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NCT Number: NCT02993380

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

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.

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Key information

Conditions

Hemodialysis

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dong-A University

Busan, Seogu, 49201, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stir-fried olive oil group

Dietary Supplement

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

Natural olive oil group

Dietary Supplement

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dong-A University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 15, 2016
Registry last updated
Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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