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

Sponsor

Dong-A University (Other)

Overall Status

Completed

CT.gov ID

NCT02993380

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Oct 1, 2015

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Erythrocyte membrane including oleic acid [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

Total cholesterol [3months after intervention]
Difference between before taking olive oil and 3 month after about total cholesterol
triglyceride [3months after intervention]
Difference between before taking olive oil and 3 month after about triglyceride
LDL-cholesterol [3months after intervention]
Difference between before taking olive oil and 3 month after about LDL-cholesterol
HDL-cholesterol [3months after intervention]
Difference between before taking olive oil and 3 month after about HDL-cholesterol

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dong-A University	Busan	Seogu	Korea, Republic of	49201

Sponsors and Collaborators

Dong-A University

Investigators

Principal Investigator: WON SUK AN, Dong-A University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

WON SUK AN, Professor, Dong-A University

ClinicalTrials.gov Identifier:

NCT02993380

Other Study ID Numbers:

OliveHD_2016

First Posted:

Dec 15, 2016

Last Update Posted:

Mar 31, 2017

Last Verified:

Mar 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by WON SUK AN, Professor, Dong-A University

Olive oil

Erythrocyte membrane fatty acid contents

Oleic acid

Study Results

No Results Posted as of Mar 31, 2017