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

Charité University Medicine Berlin

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: Balanced, energy dense, moderate protein sip feed

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02470013

ECONONS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 60+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Balanced, energy dense, moderate protein sip feed

Control Group

No Intervention group

Description:

Nutrition counselling upon hospital discharge (usual care)