Malnutrition
Conditions
Keywords
Oral Nutrition Supplementation
Brief summary
The purpose of this pilot study is to determine the effect of 3 months use of enhanced Oral Nutritional Supplement (ONS) on physical function and functional performance in malnourished elderly patients.
Detailed description
The purpose of this pilot study is to determine the effect of 3 months use of enhanced Oral Nutritional Supplementation (ONS) on muscle accretion and functional performance in malnourished elderly patients. The objectives of this study are to determine feasibility of recruitment, adherence to intervention and retention of the sample, as well as the capacity of subjects to complete functional and muscle mass measures for a planned multi-centre Randomized Controlled Trial (RCT).
Interventions
DIETARY_SUPPLEMENTEnsure
Comparison of enhanced oral nutrition supplementation versus standard of care
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomized via REDCap (Research Electronic Data Capture), a secure, centralized web-based randomization module to: 1. Ensure Enlive (enhanced ONS) + standard menu; or 2. Standard of care (including standard menu and possibly ONS) Patients randomized will receive standard menu or standard menu plus enhanced oral nutritional supplements (ONS). Patients randomized to enhanced ONS, will receive one bottle of ONS Abbott Ensure Enlive (235 mL, 350 calories), or similar product, two times daily for 90 days.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* admitted to a general medical ward and recruited within 48 hours * over the age of 65 years * malnourished (subjective global assessment categories B or C patients)
Exclusion criteria
* have an allergy or intolerance to any component of the oral supplement * are designated palliative care * are currently suffering from refeeding syndrome * have a pre-existing medical condition that prevents oral intake of full fluids, * have an expected length of stay of less than 48 hours from the time of assessment * have suspected ischemic stroke as cause for admission * reside in a residential care home * are unable to walk prior to current illness. * are pregnant/breastfeeding * have a current diagnosis of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Readmission Rate | 90 days | The number of participants who are re-admitted to hospital within 90 days of randomization. This healthcare utilization outcome will be used to determine the cost-benefit of enhanced Oral Nutritional Supplementation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful recruitment | 1 year | We will view this pilot study as demonstrating feasibility of recruitment if we are able to recruit 60 patients over twelve months (approximately 5 patients per month for the overall study). |
| Adherence to treatment | 90 days | Adherence to the study treatments will be defined as ≥85% of patients were given the allocated intervention. Preliminary estimates of non-administration of the trial intervention are needed, along with strategies that maximize exposure to the intervention. |
Countries
Canada
Outcome results
None listed