RT Journal Article
T1 Compliance with a high-protein and energy-dense oral nutritional supplement in patients with disease-related malnutrition: a randomized open-label crossover trial
A1 León Sanz, Miguel Francisco José
A1 Linares, Francisca
A1 Gonzalo, Montserrat
A1 Tapia, María José
A1 Maíz Jiménez, María
A1 Ruiz Aguado, Marta
A1 Lizán, Luis
A1 Olveira, Gabriel
AB Introduction: Patient compliance with oral nutritional supplements (ONS) is not optimal for meeting energy and nutritional requirements in a high proportion of patients with disease-related malnutrition (DRM). Energy density or prescribed volume of ONS may impact compliance. Methods: A randomized, open-label crossover trial was conducted in outpatients with DRM to compare compliance with a high energy-dense ONS (edONS, 2.4 kcal/mL) and a reference ONS (heONS, 2.0 kcal/mL; NCT05609006). Patients were randomly assigned to two 8-week treatment sequences of four-weeks periods: edONS + heONS (sequence A) or heONS + edONS (sequence B). Patients daily reported the amount of product left over gastrointestinal tolerance and satisfaction with ONS. A non-inferiority analysis was performed to compare the compliance rate (percentage of consumed energy over the prescribed) foreach period and sequence.Results: Fifty-three patients were assigned to sequence A and 50 to sequence B (55.7 ± 13.9 years, 37.0% female, 67.1% oncology patients). In sequence A, the compliance rates were 88.6% ± 14.3% vs. 84.1 ± 21.8% (p = 0.183), while in sequenceB, they were 78.9% ± 23.8% vs. 84.4% ± 21.4% (p < 0.01). In both sequences, the lower range of the confidence interval for compliance with edONS was greater than the non-inferiority threshold (for sequence A ΔCompA was 4.5% [95% CI, -2.0%to 10.0%], and for sequence, B ΔCompB was 5.6% [95% CI, -3.0% to 14.0%]). The total discarded cost for each ONS was higher for heONS than edONS, being the difference statistically significant in sequence B. BMI increased slightly and not significantly in both sequences, and the percentage of patients with severe malnutrition was reduced. The frequency of gastrointestinal symptoms was low for both sequences, and satisfaction with ONS was slightly higher for edONS. Conclusion: Our findings highlight that edONS was non-inferior to heONS in terms of consumed energy over the prescribed, with a lower amount of edONS discarded, which suggests a higher efficiency of edONS.
PB Frontiers Media S. A.,
SN 2296-861X
YR 2023
FD 2023-05-02
LK https://hdl.handle.net/20.500.14352/93104
UL https://hdl.handle.net/20.500.14352/93104
LA eng
NO Leon-Sanz M, Linares F, Gonzalo M, et al. Compliance with a high-protein and energy-dense oral nutritional supplement in patients with disease-related malnutrition: a randomized open-label crossover trial. Front Nutr. 2023;10:1182445.
DS Docta Complutense
RD 9 abr 2025