ESPEN 2022 Late Breaking Abstracts
Topic: Nutritional assessment
Abstract Submission Identifier: ESPEN22-LB-2221
COMPLIANCE WITH AN ENERGY-DENSE LOW-VOLUME ORAL NUTRITIONAL SUPPLEMENT VERSUS A STANDARD HIGH-ENERGY SUPPLEMENT: A NON-INFERIORITY RANDOMIZED CROSSOVER TRIAL
G. Olveira*, 1, F. Linares 1, M. Gonzalo 1, M. J. Tapia 1, F. J. Sánchez 1, M. Ruiz 2, M. Maiz 2, M. Aguirre 3, S. Aceituno 4, M. Prades 4, M. León-Sanz 2
1Department of Endocrinology and Nutrition, Hospital Regional Universitario de Málaga, Málaga, 2Department of Endocrinology and Nutrition, Hospital Universitario 12 de octubre, 3Danone Specialized Nutrition, Madrid, 4Outcomes'10, Castellón, Spain
Rationale: Compliance with oral nutritional supplements (ONS) is key to improving patient nutritional status, especially in disease-related malnutrition (DRM). Compliance can be influenced by the energy density and volume of the ONS. We aimed to evaluate compliance (defined as the percentage of consumed energy out of prescribed) with an energy-dense ONS (edONs) versus a high-energy standard ONS (sONS).
Methods: A randomized, crossover trial was conducted in adult patients with DRM from 2 Spanish hospitals. Patients were randomly assigned to take 2 bottles daily of an ONS for 4 weeks and then switched to the other ONS. Sequence in group A was edONS (2.4kcal/ml;125ml) + sONS (2.0kcal/ml;200ml), and in group B was sONS (2.0kcal/ml;200ml) + edONS (2.4kcal/ml;125ml). Nutritional status (SGA) and body mass index (BMI) were recorded at baseline, weeks 4 and 8. Patients daily recorded the wasted ONS volume. Based on wasted ONS recorded and energy prescribed, compliance was estimated for each group period. Statistical analysis considered a non-inferiority margin of 5% and a significance p-value <0.05 (Stata v.14).
Results: A total of 73 patients were recruited (63% male; mean age 55.7±13.9). At baseline, the mean BMI was 22, 49% were mild/moderately malnourished and 51% were severely malnourished. Patients from group A (n=42) showed 89%/84% of compliance with edONS/sONS, with a difference of 4.5% between periods (p=0.18). Group B (n=31) showed 79%/84% of compliance with sONS/edONS, with a difference of 5.6% (p=0.01). Compliance with edONS was non-inferior versus sONS. In both groups, mean BMI increased slightly with edONS; at the last visit, 9.5% in Group A and 12.9% in Group B were well-nourished.
Conclusion: Compliance with edONS is higher than sONS, achieving similar nutritional results with less wasted product.
References: None
Disclosure of Interest: None Declared
Keywords: Compliance, Energy-dense low volume oral nutrition supplement, Nutritional Status