Results of High-Protein, High-Calorie Oral Nutritional Supplementation in Malnourished Older People in Nursing Homes: An Observational, Multicenter, Prospective, Pragmatic Study (PROT-e-GER).

Objectives: To assess if the impact of oral nutritional supplements (ONS) on nutritional and functional status in malnourished older persons living in nursing homes shown by clinical trials are also found outside a trial setting.
Design: Observational, multicenter, prospective, pragmatic study.
Setting and Participants: This study was carried out in 38 nursing homes throughout Spain. Nursing home physicians recruited consecutive residents, older than 65 years, with a diagnosis of malnutrition, when a clinical decision to start ONS had been taken after unsuccessful initial management with dietary interventions.
Intervention: The participants received daily 2 bottles of an energy-rich, high-protein commercial ONS for 3 months.
Measures: Primary outcomes were changes in nutritional status [body weight, body mass index (BMI), and Mini Nutritional Assessment-Short Form (MNA-SF)]; secondary outcomes were functional changes [Functional Ambulation Classification, Barthel index, handgrip strength, and Short Physical Performance Battery (SPPB)], as well as safety and adherence after 12 weeks of follow-up.
Results: A total of 282 residents (median age 86 years, 67% women) were included, and 244 (86.5%) completed the follow-up. At baseline, 77.3% of the participants were malnourished (BMI 19.7 kg/m ² , interquartile range 18.3-21.8). After 12 weeks of follow-up, participants experienced significant increases in body weight (2.6 ± 3.1 kg, 5.2 ± 5.9%), BMI (1.0 ± 1.2 kg/m ² ) and MNA-SF (4.0 ± 2.5 points). There were also significant improvements in functional status measured by the Barthel index, handgrip strength, SPPB, and gait speed. Good adherence was registered in 94.6% of the participants. No relevant side effects were found.
Conclusions and Implications: Improvements in nutritional and functional status can be found when using a high-protein, high-calorie ONS in older undernourished people living in nursing homes.
(Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)