Cited by 24Clinical Nutrition and GastroenterologyEnhanced Recovery After SurgeryCentral Venous Catheters and Hemodialysis

Safety and efficacy of an olive oil-based triple-chamber bag for parenteral nutrition: a prospective, randomized, multi-center clinical trial in China

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OliClinomel N4 Study Group, Jia, Zhen-Yi, Yang, Jun, Xia, Yang, Tong, Da-Nian, Zaloga, Gary P., Qin, Huan-Long·2015·Nutrition Journal

Abstract

BACKGROUND: Small studies suggest differences in efficacy and safety exist between olive oil-based (OLIVE) and soybean oil-based (SOYBEAN) parenteral nutrition regimens in hospitalized adult patients. This large, prospective, randomized (1:1), open-label, multi-center, noninferiority study compared the delivery, efficacy, and safety of OLIVE (N = 226) with SOYBEAN (N = 232) in Chinese adults (≥18 years) admitted to a surgical service for whom parenteral nutrition was required. METHODS: Treatments were administered for a minimum of 5 days up to 14 days (to achieve approximately 25 kcal/kg/day, 0.9 g/kg/day amino acids, 0.8 g/kg/day lipid). Impact of treatment on anabolic/catabolic and serum inflammatory, chemistry, and hematological markers, safety, and ease of use were assessed. The primary efficacy variable was serum prealbumin level at Day 5. RESULTS: OLIVE (n = 219) was not inferior to SOYBEAN (n = 224) based on the prealbumin least square geometric mean [LSGM] ratio [95% CI] 1.12 [1.06, 1.19]; P = 0.002), improved the anabolic/catabolic status of patients enrolled in the study, and was well tolerated compared with SOYBEAN. Improved anabolic status was supported by significantly higher levels of prealbumin at Day 5, albumin at Day 5 and IGF-1 at Day 14 in the OLIVE group, while catabolism was similar between groups. C-reactive protein, intercellular adhesion molecule-1, procalcitonin, and oxidation were similar in each group, but infections were significantly lower with OLIVE (3.6% versus 10.4%; P < 0.01). CONCLUSIONS: OLIVE provided effective nutrition, was well tolerated, was associated with fewer infections, and conferred greater ease-of-use than SOYBEAN. TRIAL REGISTRATION: NTC 01579097.

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  • In the post-hoc analysis of the MetaPlus study, only the change from baseline to day 4 of EPA + DHA/LCT ratio was statistically significantly associated with six month mortality (hazard ratio 1.18, 95% CI 1.02-1.35, P=0.021).

    “In the post-hoc analysis of the MetaPlus study (252), administrating GLN, EPA/DHA and antioxidants to critically ill patients, only the change from baseline to day 4 of EPA + DHA/long chain triglyceride (LCT) ratio was statistically significantly associated with six month mortality (hazard ratio 1.18, 95% ci 1.02-1.35,P=0.021)”

    From ESPEN guideline on clinical nutrition in the intensive care unit. (2019) · cites this paper as [252]

    The Results (Lipid endpoints; page not provided) report EPA levels at baseline and day 5 for olive-oil and soybean-oil parenteral nutrition, not a day-4 EPA+DHA/LCT ratio. Searches for MetaPlus, six-month mortality, and the stated hazard ratio found no passage in our copy addressing the claimed post-hoc analysis. (LLM, conf=0.76)

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Research works printed but not linked: 38

  1. [1]Berger MM The 2013 Arvid Wretlind lecture: evolving concepts in parenteral nutrition Clin Nutr 2014 33 4 563 570 10.1016/j.clnu.2014.03.005 24768286 · DOI · Paper page
  2. [2]Jie B Jiang ZM Nolan MT Efron DT Zhu SN Yu K Impact of nutritional support on clinical outcome in patients at nutritional risk: a multicenter, prospective cohort study in Baltimore and Beijing teaching hospitals Nutrition 2010 26 11–12 1088 1093 10.1016/j.nut.2009.08.027 19963351 · DOI · Paper page
  3. [3]Jie B Jiang ZM Nolan MT Zhu SN Yu K Kondrup J Impact of preoperative nutritional support on clinical outcome in abdominal surgical patients at nutritional risk Nutrition 2012 28 10 1022 1027 10.1016/j.nut.2012.01.017 22673593 · DOI
  4. [4]Mullen JL Buzby GP Matthews DC Smale BF Rosato EF Reduction of operative morbidity and mortality by combined preoperative and postoperative nutritional support Ann Surg 1980 192 5 604 613 10.1097/00000658-198019250-00004 6776917 PMC1344940 · DOI
  5. [5]Wu MH Lin MT Chen WJ Effect of perioperative parenteral nutritional support for gastric cancer patients undergoing gastrectomy Hepatogastroenterology 2008 55 82–83 799 802 18613458
  6. [6]Mateu-de Antonio J Grau S Luque S Marin-Casino M Albert I Ribes E Comparative effects of olive oil-based and soyabean oil-based emulsions on infection rate and leucocyte count in critically ill patients receiving parenteral nutrition Br J Nutr 2008 99 4 846 854 10.1017/S0007114507837433 17916276 · DOI
  7. [7]Onar P Yildiz BD Yildiz EA Besler T Abbasoglu O Olive oil-based fat emulsion versus soy oil-based fat emulsion in abdominal oncologic surgery Nutr Clin Pract 2011 26 1 61 65 10.1177/0884533610392920 21266699 · DOI
  8. [8]Palova S Charvat J Kvapil M Comparison of soybean oil- and olive oil-based lipid emulsions on hepatobiliary function and serum triacylglycerols level during realimentation J Int Med Res 2008 36 3 587 593 10.1177/147323000803600326 18534143 · DOI
  9. [9]Puiggros C Sanchez J Chacon P Sabin P Rosello J Bou R Evolution of lipid profile, liver function, and pattern of plasma fatty acids according to the type of lipid emulsion administered in parenteral nutrition in the early postoperative period after digestive surgery JPEN J Parenter Enteral Nutr 2009 33 5 501 512 10.1177/0148607109333001 19420283 · DOI
  10. [10]Vanek VW Seidner DL Allen P Bistrian B Collier S Gura K A.S.P.E.N. position paper: clinical role for alternative intravenous fat emulsions Nutr Clin Pract 2012 27 2 150 192 10.1177/0884533612439896 22378798 · DOI
  11. [11]Cury-Boaventura MF Gorjao R de Lima TM Fiamoncini J Torres RP Mancini-Filho J Effect of olive oil-based emulsion on human lymphocyte and neutrophil death JPEN J Parenter Enteral Nutr 2008 32 1 81 87 10.1177/014860710803200181 18165452 · DOI
  12. [12]Furukawa K Yamamori H Takagi K Hayashi N Suzuki R Nakajima N Influences of soybean oil emulsion on stress response and cell-mediated immune function in moderately or severely stressed patients Nutrition 2002 18 3 235 240 10.1016/S0899-9007(01)00784-5 11882396 · DOI
  13. [13]Okada Y Klein NJ van Saene HK Webb G Holzel H Pierro A Bactericidal activity against coagulase-negative staphylococci is impaired in infants receiving long-term parenteral nutrition Ann Surg 2000 231 2 276 281 10.1097/00000658-200002000-00018 10674621 PMC1420997 · DOI
  14. [14]Siqueira J Smiley D Newton C Le NA Gosmanov AR Spiegelman R Substitution of standard soybean oil with olive oil-based lipid emulsion in parenteral nutrition: comparison of vascular, metabolic, and inflammatory effects J Clin Endocrinol Metab 2011 96 10 3207 3216 10.1210/jc.2011-0480 21832112 PMC3200250 · DOI
  15. [15]Garcia-de-Lorenzo A Denia R Atlan P Martinez-Ratero S Le Brun A Evard D Parenteral nutrition providing a restricted amount of linoleic acid in severely burned patients: a randomised double-blind study of an olive oil-based lipid emulsion v. medium/long-chain triacylglycerols Br J Nutr 2005 94 2 221 230 10.1079/BJN20051467 16115356 · DOI
  16. [16]Yaqoob P Monounsaturated fats and immune function Proc Nutr Soc 1998 57 4 511 520 10.1079/PNS19980075 10096110 · DOI
  17. [17]Ingenbleek Y Bernstein L The stressful condition as a nutritionally dependent adaptive dichotomy Nutrition 1999 15 4 305 320 10.1016/S0899-9007(99)00009-X 10319365 · DOI
  18. [18]Calder PC Jensen GL Koletzko BV Singer P Wanten GJ Lipid emulsions in parenteral nutrition of intensive care patients: current thinking and future directions Intensive Care Med 2010 36 5 735 749 10.1007/s00134-009-1744-5 20072779 PMC2850535 · DOI
  19. [19]Livingstone C Insulin-like growth factor-I (IGF-I) and clinical nutrition Clin Sci (Lond) 2013 125 6 265 280 10.1042/CS20120663 23721057 · DOI
  20. [20]Li ZZL Wang WP Hao CL Guo K Ma GW Yu H Rong TH Olive oil-based lipid emulsion for parenteral nutrition in patients after esophagectomy Chinese Journal of Clinical Nutrition 2011 19 74 81
  21. [21]Umpierrez GE Spiegelman R Zhao V Smiley DD Pinzon I Griffith DP A double-blind, randomized clinical trial comparing soybean oil-based versus olive oil-based lipid emulsions in adult medical-surgical intensive care unit patients requiring parenteral nutrition Crit Care Med 2012 40 6 1792 1798 10.1097/CCM.0b013e3182474bf9 22488002 PMC3738173 · DOI · Paper page
  22. [22]Yang JZJ Zheng QC Olive oil-based lipid emulsion for parenteral nutrition in patients after hepatectomy Chinese Journal of Clinical Nutrition 2011 2 79 82
  23. [24]Gogos CA Zoumbos N Makri M Kalfarentzos F Medium- and long-chain triglycerides have different effects on the synthesis of tumor necrosis factor by human mononuclear cells in patients under total parenteral nutrition J Am Coll Nutr 1994 13 1 40 44 10.1080/07315724.1994.10718369 8157852 · DOI
  24. [25]Mayer K Gokorsch S Fegbeutel C Hattar K Rosseau S Walmrath D Parenteral nutrition with fish oil modulates cytokine response in patients with sepsis Am J Respir Crit Care Med 2003 167 10 1321 1328 10.1164/rccm.200207-674OC 12615625 · DOI · Paper page
  25. [26]Pontes-Arruda A Dos Santos MC Martins LF Gonzalez ER Kliger RG Maia M Influence of parenteral nutrition delivery system on the development of bloodstream infections in critically ill patients: an international, multicenter, prospective, open-label, controlled study–EPICOS study JPEN J Parenter Enteral Nutr 2012 36 5 574 586 10.1177/0148607111427040 22269899 · DOI
  26. [27]Byers PM Hameed SM Asensio JA Trunkey DD Chapter 99–Preoperative and postoperative nutritional support: strategies for enteral and parenteral therapies Current Therapy of Trauma and Surgical Critical Care 2008 Philadelphia Mosby 710 717
  27. [28]Cury-Boaventura MF Gorjao R de Lima TM Piva TM Peres CM Soriano FG Toxicity of a soybean oil emulsion on human lymphocytes and neutrophils JPEN J Parenter Enteral Nutr 2006 30 2 115 123 10.1177/0148607106030002115 16517956 · DOI
  28. [29]Sedman PC Somers SS Ramsden CW Brennan TG Guillou PJ Effects of different lipid emulsions on lymphocyte function during total parenteral nutrition Br J Surg 1991 78 11 1396 1399 10.1002/bjs.1800781142 1760713 · DOI
  29. [30]Manzanares W Dhaliwal R Jurewitsch B Stapleton RD Jeejeebhoy KN Heyland DK Parenteral fish oil lipid emulsions in the critically ill: a systematic review and meta-analysis JPEN J Parenter Enteral Nutr 2014 38 1 20 28 10.1177/0148607113486006 23609773 PMC4464759 · DOI
  30. [31]Hardy G Puzovic M Formulation, stability, and administration of parenteral nutrition with new lipid emulsions Nutr Clin Pract 2009 24 5 616 625 10.1177/0884533609342445 19841249 · DOI
  31. [32]Calder PC Hot topics in parenteral nutrition. Rationale for using new lipid emulsions in parenteral nutrition and a review of the trials performed in adults Proc Nutr Soc 2009 68 3 252 260 10.1017/S0029665109001268 19426581 · DOI
  32. [33]Turpin RS Canada T Liu FX Mercaldi CJ Pontes-Arruda A Wischmeyer P Nutrition therapy cost analysis in the US: pre-mixed multi-chamber bag vs compounded parenteral nutrition Appl Health Econ Health Policy 2011 9 5 281 292 10.2165/11594980-000000000-00000 21761945 PMC3631121 · DOI
  33. [34]Berlana D Sabin P Gimeno-Ballester V Romero-Jimenez R Zapata-Rojas A Marquez E Cost analysis of adult parenteral nutrition systems: three-compartment bag versus customized Nutr Hosp 2013 28 6 2135 2141 24506393
  34. [35]Menne R Adolph M Brock E Schneider H Senkal M Cost analysis of parenteral nutrition regimens in the intensive care unit: three-compartment bag system vs multibottle system JPEN J Parenter Enteral Nutr 2008 32 6 606 612 10.1177/0148607108322404 18974238 · DOI
  35. [36]Driscoll DF Compounding TPN admixtures: then and now JPEN J Parenter Enteral Nutr 2003 27 6 433 438 10.1177/0148607103027006433 14621126 · DOI
  36. [37]Driscoll DF Stability and compatibility assessment techniques for total parenteral nutrition admixtures: setting the bar according to pharmacopeial standards Curr Opin Clin Nutr Metab Care 2005 8 3 297 303 10.1097/01.mco.0000165009.24202.64 15809533 · DOI
  37. [38]Braga M Ljungqvist O Soeters P Fearon K Weimann A Bozzetti F ESPEN guidelines on parenteral nutrition: surgery Clin Nutr 2009 28 4 378 386 10.1016/j.clnu.2009.04.002 19464088 · DOI
  38. [39]Huschak G Zur Nieden K Hoell T Riemann D Mast H Stuttmann R Olive oil based nutrition in multiple trauma patients: a pilot study Intensive Care Med 2005 31 9 1202 1208 10.1007/s00134-005-2727-9 16132897 · DOI · Paper page

Cited by

Sorted by citations

Authors
OliClinomel N4 Study Group, Jia, Z.-Y., Yang, J., Xia, Y., Tong, D.-N., Zaloga, G. P., & Qin, H.-L.
Affiliations
  • Shanghai Jiao Tong University (CN)
  • Shanghai Tenth People's Hospital (CN)
Venue
Nutrition Journal
Published
2015-11-14
Volume
14
Issue
1
Pages
119-119
ISSN
1475-2891 (ISSN-L)
OpenAlex
W2173875866
Cited by
24
References
0
Citations by year
2026: 2 · 2025: 1 · 2024: 4 · 2023: 4 · 2022: 2 · 2021: 4 · 2020: 2 · 2019: 1 · 2018: 3 · 2016: 1
FWCI
1.29
Type
journal article
Language
en
Open access
Locations
  • Nutrition Journal (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Nursing › Nutrition and Dietetics › Clinical Nutrition and Gastroenterology
  • Health Sciences › Medicine › Surgery › Enhanced Recovery After Surgery
  • Health Sciences › Health Professions › Emergency Medical Services › Central Venous Catheters and Hemodialysis
Keywords
prealbumin, insulin-like growth factor I, infection risk, inflammatory markers, surgical patients, non-inferiority
MeSH terms
Olive Oil, China, Fat Emulsions, Intravenous, Female, Humans, Male, Middle Aged, Parenteral Nutrition, Prospective Studies, Soybean Oil, Treatment Outcome

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