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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Essential fatty acid deficiency, olive oil-based intravenous lipid emulsion, and genetic polymorphisms: A pediatric
Cynthia Blanco1, Weili Chang2, Abhay J Bhatt3
1Division of Neonatology, University of Texas Health Science Center, San Antonio, Texas, USA.
Insights
An 80% olive oil/20% soybean oil intravenous lipid emulsion (ILE) is safe for pediatric patients, showing no increased risk of essential fatty acid deficiency (EFAD). This finding supports the use of reduced soybean oil content in ILEs for children requiring parenteral nutrition.
Area of Science:
- Nutritional Science
- Pediatric Medicine
- Biochemistry
Background:
- Decreasing soybean oil (SO) content in intravenous lipid emulsions (ILEs) raises concerns about essential fatty acid deficiency (EFAD) risk.
- Pediatric patients requiring prolonged parenteral nutrition are particularly vulnerable to nutritional imbalances.
Purpose of the Study:
- To evaluate the risk of EFAD in pediatric patients receiving an 80% olive oil/20% SO ILE compared to a 100% SO ILE.
- To assess the safety and tolerability of reduced SO content in ILEs for pediatric use.
Main Methods:
- A randomized, double-blind, controlled, multicenter study involving 101 pediatric patients, including preterm infants.
- Primary outcome: incidence of EFAD, assessed via plasma fatty acid (FA) profiles and genetic polymorphisms.
- Analysis included extreme arachidonic acid values and triene:tetraene (T:T) ratios.
Main Results:
- No cases of EFAD were observed in either the 80% olive oil/20% SO (OO/SO) or 100% SO groups.
- Linoleic acid increased in both groups, with a smaller increase in the OO/SO group.
- Arachidonic acid remained stable; Mead acid changes were opposite, leading to similar T:T ratios. Genetic polymorphisms were noted in patients with extreme arachidonic acid values.
Conclusions:
- An 80% OO/20% SO ILE is safe and well-tolerated in pediatric patients, not increasing EFAD risk.
- EFAD assessment should incorporate complete FA profiles and genetic polymorphisms, not solely T:T ratios.
Objectives:
There is a concern that decreasing soybean oil (SO) content in intravenous lipid emulsions (ILEs) may increase the risk for essential fatty acid deficiency (EFAD). This study evaluates the risk of EFAD in pediatric patients who were expected to require parenteral nutrition for at least 7 days with an 80% olive oil/20% SO ILE (OO/SO group) versus a 100% SO ILE (SO group).
Methods:
This randomized, double-blind, controlled, multicenter study evaluated 101 pediatric patients including 94 preterm infants. The primary outcome was the incidence of EFAD, including the analysis of the plasma fatty acid (FA) profiles and genetic polymorphism in the FA desaturase genes in patients with extreme arachidonic acid values.
Results:
Treatment duration was 10.3 ± 7.8 and 11.3 ± 9.4 days in the OO/SO and SO groups respectively. No EFAD was observed. Linoleic acid values increased in both groups but to a lesser extent in the OO/SO group. Arachidonic acid values remained stable within the two groups. The changes in mead acid value were opposite in the two groups, demonstrating an increase in the OO/SO group and a decrease in the SO group, leading to similar changes in the triene:tetraene ratio (T:T). Genetic polymorphisms were frequently observed in patients presenting extreme arachidonic acid values in both groups.
Conclusions:
The use of an 80% OO/20% SO ILE is well tolerated, safe, and does not increase the risk of EFAD in pediatric patients. The assessment of EFAD should not only consider the T:T but also the complete FA profile and genetic polymorphisms.
Trial Identification Number:
Trial Identification Number and URL: NCT04555044, https://clinicaltrials.gov/study/NCT04555044?term=NCT04555044&rank=1.
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