Effect of low volume vs. standard oral nutrition supplements on nutrition intakes and supplement wastage in hospital: a pilot comparative effectiveness trial

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2023
INTERVENTION: Oral nutrition supplements ‐ Fortisip Compact Protein This is a pilot comparative effectiveness trial of low volume oral nutrition supplements (Fortisip Compact Protein, 2 X125mL/day) vs standard oral nutrition supplements (Ensure Plus, 2 X200mL/day). The dose of the intervention product (Fortisip Compact Protein) is 125mL twice daily. The duration of its administration is 3‐4 days (depending on hospital inpatients' length of stay). The mode is oral solution (milky‐type drink). A research assistant will monitor adherence by collecting and weighing supplement drink containers after patient consumption. The intervention supplement differs to the standard supplement by volume (125mL vs 200mL) and protein content (18g per serve vs 12.5g per serve). Energy content is the same for both products (1263kJ per serve). CONDITION: Diet and Nutrition ‐ Other diet and nutrition disorders Malnutrition; ; Malnutrition PRIMARY OUTCOME: Standard deviation (SD) of the intended primary outcome for a definitive trial (% grams wastage of oral nutrition supplements) to estimate sample size required for a definitive trial. To assess this, supplement bottles will be collected by researchers and weighed using digital scales to calculate the grams consumed / grams wasted.[Supplement wastage will be measured twice daily (after patient consumption of each prescribed supplement ‐ 2 per day) by weighing the supplement container. This will occur for three days post‐randomisation.] SECONDARY OUTCOME: Oral nutrition supplement wastage (% grams wasted) between groups will be determined by a researcher collecting supplement bottles and weighing them using digital scales to calculate the grams consumed vs grams wasted.[Measured daily (by weighing oral nutrition supplement containers) for 3 days post‐randomisation] Patient energy (kJ) intake of oral nutrition supplements between groups. This will be calculated by weighing supplement containers after consumption using digital scales and calculating energy consumed based on the product's nutritional information panel.[Daily for 3 days post‐randomisation (calculated from data collected for secondary outcome 1)] Patient protein (grams) intake of oral nutrition supplements between groups. This will be calculated by weighing supplement containers after consumption using digital scales and calculating protein consumed based on the product's nutritional information panel.[Daily for 3 days post‐randomisation (calculated from data collected for secondary outcome 1)] INCLUSION CRITERIA: 1. Able to provide informed consent (aged 18 years or older, cognitively intact, able to communicate in English); 2. Able to consume food and thin fluids orally; 3. Expected to stay in hospital for at least 2 days from recruitment; and 4. Inadequate oral intake requiring 2 Xstandard oral nutrition supplements/ day, as determined by ward dietitian.
Epistemonikos ID: 851c27f0966ae2bd052bd72a024eb3ca051e3d02
First added on: Feb 20, 2024