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

Not Applicable

• Conditions: Malnutrition; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12623000503628
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-17
• Last Update Posted: 22 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

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 x standard oral nutrition supplements/ day, as determined by ward dietitian.

Exclusion Criteria

1. Prior participation in the study; 2. Dying/palliative; and 3. Contraindications for oral nutrition supplements or study participation, determined by ward dietitian and nurse unit manager or delegate (e.g. eating disorder, uncontrolled diabetes, allergy to ONS ingredients).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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)]