Oral Nutrition Supplementation in Hospitalized Patients

NCT02624752 | Completed

• 1 other identifier: SIG2014F-08B
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Keywords

Oral Nutrition Supplementation

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (2)

• Successful recruitment

  1 year

• Adherence to treatment

  90 days

Study Arms (2)

Standard of Care

NO INTERVENTION

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

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.

Dietary Supplement: Ensure

Interventions

Ensure DIETARY_SUPPLEMENT

Comparison of enhanced oral nutrition supplementation versus standard of care

Ensure

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

LHSC-University Hospital

London, Ontario, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Adam Rahman, MD, FRCPC

  St.Joseph's Health Care, London ON

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2015
• First Posted: December 8, 2015
• Study Start: October 5, 2016
• Primary Completion: August 22, 2018
• Study Completion: August 22, 2018
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)