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Community Oral Nutrition Support Trial

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Dietary Advice
Oral Nutritional Supplements (Fortisip)
Sponsored by
University of Southampton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Quality of life, Supplement, Care home, Elderly, Malnutrition

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Care Homes in Hampshire

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Dietary Advice

Oral Nutritional Supplements

Arm Description

Dietary Advice

Oral Nutritional Supplements

Outcomes

Primary Outcome Measures

The primary outcome measure is Quality of Life

Secondary Outcome Measures

Full Information

First Posted
August 10, 2007
Last Updated
September 10, 2015
Sponsor
University of Southampton
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1. Study Identification

Unique Protocol Identification Number
NCT00515125
Brief Title
Community Oral Nutrition Support Trial
Official Title
A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Nutrition in the Community.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southampton

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Quality of life, Supplement, Care home, Elderly, Malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary Advice
Arm Type
Other
Arm Description
Dietary Advice
Arm Title
Oral Nutritional Supplements
Arm Type
Other
Arm Description
Oral Nutritional Supplements
Intervention Type
Behavioral
Intervention Name(s)
Dietary Advice
Intervention Description
Dietary Advice sheet
Intervention Type
Dietary Supplement
Intervention Name(s)
Oral Nutritional Supplements (Fortisip)
Intervention Description
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 Measure Information:
Title
The primary outcome measure is Quality of Life
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marinos Elia, Professor
Organizational Affiliation
University of Southampton
Official's Role
Principal Investigator
Facility Information:
Facility Name
Care Homes in Hampshire
City
Southampton
State/Province
Hampshire
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26847947
Citation
Parsons EL, Stratton RJ, Cawood AL, Smith TR, Elia M. Oral nutritional supplements in a randomised trial are more effective than dietary advice at improving quality of life in malnourished care home residents. Clin Nutr. 2017 Feb;36(1):134-142. doi: 10.1016/j.clnu.2016.01.002. Epub 2016 Jan 11.
Results Reference
derived

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Community Oral Nutrition Support Trial

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