Overview

This trial is active, not recruiting.

Condition malnutrition
Treatments nutritional supplementation with a liquid formula, dietary advice, combination of supplement and dietary advice
Sponsor Uppsala University
Collaborator Västmanland County Council, Sweden
Start date February 2010
End date December 2016
Trial size 800 participants
Trial identifier NCT01057914, LTV-69151

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
nutritional supplementation with a liquid formula
The patient consumes 400 kcal from a liquid supplementation formula
(Experimental)
dietary advice
The patient receives dietary advice for one hour during the hospital stay.
(Experimental)
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.
(No Intervention)

Primary Outcomes

Measure
All cause mortality
time frame: Six months, one year, three years

Secondary Outcomes

Measure
Health-related quality of life
time frame: Six months, one year, three years
Health-care consumption
time frame: Six months, one year, three years
Function in activities in daily life
time frame: Six months, one year, three years

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

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.
Principal investigator Leif Bergkvist
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Uppsala University.