NCT00515125

Community Oral Nutrition Support Trial

A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Nutrition in the Community.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: University of Southampton · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Malnutrition

Interventions

Type	Name	Description
BEHAVIORAL	Dietary Advice	Dietary Advice sheet
DIETARY_SUPPLEMENT	Oral Nutritional Supplements (Fortisip)	These products are classified as non-medicinal, borderline substances, foods for special medical purposes. A range of commercially available liquid oral nutritional supplements (Fortisip) will be offered daily for a 12 week period.

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2007-08-13
• Last updated: 2015-09-11

Locations

1 site across 1 country: United Kingdom