The effect of 12-weeks Nutritional supplementation on Nutritional Intake and Status among Indonesian Older Outpatients with Malnutrition Risk, the Prolansia study: a randomized controlled trial

Background
Standard care for older outpatients who are at risk of malnutrition in Indonesia is still based on the 2017’s recommendations of the Indonesian Geriatrics Society. and does not provide nutritional supplementation as recommended by ESPEN guidelines 2019/2022.

Objective
We compared the effects of supplementation of at least 400 kcal/day including 30 g or more of protein/day as nutritional intervention as recommended by the ESPEN Guideline with standard care recommended by The Indonesian Geriatrics Society, in Indonesian older adults who are at risk of malnutrition.

Methods
Older outpatients (60 years or older) at a geriatric clinic of the national referral hospital with or at risk of malnutrition were recruited. They were randomly allocated to 12 weeks of supplementation with a nutrient dense drink twice a day on top of standard care compared to standard care only. We assessed energy and nutrient intake at baseline, after 6 and 12 weeks and nutritional status, physical performance, and vitamin D level at baseline and after 12 weeks. Data analyses were blinded.

Results
As many as 105 older outpatients (65 % women, mean age 72.5 years, SD = 6.3) were randomly assigned to the intervention (n = 54) and the control group (n = 51). One hundred and one participants completed the intervention, with an average compliance of 90% to the nutritional intervention. Nutritional supplementation significantly increased daily intake of energy, protein, total fat, vitamin D, vitamin B12, calcium (all p values <0.001) and carbohydrate (p = 0.002) in both men and women after 12 weeks. The intervention group showed an increase in vitamin D levels (p = 0.008). Furthermore, the intervention group gained more body weight than the control group did (p = 0.021)), especially in women (p = 0.017). Women in the intervention group also showed more increase in skeletal muscle mass (p = 0.023). Improvements in muscle strength and physical performance were not statistically different between the groups. No significant adverse effects were noted.

Conclusion
Nutritional supplementation is effective in improving nutritional intake and status among Indonesian outpatients with malnutrition risk, which has the potential to support and enhance the standard of care.