MalnutritionNCT02051777
Hospital Discharge Oral Nutrition Support Trial
A study testing Oral Nutritional Supplement 1, Oral Nutritional Supplement 2 and Dietary Advice in people with Malnutrition, run by Nutricia UK Ltd at 1 site in United Kingdom.
Trial summary
To investigate the effect of different strategies for managing malnutrition in the community Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- Oral Nutritional Supplement 1, Oral Nutritional Supplement 2 and Dietary Advice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2012to Mar 2015
- 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 and over
- Able to eat and drink without the need for altered texture fluids
- Identified at risk of disease related malnutrition
- Competent to provide written informed consent
- Willingness to take part in the study and to follow the study protocol
Who cannot join
- Individuals unable to eat or drink
- Chronic renal disease requiring dialysis
- Galactosaemia
- Dysphagia
- Normally or going to be residing in an institution e.g. care home upon discharge from hospital
- Palliative care
Show all 14Show fewer
- Cancer (active treatment)
- Liver failure
- Poorly controlled diabetes
- Diagnosed lactose intolerance
- Participation in other clinical trials currently or in the previous 4 weeks
- Due to be discharged to an area out of the hospital region
- Requiring tube or parenteral nutrition
- Due to be discharged from hospital on oral nutrition support recommended by a Dietitian
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effect of different strategies for managing malnutrition in the community
- Conditions
- Malnutrition
- Being tested
- Oral Nutritional Supplement 1, Oral Nutritional Supplement 2, Dietary Advice
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Nutritional Supplement 1Dietary supplement
Containing macro and micronutrients
Oral Nutritional Supplement 2Dietary supplement
Containing macro and micronutrients
Dietary AdviceDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| ONS 1 and DA | Other | Oral Nutritional Supplement 1 and Dietary Advice Receives: Dietary Supplement: Oral Nutritional Supplement 1; Dietary Supplement: Dietary Advice |
| ONS 2 and DA | Other | Oral Nutritional Supplement 2 and Dietary Advice Receives: Dietary Supplement: Oral Nutritional Supplement 2; Dietary Supplement: Dietary Advice |
| DA Alone | Other | Dietary Advice Alone Receives: Dietary Supplement: Dietary Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrient Intake
Measured by 3 day diet diaries and 24 hour recall
Measured: 12 weeks (8 week intervention followed by 4 week follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startJul 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051777
- Sponsor's protocol ID
- NCC801
- Status last verified
- Oct 2015
- First submitted
- 17 Jan 2014
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital Discharge Oral Nutrition Support Trial
- ClinicalTrials.gov ID
- NCT02051777
- Acronym / sponsor ID
- NCC801
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nutricia UK LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Jan 2014 (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.
To investigate the effect of different strategies for managing malnutrition in the community
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ONS 1 and DA | Other | Dietary Supplement: Oral Nutritional Supplement 1, Dietary Supplement: Dietary AdviceOral Nutritional Supplement 1 and Dietary Advice |
| ONS 2 and DA | Other | Dietary Supplement: Oral Nutritional Supplement 2, Dietary Supplement: Dietary AdviceOral Nutritional Supplement 2 and Dietary Advice |
| DA Alone | Other | Dietary Supplement: Dietary AdviceDietary Advice Alone |
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 and over
- Able to eat and drink without the need for altered texture fluids
- Identified at risk of disease related malnutrition
- Competent to provide written informed consent
Key exclusion criteria (14 listed)
- Individuals unable to eat or drink
- Chronic renal disease requiring dialysis
- Galactosaemia
- Dysphagia
- Normally or going to be residing in an institution e.g. care home upon discharge from hospital
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 |
|---|---|---|
| Oral Nutritional Supplement 1Containing macro and micronutrients | Dietary supplement | ONS 1 and DA |
| Oral Nutritional Supplement 2Containing macro and micronutrients | Dietary supplement | ONS 2 and DA |
| Dietary Advice | Dietary supplement | DA Alone, ONS 1 and DA, ONS 2 and DA |
Primary outcome
Nutrient Intake
Time frame: 12 weeks (8 week intervention followed by 4 week follow up)
Measured by 3 day diet diaries and 24 hour recall
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 7 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Nutritional Supplement 1, Oral Nutritional Supplement 2 and Dietary Advice in people with Malnutrition, run by Nutricia UK Ltd 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 14 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 7 Oct 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?
Nutrient Intake (time frame: 12 weeks (8 week intervention followed by 4 week follow up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2015.