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Completed

NCT Number: NCT02470013

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charite University Medicine, Research Group on Geriatrics

Berlin, 13347, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Balanced, energy dense, moderate protein sip feed

Dietary Supplement

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

Primary outcomes

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

    Time frame: Baseline (hospital discharge) and after 3 months

Secondary outcomes

  1. Functional Parameter: timed up & go

    Time frame: Baseline (hospital discharge) and after 3 months

  2. Functional Parameter: stair climbing

    Time frame: Baseline (hospital discharge) and after 3 months

  3. Functional Parameter: lung function

    Time frame: Baseline (hospital discharge) and after 3 months

  4. Functional Parameter: gait analysis

    Time frame: Baseline (hospital discharge) and after 3 months

  5. Strength Parameter: Hand grip strength

    Time frame: Baseline (hospital discharge) and after 3 months

  6. Strength Parameter: Knee extension strength

    Time frame: Baseline (hospital discharge) and after 3 months

  7. Quality of life (validated questionnaire)

    Time frame: Baseline (hospital discharge) and after 3 months

  8. Body composition (bioelectric impedance analysis)

    Time frame: Baseline (hospital discharge) and after 3 months

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

    Time frame: From baseline (hospital discharge) during subsequent 3 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Pfrimmer Nutricia GmbH, Erlangen , Germany

Registry information

Acronym: ECONONS

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2015
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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