Adult Patients in Need of High-energy Oral Nutritional SupplementationFuchsiaNCT03013803
Acceptability Study on Nutricomp® Drink Plus Fibre in Adults
A study testing Nutricomp Drink Plus Fibre in people with Adult Patients in Need of High-energy Oral Nutritional Supplementation, run by B. Braun Melsungen AG 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 Fibre 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
- Adult Patients in Need of High-energy Oral Nutritional Supplementation
- What is being tested?
- Nutricomp Drink Plus Fibre
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2016to Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants ≥ 18 years of age
- Assessed to have malnutrition or be at risk of malnutrition by a Dietician within the investigator team. Assessment to include, but not limited to weight loss history, current BMI/MUST score, anamnesis, dietary intake history and predicted future oral intake.
- Anticipated period of nutritional support ≥ 12 days
- Patient has the capacity and is willing to provide informed consent.
Who cannot join
- Participants with mental in capabilities who are unable to give informed consent
- Hypersensitivity to any of the active substances or excipients within the IP
- Severely impaired gastrointestinal function or complete failure
- More than 50% of nutrition from Parenteral Nutrition
- Simultaneous participation in another interventional study
- Participants who are unwilling or mentally and/or physically unable to adhere to study procedures
Show all 9Show fewer
- Participants with dysphagia requiring thickened fluids
- Participants with significant renal impairment (CKD)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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 Fibre to show that it is acceptable for patients in the United Kingdom.
- Being tested
- Nutricomp Drink Plus Fibre
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutricomp Drink Plus FibreDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Nutricomp Drink Plus Fibre | Experimental | Nutricomp® Drink Plus Fibre (flavours vanilla, coffee, peach-apricot and chocolate) Receives: Dietary Supplement: Nutricomp Drink Plus Fibre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of gastrointestinal tolerance parameters
Measured: Day 1 - day 13
Secondary outcomes (2)
Occurrence of (further) adverse events during the treatment period (yes/no, if yes timing/duration/assumed cause/seriousness/severity)
Measured: Day 1 - day 13
Palatability evaluation performed under controlled condition using a questionnaire with a 5 point hedonic scale rang
Measured: Day 1 - day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Patients in Need of High-energy 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013803
- Sponsor's protocol ID
- HC-G-H-1610
- Acronym
- Fuchsia
- Status last verified
- Jan 2017
- First submitted
- 19 Dec 2016
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability Study on Nutricomp® Drink Plus Fibre in Adults
- ClinicalTrials.gov ID
- NCT03013803
- Acronym / sponsor ID
- Fuchsia / HC-G-H-1610
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Jan 2017 (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 Fibre to show that it is acceptable for patients in the United Kingdom.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutricomp Drink Plus Fibre | Experimental | Dietary Supplement: Nutricomp Drink Plus FibreNutricomp® Drink Plus Fibre (flavours vanilla, coffee, peach-apricot and chocolate) |
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 participants ≥ 18 years of age
- Assessed to have malnutrition or be at risk of malnutrition by a Dietician within the investigator team. Assessment to include, but not limited to weight loss history, current BMI/MUST score, anamnesis, dietary intake history and predicted future oral intake.
- Anticipated period of nutritional support ≥ 12 days
- Patient has the capacity and is willing to provide informed consent.
Key exclusion criteria (9 listed)
- Participants with mental in capabilities who are unable to give informed consent
- Hypersensitivity to any of the active substances or excipients within the IP
- Severely impaired gastrointestinal function or complete failure
- More than 50% of nutrition from Parenteral Nutrition
- Simultaneous participation in another interventional study
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 Plus Fibre | Dietary supplement | Nutricomp Drink Plus Fibre |
Primary outcome
Occurrence of gastrointestinal tolerance parameters
Time frame: Day 1 - day 13
2 secondary outcomes
Occurrence of (further) adverse events during the treatment period (yes/no, if yes timing/duration/assumed cause/seriousness/severity)
Time frame: Day 1 - day 13
Palatability evaluation performed under controlled condition using a questionnaire with a 5 point hedonic scale rang
Time frame: Day 1 - day 13
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 Aug 2017.
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 Nutricomp Drink Plus Fibre in people with Adult Patients in Need of High-energy Oral Nutritional Supplementation, run by B. Braun Melsungen AG 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 9 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 Aug 2017. 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?
Occurrence of gastrointestinal tolerance parameters (time frame: Day 1 - day 13). 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 11 Aug 2017.