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| Name | Class |
|---|---|
| Pfrimmer Nutricia GmbH, Erlangen , Germany | INDUSTRY |
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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.
Study participants are assessed upon discharge from the hospital and again after 3 months. Upon discharge all patients receive nutrition counselling with special focus on an energy rich diet. Additionally, the intervention group receives ONS. The investigators hypothesize an improvement in functional limitations and health economic benefits due to the post-hospital nutritional intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Nutrition counselling and balanced, energy dense, moderate protein sip feed ('Fortimel Compact, Nutricia GmbH) for 3 months |
|
| Control Group | No Intervention | Nutrition counselling upon hospital discharge (usual care) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balanced, energy dense, moderate protein sip feed | Dietary Supplement | 2x 125 ml bottles (equiv. 600 kcal) of Fortimel Compact daily for 3 months in addition to normal eating habits |
| Measure | Description | Time Frame |
|---|---|---|
| Change in functional limitations and activities of daily living (single validated questionnaire) | Baseline (hospital discharge) and after 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Parameter: timed up & go | Baseline (hospital discharge) and after 3 months | |
| Functional Parameter: stair climbing | Baseline (hospital discharge) and after 3 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina Norman, PD Dr. | Charite Research Group on Geriatrics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite University Medicine, Research Group on Geriatrics | Berlin | 13347 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21407248 | Background | 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. | |
| 17964008 |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| Strength Parameter: Knee extension strength | Baseline (hospital discharge) and after 3 months |
| Quality of life (validated questionnaire) | Baseline (hospital discharge) and after 3 months |
| Body composition (bioelectric impedance analysis) | Baseline (hospital discharge) and after 3 months |
| Consumption of health care resources (questionnaire) and cost analysis | From baseline (hospital discharge) during subsequent 3 months |
| 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. |
| 22071290 | Background | 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. |