Randomized prospective trial comparing mixed oil versus soybean oil lipid emulsion: A feasibility pilot study

Mixed-oil (MO) intravenous lipid emulsions (ILEs) are increasingly used in adults receiving home parenteral nutrition (HPN), but prospective data from United States HPN programs remain limited. This feasibility pilot trial randomized adults newly initiated on HPN to MO versus soybean-oil (SO) ILE. The prespecified primary endpoint was change in total bilirubin over 12 weeks; secondary endpoints included feasibility, tolerance/safety, liver enzymes, C-reactive protein (CRP), and fatty acid profile.

This was a pragmatic, single-center, blinded, randomized, prospective trial of adults newly initiated on HPN and expected to require HPN for more than 3 months. Participants were randomized to SO ILE or MO ILE. The standard HPN follow-up protocol was used to assess tolerance, complications, laboratory outcomes, and fatty acid profiles at baseline and through 12 weeks. Analyses included randomized participants with available data at each time point.

Twenty-two participants were randomized (SO ILE n = 11; MO ILE n = 11). Groups were similar in baseline demographic and PN macronutrient characteristics, and all participants had normal baseline liver enzymes and bilirubin. Total bilirubin, the primary endpoint, did not differ significantly between groups at weeks 4, 8, or 12 (week 12 median change 0 [IQR -0.1, 0.1] in SO ILE vs 0 [0, 0.1] in MO ILE; p = 0.96). No significant between-group differences were observed in liver enzymes or CRP. MO ILE was associated with significant increases in EPA and DHA by week 4 that were maintained through week 12, whereas SO ILE was not.

In this feasibility pilot study, MO ILE was tolerated in United States adults newly initiated on HPN and produced the expected increase in EPA and DHA, with potential benefit in reduction of inflammation in the setting of inflammatory insult. Further multi-center trials are needed to confirm these findings and explore long-term outcomes.