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Effect of Olive Oil on Erythrocyte Membrane Fatty Acid Contents in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT02993380
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
WON SUK AN, Dong-A University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hemodialysis Dietary Supplement: Stir-fried olive oil group Dietary Supplement: Natural olive oil group Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Cooked Olive Oil on Erythrocyte Membrane Fatty Acid Contents in Hemodialysis Patients
Study Start Date : October 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Olive oil

Arm Intervention/treatment
Experimental: Stir-fried olive oil group
olive oil in heated under 150 degrees
Dietary Supplement: Stir-fried olive oil group
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

Experimental: Natural olive oil group
olive oil in without heated
Dietary Supplement: Natural olive oil group
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




Primary Outcome Measures :
  1. Erythrocyte membrane including oleic acid [ Time Frame: 3 months after intervention ]
    Difference between before taking olive oil and 3 month after about erythrocyte membrane including oleic acid in patient with hemodialysis


Secondary Outcome Measures :
  1. Total cholesterol [ Time Frame: 3months after intervention ]
    Difference between before taking olive oil and 3 month after about total cholesterol

  2. triglyceride [ Time Frame: 3months after intervention ]
    Difference between before taking olive oil and 3 month after about triglyceride

  3. LDL-cholesterol [ Time Frame: 3months after intervention ]
    Difference between before taking olive oil and 3 month after about LDL-cholesterol

  4. HDL-cholesterol [ Time Frame: 3months after intervention ]
    Difference between before taking olive oil and 3 month after about HDL-cholesterol



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 20 years and under 80 years , men and women who are undergoing hemodialysis at least 6months
  • Agree to participate in the clinical trial

Exclusion Criteria:

  • Use of omega-3 fatty acid currently or within 3 months
  • Intake over 10 gram of olive oil three times a week within 3 months
  • Admitted to the hospital with cardiovascular or infectious disease within 3months
  • Pregnant or expected to be pregnant
  • Accompanied Liver cirrhosis or malignant tumor
  • Serum albumin < 3.0 g/dL at the time of inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993380


Locations
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Korea, Republic of
Dong-A University
Busan, Seogu, Korea, Republic of, 49201
Sponsors and Collaborators
Dong-A University
Investigators
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Principal Investigator: WON SUK AN Dong-A University

Publications:

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Responsible Party: WON SUK AN, Professor, Dong-A University
ClinicalTrials.gov Identifier: NCT02993380     History of Changes
Other Study ID Numbers: OliveHD_2016
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by WON SUK AN, Dong-A University:
Olive oil
Erythrocyte membrane fatty acid contents
Oleic acid