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

March 30, 2017 updated by: WON SUK AN, Dong-A University

Effect of Cooked 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total cholesterol
Time Frame: 3months after intervention
Difference between before taking olive oil and 3 month after about total cholesterol
3months after intervention
triglyceride
Time Frame: 3months after intervention
Difference between before taking olive oil and 3 month after about triglyceride
3months after intervention
LDL-cholesterol
Time Frame: 3months after intervention
Difference between before taking olive oil and 3 month after about LDL-cholesterol
3months after intervention
HDL-cholesterol
Time Frame: 3months after intervention
Difference between before taking olive oil and 3 month after about HDL-cholesterol
3months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A University

Investigators

  • Principal Investigator: WON SUK AN, Dong-A University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

December 9, 2016

First Submitted That Met QC Criteria

December 14, 2016

First Posted (ESTIMATE)

December 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OliveHD_2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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