UndernutritionPhase 3NSCSNCT00688649
Nutritional Supplement Compliance Study
A Phase 3 study testing Standard Oral Nutritional Supplement (ONS) and High energy Oral Nutritional Supplement (ONS) in people with Undernutrition, run by Nutricia UK Ltd at 1 site in United Kingdom.
Trial summary
Disease-related malnutrition is common across healthcare settings in the UK and if left untreated, may have severe consequences. One of the strategies commonly used to combat malnutrition is the use of oral nutritional supplements (ONS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Undernutrition
- What is being tested?
- Standard Oral Nutritional Supplement (ONS) and High energy Oral Nutritional Supplement (ONS)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2008to Jan 2009
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Age > 18 years
- At risk of malnutrition (medium or high risk of malnutrition with 'Malnutrition Universal Screening Tool', 'MUST' score ≥ 1)
- Competent to provide written informed consent and able to answer questions
- No requirement for tube or parenteral feeding
- Willingness to take part in the study and to follow the study protocol
Who cannot join
- Requirement for tube or parenteral nutrition
- Participants receiving palliative care
- Participants with chronic renal disease requiring dialysis
- Participants with liver failure
- Participants that are pregnant or lactating
- Participation in other studies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal United Hospital, Nutrition and Dietetics Dept
Bath, Wiltshire, BA1 3Ng
About this study
Official title: An Investigation of the Effects of Different Modes of Delivery of Oral Nutritional Supplements in Participants at Risk of Malnutrition - A Pilot Study
Disease-related malnutrition is common across healthcare settings in the UK and if left untreated, may have severe consequences. One of the strategies commonly used to combat malnutrition is the use of oral nutritional supplements (ONS). However, there is uncertainty about the optimal way of delivering ONS to patients to maximize compliance and nutrient intake.
This randomised study will investigate the effect of different modes of delivery (ad libitum versus instructions on timing/serving volume) of ONS used in addition to the diet on total nutrient intake, compliance, nutritional status and outcome in participants at risk of malnutrition.
Participants will be randomised to receive one of two ONS (high energy or standard) for 4 weeks in addition to food, either taken 'Ad libitum', or according to instruction on what to take and when. The primary outcome measure is nutrient intake. Secondary outcome measures include compliance and acceptability of ONS, appetite, anthropometry, muscle strength, quality of life and gastro-intestinal tolerance.
- Conditions
- Undernutrition
- Being tested
- Standard Oral Nutritional Supplement (ONS), High energy Oral Nutritional Supplement (ONS)
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Oral Nutritional Supplement (ONS)Dietary supplement
Standard energy, oral nutritional supplement (a milk style nutritional supplement (1.5kcal/ml, 200ml) containing protein, fat, carbohydrate and micronutrients)
High energy Oral Nutritional Supplement (ONS)Dietary supplement
High Energy nutritional supplement (a milk style nutritional supplement (2.4kcal/ml, 125ml) containing protein, fat, carbohydrate and micronutrients)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard ONS Receives: Dietary Supplement: Standard Oral Nutritional Supplement (ONS) |
| 2 | Active comparator | High Energy ONS Receives: Dietary Supplement: High energy Oral Nutritional Supplement (ONS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrient intake (energy, protein and micronutrients)
Measured: 4 weeks
Secondary outcomes (1)
Compliance with ONS
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndernutritionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lucio Fumi, Study director, Nutricia UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688649
- Sponsor's protocol ID
- NCC200
- Acronym
- NSCS
- Status last verified
- Feb 2009
- First submitted
- 27 May 2008
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Effects of Different Modes of Delivery of Oral Nutritional Supplements in Participants at Risk of Malnutrition - A Pilot Study
- ClinicalTrials.gov ID
- NCT00688649
- Acronym / sponsor ID
- NSCS / NCC200
- Conditions
- Undernutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nutricia UK LtdIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 3 Jun 2008 (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.
Disease-related malnutrition is common across healthcare settings in the UK and if left untreated, may have severe consequences. One of the strategies commonly used to combat malnutrition is the use of oral nutritional supplements (ONS). However, there is uncertainty about the optimal way of delivering ONS to patients to maximize compliance and nutrient intake.
This randomised study will investigate the effect of different modes of delivery (ad libitum versus instructions on timing/serving volume) of ONS used in addition to the diet on total nutrient intake, compliance, nutritional status and outcome in participants at risk of malnutrition.
Participants will be randomised to receive one of two ONS (high energy or standard) for 4 weeks in addition to food, either taken 'Ad libitum', or according to instruction on what to take and when. The primary outcome measure is nutrient intake. Secondary outcome measures include compliance and acceptability of ONS, appetite, anthropometry, muscle strength, quality of life and gastro-intestinal tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Standard Oral Nutritional Supplement (ONS)Standard ONS |
| 2 | Active comparator | Dietary Supplement: High energy Oral Nutritional Supplement (ONS)High Energy ONS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female
- Age > 18 years
- At risk of malnutrition (medium or high risk of malnutrition with 'Malnutrition Universal Screening Tool', 'MUST' score ≥ 1)
- Competent to provide written informed consent and able to answer questions
- No requirement for tube or parenteral feeding
Key exclusion criteria (6 listed)
- Requirement for tube or parenteral nutrition
- Participants receiving palliative care
- Participants with chronic renal disease requiring dialysis
- Participants with liver failure
- Participants that are pregnant or lactating
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 |
|---|---|---|
| Standard Oral Nutritional Supplement (ONS)Standard energy, oral nutritional supplement (a milk style nutritional supplement (1.5kcal/ml, 200ml) containing protein, fat, carbohydrate and micronutrients) | Dietary supplement | 1 |
| High energy Oral Nutritional Supplement (ONS)High Energy nutritional supplement (a milk style nutritional supplement (2.4kcal/ml, 125ml) containing protein, fat, carbohydrate and micronutrients) | Dietary supplement | 2 |
Primary outcome
Nutrient intake (energy, protein and micronutrients)
Time frame: 4 weeks
1 secondary outcome
Compliance with ONS
Time frame: 4 weeks
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 4 Feb 2009.
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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.
Lucio Fumi study director
Nutricia UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Standard Oral Nutritional Supplement (ONS) and High energy Oral Nutritional Supplement (ONS) in people with Undernutrition, 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 6 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 4 Feb 2009. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (energy, protein and micronutrients) (time frame: 4 weeks). 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 4 Feb 2009.