Clinical nutrition (Edinburgh, Scotland) · 2025
Systematic high-calorie, high-protein oral nutritional support in hospitalized, moderately hypophagic patients at nutritional risk: A randomized-controlled trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Cereda Emanuele, Borioli Valeria, Caraccia Marilisa, Uggè Anna, De Simeis Francesca, Bruno Raffaele, Corsico Angelo Guido, Di Sabatino Antonio, Pedrazzoli Paolo, Caccialanza Riccardo
Аннотация
BACKGROUND: Acute diseases responsible for hospitalization negatively affect protein-calorie balance, as well as the capacity of patients to cope with it. In those who still retain spontaneous feeding, oral nutritional supplements (ONSs) administration is an effective support strategy, but evidence on the timing they should be provided along with nutritional counseling during hospitalization is lacking. Hence, we evaluated the efficacy of the systematic use of ONSs since hospital admission.
METHODS: In a single-site, open-label, randomized, controlled trial (NCT02763904; July 2016-July 2024), acutely hospitalized adults (N = 220) at nutritional risk (NRS-2002 ≥ 3), without severe hypophagia (defined as food intake <50 % of estimated calorie requirements) and with an expected length of stay (LOS) ≥7 days were randomized to receive, along with nutritional counseling, high-protein ONSs systematically since admission or on-demand since day 8. The primary endpoint was the change in phase angle (PhA) on day 8. Secondary outcomes were the change in PhA at discharge and in muscle strength, body weight and protein-calorie intake over the hospital stay. LOS and the rate of acquired infections were also evaluated.
RESULTS: A total of 201 patients were re-assessed at day 8 and at discharge. Systematic ONSs (n = 100) resulted in improved PhA at day 8 (mean difference, 0.47 [95%CI, 0.31-0.62]; P < 0.001) and at discharge (mean difference, 0.49 [95%CI, 0.33-0.64]; P < 0.001). A significant effect was also found for body weight and protein-calorie intake at all time-points (P < 0.001) and for muscle strength at discharge (P = 0.042). LOS was also reduced (-2 days; P = 0.044).
CONCLUSIONS: In acutely hospitalized adult patients at nutritional risk and without severe hypophagia, the systematic use of ONSs since admission improved body composition, muscle function, and protein-calorie intake, and reduced LOS.
METHODS: In a single-site, open-label, randomized, controlled trial (NCT02763904; July 2016-July 2024), acutely hospitalized adults (N = 220) at nutritional risk (NRS-2002 ≥ 3), without severe hypophagia (defined as food intake <50 % of estimated calorie requirements) and with an expected length of stay (LOS) ≥7 days were randomized to receive, along with nutritional counseling, high-protein ONSs systematically since admission or on-demand since day 8. The primary endpoint was the change in phase angle (PhA) on day 8. Secondary outcomes were the change in PhA at discharge and in muscle strength, body weight and protein-calorie intake over the hospital stay. LOS and the rate of acquired infections were also evaluated.
RESULTS: A total of 201 patients were re-assessed at day 8 and at discharge. Systematic ONSs (n = 100) resulted in improved PhA at day 8 (mean difference, 0.47 [95%CI, 0.31-0.62]; P < 0.001) and at discharge (mean difference, 0.49 [95%CI, 0.33-0.64]; P < 0.001). A significant effect was also found for body weight and protein-calorie intake at all time-points (P < 0.001) and for muscle strength at discharge (P = 0.042). LOS was also reduced (-2 days; P = 0.044).
CONCLUSIONS: In acutely hospitalized adult patients at nutritional risk and without severe hypophagia, the systematic use of ONSs since admission improved body composition, muscle function, and protein-calorie intake, and reduced LOS.