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

January 31, 2019 updated by: Kristina Norman, Charite University, Berlin, Germany
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13347
        • Charite University Medicine, Research Group on Geriatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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
2x 125 ml bottles (equiv. 600 kcal) of Fortimel Compact daily for 3 months in addition to normal eating habits
No Intervention: Control Group
Nutrition counselling upon hospital discharge (usual care)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional Parameter: timed up & go
Time Frame: Baseline (hospital discharge) and after 3 months
Baseline (hospital discharge) and after 3 months
Functional Parameter: stair climbing
Time Frame: Baseline (hospital discharge) and after 3 months
Baseline (hospital discharge) and after 3 months
Functional Parameter: lung function
Time Frame: Baseline (hospital discharge) and after 3 months
Baseline (hospital discharge) and after 3 months
Functional Parameter: gait analysis
Time Frame: Baseline (hospital discharge) and after 3 months
Baseline (hospital discharge) and after 3 months
Strength Parameter: Hand grip strength
Time Frame: Baseline (hospital discharge) and after 3 months
Baseline (hospital discharge) and after 3 months
Strength Parameter: Knee extension strength
Time Frame: Baseline (hospital discharge) and after 3 months
Baseline (hospital discharge) and after 3 months
Quality of life (validated questionnaire)
Time Frame: Baseline (hospital discharge) and after 3 months
Baseline (hospital discharge) and after 3 months
Body composition (bioelectric impedance analysis)
Time Frame: Baseline (hospital discharge) and after 3 months
Baseline (hospital discharge) and after 3 months
Consumption of health care resources (questionnaire) and cost analysis
Time Frame: From baseline (hospital discharge) during subsequent 3 months
From baseline (hospital discharge) during subsequent 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Pfrimmer Nutricia GmbH, Erlangen , Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

January 14, 2015

First Submitted That Met QC Criteria

June 9, 2015

First Posted (Estimate)

June 12, 2015

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECONONS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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