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

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993380
• Other study ID #: OliveHD_2016
• Status: Completed
• Phase: N/A
• First received: December 9, 2016
• Last updated: March 30, 2017
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Dong-A University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University	Busan	Seogu

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (13)

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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Martínez-González MA, Salas-Salvadó J, Estruch R, Corella D, Fitó 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. Review. — View Citation

Moreno DA, López-Berenguer C, García-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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erythrocyte membrane including oleic acid	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	Total cholesterol	Difference between before taking olive oil and 3 month after about total cholesterol	3months after intervention
Secondary	triglyceride	Difference between before taking olive oil and 3 month after about triglyceride	3months after intervention
Secondary	LDL-cholesterol	Difference between before taking olive oil and 3 month after about LDL-cholesterol	3months after intervention
Secondary	HDL-cholesterol	Difference between before taking olive oil and 3 month after about HDL-cholesterol	3months after intervention