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Community Oral Nutrition Support Trial

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ClinicalTrials.gov Identifier: NCT00515125
Recruitment Status : Completed
First Posted : August 13, 2007
Last Update Posted : September 11, 2015
Information provided by (Responsible Party):

August 10, 2007
August 13, 2007
September 11, 2015
August 2007
March 2010   (Final data collection date for primary outcome measure)
The primary outcome measure is Quality of Life [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00515125 on ClinicalTrials.gov Archive Site
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Community Oral Nutrition Support Trial
A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Nutrition in the Community.

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.

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.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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.

  • Dietary Advice
    Dietary Advice
    Intervention: Behavioral: Dietary Advice
  • Oral Nutritional Supplements
    Oral Nutritional Supplements
    Intervention: Dietary Supplement: Oral Nutritional Supplements (Fortisip)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2010
March 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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University of Southampton
University of Southampton
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Principal Investigator: Marinos Elia, Professor University of Southampton
University of Southampton
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP