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

Malnutrition Clinical Trial

Official title:

Effects of Six Months Treatment With Nutritional Supplements or Dietary Advice, Alone or in Combination on Mortality, Health-related Quality of Life and Health-care Consumption for Elderly Patients at Risk of Malnutrition.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057914
• Other study ID #: LTV-69151
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: November 2020

Study information

• Verified date: November 2020
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 671
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Nutritional supplementation with a liquid formula
The patient consumes 400 kcal from a liquid supplementation formula

Other:
• Dietary advice
The patient receives dietary advice for one hour during the hospital stay.
• Combination of supplement and dietary advice
The patient receives dietary advice for one hour during the hospital stay and consumes 400 kcal from liquid supplementation formula for six month after discharge.

Locations

Country	Name	City	State
Sweden	Mälarsjukhuset in Eskilstuna	Eskilstuna	Sörmland
Sweden	Falu lasarett	Falun	Dalarna
Sweden	Nyköpings lasarett	Nyköping	Sörmland
Sweden	Akademiska sjukhuset	Uppsala	Uppland
Sweden	Västmanlands sjukhus Västerås	Västerås	Västmanland

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Västmanland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		Six months, one year, three years
Secondary	Health-related quality of life		Six months, one year, three years
Secondary	Health-care consumption		Six months, one year, three years
Secondary	Function in activities in daily life		Six months, one year, three years