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MalnutritionECONONSNCT02470013

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

A study testing Balanced, energy dense, moderate protein sip feed in people with Malnutrition, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Malnutrition
What is being tested?
Balanced, energy dense, moderate protein sip feed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteGermany
Study dates
Nov 2014to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charite University Medicine, Research Group on Geriatrics

    Berlin, 13347

Other trials in Germany

About this study

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.

Read the 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.

Conditions
Malnutrition
Being tested
Balanced, energy dense, moderate protein sip feed
Keywords
Malnutrition, Geriatrics, Enteral Nutrition
Medical subject headings
Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Balanced, energy dense, moderate protein sip feedDietary supplement

    2x 125 ml bottles (equiv. 600 kcal) of Fortimel Compact daily for 3 months in addition to normal eating habits

Study groups in NCT02470013
Study groupRoleWhat they receive
Intervention GroupExperimentalNutrition counselling and balanced, energy dense, moderate protein sip feed ('Fortimel Compact, Nutricia GmbH) for 3 months
Receives: Dietary Supplement: Balanced, energy dense, moderate protein sip feed
Control GroupNo interventionNutrition counselling upon hospital discharge (usual care)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline (hospital discharge) and after 3 months

Secondary outcomes (9)

  1. Functional Parameter: timed up & go

    Measured: Baseline (hospital discharge) and after 3 months

  2. Functional Parameter: stair climbing

    Measured: Baseline (hospital discharge) and after 3 months

  3. Functional Parameter: lung function

    Measured: Baseline (hospital discharge) and after 3 months

  4. Functional Parameter: gait analysis

    Measured: Baseline (hospital discharge) and after 3 months

  5. Strength Parameter: Hand grip strength

    Measured: Baseline (hospital discharge) and after 3 months

  6. Strength Parameter: Knee extension strength

    Measured: Baseline (hospital discharge) and after 3 months

  7. Quality of life (validated questionnaire)

    Measured: Baseline (hospital discharge) and after 3 months

  8. Body composition (bioelectric impedance analysis)

    Measured: Baseline (hospital discharge) and after 3 months

  9. Consumption of health care resources (questionnaire) and cost analysis

    Measured: From baseline (hospital discharge) during subsequent 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2015 (estimated)
  2. Study startNov 2014
  3. Primary completionMar 2018
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02470013
Sponsor's protocol ID
ECONONS
Acronym
ECONONS
Status last verified
Jan 2019
First submitted
14 Jan 2015
Last updated
4 Feb 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21407248

  • 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.

    PubMed 17964008

  • 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.

    PubMed 22071290

Questions about this trial

What is this clinical trial studying?

A study testing Balanced, energy dense, moderate protein sip feed in people with Malnutrition, run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in functional limitations and activities of daily living (single validated questionnaire) (time frame: Baseline (hospital discharge) and after 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02470013, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.

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