RESUMO
BACKGROUND: Malnutrition often manifests as a body weight (BW) reduction and unhealthy alteration in body composition. The present study aimed to assess the efficacy of an oral nutritional supplement (ONS) in improving BW and body composition among older adults with malnutrition. METHODS: An open-label randomised controlled, parallel-group study was conducted among older adults (age ≥ 60 years) with/at risk of malnutrition (mini nutrition assessment-short form score ≤ 11). In total, 50 participants were randomly assigned to the intervention (IG) and control (CG) groups (1:1 ratio). The IG received the ONS (57 g/day; 247 kcal/serving, 12 g protein) before bedtime for 12 weeks. CG received 200 mL of water. Anthropometric measurements, body composition analysis, and dietary and physical activity assessments were performed at the beginning and end of the study. RESULTS: Forty-two participants (IG: 20, CG: 22) completed the study. The mean ± SD ages of the IG and CG were 75.4 ± 6.1 and 74.8 ± 5.2 years, respectively (p = 0.73). The IG had a significant increase in BW (+1.68 ± 1.16 vs. -0.46 ± 0.95 kg; p < 0.001), lean mass (+1.23 ± 0.93 vs. -0.45 ± 0.90 kg; p < 0.001) and fat mass (+0.54 ± 0.82 vs. -0.06 ± 0.82 kg; p = 0.02) compared to the CG. One-quarter of the IG (n = 5) achieved a weight gain > 5% of BW, whereas none in the CG did (p = 0.01). No significant changes were observed in bone mineral content in either group. CONCLUSIONS: For malnourished older adults, supplementing with an ONS, along with regular food intake, significantly increased BW, lean mass and fat mass compared to control following the regular diet without supplementation.
RESUMO
BACKGROUND: The global aging population is expanding rapidly and many individuals have a particularly higher risk of malnutrition. Malnutrition can lead to impaired body function, morbidity, and mortality. Meeting nutritional requirements is a key strategy to minimize multiple debilitating adverse outcomes associated with malnutrition in the elderly. Oral nutritional supplements (ONS) have been widely used as a dietary intervention for malnutrition in older adults. These supplements provide additional nutrients and calories to support nutritional requirements and have been shown to improve nutritional status, physical function, and quality of life in malnourished older adults. METHODS: This is an open-label, randomized controlled, parallel-group study including 50 institutionalized older adults (aged > 60 years) with malnutrition or at risk of malnutrition, living in a selected elderly care institution in Colombo, Sri Lanka. The aim is to assess improvement in healthy body weight gain and body composition in older adults with malnutrition at risk of malnutrition by using an ONS. Older adults will be screened for malnutrition using the Mini Nutrition Assessment (MNA) tool and eligible participants randomized using the simple random sampling technique to intervention and control groups (1:1 allocation ratio). The intervention group will consume 200 mL of ONS before bed continuously for 12 weeks. The primary outcome is the percentage who achieved at least 5% weight gain in the intervention group compared to the control group. Nutritional status (anthropometric, biochemical, clinical, and dietary), body composition (dual-energy X-ray absorptiometry), frailty, functional capacity (hand grip strength, knee extension, and Barthel index) cognitive status (Montreal Cognitive Assessment), and physical activity will be assessed as secondary outcomes at baseline and at the end of the 12-week intervention. Some measurements (anthropometry, dietary, and functional assessments) will also be performed at the end of the 4th week. Data will be analyzed using SPSS V-23. DISCUSSION: This study will determine whether the use of an ONS is effective in promoting healthy weight gain in older adults with malnutrition or at risk of malnutrition. In addition, investigating the impact of an ONS on multiple outcomes via clinical, nutritional, functional, and cognitive function will provide a more comprehensive understanding of the potential benefits of these supplements. TRIAL REGISTRATION: Sri Lanka Clinical Trail Registry SLCTR/2022/021. Oct. 6, 2022.
