Effects of Nutritional Supplementation and Dietary Advice in Elderly Patients After Hospital Discharge.

Uppsala University

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: Nutritional supplementation with a liquid formula; Other: Combination of supplement and dietary advice; Other: Dietary advice

Study type: Interventional

Funder types: Other

Identifiers

NCT01057914

LTV-69151

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of nutritional therapy in elderly malnourished patients. The hypothesises are that nutritional supplementation and dietary advice alone or in combination affects mortality, quality of life and health-care consumption after six month of treatment.

Enrollment: 671 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥65 years old
• Admitted to one of the participating wards during the recruitment period

Exclusion criteria

• Well-nourished
• No consent to participate
• Not able to communicate
• Not able to understand swedish
• Presumed life-expectancy <1 year
• Already receiving nutritional therapy including dietary advice, supplements, tube-feeding or parenteral nutrition
• Dietary restrictions due to illness or disease inconsistent with the intervention
• Impaired cognitive function or dementia
• Body mass index ≥35
• Living in old peoples homes, sheltered housing, institution, service flats or nursing homes
• Participant in a study evaluating differences in 3-year mortality between well-nourished patients, patients at risk of malnutrition and malnourished patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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671 participants in 4 patient groups

Supplemention

Experimental group

Treatment:

Dietary Supplement: Nutritional supplementation with a liquid formula

Dietary advice

Experimental group

Treatment:

Other: Dietary advice

Combination treatment

Experimental group

Treatment:

Other: Combination of supplement and dietary advice

Usual care

No Intervention group