<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/NCT02263183</url>
  </required_header>
  <id_info>
    <org_study_id>PD164/12</org_study_id>
    <nct_id>NCT02263183</nct_id>
  </id_info>
  <brief_title>Red Palm Olein and Cardiovascular Health</brief_title>
  <official_title>Red Palm Olein and Cardiovascular Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Malaysia Palm Oil Board</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Malaysia Palm Oil Board</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Red palm oil is obtained from crude palm oil through a novel low-temperature process. Owing&#xD;
      to this special process, RPO possesses a special flavour and aroma, and is rich in&#xD;
      phytonutrients that include carotenes, vitamin E, phytosterols, phospholipids, squalene,&#xD;
      phenolic acids, flavonoids and co-enzyme Q10. These phytonutrients are the main constituents&#xD;
      through which palm oil exhibits its nutritional properties. Among the major health promoting&#xD;
      properties are anti-cancer, cardio-protection, anti-angiogenesis, cholesterol inhibition,&#xD;
      brain development and neuro-protective properties, antioxidative defence mechanisms,&#xD;
      provitamin A activity and anti-diabetes. As red palm oil has variety of phytonutrients and&#xD;
      health benefits, the potential of improved cardiovascular health should be considered to&#xD;
      understand better and thus treasure more our golden oil.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The oil palm Elaeis guineesis, is the source of palm oil - the 'tropical golden oil'.&#xD;
      Malaysia is the world's largest exporter of this golden oil. Triglycerides constitute the&#xD;
      major component of crude palm oil, with smaller proportions of diglycerides and&#xD;
      monoglycerides. The oil also contains other minor constituents, such as free fatty acids and&#xD;
      phytonutrients. This composition determines the oil's physical, chemical and physiological&#xD;
      characteristics. In food application, palm oil not only imparts functional properties as a&#xD;
      heating medium (as in frying of foods) and in having spreadability (as in formulations for&#xD;
      solid fat products like margarines and shortenings), but is also a good source of&#xD;
      phytonutrients. Although the phytonutrients constitute only about 1% of its weight in crude&#xD;
      palm oil, these are the main constituents through which palm oil exhibits its nutritional&#xD;
      properties. Among the major health promoting properties shown to be associated with the&#xD;
      various types of phytonutrients present in palm oil are anti-cancer, cardio-protection and&#xD;
      anti-angiogenesis, cholesterol inhibition, brain development and neuro-protective properties,&#xD;
      antioxidative defence mechanisms, provitamin A activity and anti-diabetes. Red palm oil (RPO)&#xD;
      is obtained from crude palm oil through a novel low-temperature process. Owing to this&#xD;
      special process, RPO possesses a special flavour and aroma, and is rich in phytonutrients&#xD;
      that include carotenes (thus giving the oil a bright red colour), vitamin E, phytosterols,&#xD;
      phospholipids, squalene, phenolic acids, flavonoids and co-enzyme Q10.&#xD;
&#xD;
      Little is known about the physiological effects of red palm oil. The link between dietary&#xD;
      fats and cardiovascular diseases has always been controversial in the context of palm oil.&#xD;
      Narang et al., 2004 demonstrated that the anti-oxidant vitamins in palm olein play a vital&#xD;
      role in the protection of the rat's heart against oxidative stress induced by&#xD;
      ischemic-reperfusion injury. The unique isomeric position of its fatty acids and the presence&#xD;
      of tocotrienols cause the endogenous cholesterol level to drop. Besides palm oil could reduce&#xD;
      the risk of arterial thrombosis and atherosclerosis, inhibit endogenous cholesterol&#xD;
      biosynthesis, platelet aggregation, and reduce blood pressure. The composition of palm oil&#xD;
      with an unsaturated-to-saturated fatty acid ratio close to one and rich in antioxidants&#xD;
      vitamins could attenuate the progression of salt-induced hypertension and mortality in rats&#xD;
      by modulation of endothelial function and reduction in oxidative stress. In Chinese diet&#xD;
      preparation, Zhang et al.,2003 demonstrated that red palm oil is a good source of carotenoids&#xD;
      and vitamin E, and it could significantly increase plasma concentration of alpha-carotene,&#xD;
      beta-carotene, lycopene and alpha-tocopherol. Following a chronic human study, Scholtz et&#xD;
      al., 2004 observed that red palm olein had less detrimental effects on the lipid profile and&#xD;
      decreased tissue plasminogen activator antigen as compared to palm olein. As red palm oil has&#xD;
      variety of phytonutrients and health benefits, the potential of improved cardiovascular&#xD;
      health should be considered to understand better and thus treasure more our golden oil. The&#xD;
      present study was designed to investigate the effect of consumption of red palm olein on&#xD;
      inflammatory and metabolic risk markers&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2015</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in plasma Interleukin-6 status</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Changes in inflammatory response</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in endothelial function</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in lipid profile</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in plasma antioxidant status</measure>
    <time_frame>3 years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Cardiovascular Risk Factor</condition>
  <arm_group>
    <arm_group_label>red palm olein(labelled A)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>red palm olein (labelled A)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>palm olein(labelled B)(control)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>palm olein(labelled B)(control)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Red Palm Olein</intervention_name>
    <description>Red Palm Olein contains corresponding fatty acids like Palm Olein except having more phytonutrients (carotenoids and vitamin E)</description>
    <arm_group_label>red palm olein(labelled A)</arm_group_label>
    <other_name>Carotino</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Palm Olein</intervention_name>
    <description>Palm Olein contains corresponding fatty acids like Red Palm Olein except having less phytonutrients (no carotenoids and less vitamin E)</description>
    <arm_group_label>palm olein(labelled B)(control)</arm_group_label>
    <other_name>Carotino</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Abdominally obese males and females (waist circumference &gt; 90 cm for male, &gt; 80 cm for&#xD;
             female), age between 20-60 years and BMI ≥18.5kgm2 will be recruited.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical history of myocardial infarction, angina, thrombosis, stroke, cancer or&#xD;
             diabetes&#xD;
&#xD;
          -  Blood glucose; &gt;7.0 mmol/L&#xD;
&#xD;
          -  Serum triacylglycerol; &gt;4.5 mmol/L&#xD;
&#xD;
          -  Serum total cholesterol; &gt;6.5 mmol/L&#xD;
&#xD;
          -  Body mass index &lt;18.5 kg/m2&#xD;
&#xD;
          -  Current use of antihypertensive or lipid lowering medication&#xD;
&#xD;
          -  Alcohol intake exceeding a moderate intake (&gt;28 units per week)&#xD;
&#xD;
          -  Breastfeeding or pregnant&#xD;
&#xD;
          -  Consume supplement such as herbs and hormone pills&#xD;
&#xD;
          -  Smoking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Radhika Loganathan, Masters</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malaysia Palm Oil Board</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Malaysia Palm Oil Board</name>
      <address>
        <city>Kajang</city>
        <state>Selangor</state>
        <zip>50720</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <results_reference>
    <citation>Bayorh MA, Abukhalaf IK, Ganafa AA. Effect of palm oil on blood pressure, endothelial function and oxidative stress. Asia Pac J Clin Nutr. 2005;14(4):325-39.</citation>
    <PMID>16326639</PMID>
  </results_reference>
  <results_reference>
    <citation>Choo YM, Ng MH, Ma AN, Chuah CH, Hashim MA. Application of supercritical fluid chromatography in the quantitative analysis of minor components (carotenes, vitamin E, sterols, and squalene) from palm oil. Lipids. 2005 Apr;40(4):429-32. doi: 10.1007/s11745-006-1400-6.</citation>
    <PMID>16028723</PMID>
  </results_reference>
  <results_reference>
    <citation>Edem DO. Palm oil: biochemical, physiological, nutritional, hematological, and toxicological aspects: a review. Plant Foods Hum Nutr. 2002 Fall;57(3-4):319-41. doi: 10.1023/a:1021828132707.</citation>
    <PMID>12602939</PMID>
  </results_reference>
  <results_reference>
    <citation>Loganathan R Jr, Selvaduray KR, Nesaretnam K, Radhakrishnan AK. Health promoting effects of phytonutrients found in palm oil. Malays J Nutr. 2010 Aug;16(2):309-22. Epub 2010 Aug 15.</citation>
    <PMID>22691935</PMID>
  </results_reference>
  <results_reference>
    <citation>Narang D, Sood S, Thomas MK, Dinda AK, Maulik SK. Effect of dietary palm olein oil on oxidative stress associated with ischemic-reperfusion injury in isolated rat heart. BMC Pharmacol. 2004 Nov 9;4:29. doi: 10.1186/1471-2210-4-29.</citation>
    <PMID>15535879</PMID>
  </results_reference>
  <results_reference>
    <citation>Scholtz SC, Pieters M, Oosthuizen W, Jerling JC, Bosman MJ, Vorster HH. The effect of red palm olein and refined palm olein on lipids and haemostatic factors in hyperfibrinogenaemic subjects. Thromb Res. 2004;113(1):13-25. doi: 10.1016/j.thromres.2004.02.004.</citation>
    <PMID>15081561</PMID>
  </results_reference>
  <results_reference>
    <citation>van Jaarsveld PJ, Benade AJ. Effect of palm olein oil in a moderate-fat diet on low-density lipoprotein composition in non-human primates. Asia Pac J Clin Nutr. 2002;11 Suppl 7:S416-23. doi: 10.1046/j.1440-6047.11.s.7.2.x.</citation>
    <PMID>12492628</PMID>
  </results_reference>
  <results_reference>
    <citation>Volek JS, Phinney SD, Forsythe CE, Quann EE, Wood RJ, Puglisi MJ, Kraemer WJ, Bibus DM, Fernandez ML, Feinman RD. Carbohydrate restriction has a more favorable impact on the metabolic syndrome than a low fat diet. Lipids. 2009 Apr;44(4):297-309. doi: 10.1007/s11745-008-3274-2. Epub 2008 Dec 12.</citation>
    <PMID>19082851</PMID>
  </results_reference>
  <results_reference>
    <citation>Zhang J, Wang CR, Xue AN, Ge KY. Effects of red palm oil on serum lipids and plasma carotenoids level in Chinese male adults. Biomed Environ Sci. 2003 Dec;16(4):348-54.</citation>
    <PMID>15011966</PMID>
  </results_reference>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>September 13, 2016</last_update_submitted>
  <last_update_submitted_qc>September 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Metabolic risk</keyword>
  <keyword>Abdominally overweight</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/NCT02263183
org study id: PD164/12
nct id: NCT02263183
lead sponsor: 
has dmc: No
Red palm oil is obtained from crude palm oil through a novel low-temperature process. Owing
      to this special process, RPO possesses a special flavour and aroma, and is rich in
      phytonutrients that include carotenes, vitamin E, phytosterols, phospholipids, squalene,
      phenolic acids, flavonoids and co-enzyme Q10. These phytonutrients are the main constituents
      through which palm oil exhibits its nutritional properties. Among the major health promoting
      properties are anti-cancer, cardio-protection, anti-angiogenesis, cholesterol inhibition,
      brain development and neuro-protective properties, antioxidative defence mechanisms,
      provitamin A activity and anti-diabetes. As red palm oil has variety of phytonutrients and
      health benefits, the potential of improved cardiovascular health should be considered to
      understand better and thus treasure more our golden oil.
The oil palm Elaeis guineesis, is the source of palm oil - the 'tropical golden oil'.
      Malaysia is the world's largest exporter of this golden oil. Triglycerides constitute the
      major component of crude palm oil, with smaller proportions of diglycerides and
      monoglycerides. The oil also contains other minor constituents, such as free fatty acids and
      phytonutrients. This composition determines the oil's physical, chemical and physiological
      characteristics. In food application, palm oil not only imparts functional properties as a
      heating medium (as in frying of foods) and in having spreadability (as in formulations for
      solid fat products like margarines and shortenings), but is also a good source of
      phytonutrients. Although the phytonutrients constitute only about 1% of its weight in crude
      palm oil, these are the main constituents through which palm oil exhibits its nutritional
      properties. Among the major health promoting properties shown to be associated with the
      various types of phytonutrients present in palm oil are anti-cancer, cardio-protection and
      anti-angiogenesis, cholesterol inhibition, brain development and neuro-protective properties,
      antioxidative defence mechanisms, provitamin A activity and anti-diabetes. Red palm oil (RPO)
      is obtained from crude palm oil through a novel low-temperature process. Owing to this
      special process, RPO possesses a special flavour and aroma, and is rich in phytonutrients
      that include carotenes (thus giving the oil a bright red colour), vitamin E, phytosterols,
      phospholipids, squalene, phenolic acids, flavonoids and co-enzyme Q10.

      Little is known about the physiological effects of red palm oil. The link between dietary
      fats and cardiovascular diseases has always been controversial in the context of palm oil.
      Narang et al., 2004 demonstrated that the anti-oxidant vitamins in palm olein play a vital
      role in the protection of the rat's heart against oxidative stress induced by
      ischemic-reperfusion injury. The unique isomeric position of its fatty acids and the presence
      of tocotrienols cause the endogenous cholesterol level to drop. Besides palm oil could reduce
      the risk of arterial thrombosis and atherosclerosis, inhibit endogenous cholesterol
      biosynthesis, platelet aggregation, and reduce blood pressure. The composition of palm oil
      with an unsaturated-to-saturated fatty acid ratio close to one and rich in antioxidants
      vitamins could attenuate the progression of salt-induced hypertension and mortality in rats
      by modulation of endothelial function and reduction in oxidative stress. In Chinese diet
      preparation, Zhang et al.,2003 demonstrated that red palm oil is a good source of carotenoids
      and vitamin E, and it could significantly increase plasma concentration of alpha-carotene,
      beta-carotene, lycopene and alpha-tocopherol. Following a chronic human study, Scholtz et
      al., 2004 observed that red palm olein had less detrimental effects on the lipid profile and
      decreased tissue plasminogen activator antigen as compared to palm olein. As red palm oil has
      variety of phytonutrients and health benefits, the potential of improved cardiovascular
      health should be considered to understand better and thus treasure more our golden oil. The
      present study was designed to investigate the effect of consumption of red palm olein on
      inflammatory and metabolic risk markers
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Changes in plasma Interleukin-6 status
time frame: 3 years
measure: Changes in inflammatory response
time frame: 3 years
measure: Changes in endothelial function
time frame: 3 years
measure: Changes in lipid profile
time frame: 3 years
measure: Changes in plasma antioxidant status
time frame: 3 years
arm group label: red palm olein(labelled A)
arm group type: Active Comparator
description: red palm olein (labelled A)
arm group label: palm olein(labelled B)(control)
arm group type: Placebo Comparator
description: palm olein(labelled B)(control)
intervention type: Dietary Supplement
intervention name: Red Palm Olein
description: Red Palm Olein contains corresponding fatty acids like Palm Olein except having more phytonutrients (carotenoids and vitamin E)
arm group label: red palm olein(labelled A)
other name: Carotino
intervention type: Dietary Supplement
intervention name: Palm Olein
description: Palm Olein contains corresponding fatty acids like Red Palm Olein except having less phytonutrients (no carotenoids and less vitamin E)
arm group label: palm olein(labelled B)(control)
other name: Carotino
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Radhika Loganathan, Masters
role: Principal Investigator
affiliation: Malaysia Palm Oil Board
facility: 
country: Malaysia
citation: Bayorh MA, Abukhalaf IK, Ganafa AA. Effect of palm oil on blood pressure, endothelial function and oxidative stress. Asia Pac J Clin Nutr. 2005;14(4):325-39.
PMID: 16326639
citation: Choo YM, Ng MH, Ma AN, Chuah CH, Hashim MA. Application of supercritical fluid chromatography in the quantitative analysis of minor components (carotenes, vitamin E, sterols, and squalene) from palm oil. Lipids. 2005 Apr;40(4):429-32. doi: 10.1007/s11745-006-1400-6.
PMID: 16028723
citation: Edem DO. Palm oil: biochemical, physiological, nutritional, hematological, and toxicological aspects: a review. Plant Foods Hum Nutr. 2002 Fall;57(3-4):319-41. doi: 10.1023/a:1021828132707.
PMID: 12602939
citation: Loganathan R Jr, Selvaduray KR, Nesaretnam K, Radhakrishnan AK. Health promoting effects of phytonutrients found in palm oil. Malays J Nutr. 2010 Aug;16(2):309-22. Epub 2010 Aug 15.
PMID: 22691935
citation: Narang D, Sood S, Thomas MK, Dinda AK, Maulik SK. Effect of dietary palm olein oil on oxidative stress associated with ischemic-reperfusion injury in isolated rat heart. BMC Pharmacol. 2004 Nov 9;4:29. doi: 10.1186/1471-2210-4-29.
PMID: 15535879
citation: Scholtz SC, Pieters M, Oosthuizen W, Jerling JC, Bosman MJ, Vorster HH. The effect of red palm olein and refined palm olein on lipids and haemostatic factors in hyperfibrinogenaemic subjects. Thromb Res. 2004;113(1):13-25. doi: 10.1016/j.thromres.2004.02.004.
PMID: 15081561
citation: van Jaarsveld PJ, Benade AJ. Effect of palm olein oil in a moderate-fat diet on low-density lipoprotein composition in non-human primates. Asia Pac J Clin Nutr. 2002;11 Suppl 7:S416-23. doi: 10.1046/j.1440-6047.11.s.7.2.x.
PMID: 12492628
citation: Volek JS, Phinney SD, Forsythe CE, Quann EE, Wood RJ, Puglisi MJ, Kraemer WJ, Bibus DM, Fernandez ML, Feinman RD. Carbohydrate restriction has a more favorable impact on the metabolic syndrome than a low fat diet. Lipids. 2009 Apr;44(4):297-309. doi: 10.1007/s11745-008-3274-2. Epub 2008 Dec 12.
PMID: 19082851
citation: Zhang J, Wang CR, Xue AN, Ge KY. Effects of red palm oil on serum lipids and plasma carotenoids level in Chinese male adults. Biomed Environ Sci. 2003 Dec;16(4):348-54.
PMID: 15011966
responsible party type: Sponsor