Effects of Oral Nutritional Supplements in Nursing Home Residents
Primary Purpose
Nursing Home Residents, Malnutrition or Risk of Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Oral nutritional supplement
Sponsored by
About this trial
This is an interventional prevention trial for Nursing Home Residents
Eligibility Criteria
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
Sites / Locations
- Institute for Biomedicine of Aging, Universität Erlangen-Nürnberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Oral nutritional supplement
Control
Arm Description
2 * 125 mL low volume, energy and nutrient dense ONS per day (2 * 300 kcal) in addition to usual nutritional care
Usual nutritional care
Outcomes
Primary Outcome Measures
Body weight
Secondary Outcome Measures
Full Information
NCT ID
NCT01859416
First Posted
May 17, 2013
Last Updated
May 17, 2013
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Pfrimmer Nutricia GmbH, Erlangen , Germany
1. Study Identification
Unique Protocol Identification Number
NCT01859416
Brief Title
Effects of Oral Nutritional Supplements in Nursing Home Residents
Official Title
Effects of Oral Nutritional Supplements in Nursing Home Residents
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Pfrimmer Nutricia GmbH, Erlangen , Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nursing Home Residents, Malnutrition or Risk of Malnutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral nutritional supplement
Arm Type
Experimental
Arm Description
2 * 125 mL low volume, energy and nutrient dense ONS per day (2 * 300 kcal) in addition to usual nutritional care
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual nutritional care
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral nutritional supplement
Primary Outcome Measure Information:
Title
Body weight
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institute for Biomedicine of Aging, Universität Erlangen-Nürnberg
City
Nürnberg
ZIP/Postal Code
90408
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Effects of Oral Nutritional Supplements in Nursing Home Residents
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