Safety and efficacy of an olive oil-based triple-chamber bag for parenteral nutrition: a prospective, randomized, multi-center clinical trial in China
Open accessAbstract
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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ESPEN guideline on clinical nutrition in the intensive care unit.
Singer, P., Blaser, A. R., Berger, M. M., Alhazzani, W., Calder, P. C., Casaer, M. P., Hiesmayr, M., Mayer, K., Montejo, J. C., Pichard, C., et al. (2019) · Clinical Nutrition · doi:10.1016/j.clnu.2018.08.037 · Cited by 2,904 · see citing works
Biological and Clinical Aspects of an Olive Oil-Based Lipid Emulsion—A Review
Cai, W., Calder, P. C., Cury-Boaventura, M. F., De Waele, E., Jakubowski, J., & Zaloga, G. (2018) · Nutrients · doi:10.3390/nu10060776 · Cited by 48 · see citing works
Self-citationTrends in Natural Nutrients for Oxidative Stress and Cell Senescence
Omidifar, N., moghadami, M., Mousavi, S. M., Hashemi, S. A., Gholami, A., Shokripour, M., & Sohrabi, Z. (2021) · Oxidative Medicine and Cellular Longevity · doi:10.1155/2021/7501424 · Cited by 36 · see citing works
- 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)
- PMC
- PMC4647821
- 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
- gold
- doi.org
- Licence
- 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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