Community Oral Nutrition Support Trial

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00515125

Enrollment

104

Registered

2007-08-13

Start date

2007-08-31

Completion date

2010-03-31

Last updated

2015-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Keywords

Quality of life, Supplement, Care home, Elderly, Malnutrition

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.

Interventions

BEHAVIORALDietary Advice

Dietary Advice sheet

DIETARY_SUPPLEMENTOral 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is Quality of Life	6 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026