OBJECTIVES:Fish 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. METHODS: A 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. RESULTS:Nineteen 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. CONCLUSION:Plasma accumulation of PS and high values of GGT, AP, andALT can be prevented with the exclusive administration of FO-based LE.
RCT Entities:
OBJECTIVES: Fish 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. METHODS: A 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. RESULTS: Nineteen 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. CONCLUSION: Plasma accumulation of PS and high values of GGT, AP, and ALT can be prevented with the exclusive administration of FO-based LE.
Authors: Jose Abuín-Fernández; María José Tapia-Guerrero; Rafael López-Urdiales; Sandra Herranz-Antolín; Jose Manuel García-Almeida; Katherine García-Malpartida; Mercedes Ferrer-Gómez; Emilia Cancer-Minchot; Luis Miguel Luengo-Pérez; Julia Álvarez-Hernández; Carmen Aragón Valera; Julia Ocón-Bretón; Álvaro García-Manzanares; Irene Bretón-Lesmes; Pilar Serrano-Aguayo; Natalia Pérez-Ferre; Juan José López-Gómez; Josefina Olivares-Alcolea; Carmen Arraiza-Irigoyen; Cristina Tejera-Pérez; Jorge Daniel Martínez-González; Ana Urioste-Fondo; Ángel Luis Abad-González; María José Molina-Puerta; Ana Zugasti-Murillo; Juan Parra-Barona; Irela López-Cobo; And Gabriel Olveira-Fuster Journal: Nutrients Date: 2020-05-27 Impact factor: 5.717