Safety, acceptability and efficacy of a high-energy, fibre-containing oralnutritional supplement in malnourished patients: an observational study

We describe an open, uncontrolled, observational study to evaluate the safe ty, acceptability and efficacy of a high-energy, fibre-containing oral nutr itional supplement in patients who were either malnourished or who had expe rienced recent, acute weight loss and therefore needed a high-energy and/or fibre supplement. Assessments For assessment of safety and tolerance, occurrence of adverse e vents and oedema were to be documented during the 2-week trial and routine blood biochemistry was measured. The acceptability of the oral nutritional supplement was rated by the patients. In order to assess efficacy, patients ' body mass index (BMI) was calculated at baseline and following 2 weeks of nutritional intervention. Results A daily intake of 400-600 mL of a high-energy, fibre-containing liq uid nutritional supplement was well accepted and Ilo adverse events or prob lems with compliance were recorded. The high acceptability was underlined b y favourable ratings of taste, smell, texture and overall acceptability. Th e patients' median (interquartile range) BMI increased from 18 kg m(-2) (18 -19 kg m(-2)) to 20 kg m(-2) (19-20 kg m(-2)); this increase was highly sig nificant (P < 0.001). Conclusion We conclude that a high-energy, fibre-containing nutritional sup plement is safe, well tolerated and associated with improved nutritional st atus in malnourished patients.