Community Oral Nutrition Support Trial

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Oral Nutritional Supplements (Fortisip); Behavioral: Dietary Advice

• Registration Number: NCT00515125
• Lead Sponsor: University of Southampton

Brief 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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-10
• Study First Submitted QC: 2007-08-10
• Study First Posted: 2007-08-13
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-09-10
• Last Update Posted: 2015-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Nutritional Supplements	Oral Nutritional Supplements (Fortisip)	Oral Nutritional Supplements
Dietary Advice	Dietary Advice	Dietary Advice

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is Quality of Life	6 months

Trial Locations

Locations (1)

Care Homes in Hampshire; 🇬🇧 Southampton, Hampshire, United Kingdom