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

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Balanced, energy dense, moderate protein sip feed
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Malnutrition, Geriatrics, Enteral Nutrition

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charite University Medicine, Research Group on Geriatrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Nutrition counselling and balanced, energy dense, moderate protein sip feed ('Fortimel Compact, Nutricia GmbH) for 3 months

Nutrition counselling upon hospital discharge (usual care)

Outcomes

Primary Outcome Measures

Change in functional limitations and activities of daily living (single validated questionnaire)

Secondary Outcome Measures

Functional Parameter: timed up & go
Functional Parameter: stair climbing
Functional Parameter: lung function
Functional Parameter: gait analysis
Strength Parameter: Hand grip strength
Strength Parameter: Knee extension strength
Quality of life (validated questionnaire)
Body composition (bioelectric impedance analysis)
Consumption of health care resources (questionnaire) and cost analysis

Full Information

First Posted
January 14, 2015
Last Updated
January 31, 2019
Sponsor
Charite University, Berlin, Germany
Collaborators
Pfrimmer Nutricia GmbH, Erlangen , Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02470013
Brief Title
Medical and Health Economic Benefit of Oral Nutritional Supplements (ONS) in Ambulant Patients
Acronym
ECONONS
Official Title
Medical and Health Economic Benefit of Oral Nutritional Supplements (ONS) in Ambulant Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Pfrimmer Nutricia GmbH, Erlangen , Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Malnutrition, Geriatrics, Enteral Nutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Nutrition counselling and balanced, energy dense, moderate protein sip feed ('Fortimel Compact, Nutricia GmbH) for 3 months
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Nutrition counselling upon hospital discharge (usual care)
Intervention Type
Dietary Supplement
Intervention Name(s)
Balanced, energy dense, moderate protein sip feed
Intervention Description
2x 125 ml bottles (equiv. 600 kcal) of Fortimel Compact daily for 3 months in addition to normal eating habits
Primary Outcome Measure Information:
Title
Change in functional limitations and activities of daily living (single validated questionnaire)
Time Frame
Baseline (hospital discharge) and after 3 months
Secondary Outcome Measure Information:
Title
Functional Parameter: timed up & go
Time Frame
Baseline (hospital discharge) and after 3 months
Title
Functional Parameter: stair climbing
Time Frame
Baseline (hospital discharge) and after 3 months
Title
Functional Parameter: lung function
Time Frame
Baseline (hospital discharge) and after 3 months
Title
Functional Parameter: gait analysis
Time Frame
Baseline (hospital discharge) and after 3 months
Title
Strength Parameter: Hand grip strength
Time Frame
Baseline (hospital discharge) and after 3 months
Title
Strength Parameter: Knee extension strength
Time Frame
Baseline (hospital discharge) and after 3 months
Title
Quality of life (validated questionnaire)
Time Frame
Baseline (hospital discharge) and after 3 months
Title
Body composition (bioelectric impedance analysis)
Time Frame
Baseline (hospital discharge) and after 3 months
Title
Consumption of health care resources (questionnaire) and cost analysis
Time Frame
From baseline (hospital discharge) during subsequent 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina Norman, PD Dr.
Organizational Affiliation
Charite Research Group on Geriatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charite University Medicine, Research Group on Geriatrics
City
Berlin
ZIP/Postal Code
13347
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21407248
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.
Results Reference
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PubMed Identifier
17964008
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.
Results Reference
background
PubMed Identifier
22071290
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.
Results Reference
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Medical and Health Economic Benefit of Oral Nutritional Supplements (ONS) in Ambulant Patients

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