A prospective, observational study of the use of a high-calorie, high-protein tube feeding formula with slow-release carbohydrates and monounsaturated fatty acids in a malnourished population with diabetes

Abstract

<h2>Summary</h2><h3>Background and aims</h3> Diabetes mellitus is associated with an increased risk of malnutrition. Reduced dietary intake is central to the development of malnutrition. Therefore, increasing nutritional intake may be one of the most effective approaches for treating malnutrition in diabetes mellitus. The aim of this study was to evaluate the effect of a high calorie, high protein tube feeding diabetes-specific formula used under standard of care on weight change, nutritional status, glycaemic control, quality of life and functionality in malnourished patients with diabetes mellitus after 12 weeks. <h3>Methods</h3> This was a prospective, non-interventional study conducted at hospital care settings in Spain, enrolling malnourished patients with diabetes, who had been prescribed a high-calorie, high-protein tube feeding formula with slow-release carbohydrates and monounsaturated fatty acids (MUFA) by their health care professional per standard of care as a sole source of nutrition for 12 weeks. <h3>Results</h3> Forty-nine patients from 8 sites were enrolled, and 36 completed the study. The mean age was 75.3 ± 12.0 years and 67.3% were male (33/49). At V1 and V2, 87.5% (35/40) and 93.1% (27/36) of the patients, respectively, either increased or maintained their weight (<1% weight loss) from their baseline weight. At baseline, 100.0% (49/49) of the patients were at high risk of malnutrition according to Malnutrition Universal Screening Tool (MUST) score and 87.8 % were malnourished per Subjective Global Assessment (SGA). At week 12, 77.9% of patients were well-nourished per MUST and 72.2% (26/36) of the patients were well nourished per SGA (<i>P</i> < 0.0001). With regards to metabolic glycaemia control, the mean HbA1c % decreased from baseline to weeks 6 and 12, -0.4 ± 0.7 (<i>P</i> = 0.0073) and -0.3 ± 1.2 (<i>P</i> = 0.2702), respectively. Regarding quality of life and functionality, the mean total score for Barthel Index of activities of daily living improved from 8.8 at baseline to 9.6 at week 12 (<i>P</i> = 0.0512); and the mean EQ-5D-5L Health State Score significantly improved at week 12 (<i>P</i> = 0.0002). No adverse events related to the study product were reported. <h3>Conclusions</h3> Malnourished patients with diabetes, treated with a high-calorie, high-protein diabetes-specific tube feeding formula with slow-release carbohydrates and MUFA as a sole source of nutrition for 12 weeks, improved their nutritional parameters, quality of life and functionality while reducing HbA1c at week 6, with no safety concerns.