake (&gt; 28 units per week);&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  smoker and&#xD;
&#xD;
          -  breastfeeding.&#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>Teng Kim Tiu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MPOB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Malaysia Palm Oil Board (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>August 2012</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inflammation</keyword>
  <keyword>Insulin sensitivity</keyword>
  <keyword>Interleukin-6 (IL-6)</keyword>
  <keyword>C-peptide</keyword>
  <keyword>Saturated fatty acid (SFA)</keyword>
  <keyword>Monounsaturated fatty acid (MUFA)</keyword>
  <keyword>Carbohydrate (CARB)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Obesity, Abdominal</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Inflammation</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/NCT01665482
org study id: PD155/11
nct id: NCT01665482
lead sponsor: 
collaborator: 
has dmc: Yes
Rationale: It is well established that increased intake of saturated fatty acids (SFA) is
      associated with incidence of cardiovascular heart disease (CHD). This effect is mediated by
      dietary saturated fat's impact on fasting plasma cholesterol levels. Research is needed to
      clarify the association between dietary fatty acids and metabolic risk markers beyond lipid
      profile. World Health Organisation (WHO) has recommended reduced intake of SFA with energy
      replacement from monounsaturated fatty acids (MUFA) or carbohydrates (CARB). However, limited
      evidence is available on the effects of dietary fatty acids on insulin sensitivity and
      secretion. The current study is designed to investigate the effects of SFA versus MUFA versus
      CARB on insulinemic response and lipid metabolism in healthy individuals with central
      obesity.

      Study design: A randomized, crossover, single blind design study was carried out. The
      subjects consumed controlled diets for 6 weeks each. They were provided 3 meals per day
      during weekdays in which SFA, MUFA and CARB diet was assigned to them randomly. Protein
      content was standardised at 14% energy. The SFA and MUFA diets each provided 31.5% energy
      intake from fat, with 69% of the total fats replaced by test fats (approximately 49 g/d based
      on a 2000 kcal basic diet). Each individual fatty acid provided approximately 7% of the total
      energy intake. The CARB diet provided approximately 34 g/day experimental fat based on a 2000
      kcal basic diet. The CARB diet replaced 7 % energy of carbohydrate from total fat with the
      exchange from oleic acid (C18:1).

      Hypothesis: Changing energy from dietary fat (SFA and MUFA) to carbohydrate will influence
      insulin sensitivity, endothelial and vascular function, pro-inflammatory markers and lipid
      metabolism differently in individuals with metabolic syndrome. SFA (palm olein) may be
      comparable with MUFA (high oleic sunflower oil) with regards to its effects on insulin
      sensitivity, endothelial and vascular function and inflammation
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Interleukin-6
time frame: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.
measure: C-peptide
time frame: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.
measure: hsCRP
time frame: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.
arm group label: Saturated fat rich diet
arm group type: Active Comparator
arm group label: Monounsaturated fat rich diet
arm group type: Active Comparator
arm group label: Carbohydrate/ Low fat diet
arm group type: Active Comparator
intervention type: Other
intervention name: A 2000 kcal test meal
arm group label: Monounsaturated fat rich diet
arm group label: Saturated fat rich diet
intervention type: Other
intervention name: A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate
arm group label: Carbohydrate/ Low fat diet
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Teng Kim Tiu, PhD
role: Principal Investigator
affiliation: MPOB
facility: 
country: Malaysia
responsible party type: Sponsor
mesh term: Insulin Resistance
mesh term: Obesity, Abdominal
mesh term: Hypersensitivity
mesh term: Inflammation