OncologyPREFERNCT05518825
Assessment of ONS-flavour Preference in Cancer Patients With and Without Taste Alterations
A study testing Fortimel/Nutridrink Compact Protein in people with Oncology and Taste, Altered, run by Nutricia Research at 1 site in Netherlands.
Trial summary
A single arm intervention study examining ONS-flavour preference in cancer patients with and without taste alterations Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Taste, Altered
- What is being tested?
- Fortimel/Nutridrink Compact Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteNetherlands
- Study dates
- 6 Oct 2022to 28 Mar 2023
- 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
- Being diagnosed with cancer
- Undergoing, or having undergone systemic anti-cancer treatment or radiotherapy in the past 12 months.
- Age > 18 years
- Written informed consent
Who cannot join
- Taste and smell alterations not caused by the cancer or anti-cancer treatment
- Galactosaemia
- Use of thickener to be able to swallow safely
- Allergies to any of the product ingredients or any of the flavours
- Current prescription for ONS, enteral nutrition or parenteral nutrition
- Diabetes mellitus Type I or Type II
Show all 15Show fewer
- Open sores or severe inflammation in the mouth or throat
- Undergoing dialysis
- Hepatic encephalopathy
- Patients with heart failure who have symptoms of heart failure at rest and/or are unable to carry on any physical activity without discomfort
- Known pregnancy or lactation
- Average alcohol use of > 21 glasses per week for men or > 14 glasses per week for women or drug abuse in opinion of the investigator
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- Participation in any other studies involving food products concomitantly or within two weeks prior to entry into the study.
- Employees of Nutricia Research and/or partners, parents, children and brothers/sisters of employees
Trial locations and contacts
1 site in 1 country.
About this study
A single arm intervention study examining ONS-flavour preference in cancer patients with and without taste alterations
- Conditions
- Oncology, Taste, Altered
- Being tested
- Fortimel/Nutridrink Compact Protein
- Keywords
- Oral nutritional supplement, Oncology, Taste alterations
- Medical subject headings
- Neoplasms, Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortimel/Nutridrink Compact ProteinDietary supplement
Twice daily serving of the study product
| Study group | Role | What they receive |
|---|---|---|
| Fortimel/Nutridrink Compact Protein | Experimental | Twice daily serving of the study product Receives: Dietary Supplement: Fortimel/Nutridrink Compact Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choice for the Fortimel/Nutridrink Compact Protein sensation flavour over the Fortimel/Nutridrink Compact Protein regular flavour
Subjects take one sensation flavour and one regular flavour and are asked in a direct question which flavour they prefer.
Measured: On 4 days
Secondary outcomes (3)
Difference between average liking scores [score 0-10] for Fortimel/Nutridrink Compact Protein sensation flavour range versus Fortimel/Nutridrink Compact Protein regular flavour range
Measured: On 4 days
Choice for the Fortimel/Nutridrink Compact Protein sensation flavours over the Fortimel/Nutridrink Compact Protein regular flavours between patients with and patients without Taste and Smell Alterations
Subjects take one sensation flavour and one regular flavour and are asked in a direct question which flavour they prefer.
Measured: On 4 days
Difference in average liking scores [score 0-10] for Fortimel/Nutridrink Compact Protein sensation flavour versus Fortimel/Nutridrink Compact Protein regular flavour between patients with and patients without Taste and Smell Alterations
Measured: On 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start6 Oct 2022
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518825
- Sponsor's protocol ID
- SBB21R&36579
- Acronym
- PREFER
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2022
- Last updated
- 24 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of ONS-flavour Preference in Cancer Patients With and Without Taste Alterations
- ClinicalTrials.gov ID
- NCT05518825
- Acronym / sponsor ID
- PREFER / SBB21R&36579
- Conditions
- Oncology, Taste, Altered
- Keywords
- Oral nutritional supplement, Oncology, Taste alterations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 29 Aug 2022 (actual)
- 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.
A single arm intervention study examining ONS-flavour preference in cancer patients with and without taste alterations
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fortimel/Nutridrink Compact Protein | Experimental | Dietary Supplement: Fortimel/Nutridrink Compact ProteinTwice daily serving of the study product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being diagnosed with cancer
- Undergoing, or having undergone systemic anti-cancer treatment or radiotherapy in the past 12 months.
- Age > 18 years
- Written informed consent
Key exclusion criteria (15 listed)
- Taste and smell alterations not caused by the cancer or anti-cancer treatment
- Galactosaemia
- Use of thickener to be able to swallow safely
- Allergies to any of the product ingredients or any of the flavours
- Current prescription for ONS, enteral nutrition or parenteral nutrition
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 |
|---|---|---|
| Fortimel/Nutridrink Compact ProteinTwice daily serving of the study product | Dietary supplement | Fortimel/Nutridrink Compact Protein |
Primary outcome
Choice for the Fortimel/Nutridrink Compact Protein sensation flavour over the Fortimel/Nutridrink Compact Protein regular flavour
Time frame: On 4 days
Subjects take one sensation flavour and one regular flavour and are asked in a direct question which flavour they prefer.
3 secondary outcomes
Difference between average liking scores [score 0-10] for Fortimel/Nutridrink Compact Protein sensation flavour range versus Fortimel/Nutridrink Compact Protein regular flavour range
Time frame: On 4 days
Choice for the Fortimel/Nutridrink Compact Protein sensation flavours over the Fortimel/Nutridrink Compact Protein regular flavours between patients with and patients without Taste and Smell Alterations
Time frame: On 4 days
Difference in average liking scores [score 0-10] for Fortimel/Nutridrink Compact Protein sensation flavour versus Fortimel/Nutridrink Compact Protein regular flavour between patients with and patients without Taste and Smell Alterations
Time frame: On 4 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 24 Aug 2023.
- Individual participant dataSharing planned: No
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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 Fortimel/Nutridrink Compact Protein in people with Oncology and Taste, Altered, run by Nutricia Research at 1 site in Netherlands.
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 15 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 24 Aug 2023. 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 Netherlands. 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?
Choice for the Fortimel/Nutridrink Compact Protein sensation flavour over the Fortimel/Nutridrink Compact Protein regular flavour (time frame: On 4 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 24 Aug 2023.