Effects of Oral Nutritional Supplements in Nursing Home Residents

May 7, 2024 updated by: University of Erlangen-Nürnberg Medical School

Although oral nutritional supplements (ONS) are known to be effective to treat malnutrition in older persons, evidence from nursing home populations including demented residents is rare, especially with regard to functionality and well-being. A known barrier for ONS use among older persons is the volume that needs to be consumed, resulting in low compliance and thus reduced effectiveness.

Thus, this study aimed to investigate the effects of a new, low volume, energy- and nutrient-dense ONS on nutritional status, functionality and quality of life of nursing home residents with malnutrition or at risk of malnutrition.

In 6 nursing homes in Nuremberg and Fuerth, Germany, a standardized screening was performed to identify all residents with malnutrition or at risk of malnutrition who might possibly benefit from nutritional intervention. All subjects with either a Mini Nutritional Assessment (MNA®) score below 24 points, BMI ≤22 kg/m², a low food intake according to the nurses' perception or weight loss of ≥5% in the last 3 or ≥10% in 6 months, respectively, were invited to participate and asked for informed consent.

Eligible residents with informed consent were randomly assigned to the intervention group (IG) which received two bottles of the ONS per day (250 mL, 600 kcal) in addition to usual nutritional care or to the control group (CG) which received usual nutritional care only.

Assessment of nutritional parameters included body weight, BMI, arm- and calf-circumference and Mini Nutritional Assessment (MNA). Cognitive status, depression, activities of daily living, handgrip strength, gait speed and quality of life were examined using standardized instruments and protocols. All measurements and tests were performed at baseline, after 12 and 24 weeks.

Compliance and tolerance were documented daily by nursing staff and regularly controlled by the study team.

Statistical analysis was performed following the intention-to-treat (ITT) approach including all residents originally assigned to either the IG or CG unless residents died during the study. A sample size calculation was performed with body weight as the primary outcome parameter (0.8 power to detect a significant difference p<0.05, two-sided) based on an estimated mean body weight 55 kg and a mean difference in body weight between the groups after 12 weeks of 1.5±2.2 kg comparable to results previously observed in this population. To detect a significant difference between IG and CG, 35 subjects were needed for each group. While sample size calculation aimed at ensuring adequate power to detect meaningful differences, the actual statistical analysis was of exploratory nature.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Nürnberg, Germany, 90408
        • Institute for Biomedicine of Aging, Universität Erlangen-Nürnberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • nursing home resident
  • Mini Nutritional Assessment (MNA®) score <24 points or BMI ≤22 kg/m² or low food intake according to the nurses' perception or weight loss of ≥5% in the last 3 or ≥10% in 6 months
  • informed consent

Exclusion Criteria:

  • anticipated hospital stay (>1 week)
  • renal disease (dialysis)
  • end-stage disease
  • intolerance to ONS according to previous attempts to administer these

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral nutritional supplement
2 * 125 mL low volume, energy and nutrient dense ONS per day (2 * 300 kcal) in addition to usual nutritional care
Dietary supplement: Oral nutritional supplement
No Intervention: Control
Usual nutritional care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

Pfrimmer Nutricia GmbH, Erlangen , Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

May 17, 2013

First Submitted That Met QC Criteria

May 17, 2013

First Posted (Estimated)

May 21, 2013

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBA-2013(1)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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