Oral Nutrition Supplementation in Hospitalized Patients

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Ensure

• Registration Number: NCT02624752
• Lead Sponsor: Lawson Health Research Institute

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-12-04
• Study First Submitted QC: 2015-12-04
• Study First Posted: 2015-12-08
• Study Start: 2016-10-05
• Primary Completion: 2018-08-22
• Study Completion: 2018-08-22
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ensure	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

LHSC-University Hospital; 🇨🇦 London, Ontario, Canada