JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Effects of a low-volume, nutrient- and energy-dense oral nutritional supplement on nutritional and functional status: a randomized, controlled trial in nursing home residents.

OBJECTIVES: Although oral nutritional supplements (ONS) are known to be effective to treat malnutrition in the elderly, evidence from nursing home populations, including individuals with dementia, is rare, especially with regard to functionality and well-being. A known barrier for ONS use among elderly is the volume that needs to be consumed, resulting in low compliance and thus reduced effectiveness. This study aimed to investigate the effects of a low-volume, energy- and nutrient-dense ONS on nutritional status, functionality, and quality of life (QoL) of nursing home residents.

DESIGN: Randomized controlled intervention trial.

SETTING: Six nursing homes in Nürnberg and Fuerth, Germany.

PARTICIPANTS: Nursing home residents affected by malnutrition or at risk of malnutrition.

INTERVENTION: Random assignment to intervention (IG) and control group (CG), receiving 2 × 125 mL ONS (600 kcal, 24 g protein) per day and routine care, respectively, for 12 weeks.

MEASUREMENTS: Nutritional (weight, body mass index [BMI], upper arm and calf circumferences, MNA-SF) and functional parameters (handgrip strength, gait speed, depressive mood [GDS], cognition [MMSE], activities of daily living [Barthel ADL]) as well as QoL (QUALIDEM) were assessed at baseline (T1) and after 12 weeks (T2). ONS intake was registered daily and compliance calculated.

RESULTS: A total of 77 residents (87 ± 6 y, 91% female) completed the study; 78% had dementia (MMSE <17) and 55% were fully dependent (ADL ≤30). Median compliance was 73% (IQR 23.5%-86.5%) with median intake of 438 (141-519) kcal per day. Body weight, BMI, and arm and calf circumferences increased in the IG (n = 42) and did not change in the CG (n = 35). Changes of all nutritional parameters except MNA-SF significantly differed between groups in favor of the IG (P < .05). GDS, handgrip strength, and gait speed could not be assessed in 46%, 38%, and 49% of participants at T1 and/or T2, because of immobility and cognitive impairment. In residents able to perform the test at both times, functionality remained stable in IG and CG, except for ADLs, deteriorating in both groups. From 10 QoL categories, "positive self-perception" increased in IG (78 [33-100] to 83 [56-100]; P < .05) and tended to decrease in CG (100 [78-100] to 89 [56-100]; P = .06), "being busy" significantly dropped in CG (33 [0-50] to 0 [0-50]; P < .05).

CONCLUSION: Low-volume, nutrient- and energy-dense ONS were well accepted among elderly nursing home residents with high functional impairment and resulted in significant improvements of nutritional status and, thus, were effective to support treatment of malnutrition. Assessment of function was hampered by dementia and immobility, limiting the assessment of functionality, and highlighting the need for better tools for elderly with functional impairments. ONS may positively affect QoL but this requires further research.

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