A new intravenous fat emulsion containing soybean oil, medium-chain triglycerides, olive oil, and fish oil: a single-center, double-blind randomized study on efficacy and safety in pediatric patients receiving home parenteral nutrition
Goulet O, Antébi H, Wolf C, Talbotec C, Alcindor LG, Corriol O, Lamor M, Colomb-Jung V
JPEN. Journal of parenteral and enteral nutrition · 145 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
- Intake measured by
- Not stated
Who paid for it
- Funding
- Funding not disclosed
Publication
- Published
- 2010-09-01 · JPEN J Parenter Enteral Nutr · vol. 34 · issue 5 · pp. 485–495
- Publisher
- Wiley
- Cited
- 238 citations · more than 99% of similar papers · 12.4× the field average
- Impact
- Top 10% most cited in its field
- References
- 75 works
- Access
- Paywalled
- Research areas
- Clinical Nutrition and Gastroenterology · Neonatal Respiratory Health Research · Enhanced Recovery After Surgery
- Keywords
- Docosahexaenoic acid, Fish oil, Eicosapentaenoic acid, Soybean oil, TBARS, Parenteral nutrition, Oleic acid, Medicine, Chemistry, Triglyceride, Fatty acid, Lipid peroxidation, Animal science, Food science, Biochemistry, Polyunsaturated fatty acid, Internal medicine, Biology, Antioxidant, Cholesterol, Fish <Actinopterygii>, Fishery
- MeSH
- humans, thiobarbituric acid reactive substances, bilirubin, dietary fats, fatty acids, omega-3, soybean oil, fat emulsions, intravenous, triglycerides, phospholipids, fish oils, plant oils, alpha-tocopherol, treatment outcome, parenteral nutrition, home, double-blind method, lipid peroxidation, adolescent, child, child, preschool, infant, female, male, cholesterol, ldl, olive oil
8 authors
From FR
- Olivier Goulet · correspondingUniversité Paris Cité; Hôpital des Enfants
- H. AntébiHôpitaux Universitaires Paris-Ouest
- Claude WolfHôpital Saint-Antoine
- Cécile TalbotecUniversité Paris Cité; Hôpital des Enfants
- Louis‐Gérald AlcindorHôpitaux Universitaires Paris-Ouest
- Odile CorriolUniversité Paris Cité; Hôpital des Enfants
Abstract
Background
SMOFlipid 20% is an intravenous lipid emulsion (ILE) containing soybean oil, medium-chain triglycerides, olive oil, and fish oil developed to provide energy, essential fatty acids (FAs), and long-chain ω-3 FAs as a mixed emulsion containing α-tocopherol. The aim was to assess the efficacy and safety of this new ILE in pediatric patients receiving home parenteral nutrition (HPN) compared with soybean oil emulsion (SOE).
Methods
This single-center, randomized, double-blind study included 28 children on HPN allocated to receive either SMOFlipid 20% (n = 15) or a standard SOE (Intralipid 20%, n = 13). ILE was administered 4 to 5 times per week (goal dose, 2.0 g/kg/d) within a parenteral nutrition regimen. Assessments, including safety and efficacy parameters, were performed on day 0 and after the last study infusion (day 29). Lipid peroxidation was determined by measurement of thiobarbituric acid reactive substances (TBARS).
Results
There were no significant differences in laboratory safety parameters, including liver enzymes, between the groups on day 29. The mean ± standard deviation changes in the total bilirubin concentration between the initial and final values (day 29 to day 0) were significantly different between groups: SMOFlipid group -1.5 ± 2.4 µmol/L vs SOE group 2.3 ± 3.5 µmol/L, P < .01; 95% confidence interval [CI], -6.2 to -1.4). In plasma and red blood cell (RBC) phospholipids, the ω-3 FAs C20:5ω-3 (eicosapentaenoic acid) and + C22:6ω-3 (docosahexaenoic acid) increased significantly in the SMOFlipid group on day 29. The ω-3:ω-6 FA ratio was significantly elevated with SMOFlipid 20% compared with SOE group (plasma, day 29: 0.15 ± 0.06 vs 0.07 ± 0.02, P < .01, 95% CI, 0.04-0.11; and RBC, day 29: 0.23 ± 0.07 vs 0.14 ± 0.04, P < .01, 95% CI, 0.04-0.13). Plasma α-tocopherol concentration increased significantly more with SMOFlipid 20% (15.7 ± 15.9 vs 5.4 ± 15.2 µmol/L, P < .05; 95% CI, -2.1 to 22.6). The low-density lipoprotein-TBARS concentrations were not significantly different between both groups, indicating that lipid peroxidation did not differ between groups.
Conclusions
SMOFlipid 20%, which contains 15% fish oil, was safe and well tolerated, decreased plasma bilirubin, and increased ω-3 FA and α-tocopherol status without changing lipid peroxidation.
Abstract via Europe PMC. Copyright remains with the authors or publisher.
Community trust
Loading…
How much do you trust this study's findings?
Comments
Sign in to rate, comment on or flag this study.Sign inSomething wrong here?
Flag this study if its information, labels or funding look wrong. An editor reviews every flag.
Sign in to rate, comment on or flag this study.Sign inEducational information about published research. Not medical advice, and not a recommendation to start or stop anything.