<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/NCT02993380</url>
  </required_header>
  <id_info>
    <org_study_id>OliveHD_2016</org_study_id>
    <nct_id>NCT02993380</nct_id>
  </id_info>
  <brief_title>Effect of Olive Oil on Erythrocyte Membrane Fatty Acid Contents in Hemodialysis Patients</brief_title>
  <official_title>Effect of Cooked Olive Oil on Erythrocyte Membrane Fatty Acid Contents in Hemodialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dong-A University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dong-A University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with chronic kidney disease (CKD) have higher mortality rate than general&#xD;
      population. Especially, the most common cause of mortality was known as cardiovascular&#xD;
      disease that account for almost 50 percent in patients with dialysis. Mediterranean diet was&#xD;
      reported for lowering risk of coronary artery disease in general population. Mediterranean&#xD;
      diet is not acceptable in CKD patients because of restriction of potassium, phosphorus, and&#xD;
      protein.&#xD;
&#xD;
      Relatively proper food among Mediterranean diet for hemodialysis patients is olive oil. Many&#xD;
      researchers usually preferred olive oil as control group for evaluating effect of omega-3&#xD;
      fatty acid. However, previous studies reported that control groups using olive oil of 3g in a&#xD;
      day have shown increased components of omega-3 fatty acid such as eicosapentaenoic acid (EPA)&#xD;
      or docosahexaenoic acid (DHA). Therefore, cardioprotective effect of olive oil may be&#xD;
      associated with increasing of omega-3 fatty acid levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fatty acid contents of erythrocyte membrane as a biomarker that reveals status of fatty acid&#xD;
      within recent 3 months. Omega-3 fatty acid such as EPA or DHA, omega-3 index that calculated&#xD;
      by sum of EPA and DHA, and ratio of EPA/arachidonic aicd (AA) are frequently reported as&#xD;
      important biomarkers of its association with cardiovascular accidents. One of the fatty acid&#xD;
      contents of erythrocyte membrane, oleic acid was increased in patients with acute coronary&#xD;
      disease compared to control group. Oleic acid of erythrocyte membrane in hemodialysis&#xD;
      patients with taking omega-3 was significantly decreased compared to group with taking olive&#xD;
      oil. In addition, control group using olive oil was also meaningfully decreased erythrocyte&#xD;
      membrane oleic acid compared to baseline levels. In this way, olive oil seemed to have&#xD;
      similar effect as omega-3 fatty acid. supplement of enough amount olive oil with balanced&#xD;
      meal may show similar effect of omega-3 fatty acid supplementation.&#xD;
&#xD;
      It is ideal way to intake olive oil in uncooked state with vegetables or breads, but&#xD;
      practically peoples stir-fry or fry foods in olive oil instead of cooking oil. Ignition point&#xD;
      of olive oil is 185-205 degrees of Celsius with depending on its oxidation degrees. There is&#xD;
      a study that the contents of vitamin C in broccoli were scantly changed when broccoli was&#xD;
      stir-fried in olive oil. It needs to identify the change of erythrocyte membrane contents&#xD;
      between taking uncooked or natural olive oil and taking fried or stir fried olive oil with&#xD;
      other foods. Taking meals with olive oil can change erythrocyte membrane fatty acid contents&#xD;
      including oleic acid in hemodialysis patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Erythrocyte membrane including oleic acid</measure>
    <time_frame>3 months after intervention</time_frame>
    <description>Difference between before taking olive oil and 3 month after about erythrocyte membrane including oleic acid in patient with hemodialysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>3months after intervention</time_frame>
    <description>Difference between before taking olive oil and 3 month after about total cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>triglyceride</measure>
    <time_frame>3months after intervention</time_frame>
    <description>Difference between before taking olive oil and 3 month after about triglyceride</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-cholesterol</measure>
    <time_frame>3months after intervention</time_frame>
    <description>Difference between before taking olive oil and 3 month after about LDL-cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-cholesterol</measure>
    <time_frame>3months after intervention</time_frame>
    <description>Difference between before taking olive oil and 3 month after about HDL-cholesterol</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Hemodialysis</condition>
  <arm_group>
    <arm_group_label>Stir-fried olive oil group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>olive oil in heated under 150 degrees</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Natural olive oil group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>olive oil in without heated</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Stir-fried olive oil group</intervention_name>
    <description>Stir-fried olive oil group taking food with extra-virgin olive oil in stir fried food or any food with olive oil in heated under 150 degrees of celsius minimal dose per week is 30gram, providing amount of olive oil with meals is 10gram, three times in a weeks</description>
    <arm_group_label>Stir-fried olive oil group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Natural olive oil group</intervention_name>
    <description>Natural olive oil group taking food with extra-virgin any food with olive oil in , minimal dose per week is 30grams, providing amount of olive oil with meals is 10gram, three times in a weeks</description>
    <arm_group_label>Natural olive oil group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 20 years and under 80 years , men and women who are undergoing hemodialysis at&#xD;
             least 6months&#xD;
&#xD;
          -  Agree to participate in the clinical trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of omega-3 fatty acid currently or within 3 months&#xD;
&#xD;
          -  Intake over 10 gram of olive oil three times a week within 3 months&#xD;
&#xD;
          -  Admitted to the hospital with cardiovascular or infectious disease within 3months&#xD;
&#xD;
          -  Pregnant or expected to be pregnant&#xD;
&#xD;
          -  Accompanied Liver cirrhosis or malignant tumor&#xD;
&#xD;
          -  Serum albumin &lt; 3.0 g/dL at the time of inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>WON SUK AN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dong-A University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dong-A University</name>
      <address>
        <city>Busan</city>
        <state>Seogu</state>
        <zip>49201</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Foley RN. Clinical epidemiology of cardiovascular disease in chronic kidney disease. J Ren Care. 2010 May;36 Suppl 1:4-8. doi: 10.1111/j.1755-6686.2010.00171.x.</citation>
    <PMID>20586894</PMID>
  </reference>
  <reference>
    <citation>Keith DS, Nichols GA, Gullion CM, Brown JB, Smith DH. Longitudinal follow-up and outcomes among a population with chronic kidney disease in a large managed care organization. Arch Intern Med. 2004 Mar 22;164(6):659-63. doi: 10.1001/archinte.164.6.659.</citation>
    <PMID>15037495</PMID>
  </reference>
  <reference>
    <citation>Keys A, Menotti A, Karvonen MJ, Aravanis C, Blackburn H, Buzina R, Djordjevic BS, Dontas AS, Fidanza F, Keys MH, et al. The diet and 15-year death rate in the seven countries study. Am J Epidemiol. 1986 Dec;124(6):903-15. doi: 10.1093/oxfordjournals.aje.a114480.</citation>
    <PMID>3776973</PMID>
  </reference>
  <reference>
    <citation>Martinez-Gonzalez MA, Salas-Salvado J, Estruch R, Corella D, Fito M, Ros E; PREDIMED INVESTIGATORS. Benefits of the Mediterranean Diet: Insights From the PREDIMED Study. Prog Cardiovasc Dis. 2015 Jul-Aug;58(1):50-60. doi: 10.1016/j.pcad.2015.04.003. Epub 2015 May 1.</citation>
    <PMID>25940230</PMID>
  </reference>
  <reference>
    <citation>Lee SM, Son YK, Kim SE, An WS. The effects of omega-3 fatty acid on vitamin D activation in hemodialysis patients: a pilot study. Mar Drugs. 2015 Jan 28;13(2):741-55. doi: 10.3390/md13020741.</citation>
    <PMID>25636157</PMID>
  </reference>
  <reference>
    <citation>Lee SM, Chung SH, Park Y, Park MK, Son YK, Kim SE, An WS. Effect of Omega-3 Fatty Acid on the Fatty Acid Content of the Erythrocyte Membrane and Proteinuria in Patients with Diabetic Nephropathy. Int J Endocrinol. 2015;2015:208121. doi: 10.1155/2015/208121. Epub 2015 May 18.</citation>
    <PMID>26089878</PMID>
  </reference>
  <reference>
    <citation>An WS, Lee SM, Son YK, Kim SE, Kim KH, Han JY, Bae HR, Park Y. Effect of omega-3 fatty acids on the modification of erythrocyte membrane fatty acid content including oleic acid in peritoneal dialysis patients. Prostaglandins Leukot Essent Fatty Acids. 2012 Jan-Feb;86(1-2):29-34. doi: 10.1016/j.plefa.2011.10.009. Epub 2011 Nov 8.</citation>
    <PMID>22071008</PMID>
  </reference>
  <reference>
    <citation>An WS, Lee SM, Son YK, Kim SE, Kim KH, Han JY, Bae HR, Rha SH, Park Y. Omega-3 fatty acid supplementation increases 1,25-dihydroxyvitamin D and fetuin-A levels in dialysis patients. Nutr Res. 2012 Jul;32(7):495-502. doi: 10.1016/j.nutres.2012.06.005. Epub 2012 Jul 20.</citation>
    <PMID>22901557</PMID>
  </reference>
  <reference>
    <citation>Leaf A, Kang JX, Xiao YF, Billman GE. Clinical prevention of sudden cardiac death by n-3 polyunsaturated fatty acids and mechanism of prevention of arrhythmias by n-3 fish oils. Circulation. 2003 Jun 3;107(21):2646-52. doi: 10.1161/01.CIR.0000069566.78305.33. No abstract available.</citation>
    <PMID>12782616</PMID>
  </reference>
  <reference>
    <citation>Harris WS, Von Schacky C. The Omega-3 Index: a new risk factor for death from coronary heart disease? Prev Med. 2004 Jul;39(1):212-20. doi: 10.1016/j.ypmed.2004.02.030.</citation>
    <PMID>15208005</PMID>
  </reference>
  <reference>
    <citation>Block RC, Harris WS, Reid KJ, Spertus JA. Omega-6 and trans fatty acids in blood cell membranes: a risk factor for acute coronary syndromes? Am Heart J. 2008 Dec;156(6):1117-23. doi: 10.1016/j.ahj.2008.07.014. Epub 2008 Oct 14.</citation>
    <PMID>19033007</PMID>
  </reference>
  <reference>
    <citation>An WS, Kim SE, Kim KH, Lee S, Park Y, Kim HJ, Vaziri ND. Comparison of fatty acid contents of erythrocyte membrane in hemodialysis and peritoneal dialysis patients. J Ren Nutr. 2009 Jul;19(4):267-74. doi: 10.1053/j.jrn.2009.01.027.</citation>
    <PMID>19539181</PMID>
  </reference>
  <reference>
    <citation>Moreno DA, Lopez-Berenguer C, Garcia-Viguera C. Effects of stir-fry cooking with different edible oils on the phytochemical composition of broccoli. J Food Sci. 2007 Jan;72(1):S064-8. doi: 10.1111/j.1750-3841.2006.00213.x.</citation>
    <PMID>17995900</PMID>
  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>March 30, 2017</last_update_submitted>
  <last_update_submitted_qc>March 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dong-A University</investigator_affiliation>
    <investigator_full_name>WON SUK AN</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Olive oil</keyword>
  <keyword>Erythrocyte membrane fatty acid contents</keyword>
  <keyword>Oleic acid</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02993380
org study id: OliveHD_2016
nct id: NCT02993380
lead sponsor: 
has dmc: No
Patients with chronic kidney disease (CKD) have higher mortality rate than general
      population. Especially, the most common cause of mortality was known as cardiovascular
      disease that account for almost 50 percent in patients with dialysis. Mediterranean diet was
      reported for lowering risk of coronary artery disease in general population. Mediterranean
      diet is not acceptable in CKD patients because of restriction of potassium, phosphorus, and
      protein.

      Relatively proper food among Mediterranean diet for hemodialysis patients is olive oil. Many
      researchers usually preferred olive oil as control group for evaluating effect of omega-3
      fatty acid. However, previous studies reported that control groups using olive oil of 3g in a
      day have shown increased components of omega-3 fatty acid such as eicosapentaenoic acid (EPA)
      or docosahexaenoic acid (DHA). Therefore, cardioprotective effect of olive oil may be
      associated with increasing of omega-3 fatty acid levels.
Fatty acid contents of erythrocyte membrane as a biomarker that reveals status of fatty acid
      within recent 3 months. Omega-3 fatty acid such as EPA or DHA, omega-3 index that calculated
      by sum of EPA and DHA, and ratio of EPA/arachidonic aicd (AA) are frequently reported as
      important biomarkers of its association with cardiovascular accidents. One of the fatty acid
      contents of erythrocyte membrane, oleic acid was increased in patients with acute coronary
      disease compared to control group. Oleic acid of erythrocyte membrane in hemodialysis
      patients with taking omega-3 was significantly decreased compared to group with taking olive
      oil. In addition, control group using olive oil was also meaningfully decreased erythrocyte
      membrane oleic acid compared to baseline levels. In this way, olive oil seemed to have
      similar effect as omega-3 fatty acid. supplement of enough amount olive oil with balanced
      meal may show similar effect of omega-3 fatty acid supplementation.

      It is ideal way to intake olive oil in uncooked state with vegetables or breads, but
      practically peoples stir-fry or fry foods in olive oil instead of cooking oil. Ignition point
      of olive oil is 185-205 degrees of Celsius with depending on its oxidation degrees. There is
      a study that the contents of vitamin C in broccoli were scantly changed when broccoli was
      stir-fried in olive oil. It needs to identify the change of erythrocyte membrane contents
      between taking uncooked or natural olive oil and taking fried or stir fried olive oil with
      other foods. Taking meals with olive oil can change erythrocyte membrane fatty acid contents
      including oleic acid in hemodialysis patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Erythrocyte membrane including oleic acid
time frame: 3 months after intervention
description: Difference between before taking olive oil and 3 month after about erythrocyte membrane including oleic acid in patient with hemodialysis
measure: Total cholesterol
time frame: 3months after intervention
description: Difference between before taking olive oil and 3 month after about total cholesterol
measure: triglyceride
time frame: 3months after intervention
description: Difference between before taking olive oil and 3 month after about triglyceride
measure: LDL-cholesterol
time frame: 3months after intervention
description: Difference between before taking olive oil and 3 month after about LDL-cholesterol
measure: HDL-cholesterol
time frame: 3months after intervention
description: Difference between before taking olive oil and 3 month after about HDL-cholesterol
arm group label: Stir-fried olive oil group
arm group type: Experimental
description: olive oil in heated under 150 degrees
arm group label: Natural olive oil group
arm group type: Experimental
description: olive oil in without heated
intervention type: Dietary Supplement
intervention name: Stir-fried olive oil group
description: Stir-fried olive oil group taking food with extra-virgin olive oil in stir fried food or any food with olive oil in heated under 150 degrees of celsius minimal dose per week is 30gram, providing amount of olive oil with meals is 10gram, three times in a weeks
arm group label: Stir-fried olive oil group
intervention type: Dietary Supplement
intervention name: Natural olive oil group
description: Natural olive oil group taking food with extra-virgin any food with olive oil in , minimal dose per week is 30grams, providing amount of olive oil with meals is 10gram, three times in a weeks
arm group label: Natural olive oil group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: WON SUK AN
role: Principal Investigator
affiliation: Dong-A University
facility: 
country: Korea, Republic of
citation: Foley RN. Clinical epidemiology of cardiovascular disease in chronic kidney disease. J Ren Care. 2010 May;36 Suppl 1:4-8. doi: 10.1111/j.1755-6686.2010.00171.x.
PMID: 20586894
citation: Keith DS, Nichols GA, Gullion CM, Brown JB, Smith DH. Longitudinal follow-up and outcomes among a population with chronic kidney disease in a large managed care organization. Arch Intern Med. 2004 Mar 22;164(6):659-63. doi: 10.1001/archinte.164.6.659.
PMID: 15037495
citation: Keys A, Menotti A, Karvonen MJ, Aravanis C, Blackburn H, Buzina R, Djordjevic BS, Dontas AS, Fidanza F, Keys MH, et al. The diet and 15-year death rate in the seven countries study. Am J Epidemiol. 1986 Dec;124(6):903-15. doi: 10.1093/oxfordjournals.aje.a114480.
PMID: 3776973
citation: Martinez-Gonzalez MA, Salas-Salvado J, Estruch R, Corella D, Fito M, Ros E; PREDIMED INVESTIGATORS. Benefits of the Mediterranean Diet: Insights From the PREDIMED Study. Prog Cardiovasc Dis. 2015 Jul-Aug;58(1):50-60. doi: 10.1016/j.pcad.2015.04.003. Epub 2015 May 1.
PMID: 25940230
citation: Lee SM, Son YK, Kim SE, An WS. The effects of omega-3 fatty acid on vitamin D activation in hemodialysis patients: a pilot study. Mar Drugs. 2015 Jan 28;13(2):741-55. doi: 10.3390/md13020741.
PMID: 25636157
citation: Lee SM, Chung SH, Park Y, Park MK, Son YK, Kim SE, An WS. Effect of Omega-3 Fatty Acid on the Fatty Acid Content of the Erythrocyte Membrane and Proteinuria in Patients with Diabetic Nephropathy. Int J Endocrinol. 2015;2015:208121. doi: 10.1155/2015/208121. Epub 2015 May 18.
PMID: 26089878
citation: An WS, Lee SM, Son YK, Kim SE, Kim KH, Han JY, Bae HR, Park Y. Effect of omega-3 fatty acids on the modification of erythrocyte membrane fatty acid content including oleic acid in peritoneal dialysis patients. Prostaglandins Leukot Essent Fatty Acids. 2012 Jan-Feb;86(1-2):29-34. doi: 10.1016/j.plefa.2011.10.009. Epub 2011 Nov 8.
PMID: 22071008
citation: An WS, Lee SM, Son YK, Kim SE, Kim KH, Han JY, Bae HR, Rha SH, Park Y. Omega-3 fatty acid supplementation increases 1,25-dihydroxyvitamin D and fetuin-A levels in dialysis patients. Nutr Res. 2012 Jul;32(7):495-502. doi: 10.1016/j.nutres.2012.06.005. Epub 2012 Jul 20.
PMID: 22901557
citation: Leaf A, Kang JX, Xiao YF, Billman GE. Clinical prevention of sudden cardiac death by n-3 polyunsaturated fatty acids and mechanism of prevention of arrhythmias by n-3 fish oils. Circulation. 2003 Jun 3;107(21):2646-52. doi: 10.1161/01.CIR.0000069566.78305.33. No abstract available.
PMID: 12782616
citation: Harris WS, Von Schacky C. The Omega-3 Index: a new risk factor for death from coronary heart disease? Prev Med. 2004 Jul;39(1):212-20. doi: 10.1016/j.ypmed.2004.02.030.
PMID: 15208005
citation: Block RC, Harris WS, Reid KJ, Spertus JA. Omega-6 and trans fatty acids in blood cell membranes: a risk factor for acute coronary syndromes? Am Heart J. 2008 Dec;156(6):1117-23. doi: 10.1016/j.ahj.2008.07.014. Epub 2008 Oct 14.
PMID: 19033007
citation: An WS, Kim SE, Kim KH, Lee S, Park Y, Kim HJ, Vaziri ND. Comparison of fatty acid contents of erythrocyte membrane in hemodialysis and peritoneal dialysis patients. J Ren Nutr. 2009 Jul;19(4):267-74. doi: 10.1053/j.jrn.2009.01.027.
PMID: 19539181
citation: Moreno DA, Lopez-Berenguer C, Garcia-Viguera C. Effects of stir-fry cooking with different edible oils on the phytochemical composition of broccoli. J Food Sci. 2007 Jan;72(1):S064-8. doi: 10.1111/j.1750-3841.2006.00213.x.
PMID: 17995900
responsible party type: Principal Investigator
investigator affiliation: Dong-A University
investigator full name: WON SUK AN
investigator title: Professor
sharing ipd: Undecided