Oral Nutrition Supplementation in Hospitalized Patients

NCT ID: NCT02624752

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-05
• Study Completion Date: 2018-08-22

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).

Conditions

Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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."

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Ensure

Intervention Type: DIETARY_SUPPLEMENT

Comparison of enhanced oral nutrition supplementation versus standard of care

Interventions

Ensure

Comparison of enhanced oral nutrition supplementation versus standard of care

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Rahman, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

St.Joseph's Health Care, London ON

Locations

LHSC-University Hospital

London, Ontario, Canada

Countries

Canada

Other Identifiers

SIG2014F-08B

Identifier Type: -

Identifier Source: org_study_id