title: Safety and efficacy of an olive oil-based triple-chamber bag for parenteral nutrition: a prospective, randomized, multi-center clinical trial in China.
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.
  
  
  BACKGROUND
  NTC 01579097.
authors.affiliation: Department of Surgery, Shanghai Sixth People's Hospital, Affiliated to Shanghai Jiao Tong University, Shanghai, 200233, China. jzhyjia@163.com.
authors.forename: Zhen-Yi
authors.initials: ZY
authors.lastname: Jia
authors.affiliation: Department of Surgery, Shanghai Sixth People's Hospital, Affiliated to Shanghai Jiao Tong University, Shanghai, 200233, China. yanjuns@foxmail.com.
authors.forename: Jun
authors.initials: J
authors.lastname: Yang
authors.affiliation: Department of Surgery, Shanghai Sixth People's Hospital, Affiliated to Shanghai Jiao Tong University, Shanghai, 200233, China. xiayang73@163.com.
authors.forename: Yang
authors.initials: Y
authors.lastname: Xia
authors.affiliation: Department of Surgery, Shanghai Sixth People's Hospital, Affiliated to Shanghai Jiao Tong University, Shanghai, 200233, China. danian78@163.com.
authors.forename: Da-Nian
authors.initials: DN
authors.lastname: Tong
authors.affiliation: Baxter Healthcare, Deerfield, IL, 60015, USA. gary_zaloga@baxter.com.
authors.forename: Gary P
authors.initials: GP
authors.lastname: Zaloga
authors.affiliation: Department of Surgery, Shanghai Sixth People's Hospital, Affiliated to Shanghai Jiao Tong University, Shanghai, 200233, China. hlqin1965@163.com.|General Surgery, Shanghai Tenth People's Hospital (Tenth People'sHospital of Tongii University), Shanghai, 200072, China. hlqin1965@163.com.
authors.forename: Huan-Long
authors.initials: HL
authors.lastname: Qin
mesh_terms: D002681:China; D005217:Fat Emulsions, Intravenous / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069463:Olive Oil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010288:Parenteral Nutrition / Q000295:instrumentation* / Q000379:methods*; D011446:Prospective Studies; D013024:Soybean Oil / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D005217:Fat Emulsions, Intravenous; D000069463:Olive Oil; D013024:Soybean Oil