Medical and Health Economic Benefit of Oral Nutritional Supplements (ONS) in Ambulant Patients
ECONONS
1 other identifier
interventional
160
1 country
1
Brief Summary
The aim of this study is to assess the benefit of a 3-month intervention with oral nutritional supplements (ONS) in older ambulant patients with reference to functional limitations and quality of life as well as the consumption of health care resources.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 14, 2015
CompletedFirst Posted
Study publicly available on registry
June 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedFebruary 4, 2019
January 1, 2019
3.3 years
January 14, 2015
January 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in functional limitations and activities of daily living (single validated questionnaire)
Baseline (hospital discharge) and after 3 months
Secondary Outcomes (9)
Functional Parameter: timed up & go
Baseline (hospital discharge) and after 3 months
Functional Parameter: stair climbing
Baseline (hospital discharge) and after 3 months
Functional Parameter: lung function
Baseline (hospital discharge) and after 3 months
Functional Parameter: gait analysis
Baseline (hospital discharge) and after 3 months
Strength Parameter: Hand grip strength
Baseline (hospital discharge) and after 3 months
- +4 more secondary outcomes
Study Arms (2)
Intervention Group
EXPERIMENTALNutrition counselling and balanced, energy dense, moderate protein sip feed ('Fortimel Compact, Nutricia GmbH) for 3 months
Control Group
NO INTERVENTIONNutrition counselling upon hospital discharge (usual care)
Interventions
2x 125 ml bottles (equiv. 600 kcal) of Fortimel Compact daily for 3 months in addition to normal eating habits
Eligibility Criteria
You may qualify if:
- Age ≥ 60 years
- Informed written consent
- Independent community dwelling after discharge
- Existing or risk of malnutrition
- Normal cognitive status according to Mini-Mental State Examination (MMSE ≥ 24 points)
- Life expectancy of \> 3 months according to treating doctor
- No severe heart disease (New York Heart Association (NYHA) functional classification of 3+), liver disease (Child Pugh Score = A, B) or kidney insufficiency (glomerular filtration rate \< 30 ml/min)
- No chemo or radiation therapy
- No derailed diabetes mellitus or metabolic decompensation
You may not qualify if:
- Age \< 60 years
- Lack of informed written consent
- Dependent living conditions after discharge
- No risk of malnutrition
- Low cognitive status according to Mini-Mental State Examination (MMSE \< 24 points)
- Life expectancy of \< 3 months according to treating doctor
- Severe heart disease (New York Heart Association (NYHA) functional classification of 3+), liver disease (Child Pugh Score = C) or kidney insufficiency (glomerular filtration rate \< 30 ml/min)
- Chemo or radiation therapy
- Derailed diabetes mellitus or metabolic decompensation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charite University Medicine, Research Group on Geriatrics
Berlin, 13347, Germany
Related Publications (3)
Norman K, Pirlich M, Smoliner C, Kilbert A, Schulzke JD, Ockenga J, Lochs H, Reinhold T. Cost-effectiveness of a 3-month intervention with oral nutritional supplements in disease-related malnutrition: a randomised controlled pilot study. Eur J Clin Nutr. 2011 Jun;65(6):735-42. doi: 10.1038/ejcn.2011.31. Epub 2011 Mar 16.
PMID: 21407248BACKGROUNDNorman K, Kirchner H, Freudenreich M, Ockenga J, Lochs H, Pirlich M. Three month intervention with protein and energy rich supplements improve muscle function and quality of life in malnourished patients with non-neoplastic gastrointestinal disease--a randomized controlled trial. Clin Nutr. 2008 Feb;27(1):48-56. doi: 10.1016/j.clnu.2007.08.011. Epub 2007 Oct 25.
PMID: 17964008BACKGROUNDNeelemaat F, Bosmans JE, Thijs A, Seidell JC, van Bokhorst-de van der Schueren MA. Oral nutritional support in malnourished elderly decreases functional limitations with no extra costs. Clin Nutr. 2012 Apr;31(2):183-90. doi: 10.1016/j.clnu.2011.10.009. Epub 2011 Nov 8.
PMID: 22071290BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristina Norman, PD Dr.
Charite Research Group on Geriatrics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. Kristina Norman
Study Record Dates
First Submitted
January 14, 2015
First Posted
June 12, 2015
Study Start
November 1, 2014
Primary Completion
March 1, 2018
Study Completion
July 1, 2018
Last Updated
February 4, 2019
Record last verified: 2019-01