Nutrition Supplementation in Hospitalized Patients (NutriSup Oral)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Hospital Readmission Rate
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Standard of Care
Standard of care could include liberalized diet consisting of 3 meals and snacks served daily or the standard oral nutrition supplementation (ONS) routinely used in the hospital, as prescribed by the medical team.These routine meals and snacks are the "standard of care."
Ensure
Patients randomized to Enhanced Oral Nutritional Supplementation (ONS) will receive the standard of care hospital menu (3 meals and snacks per day) plus 2 cans of Ensure (or similar product) per day while in hospital and will continue 2 cans per day of Ensure when discharged home until they have been receiving the enhanced ONS for a total of 90 days.
Intervention: Ensure (Dietary Supplement)
Outcomes
Primary Outcomes
Hospital Readmission Rate
Time Frame: 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 Outcomes
- Successful recruitment(1 year)
- Adherence to treatment(90 days)