Community Oral Nutrition Support Trial | NCT00515125

Studies
Community Oral Nutrition Support Trial

NCT00515125

Sponsor

University of Southampton

Status

Completed

Last Update Posted

Sep 11, 2015Estimated

Enrollment

104Actual

Phase

Not Applicable

Conditions

Malnutrition

Interventions

Dietary Advice
Oral Nutritional Supplements (Fortisip)

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Aug 10, 2007

First Submission Date that Met QC Criteria

Aug 10, 2007

First Posted Date

Aug 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2015

Last Update Posted Date

Sep 11, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dietary Advice	Other	Dietary Advice	Behavioral: Dietary Advice
Oral Nutritional Supplements	Other	Oral Nutritional Supplements	Dietary Supplement: Oral Nutritional Supplements (Fortisip)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dietary Advice	Behavioral	Dietary Advice sheet	Dietary Advice
Oral Nutritional Supplements (Fortisip)

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marinos Elia, Professor	University of Southampton	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Care Homes in Hampshire		Southampton	Hampshire		United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26847947	Derived	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.

Type	Date	Date Unknown
Release	Nov 19, 2021
Reset	Jan 27, 2022

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D015596	Nutrition Assessment
D019587	Dietary Supplements

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms