Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00515125
Status:
COMPLETED
Last Update Posted:
2015-09-11
First Post:
2007-08-10
Brief Title:
Community Oral Nutrition Support Trial
Sponsor:
University of Southampton
Organization:
University of Southampton
Study Overview
Official Title:
A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Nutrition in the Community
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None