<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/NCT01710280</url>
  </required_header>
  <id_info>
    <org_study_id>IRIS</org_study_id>
    <nct_id>NCT01710280</nct_id>
  </id_info>
  <brief_title>Palmitic Acid in the Sn-2 Position of Triacylglycerols and Postprandial Lipemia</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King's College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether high-fat meals rich in palmitic acid in the&#xD;
      sn-2 position decrease lipaemia in men aged 40-70 y with higher than optimal fasting&#xD;
      triacylglycerol concentrations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">December 2011</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incremental AUC (change from baseline in overall response) for plasma triacylglycerol concentrations</measure>
    <time_frame>1-6 h post-meal</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incremental AUC for plasma non-esterified fatty acid concentrations</measure>
    <time_frame>1-6 h post-meal</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in digital volume pulse</measure>
    <time_frame>2,4,5,6 h post-meal</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in blood pressure</measure>
    <time_frame>2,4,5,6 h post-meal</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Incremental AUC for plasma total cholesterol concentrations</measure>
    <time_frame>1-6 h post-meal</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Healthy Men</condition>
  <condition>Raised Fasting Plasma Triacylglycerol Concentrations</condition>
  <arm_group>
    <arm_group_label>Native palm olein</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>75 g native palm olein</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Interesterified palm olein</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>75 g interesterified palm olein</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>High-fat meal containing native palm olein</intervention_name>
    <arm_group_label>Native palm olein</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>High-fat meal containing interesterified palm olein</intervention_name>
    <arm_group_label>Interesterified palm olein</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males&#xD;
&#xD;
          -  Non-smokers&#xD;
&#xD;
          -  Aged 40-70 years&#xD;
&#xD;
          -  Fasting TAG concentrations ≥1.5 mmol/L.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Reported history of CVD (myocardial infarction, angina, venous thrombosis, stroke),&#xD;
             impaired fasting glucose/uncontrolled type 2 diabetes (or fasting glucose ≥ 6.1&#xD;
             mmol/L), cancer, kidney, liver or bowel disease.&#xD;
&#xD;
          -  Presence of gastrointestinal disorder or use of drug, which is likely to alter&#xD;
             gastrointestinal motility or nutrient absorption.&#xD;
&#xD;
          -  History of substance abuse or alcoholism (previous weekly alcohol intake &gt;60&#xD;
             units/men)&#xD;
&#xD;
          -  Current self-reported weekly alcohol intake exceeding 28 units&#xD;
&#xD;
          -  Allergy or intolerance to any component of test meals&#xD;
&#xD;
          -  Unwilling to restrict consumption of any source of fish oil for the length of the&#xD;
             study&#xD;
&#xD;
          -  Weight change of &gt;3kg in preceding 2 months&#xD;
&#xD;
          -  Body Mass Index &lt;20 and &gt;35 kg/m2&#xD;
&#xD;
          -  Fasting blood cholesterol &gt; 7.8 mmol/L&#xD;
&#xD;
          -  Current cigarette smoker.&#xD;
&#xD;
          -  Current use of lipid lowering medication&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Diabetes &amp; Nutritional Sciences Division, King's College London.</name>
      <address>
        <city>London</city>
        <zip>SE1 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/25103522</url>
    <description>Primary publication</description>
  </link>
  <reference>
    <citation>Sanders TA, Filippou A, Berry SE, Baumgartner S, Mensink RP. Palmitic acid in the sn-2 position of triacylglycerols acutely influences postprandial lipid metabolism. Am J Clin Nutr. 2011 Dec;94(6):1433-41. doi: 10.3945/ajcn.111.017459. Epub 2011 Oct 26.</citation>
    <PMID>22030225</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>September 12, 2019</last_update_submitted>
  <last_update_submitted_qc>September 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King's College London</investigator_affiliation>
    <investigator_full_name>Dr Wendy Hall</investigator_full_name>
    <investigator_title>Lecturer in Nutritional Sciences</investigator_title>
  </responsible_party>
  <keyword>Lipemia</keyword>
  <keyword>Vascular function</keyword>
  <keyword>Blood pressure</keyword>
  <!-- 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/NCT01710280
org study id: IRIS
nct id: NCT01710280
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether high-fat meals rich in palmitic acid in the
      sn-2 position decrease lipaemia in men aged 40-70 y with higher than optimal fasting
      triacylglycerol concentrations.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incremental AUC (change from baseline in overall response) for plasma triacylglycerol concentrations
time frame: 1-6 h post-meal
measure: Incremental AUC for plasma non-esterified fatty acid concentrations
time frame: 1-6 h post-meal
measure: Changes from baseline in digital volume pulse
time frame: 2,4,5,6 h post-meal
measure: Changes from baseline in blood pressure
time frame: 2,4,5,6 h post-meal
measure: Incremental AUC for plasma total cholesterol concentrations
time frame: 1-6 h post-meal
arm group label: Native palm olein
arm group type: Active Comparator
description: 75 g native palm olein
arm group label: Interesterified palm olein
arm group type: Experimental
description: 75 g interesterified palm olein
intervention type: Dietary Supplement
intervention name: High-fat meal containing native palm olein
arm group label: Native palm olein
intervention type: Dietary Supplement
intervention name: High-fat meal containing interesterified palm olein
arm group label: Interesterified palm olein
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
url: http://www.ncbi.nlm.nih.gov/pubmed/25103522
description: Primary publication
citation: Sanders TA, Filippou A, Berry SE, Baumgartner S, Mensink RP. Palmitic acid in the sn-2 position of triacylglycerols acutely influences postprandial lipid metabolism. Am J Clin Nutr. 2011 Dec;94(6):1433-41. doi: 10.3945/ajcn.111.017459. Epub 2011 Oct 26.
PMID: 22030225
responsible party type: Principal Investigator
investigator affiliation: King's College London
investigator full name: Dr Wendy Hall
investigator title: Lecturer in Nutritional Sciences