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

Malnutrition Clinical Trial

— ECONONS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470013
• Other study ID #: ECONONS
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: July 2018

Study information

• Verified date: January 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Balanced, 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

Locations

Country	Name	City	State
Germany	Charite University Medicine, Research Group on Geriatrics	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Pfrimmer Nutricia GmbH, Erlangen , Germany

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. Epub 2007 Oct 25. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in functional limitations and activities of daily living (single validated questionnaire)		Baseline (hospital discharge) and after 3 months
Secondary	Functional Parameter: timed up & go		Baseline (hospital discharge) and after 3 months
Secondary	Functional Parameter: stair climbing		Baseline (hospital discharge) and after 3 months
Secondary	Functional Parameter: lung function		Baseline (hospital discharge) and after 3 months
Secondary	Functional Parameter: gait analysis		Baseline (hospital discharge) and after 3 months
Secondary	Strength Parameter: Hand grip strength		Baseline (hospital discharge) and after 3 months
Secondary	Strength Parameter: Knee extension strength		Baseline (hospital discharge) and after 3 months
Secondary	Quality of life (validated questionnaire)		Baseline (hospital discharge) and after 3 months
Secondary	Body composition (bioelectric impedance analysis)		Baseline (hospital discharge) and after 3 months
Secondary	Consumption of health care resources (questionnaire) and cost analysis		From baseline (hospital discharge) during subsequent 3 months