Medical and Health Economic Benefit of Oral Nutritional Supplements (ONS) in Ambulant Patients
NCT ID: NCT02470013
Last Updated: 2019-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2014-11-30
2018-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Group
Nutrition counselling and balanced, energy dense, moderate protein sip feed ('Fortimel Compact, Nutricia GmbH) for 3 months
Balanced, energy dense, moderate protein sip feed
2x 125 ml bottles (equiv. 600 kcal) of Fortimel Compact daily for 3 months in addition to normal eating habits
Control Group
Nutrition counselling upon hospital discharge (usual care)
No interventions assigned to this group
Interventions
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Balanced, energy dense, moderate protein sip feed
2x 125 ml bottles (equiv. 600 kcal) of Fortimel Compact daily for 3 months in addition to normal eating habits
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
60 Years
ALL
No
Sponsors
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Pfrimmer Nutricia GmbH, Erlangen , Germany
INDUSTRY
Charite University, Berlin, Germany
OTHER
Responsible Party
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Kristina Norman
PD Dr. Kristina Norman
Principal Investigators
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Kristina Norman, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
Charite Research Group on Geriatrics
Locations
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Charite University Medicine, Research Group on Geriatrics
Berlin, , Germany
Countries
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References
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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.
Norman 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.
Neelemaat 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.
Other Identifiers
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ECONONS
Identifier Type: -
Identifier Source: org_study_id
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