Community Oral Nutrition Support Trial

September 10, 2015 updated by: University of Southampton

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Hampshire
      • Southampton, Hampshire, United Kingdom
        • Care Homes in Hampshire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Dietary Advice
Behavioral: Dietary Advice
Dietary Advice sheet
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure is Quality of Life
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southampton

Investigators

  • Principal Investigator: Marinos Elia, Professor, University of Southampton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

August 10, 2007

First Submitted That Met QC Criteria

August 10, 2007

First Posted (Estimate)

August 13, 2007

Study Record Updates

Last Update Posted (Estimate)

September 11, 2015

Last Update Submitted That Met QC Criteria

September 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELIA0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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