Discussion
malnutrition
MALNOURISHED, RECRUITMENT, MALNUTRITION
This study provides a protocol for a RCT to investigate the impact of ONS on anthropometric parameters, body composition, biochemical parameters, functional capacity, frailty, cognitive status, and physical activity level of older adults with malnutrition or at-risk of malnutrition. This may ultimately increase the capacity for independent survival and quality of life of malnourished older adults.To date, several studies have investigated the effect of ONS on anthropometric parameters, muscle strength, and functional status [The study faces several challenges including the high number of tests and the potential increased risk of dropouts. Therefore, participants will be carefully informed about the various tests before and throughout the study to reduce the possibility of dropouts. Further challenges may occur in recruiting participants and their subsequent compliance with supplementation. In order to limit the impact of these challenges, recruitment will be performed by health care personnel, physiotherapists, and nutritionists and caregivers will be thoroughly instructed about the preparation methods of the ONS and advised to monitor carefully the participants’ consumption of the ONS. Additional challenges may occur in transporting participants to the Nawaloka Hospitals Colombo (about 10–20 km away from the elderly care institution) for DXA scanning and blood investigations. Because of the frailty of many participants, special care will be needed during this time.Finally, a major limitation of the trial may be contamination bias when participants in the control group inadvertently receive the ONS. Participants will be educated as much as possible against contamination and clear information about the purposes of the trial will be provided with supplements provided to caregivers in person. The absence of blinding may also introduce performance bias; however, blinding either participants or investigators is not possible due to the nature of the intervention.