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).

Abstract

OBJECTIVES\nTo 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.\n\n\nDESIGN\nObservational, multicenter, prospective, pragmatic study.\n\n\nSETTING AND PARTICIPANTS\nThis study was carried out in 38 nursing homes throughout Spain. Nursing home physicians recruited consecutive residents, older than 65\xa0years, with a diagnosis of malnutrition, when a clinical decision to start ONS had been taken after unsuccessful initial management with dietary interventions.\n\n\nINTERVENTION\nThe participants received daily 2 bottles of an energy-rich, high-protein commercial ONS for 3\xa0months.\n\n\nMEASURES\nPrimary 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\xa0weeks of follow-up.\n\n\nRESULTS\nA total of 282 residents (median age 86\xa0years, 67% women) were included, and 244 (86.5%) completed the follow-up. At baseline, 77.3% of the participants were malnourished (BMI 19.7\xa0kg/m2, interquartile range 18.3-21.8). After 12\xa0weeks of follow-up, participants experienced significant increases in body weight (2.6\xa0±\xa03.1\xa0kg, 5.2 ± 5.9%), BMI (1.0\xa0±\xa01.2\xa0kg/m2) and MNA-SF (4.0\xa0±\xa02.5 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.\n\n\nCONCLUSIONS AND IMPLICATIONS\nImprovements in nutritional and functional status can be found when using a high-protein, high-calorie ONS in older undernourished people living in nursing homes.