Effectiveness of “Entrasol Platinum” to improve the nutrition status in older adults

INTERVENTION: The proposed study will be conducted at four selected residential care facilities registered in the National Secretariat for Elders in the Colombo district. The participants will be permanent residents who have been staying for more than one year at the same elderly care homes. Two parallel study groups will be recruited for the treatment group and the control group from four elders’ homes. Elderly care homes with eligible participants will be listed down. From that list, we are going to randomize two elderly care homes for the treatment group and the other two for the control group. All adult men and women permanently living in the selected elders’ homes will be invited to take part in the research after a brief explanation of the study procedure. All participants will complete a structured assessment for eligibility by the trained research team. The whole residents’ home is the unit of randomization. At the baseline data collection, the institutional care personnel in the treatment group elders’ home will be instructed to provide each participant with a 200 mL serving of study product (Entrasol Platinum, Kalbe Lanka Pvt. Ltd) containing 12 g protein and 247 kcal per serving, in addition to their usual diet in a day for 12 weeks before bedtime. The institutional care personnel in the control group elders’ home will be instructed to provide each participant with 200 mL of water in addition to their usual diet a day for 12 weeks before bedtime. Care personnel will be advised to encourage residents to consume the amount offered but not to force feed the supplement or water. Further, they will be instructed to keep a daily record of the volume left from the daily serving and reasons for refusal throughout the trial. Furthermore, the participants and the care personne CONDITION: Older adults with malnutrition or at risk of malnutrition PRIMARY OUTCOME: The number of participants who achieved a 5% weight gain at the end of 12th week in intervention group and control group [12th week of introducing intervention]; INCLUSION CRITERIA: ‐ Aged above 60 years ‐ Residing in the selected elder’s homes for more than 1 year and planned to stay for another 6 months ‐ Malnourished or at risk of malnutrition (Mini Nutrition Assessment (MNA) score < 11) SECONDARY OUTCOME: i. Change in anthropometric parameters (Body weight, Body Mass Inde X(BMI), Mid Upper Arm Circumference (MUAC), Calf Circumference (CC) ; ii. Mean change in body composition (DXA lean body mass and fat mass, triceps skin fold thickness) ; iii. Mean change in biochemical parameters (Full Blood Count ; (FBC), High Sensitivity C‐reactive protein (HS‐CRP), serum albumin, total cholesterol, serum vitamin D3) ; iv. Mean change in functional capacity (hand grip strength, muscle strength and Activities of Daily Living (ADL) ; v. Mean change in frailty (Five fried model indicator) ; vi. Mean change in respiratory muscle strength [Peak expiratory flow rate (PEFR)] ; vii. Mean change in systolic and diastolic blood pressure ; viii. Mean change in energy and macro nutrient intake per day ; ix. Mean change in cognitive status [Montreal Cognitive Assessment (MoCA)] ; x. Mean change in physical activity level [International Physical Activity Questionnaire (IPAQ)‐ Short form] ; ; The measurements will be done in the intervention group and the control group [At baseline and 12th week. Body weight, MUAC, hand grip strength, and muscle strength will be measured at 4th week and 12th week.];