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Randomized Clinical Trial of Nutritional Supplementation Shows Little Effect on Functional Status among Free-Living Frail Elderly^1,2,3,

School of Dietetics and Human Nutrition and the Department of Epidemiology and Biostatistics, McGill University, Montreal, PQ, Canada ^* Research Centre in Gerontology and Geriatrics, Faculty of Medicine, University of Sherbrooke, Sherbrooke, PQ, Canada J1H 4C4

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). Frall 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.

KEY WORDS: • nutritional supplementation • functional status • body weight • elderly • humans

¹ Funded by the National Health Research and Development Program (NHRDP), Health Canada (grant no. 6605-3833-62), Hélène Payette is a National Health Research Scholar of the NHRDP, Health Canada.

² Presented at the 35th Annual Meeting of The American Society for Clinical Nutrition & San Diego, California, May 4–6, 1995 [Payette, H., Gray-Donald, K. & Boutier, V. (1995) The Impact of Nutritional Supplementation on Functional Status of Free-Living Frail Elderly. 35th Annual Meeting of the ASCN, San Diego, CA, Abs. no. 17]

³ The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked "advertisement" in accordance with 18 USC section 1734 solely to indicate this fact.

⁴ To whom correspondence and reprint requests should be addressed.

Manuscript received 8 May 1995. Revision accepted 14 August 1995.