Clinical Trial Summary
Although oral nutritional supplements (ONS) are known to be effective to treat malnutrition
in older persons, evidence from nursing home populations including demented residents is
rare, especially with regard to functionality and well-being. A known barrier for ONS use
among older persons is the volume that needs to be consumed, resulting in low compliance and
thus reduced effectiveness.
Thus, this study aimed to investigate the effects of a new, low volume, energy- and
nutrient-dense ONS on nutritional status, functionality and quality of life of nursing home
residents with malnutrition or at risk of malnutrition.
In 6 nursing homes in Nuremberg and Fuerth, Germany, a standardized screening was performed
to identify all residents with malnutrition or at risk of malnutrition who might possibly
benefit from nutritional intervention. All subjects with either a Mini Nutritional Assessment
(MNA®) score below 24 points, BMI ≤22 kg/m², a low food intake according to the nurses'
perception or weight loss of ≥5% in the last 3 or ≥10% in 6 months, respectively, were
invited to participate and asked for informed consent.
Eligible residents with informed consent were randomly assigned to the intervention group
(IG) which received two bottles of the ONS per day (250 mL, 600 kcal) in addition to usual
nutritional care or to the control group (CG) which received usual nutritional care only.
Assessment of nutritional parameters included body weight, BMI, arm- and calf-circumference
and Mini Nutritional Assessment (MNA). Cognitive status, depression, activities of daily
living, handgrip strength, gait speed and quality of life were examined using standardized
instruments and protocols. All measurements and tests were performed at baseline, after 12
and 24 weeks.
Compliance and tolerance were documented daily by nursing staff and regularly controlled by
the study team.
Statistical analysis was performed following the intention-to-treat (ITT) approach including
all residents originally assigned to either the IG or CG unless residents died during the
study. A sample size calculation was performed with body weight as the primary outcome
parameter (0.8 power to detect a significant difference p<0.05, two-sided) based on an
estimated mean body weight 55 kg and a mean difference in body weight between the groups
after 12 weeks of 1.5±2.2 kg comparable to results previously observed in this population. To
detect a significant difference between IG and CG, 35 subjects were needed for each group.
While sample size calculation aimed at ensuring adequate power to detect meaningful
differences, the actual statistical analysis was of exploratory nature.
