Randomized clinical trial of nutritional supplementation shows little effect on functional status among free-living...

Nutritional deficiencies, frequently observed among the frail elderly, have been associated with increased morbidity and dependency. A randomized clinical trial was conducted to assess the impact of nutritional supplementation on the functional status of frail elderly living at home. Subjects (n = 50) over age 60 (mean 78 y) requiring community services and at elevated risk of undernutrition (excessive weight loss or body mass index < 24 kg/m2) were randomized to a high energy nutrient dense supplement provided by a dietitian or a control group receiving visits only. Outcome measures, including changes in handgrip strength, general well-being score, perception of health and number of falls, were measured by an investigator who was unaware of treatment assignment. After 12 wk, weight gain was greater in the supplemented group (2.1 +/- 2.3 vs. 0.6 +/- 1.6 kg; P < 0.01). Despite adequate statistical power, no functional measures differed except that the number of falls was lower among treated subjects vs. controls (0% vs. 21%; P = 0.05). Frail elderly can gain weight through oral supplementation, indicating the reversibility of weight loss in this group, but changes in functional status indicators may require a longer period of supplementation.