Oral Nutritional SupplementationPhase 4NCT02538250
Acceptability Study on Oral Nutrition Supplement (ONS)
A Phase 4 study testing Nutricomp Drink Plus in people with Oral Nutritional Supplementation, run by B. Braun Medical UK Ltd. at 1 site in United Kingdom.
Trial summary
Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus to show that it is acceptable for patients in the United Kingdom. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Nutritional Supplementation
- What is being tested?
- Nutricomp Drink Plus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Oct 2015
- Phase
- Phase 4
- 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 and female patients
- ≥ 18 years of age
- Patients of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 7 days
- Patient is able and willing to provide written informed consent
Who cannot join
- Hypersensitivity to milk, whey, soy, fish or any of the active substances or excipients
- Patients with available or potential impairment of sense of taste or smell due to disease (e.g. patients with cold, cancer patients) or medication (e.g. D-Penicillamine)
- Patients who express general dislike to two or more of the four flavours
- Severely impaired gastrointestinal function or complete failure
- Severe metabolic or circulatory disorders
- Acute disease
Show all 12Show fewer
- Unstable vital functions
- Necessity of total parenteral nutrition or more than 50% Parenteral Nutrition in combined therapy
- Simultaneous participation in another interventional study
- Patients who are unwilling or mentally and/or physically unable to adhere to study procedures
- Pregnancy
- Emergencies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust, The Royal Hallamshire Hospital, Regional Gastrointestinal and Liver Unit
Sheffield, S10 2JF
About this study
Official title: Acceptability Study on Nutricomp Drink Plus in Adult Patients
Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus to show that it is acceptable for patients in the United Kingdom.
- Conditions
- Oral Nutritional Supplementation
- Being tested
- Nutricomp Drink Plus
- Keywords
- Oral nutritional supplement, supplementation, adult patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutricomp Drink PlusDietary supplement
Oral nutritional supplementation
| Study group | Role | What they receive |
|---|---|---|
| 1 Nutricomp Drink Plus | Experimental | Nutricomp Drink Plus Receives: Dietary Supplement: Nutricomp Drink Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of gastrointestinal tolerance parameters (Diarrhoea, Constipation, Bloating, Distension, Nausea, Vomiting, Burping, Regurgitation, Flatulence, Abdominal discomfort, Abdominal pain, Other (further gastrointestinal adverse events)
Parameters asked as required for acceptability studies by Advisory Committee for Borderline Substances- documented in a patient diary
Measured: 7 days
Secondary outcomes (3)
Occurrence of further adverse effects
Measured: 7 days
Evaluation of palatability by questionnaire
Five point hedonic scale
Measured: 1 day
Evaluation of compliance.
Comparison of prescription and actual intake
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Nutritional SupplementationStudies 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 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Medical UK Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Sanders, Prof., Principal investigator, The Royal Hallamshire Hospital,Regional Gastrointestinal and Liver Unit, Sheffield, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538250
- Sponsor's protocol ID
- HC-G-H-1422
- Status last verified
- Oct 2016
- First submitted
- 24 Jun 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability Study on Nutricomp Drink Plus in Adult Patients
- ClinicalTrials.gov ID
- NCT02538250
- Acronym / sponsor ID
- HC-G-H-1422
- Conditions
- Oral Nutritional Supplementation
- Keywords
- Oral nutritional supplement, supplementation, adult patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- B. Braun Medical UK Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Sep 2015 (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.
Required for Advisory Committee for Borderline Substances (ACBS) approval. Aim of this study is to access the palatability, compliance and GI-tolerance of Nutricomp® Drink Plus to show that it is acceptable for patients in the United Kingdom.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 Nutricomp Drink Plus | Experimental | Dietary Supplement: Nutricomp Drink PlusNutricomp Drink Plus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients
- ≥ 18 years of age
- Patients of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 7 days
- Patient is able and willing to provide written informed consent
Key exclusion criteria (12 listed)
- Hypersensitivity to milk, whey, soy, fish or any of the active substances or excipients
- Patients with available or potential impairment of sense of taste or smell due to disease (e.g. patients with cold, cancer patients) or medication (e.g. D-Penicillamine)
- Patients who express general dislike to two or more of the four flavours
- Severely impaired gastrointestinal function or complete failure
- Severe metabolic or circulatory disorders
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 |
|---|---|---|
| Nutricomp Drink PlusOral nutritional supplementation | Dietary supplement | 1 Nutricomp Drink Plus |
Primary outcome
Occurrence of gastrointestinal tolerance parameters (Diarrhoea, Constipation, Bloating, Distension, Nausea, Vomiting, Burping, Regurgitation, Flatulence, Abdominal discomfort, Abdominal pain, Other (further gastrointestinal adverse events)
Time frame: 7 days
Parameters asked as required for acceptability studies by Advisory Committee for Borderline Substances- documented in a patient diary
3 secondary outcomes
Occurrence of further adverse effects
Time frame: 7 days
Evaluation of palatability by questionnaire
Time frame: 1 day
Evaluation of compliance.
Time frame: 7 days
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 13 Oct 2016.
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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.
David Sanders, Prof. principal investigator
The Royal Hallamshire Hospital,Regional Gastrointestinal and Liver Unit, Sheffield, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nutricomp Drink Plus in people with Oral Nutritional Supplementation, run by B. Braun Medical 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 4 inclusion and 12 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 13 Oct 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Occurrence of gastrointestinal tolerance parameters (Diarrhoea, Constipation, Bloating, Distension, Nausea, Vomiting, Burping, Regurgitation, Flatulence, Abdominal discomfort, Abdominal pain, Other (further gastrointestinal adverse events) (time frame: 7 days). 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 13 Oct 2016.