Community Oral Nutrition Support Trial

University of Southampton

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: Oral Nutritional Supplements (Fortisip); Behavioral: Dietary Advice

Study type: Interventional

Funder types: Other

Identifiers

NCT00515125

ELIA0001

Details and patient eligibility

About

The purpose of this study is to determine the best form of dietary intervention to undernourished elderly individuals in care homes.

The research aims to test the null hypothesis that there is no difference between oral nutritional supplements and dietary advice as the first line treatment for malnutrition.

Full description

A prospective, randomised, parallel, open-label trial, study in malnourished care home residents, without obvious dementia, to compare the effects of two common forms of nutritional support; dietary advice (DA) and oral nutritional supplements (ONS), on quality of life (QoL) and other outcomes including weight, nutritional intake and appetite. The residents were randomised to receive either DA provided by a dietitian or ONS for a period of 12 weeks. The primary outcome measure was QoL and the secondary outcome measure was dietary intake.

Enrollment: 104 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female
• Age > 50 years
• At risk of malnutrition
• Competent to provide written informed consent and to answer questions
• Able to eat and drink
• Willingness to take part in the trial and to follow the trial protocol

Exclusion criteria

• Requirement for tube or parenteral nutrition
• Galactosemia
• Receiving current oral nutritional supplementation
• Palliative care
• Chronic renal disease requiring dialysis
• Liver failure
• Malignancy
• Participation in other studies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Dietary Advice

Other group

Description:

Dietary Advice

Treatment:

Behavioral: Dietary Advice

Oral Nutritional Supplements

Other group

Description:

Oral Nutritional Supplements

Treatment:

Dietary Supplement: Oral Nutritional Supplements (Fortisip)