Background: Long-term inadequate dietary consumption may increase the possibility of malnutrition, morbidity and mortality. Enteral nutrition (EN) is a beneficial support that could help to maintain nutritional status and gut function.
Aim: Our aim was to evaluate the effect of moderately high-protein enteral formula containing fibre on nutritional status, and its safety.
Method: A total of 23 tube-feeding-dependent adult patients were included in this multicentre, open-label study. The patients were fed with the study formula for 7-12 days or equal to the required nutritional support period, during which we performed physical examinations and assessed nutritional status. The primary endpoint was the statistical difference in nutritional status after the treatment, and the secondary outcome was the desirable safety profile.
Results: A significant improvement in cumulative energy balance after intervention was observed ( p = 0.008). However, the differences in nutritional status, weight and BMI before and after the intervention do not reach statistical significance. Retinol-binding protein (RBP), a marker for nutritional status, increased from baseline levels. Few cases of diarrhoea and constipation had been reported during the study as a safety concern.
Conclusions: This study investigated the efficacy and safety of an enteral feed formulation containing fibre. The patients were nourished with the studied formulation via tube feeding for a short period without serious adverse events. After the intervention, the significant increase in cumulative energy balance was observed. However, an extended period of the intervention may be required to attain the significance in other indicators for nutritional status.
Keywords: High-protein formulas; enteral nutrition; open-label study; retinol-binding protein; tube-feeding.