MalnutritionNCT02648451
Acceptability and Tolerance Study of New Oral Nutritional Supplement
A study testing AYMES ROME in people with Malnutrition, run by Aymes International Limited.
Trial summary
To evaluate tolerance and acceptability of AYMES ROME in patients requiring supplementary oral nutritional support compared with currently available alternatives. To obtain data to support a submission to Advisory Committee on Borderline Substances (ACBS) for AYMES ROME (to allow for prescription in the community at… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- AYMES ROME
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2015
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years) who are able to communicate their views regarding acceptability.
- Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing approximately 300kcal/day
- Patients expected to require oral nutritional supplementation for at least 2 further weeks.
- Informed consent obtained.
Who cannot join
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
- Patients requiring a milk free diet
- Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list)
- Patients with significant renal or hepatic impairment
- Patients with swallowing impairment requiring thickened fluids
- Patients with inflammatory bowel disease or previous bowel resection.
About this study
Official title: Tolerance and Acceptability of AYMES ROME
- To evaluate tolerance and acceptability of AYMES ROME in patients requiring supplementary oral nutritional support compared with currently available alternatives.
- To obtain data to support a submission to Advisory Committee on Borderline Substances (ACBS) for AYMES ROME (to allow for prescription in the community at National Health Service (NHS) expense).
Read the detailed description
To evaluate tolerance and acceptability of AYMES ROME 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 AYMES ROME (to allow for prescription in the community at NHS expense).
- Conditions
- Malnutrition
- Being tested
- AYMES ROME
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AYMES ROMEDietary supplement
AYMES Rome is a powder, designed to be mixed with 250 ml water to make up a juice style ONS. When made up AYMES Rome provides 300 kcal (1 kcal / ml) and 10.7 g protein. It is not designed to be used as a sole source of nutrition. It is a Food for Special Medical Purposes (FSMP) and must therefore be used under medical supervision.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Patients established on an oral nutritional supplement, being prescribed 1-2 oral nutritional supplement (ONS) providing at least 300 kcal/day will be changed onto an equivalent prescription of AYMES Rome for a period of 9 days Receives: Dietary Supplement: AYMES ROME |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI side effects when using AYMES Rome
Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES Rome as assessed by presence / absence of side effect compared to baseline period
Measured: 9 days
Secondary outcomes (4)
Change to bodyweight of subjects when using AYMES Rome
Recording of bodyweight (in kg) at start of study, start of intervention and end of intervention for comparison to investigate any trend in weight change during the intervention period compared to baseline
Measured: 9 days
Compliance with prescription of AYMES Rome
Recording of amount of AYMES Rome consumed by subjects compared to amount prescribed. Good compliance = >80% of prescribed being consumed. Same data collected for baseline product and compared with that of AYMES Rome
Measured: 9 days
Bowel habits of subjects when using AYMES Rome - frequency
Recording of bowel habits whilst subjects consuming AYMES Rome, as assessed by frequency of bowel movements (number of stools per day) and compared to same data recorded during baseline period
Measured: 9 days
Bowel habits of subjects when using AYMES Rome - stool consistency
Recording of bowel habits whilst subjects consuming AYMES Rome, as assessed by consistency of stools (assessed by Bristol Stool Chart) and compared to same data recorded during baseline period
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 posted7 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionMar 2015
- Study completionMar 2015
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aymes International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alison Clark Health and Nutrition
- Responsible party
- Sponsor
- Investigators
- Alison Clarke, BSc (Hons), Principal investigator, Alison Clark Health and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648451
- Sponsor's protocol ID
- AY:SJ1
- Status last verified
- Jan 2016
- First submitted
- 18 Dec 2015
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Acceptability of AYMES ROME
- ClinicalTrials.gov ID
- NCT02648451
- Acronym / sponsor ID
- AY:SJ1
- Conditions
- Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Aymes International LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Alison Clark Health and Nutrition
- Study start
- Jan 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Jan 2016 (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.
- To evaluate tolerance and acceptability of AYMES ROME in patients requiring supplementary oral nutritional support compared with currently available alternatives.
- To obtain data to support a submission to Advisory Committee on Borderline Substances (ACBS) for AYMES ROME (to allow for prescription in the community at National Health Service (NHS) expense).
Detailed description
To evaluate tolerance and acceptability of AYMES ROME 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 AYMES ROME (to allow for prescription in the community at NHS expense).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Dietary Supplement: AYMES ROMEPatients established on an oral nutritional supplement, being prescribed 1-2 oral nutritional supplement (ONS) providing at least 300 kcal/day will be changed onto an equivalent prescription of AYMES Rome for a period of 9 days |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (≥18 years) who are able to communicate their views regarding acceptability.
- Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing approximately 300kcal/day
- Patients expected to require oral nutritional supplementation for at least 2 further weeks.
- Informed consent obtained.
Key exclusion criteria (6 listed)
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
- Patients requiring a milk free diet
- Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list)
- Patients with significant renal or hepatic impairment
- Patients with swallowing impairment requiring thickened fluids
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 ROMEAYMES Rome is a powder, designed to be mixed with 250 ml water to make up a juice style ONS. When made up AYMES Rome provides 300 kcal (1 kcal / ml) and 10.7 g protein. It is not designed to be used as a sole source of nutrition. It is a Food for Special Medical Purposes (FSMP) and must therefore be used under medical supervision. | Dietary supplement | intervention |
Primary outcome
GI side effects when using AYMES Rome
Time frame: 9 days
Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES Rome as assessed by presence / absence of side effect compared to baseline period
4 secondary outcomes
Change to bodyweight of subjects when using AYMES Rome
Time frame: 9 days
Compliance with prescription of AYMES Rome
Time frame: 9 days
Bowel habits of subjects when using AYMES Rome - frequency
Time frame: 9 days
Bowel habits of subjects when using AYMES Rome - stool consistency
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 2016.
- 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.
Alison Clarke, BSc (Hons) principal investigator
Alison Clark Health and Nutrition
Questions about this trial
What is this clinical trial studying?
A study testing AYMES ROME in people with Malnutrition, run by Aymes International Limited.
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 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 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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 side effects when using AYMES Rome (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 2016.