MalnutritionNCT03836274
Tolerance and Acceptability Evaluation of MONACO
A study testing AYMES MONACO in people with Malnutrition, run by Aymes International Limited at 1 site in United Kingdom.
Trial summary
To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral nutritional support compared with currently available alternatives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition
- What is being tested?
- AYMES MONACO
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2017to 1 Jan 2020
- 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
- Patients (>18 years) who are able to communicate clearly.
- Patients with or at risk of malnutrition as determined by growth charts and/or by professional clinical judgement.
- Patients expected to require oral nutritional supplementation for at least 2 further weeks.
- Patients requiring supplementary intake approximately 300 kcal /day from an oral nutritional supplement
- Informed assent/consent obtained.
Who cannot join
- Patients with cow's milk protein allergy requiring a milk free diet
- Patients with inherited metabolic conditions.
- Patients requiring enteral tube feeding or parenteral nutrition.
- Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 for full ingredient list)
- Patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis)
- Patients with dysphagia requiring stage 1, 2 or 3 thickened fluids.
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- Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
- Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements
- Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral nutritional support compared with currently available alternatives.
Read the detailed description
To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference, convenience etc.
To obtain data to support an ACBS submissions for 'MONACO' (to allow for prescription in the community at NHS expense).
- Conditions
- Malnutrition
- Being tested
- AYMES MONACO
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AYMES MONACODietary supplement
AYMES MONACO is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is not designed as a sole source of nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients established on an oral nutritional supplement (ONS), requiring nutritional supplementation of at least 300kcal/day will be changed onto an equivalent prescription of AYMES 'MONACO' for a period of 9 days. Receives: Dietary Supplement: AYMES MONACO |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI Tolerance
To assess gastro-intestinal tolerance of 'MONACO' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number and consistency of bowel movements, any episodes of nausea, vomiting, abdominal pain, bloating or diarrhoea.
Measured: 9 Days
Secondary outcomes (1)
Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire
To assess the acceptability of 'MONACO' in patients in the community requiring oral nutritional supplementation. At the end of the intervention period an acceptability and preference questionnaire will be completed by the patient in order to seek their opinion on the taste, smell, texture and overall liking of the new supplement drink. A 5 point hedonic scale will be used.
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start1 Nov 2017
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aymes International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836274
- Sponsor's protocol ID
- AY:ASK-SCH
- Status last verified
- Jan 2020
- First submitted
- 6 Feb 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- 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 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Acceptability Evaluation of MONACO
- ClinicalTrials.gov ID
- NCT03836274
- Acronym / sponsor ID
- AY:ASK-SCH
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Aymes International LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 11 Feb 2019 (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.
To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral nutritional support compared with currently available alternatives.
Detailed description
To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference, convenience etc.
To obtain data to support an ACBS submissions for 'MONACO' (to allow for prescription in the community at NHS expense).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: AYMES MONACOPatients established on an oral nutritional supplement (ONS), requiring nutritional supplementation of at least 300kcal/day will be changed onto an equivalent prescription of AYMES 'MONACO' for a period of 9 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients (>18 years) who are able to communicate clearly.
- Patients with or at risk of malnutrition as determined by growth charts and/or by professional clinical judgement.
- Patients expected to require oral nutritional supplementation for at least 2 further weeks.
- Patients requiring supplementary intake approximately 300 kcal /day from an oral nutritional supplement
- Informed assent/consent obtained.
Key exclusion criteria (9 listed)
- Patients with cow's milk protein allergy requiring a milk free diet
- Patients with inherited metabolic conditions.
- Patients requiring enteral tube feeding or parenteral nutrition.
- Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 for full ingredient list)
- Patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis)
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 |
|---|---|---|
| AYMES MONACOAYMES MONACO is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is not designed as a sole source of nutrition. | Dietary supplement | Experimental |
Primary outcome
GI Tolerance
Time frame: 9 Days
To assess gastro-intestinal tolerance of 'MONACO' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number and consistency of bowel movements, any episodes of nausea, vomiting, abdominal pain, bloating or diarrhoea.
1 secondary outcome
Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire
Time frame: 9 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 7 Jan 2020.
- 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 AYMES MONACO in people with Malnutrition, run by Aymes International Limited 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 5 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 7 Jan 2020. 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?
GI Tolerance (time frame: 9 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 7 Jan 2020.