Community Oral Nutrition Support Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Southampton
ClinicalTrials.gov Identifier:
NCT00515125
First received: August 10, 2007
Last updated: September 10, 2015
Last verified: June 2015

August 10, 2007
September 10, 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 ] [ Designated as safety issue: No ]
The primary outcome measure is Quality of Life [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00515125 on ClinicalTrials.gov Archive Site
Not Provided
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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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malnutrition
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00515125
ELIA0001
No
Not Provided
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University of Southampton
University of Southampton
Not Provided
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