Community Oral Nutrition Support Trial
A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Nutrition in the Community.
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2007
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 10, 2007
CompletedFirst Posted
Study publicly available on registry
August 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedSeptember 11, 2015
June 1, 2015
2.6 years
August 10, 2007
September 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome measure is Quality of Life
6 months
Study Arms (2)
Dietary Advice
OTHERDietary Advice
Oral Nutritional Supplements
OTHEROral Nutritional Supplements
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Care Homes in Hampshire
Southampton, Hampshire, United Kingdom
Related Publications (1)
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.
PMID: 26847947DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marinos Elia, Professor
University of Southampton
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2007
First Posted
August 13, 2007
Study Start
August 1, 2007
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
September 11, 2015
Record last verified: 2015-06