Medical and Health Economic Benefit of Oral Nutritional Supplements (ONS) in Ambulant Patients
Not Applicable
Completed
- Conditions
- Malnutrition
- Interventions
- Dietary Supplement: Balanced, energy dense, moderate protein sip feed
- Registration Number
- NCT02470013
- Lead Sponsor
- Charite University, Berlin, Germany
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Balanced, energy dense, moderate protein sip feed Nutrition counselling and balanced, energy dense, moderate protein sip feed ('Fortimel Compact, Nutricia GmbH) for 3 months
- Primary Outcome Measures
Name Time Method Change in functional limitations and activities of daily living (single validated questionnaire) Baseline (hospital discharge) and after 3 months
- Secondary Outcome Measures
Name Time Method Functional Parameter: timed up & go Baseline (hospital discharge) and after 3 months Functional Parameter: stair climbing Baseline (hospital discharge) and after 3 months Strength Parameter: Hand grip strength Baseline (hospital discharge) and after 3 months Functional Parameter: gait analysis Baseline (hospital discharge) and after 3 months Strength Parameter: Knee extension strength 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: lung function 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
Trial Locations
- Locations (1)
Charite University Medicine, Research Group on Geriatrics
🇩🇪Berlin, Germany