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Completed

NCT Number: NCT00515125

Community Oral Nutrition Support Trial

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.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Care Homes in Hampshire

Southampton, Hampshire, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Advice

Behavioral

Dietary Advice sheet

Oral Nutritional Supplements (Fortisip)

Dietary Supplement

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.

Primary outcomes

  1. The primary outcome measure is Quality of Life

    Time frame: 6 months

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 13, 2007
Registry last updated
Sep 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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