Oral Nutrition Supplementation in Hospitalized Patients (NutriSup Oral)

Lawson Health Research Institute

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: Ensure

Study type: Interventional

Funder types: Other

Identifiers

NCT02624752

SIG2014F-08B

Details and patient eligibility

About

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.

Full 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).

Enrollment: 63 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Standard of Care

No Intervention group

Description:

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Ensure