Malnutrition
Conditions
Keywords
Malnutrition, Geriatrics, Enteral Nutrition
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTBalanced, 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
Sponsors
Pfrimmer Nutricia GmbH, Erlangen , Germany
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in functional limitations and activities of daily living (single validated questionnaire) | Baseline (hospital discharge) and after 3 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Functional Parameter: timed up & go | Baseline (hospital discharge) and after 3 months |
| Strength Parameter: Hand grip strength | 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 |
| Consumption of health care resources (questionnaire) and cost analysis | From baseline (hospital discharge) during subsequent 3 months |
| Functional Parameter: stair climbing | Baseline (hospital discharge) and after 3 months |
Countries
Germany
Outcome results
None listed