Community Oral Nutrition Support Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00515125
Recruitment Status : Completed
First Posted : August 13, 2007
Last Update Posted : September 11, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Malnutrition Behavioral: Dietary Advice Dietary Supplement: Oral Nutritional Supplements (Fortisip) Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Nutrition in the Community.
Study Start Date : August 2007
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Dietary Advice
Dietary Advice
Behavioral: Dietary Advice
Dietary Advice sheet

Oral Nutritional Supplements
Oral Nutritional Supplements
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.

Primary Outcome Measures :
  1. The primary outcome measure is Quality of Life [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00515125

United Kingdom
Care Homes in Hampshire
Southampton, Hampshire, United Kingdom
Sponsors and Collaborators
University of Southampton
Principal Investigator: Marinos Elia, Professor University of Southampton

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Southampton Identifier: NCT00515125     History of Changes
Other Study ID Numbers: ELIA0001
First Posted: August 13, 2007    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: June 2015

Keywords provided by University of Southampton:
Quality of life
Care home

Additional relevant MeSH terms:
Nutrition Disorders