Oral Nutrition Supplementation in Hospitalized Patients

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's63 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malnutrition

Interventions

EnsureDIETARY_SUPPLEMENT

Comparison of enhanced oral nutrition supplementation versus standard of care

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

LHSC-University Hospital

London, Ontario, Canada

Outcomes

Primary Outcomes

Hospital Readmission Rate

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.

Time frame: 90 days

Secondary Outcomes

Successful recruitment

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).

Time frame: 1 year

Adherence to treatment

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.

Time frame: 90 days

Data from ClinicalTrials.gov

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