MalnutritionNCT00515125
Community Oral Nutrition Support Trial
A study testing Dietary Advice and Oral Nutritional Supplements (Fortisip) in people with Malnutrition, run by University of Southampton at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Dietary Advice and Oral Nutritional Supplements (Fortisip)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2007to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Malnutrition
- Being tested
- Dietary Advice, Oral Nutritional Supplements (Fortisip)
- Keywords
- Quality of life, Supplement, Care home, Elderly, Malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary AdviceBehavioural
Dietary Advice sheet
Oral Nutritional Supplements (Fortisip)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Advice | Other | Dietary Advice Receives: Behavioral: Dietary Advice |
| Oral Nutritional Supplements | Other | Oral Nutritional Supplements Receives: Dietary Supplement: Oral Nutritional Supplements (Fortisip) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is Quality of Life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marinos Elia, Professor, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515125
- Sponsor's protocol ID
- ELIA0001
- Status last verified
- Jun 2015
- First submitted
- 10 Aug 2007
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26847947
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Trial of Oral Nutritional Supplements Versus Dietary Advice on Clinical Nutrition in the Community.
- ClinicalTrials.gov ID
- NCT00515125
- Acronym / sponsor ID
- ELIA0001
- Conditions
- Malnutrition
- Keywords
- Quality of life, Supplement, Care home, Elderly, Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 13 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Advice | Other | Behavioral: Dietary AdviceDietary Advice |
| Oral Nutritional Supplements | Other | Dietary Supplement: Oral Nutritional Supplements (Fortisip)Oral Nutritional Supplements |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Requirement for tube or parenteral nutrition
- Galactosemia
- Receiving current oral nutritional supplementation
- Palliative care
- Chronic renal disease requiring dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary AdviceDietary Advice sheet | Behavioural | Dietary Advice |
| 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. | Dietary supplement | Oral Nutritional Supplements |
Primary outcome
The primary outcome measure is Quality of Life
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
- Derived from this study: PubMed 26847947Parsons 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marinos Elia, Professor principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Advice and Oral Nutritional Supplements (Fortisip) in people with Malnutrition, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is Quality of Life (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00515125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2015.