Medical and Health Economic Benefit of Oral Nutritional Supplements (ONS) in Ambulant Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Medical and Health Economic Benefit of Oral Nutritional Supplements (ONS) in Ambulant Patients

Conditions
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Malnutrition

Intervention / Treatment
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* Dietary Supplement: Balanced, energy dense, moderate protein sip feed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Nutrition counselling and balanced, energy dense, moderate protein sip feed ('Fortimel Compact, Nutricia GmbH) for 3 months | Dietary Supplement: Balanced, energy dense, moderate protein sip feed<br>* 2x 125 ml bottles (equiv. 600 kcal) of Fortimel Compact daily for 3 months in addition to normal eating habits<br>|
| No Intervention: Control Group<br>Nutrition counselling upon hospital discharge (usual care) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional limitations and activities of daily living (single validated questionnaire) |  | Baseline (hospital discharge) and after 3 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malnutrition, Geriatrics, Enteral Nutrition