None listed
Conditions
Brief summary
The purpose of this pilot comparative effectiveness trial is to estimate the standard deviation of the primary outcome (% grams wastage of oral nutrition supplements (ONS) among hospital patients) for a larger definitive trial.
Interventions
Oral nutrition supplements - Fortisip Compact Protein
This is a pilot comparative effectiveness trial of low volume oral nutrition supplements (Fortisip Compact Protein, 2 x 125mL/day) vs standard oral nutrition supplements (Ensure Plus, 2 x 200mL/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 ass
Oral nutrition supplements - Fortisip Compact Protein This is a pilot comparative effectiveness trial of low volume oral nutrition supplements (Fortisip Compact Protein, 2 x 125mL/day) vs standard oral nutrition supplements (Ensure Plus, 2 x 200mL/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).
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
Outcome results
None listed