Clinical trial NCT02470013: Medical and Health Economic Benefit of Oral Nutritional Supplements (ONS) in Ambulant Patients
Official title: Medical and Health Economic Benefit of Oral Nutritional Supplements (ONS) in Ambulant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Malnutrition
Geriatrics
Enteral Nutrition
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Pfrimmer Nutricia GmbH, Erlangen , Germany
First posted: 2015-06-12
Enrollment: 160
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in functional limitations and activities of daily living (single validated questionnaire)
timeFrame: Baseline (hospital discharge) and after 3 months
Secondary outcomes:
measure: Functional Parameter: timed up & go
timeFrame: Baseline (hospital discharge) and after 3 months
measure: Functional Parameter: stair climbing
timeFrame: Baseline (hospital discharge) and after 3 months
measure: Functional Parameter: lung function
timeFrame: Baseline (hospital discharge) and after 3 months
measure: Functional Parameter: gait analysis
timeFrame: Baseline (hospital discharge) and after 3 months
measure: Strength Parameter: Hand grip strength
timeFrame: Baseline (hospital discharge) and after 3 months
measure: Strength Parameter: Knee extension strength
timeFrame: Baseline (hospital discharge) and after 3 months
measure: Quality of life (validated questionnaire)
timeFrame: Baseline (hospital discharge) and after 3 months
measure: Body composition (bioelectric impedance analysis)
timeFrame: Baseline (hospital discharge) and after 3 months
measure: Consumption of health care resources (questionnaire) and cost analysis
timeFrame: From baseline (hospital discharge) during subsequent 3 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University Medicine, Research Group on Geriatrics
Study officials:
affiliation: Charite Research Group on Geriatrics
name: Kristina Norman, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.