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Randomized Controlled Trial
Phytosterolemia and γ-glutamyl transferase in adults with parenteral nutrition: Fish versus vegetal lipids: A randomized clinical trial.
- Josep Llop-Talaveron, Maria Badía-Tahull, Toni Lozano-Andreu, Raúl Rigo-Bonnin, Núria Virgili-Casas, Leandre Farran-Teixidó, Monica Miró-Martín, Ana Suárez-Lledó, and Elisabet Leiva-Badosa.
- Pharmacy Department, Hospital Universitari Bellvitge, IDIBELL, Universitat Barcelona, Barcelona, Spain.
- Nutrition. 2020 Feb 1; 70: 110587.
ObjectivesFish oil (FO)-based lipid emulsions (LEs) have been reported to prevent hepatic dysfunction in patients treated with parenteral nutrition (PN). We studied patients with alterations of γ-glutamyl transferase (GGT) associated with the administration of PN containing olive/soybean (O/S)-based LE. The aim of this study was to determine whether the strategy of reducing the lipid dose by 50%, by changing to an FO-based LE, reduced plasma levels of phytosterols (PS) and GGT more effectively and safely, than the strategy of reducing lipid contribution by 50% while maintaining the same LE composition.MethodsA randomized double-blind clinical trial was carried out in patients with normal initial GGT, who after a minimum of 1 wk of daily PN (0.8 g/kg of O/S-based LE) presented with GGT values twice the upper normal value. At the time of randomization 1:1, lipids were reduced to 0.4 g/kg daily. Group A maintained O/S LE and group B changed to FO LE. The primary endpoints were reduction of plasmatic PS and GGT on day 7 after randomization, performed in the study population per protocol by Student's t test and simple linear regression. Secondary outcomes included alkaline phosphatase (AP), alanine transaminase (ALT), and total bilirubin (BIL), and safety variables.ResultsNineteen patients were included. On day 7 after randomization, GGT and AP values were higher in the O/S group (n = 10; GGT: median [Med], 4.99; interquartile range [IQR], 4.09; AP: Med, 2.59 μkat/L; IQR 1.74) than in the FO group (n = 9; GGT: Med, 2.26 μkat/L; IQR, 1.07; AP: Med, 1.2 μkat/L; IQR 1.44). Although there were no differences in ALT and BIL values, the ALT decrease was larger and more statistically significant in the FO group than in the O/S group (P = 0.009). Total PS (Med, 21.10 μg/mL; IQR, 5.50) in the O/S group was higher than in the FO group (Med, 13.4 μg/mL; IQR, 10.65; P = 0.002). Significant decreases in PS and their fractions were observed, with the exception of campesterol and stigmasterol.ConclusionPlasma accumulation of PS and high values of GGT, AP, and ALT can be prevented with the exclusive administration of FO-based LE.Copyright © 2019 Elsevier Inc. All rights reserved.
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