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

NCT02993380 | Completed

• 1 other identifier: OliveHD_2016
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis

Keywords

Olive oil; Erythrocyte membrane fatty acid contents; Oleic acid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Total cholesterol

  3months after intervention

• triglyceride

  3months after intervention

• LDL-cholesterol

  3months after intervention

• HDL-cholesterol

  3months after intervention

Study Arms (2)

Stir-fried olive oil group

EXPERIMENTAL

olive oil in heated under 150 degrees

Dietary Supplement: Stir-fried olive oil group

Natural olive oil group

EXPERIMENTAL

olive oil in without heated

Dietary Supplement: Natural olive oil group

Interventions

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

Stir-fried olive oil group

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

Natural olive oil group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A University: lead

Study Sites (1)

Dong-A University

Busan, Seogu, 49201, South Korea

Location

Related Publications (13)

• 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.

  PMID: 20586894 BACKGROUND

• 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. doi: 10.1001/archinte.164.6.659.

  PMID: 15037495 BACKGROUND

• 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. doi: 10.1093/oxfordjournals.aje.a114480.

  PMID: 3776973 BACKGROUND

• Martinez-Gonzalez MA, Salas-Salvado J, Estruch R, Corella D, Fito 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. Epub 2015 May 1.

  PMID: 25940230 BACKGROUND

• 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.

  PMID: 25636157 BACKGROUND

• 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.

  PMID: 26089878 BACKGROUND

• 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.

  PMID: 22071008 BACKGROUND

• 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.

  PMID: 22901557 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000069566.78305.33. No abstract available.

  PMID: 12782616 BACKGROUND

• 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. doi: 10.1016/j.ypmed.2004.02.030.

  PMID: 15208005 BACKGROUND

• 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.

  PMID: 19033007 BACKGROUND

• 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.

  PMID: 19539181 BACKGROUND

• Moreno DA, Lopez-Berenguer C, Garcia-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. doi: 10.1111/j.1750-3841.2006.00213.x.

  PMID: 17995900 BACKGROUND

Study Officials

• WON SUK AN

  Dong-A University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 15, 2016
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 31, 2017

Record last verified: 2017-03

Locations

KR (1)