Effectiveness of an oral diabetes-specific supplement on nutritional status, metabolic control, quality or life, and functional status in elderly patients. A multicentre study.

BACKGROUND & AIMS: The purpose of this study was to assess nutritional status, quality of life (QoL) and function in malnourished or at risk for malnutrition community-dwelling (CD) and nursing home-dwelling (NHD) elderly patients with type 2 diabetes mellitus (DM2), receiving treatment with a diabetes-specific oral nutritional supplement (DSONS). METHODS: A prospective, multicentre, observational study was conducted. A DSONS (high-calorie, high-protein, with slow-digestible carbohydrate and high monounsaturated fatty acid - MUFA-content - Glucerna® 1.5 Cal) had been prescribed the week before inclusion. The following assessments were undertaken at baseline (BL), at week 6 (V1) and at month 3 (FV): body mass index (BMI), glycosylated haemoglobin (HbA1c), nutritional status (Mini Nutritional Assessment - MNA), QoL (EQ-5D questionnaire), and functional status (Katz Index - KI of Independence in Activities of Daily Living). The data were reported in the overall population (OP) and in the CD and NHD groups. RESULTS: A total of 402 patients aged 80.8 ± 8.5 years were evaluable (44.5% men), including 61.7% CD and 38.3% NHD. BMI (kg/m2) increased in the OP from 22.0 ± 3.5 at BL to 22.5 ± 3.6 at V1 (p < 0.001) and 23.0 ± 3.7 at the FV (p < 0.001). BMI also increased in the CD group (p < 0.001) and in the NHD group (p < 0.001). HbA1c decreased in the OP from 7.3 ± 1.1% at BL to 7.2 ± 1.0% at V1 and 7.0 ± 0.9% at the FV (p < 0.001), in both the CD (p < 0.001) and the NHD groups (p = 0.020). The mean overall MNA score increased in the OP from 13.1 ± 4.8 at BL to 17.0 ± 4.7 at V1 and 18.6 ± 5.1 at the FV (p < 0.001). The mean overall MNA score also increased in the CD (p < 0.001) and the NHD groups (p < 0.001). The mean overall EQ-5D score improved in the OP from 46.0 ± 18.0 at BL to 54.8 ± 17.5 at V1 and 59.7 ± 18.8 at the FV (p < 0.001). The mean overall EQ-5D score also improved in the CD (p < 0.001) and the NHD groups (p < 0.001). Gastrointestinal adverse events were seen in only 2% of patients. Treatment compliance was 94.4%. CONCLUSIONS: In this study, conducted in routine, multicentre, clinical settings, the treatment with the high-calorie, high-protein, with slow-digestible carbohydrate, and high MUFA content DSNOS - Glucerna® 1.5 Cal-, was associated with improvements in HbA1c, nutritional status, BMI and QoL following 6 weeks and 3 months of treatment in both institutionalised and non-institutionalised elderly patients with diabetes who were malnourished or at risk for malnutrition. A slight improvement in functional status was also observed at 12 weeks. As this is an observational effectiveness study, a randomized controlled trial would be necessary to establish a causal relationship between the DSNOS and the described events.

The effects of a high-protein, high-calorie, fiber- and fructo-oligosaccharide-enriched enteral formula on nutritional status, bowel habits and tolerance: Safety and Effectiveness of Enteral Nutrition in elderly Spanish patients (SENS Study) / Fórmula enteral hiperproteica e hipercalórica, enriquecida en fibra y en fructooligosacáridos: efecto sobre el estado nutricional, hábitos gastrointestinales y tolerancia en pacientes ancianos españoles (Estudio SENS)

Background: Enteral nutrition (EN) is an effective nutritional intervention for patients at risk of malnutrition or malnourished. However, complications such as gastrointestinal intolerance, hyperglycemia or refeeding syndrome can be triggered by EN. Aim: To investigate the effects of a tube feeding formula (TFF) on patients' nutritional status, biochemical status, bowel habits and safety. Methodology: Observational, prospective and multicenter study. Patients ≥ 18 years, undernourished or at nutritional risk, who were prescribed a high-calorie, high-protein, fiber-fortified TFF were included. Patients were evaluated over a period of eight weeks (baseline [V1], four weeks [V2] and eight weeks [V3]). Results: A statistically significant increase in weight (1.5 kg), body mass index (0.6 kg/m2) and nutritional intake (59.7 kcal/day) was observed between V1 and V2. Between V1 and V3, there was a statistically significant decrease in the percentage of individuals with abnormal biochemical markers for glucose, potassium, total protein and albumin. The number of patients’ bowel movements remained stable throughout the study with a mean of 1.1 daily bowel movements. Conclusion: The TFF was safe and well tolerated, improving patients’ nutritional status without altering patients' bowel habits (AU)

Introducción: la nutrición enteral es una intervención efectiva para pacientes desnutridos o en riesgo de sufrir desnutrición. Sin embargo, puede desencadenar complicaciones como intolerancia gastrointestinal, hiperglicemia o síndrome de realimentación. Objetivo: investigar los efectos de una fórmula de nutrición enteral por sonda en el estado nutricional y bioquímico, hábitos gastrointestinales y seguridad de los pacientes. Metodología: estudio observacional, prospectivo y multicéntrico. Se incluyeron pacientes ≥ 18 años, desnutridos o en riesgo de desnutrición, tributarios de recibir una fórmula de nutrición enteral hipercalórica, hiperproteica, y rica en fibra y fructooligosacáridos. Los pacientes fueron evaluados durante 8 semanas en 3 visitas (V1, inicial; V2, 4 semanas; V3, 8 semanas). Resultados: entre V1 y V2 se observó un incremento estadísticamente significativo en peso (1,5 kg), índice de masa corporal (0,6 kg/m2) e ingesta calórica (59,7 kcal/día). Entre V1 y V3, existió un descenso en el porcentaje de pacientes con valores anormales de glucosa, potasio, proteína total y albúmina. Los hábitos intestinales se mantuvieron estables durante el estudio (1,1 deposiciones diarias de media). Conclusión: la fórmula fue segura, tolerada, y mejoró el estado nutricional del paciente sin alterar los hábitos intestinales (AU)