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Completed

NCT Number: NCT02624752

Oral Nutrition Supplementation in Hospitalized Patients

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LHSC-University Hospital

London, Ontario, N6A 5A5, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ensure

Dietary Supplement

Comparison of enhanced oral nutrition supplementation versus standard of care

Primary outcomes

  1. Hospital Readmission Rate

    Time frame: 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 outcomes

  1. Successful recruitment

    Time frame: 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).

  2. Adherence to treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Nutrition Supplementation in Hospitalized Patients (NutriSup Oral)

Acronym: NutriSup Oral

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 8, 2015
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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