Tolerability and efficacy of a semi-elemental formula to enterally fed patients in long-term care facilities

Abstract

Objectives: The semi-elemental formula EDPAC-01 was administered to tube-fed patients in a clinical setting. Herein, this study aimed to evaluate its tolerability and efficacy. Methods: After a 2-week baseline period, the ongoing nutrition formula of tube-fed patients in long-term care was switched to EDPAC-01, which was administered for 4 weeks following the same energy intake. Tolerability was evaluated in terms of gastrointestinal symptoms, bowel movement, number of days with fever, adverse events, and side effects. Efficacy was evaluated in terms of body weight, serum albumin level, and transthyretin, formerly called prealbumin, level. An exploratory analysis on several laboratory test values was also performed. Results: The study included 13 participants. No serious severe adverse events were reported. The blood glucose level increased in one participant as a side effect, but was mild in severity and did not require treatment. No significant change was observed in any investigated measurement other than the transthyretin level. The transthyretin level was below the reference range in the baseline period (19.32 ± 5.53 mg/dL), but increased on week 2 of the feeding period (21.49 ± 5.88 mg/dL) and eventually reached the reference range by week 4 of the feeding period (22.74 ± 8.75 mg/dL). The exploratory analysis revealed a significant increase in total lymphocyte count and a significant decrease in urea nitrogen, triglyceride, and alkaline phosphatase levels. Conclusions: The semi-elemental formula EDPAC-01 is safe to use and potentially improves the nutritional status in tube-fed patients in long-term care.