Impact of specialized oral nutritional supplement on clinical, nutritional, and functional outcomes: A randomized, placebo-controlled trial in community-dwelling older adults at risk of malnutrition

Background & aims: The world's over-65 population is expanding rapidly, and the risk of malnutrition is prevalent in this population. Meeting nutritional needs is a recognized strategy to reduce and address multiple debilitating adverse health outcomes associated with malnutrition. The objective of this randomized, controlled trial was to determine the effects of oral nutritional supplement (ONS) containing beta-hydroxy-beta-methylbutyrate (HMB), along with dietary counseling, on health outcomes in community-dwelling older adults at risk of malnutrition. Methods: Strengthening Health In ELDerly through nutrition (SHIELD) studied adults aged > 65 years in Singapore who were recruited between August 2017 and March 2019. Participants were community ambulant and classified as medium or high risk for malnutrition using Malnutrition Universal Screening Tool (MUST). Participants (n = 811) were randomly assigned to one of two study treatments for 180 days: (i) two servings/day of ONS containing HMB with dietary counseling (n = 405) or (ii) two servings/day of placebo supplement with dietary counseling (n = 406). The primary composite outcome was 'survival without hospital (re)admission and with at least 5% weight gain to day 180'. Dietary intakes, nutritional and functional outcomes were measured at baseline, 30, 90, and 180 days. Results: A higher proportion in intervention group met the 180-day primary composite outcome compared to placebo (33.4% vs. 8.7%, P < 0.001), largely driven by body weight component (36.2% vs. 9.4%, P < 0.001). Survival and hospital (re)admission rate were not significantly different between the groups. Weight, BMI, and mid upper arm circumference were significantly greater in the intervention group compared to placebo during the study (all P < 0.001), and at days 30, 90, and 180 (all P < 0.05). The odds of having better nutritional status during the study were also significantly higher in the intervention group compared to placebo, as measured using MUST risk (OR = 2.68, P < 0.001) and vitamin Dstatus (OR = 4.23, P < 0.001). Intervention group had significantly higher energy, protein, fat, and carbohydrate intakes than the placebo group (all P < 0.017). Leg strength at day 90 was significantly greater for the intervention group than for the placebo group (LSM +/- SE: 12.85 +/- 0.22 vs. 12.17 +/- 0.22; P = 0.030). Handgrip strength for females was significantly higher at day 180 for the intervention group compared to placebo (LSM +/- SE: 14.18 +/- 0.17 vs. 13.70 +/- 0.17; P = 0.048). Within the low appendicular skeletal muscle mass index (ASMI) subgroup, the intervention group had significantly greater calf circumference at days 90 and 180 compared to placebo (both P < 0.0289). Conclusions: For community-dwelling older adults at risk of malnutrition, daily consumption of specialized ONS containing HMB and vitamin D for six months, along with dietary counseling, significantly improved nutritional and functional outcomes compared to placebo supplement with dietary counseling. Clinical trial registration: www.ClinicalTrials.gov NCT03245047. (c) 2020 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).