Disease Related MalnutritionNCT07452523
Tolerance, Palatability and Acceptability Evaluation of an Oral Nutrition Supplement
A study testing AYMES SWIFT oral nutritional supplement, AYMES SWIFT FIBRE and AYMES SWIFT PLANT in people with Disease Related Malnutrition, run by Aymes International Limited at 1 site in United Kingdom.
Trial summary
To evaluate the tolerance (gastrointestinal) and acceptability of a new Oral Nutrition Supplement in patients with or at risk of disease related malnutrition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disease Related Malnutrition
- What is being tested?
- AYMES SWIFT oral nutritional supplement, AYMES SWIFT FIBRE and AYMES SWIFT PLANT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2022to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 or female
- •≥ 18 years of age
- Identified as being malnourished/at risk of malnutrition-by-malnutrition screening tools [i.e., MUST score ≥1, and/or using or requiring ONS at least once daily as part of nutritional management plan]
- Expected to receive at least one bottle of ONS per day
- Written or electronic informed consent from patient, or verbally given consent countersigned by a witness for those physically unable to sign
Who cannot join
- Participants receiving parenteral nutrition or ≥70% total energy requirements from enteral tube feeding
- Participants with major hepatic dysfunction (i.e., decompensated liver disease)
- Participants with major renal dysfunction [i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD)]
- Participants with active/chronic gastrointestinal disease or impaired gastrointestinal function
- Participants with significant dysphagia/high aspiration risk
- Participation in other clinical intervention studies within 1 month of this study
Show all 9Show fewer
- Participants lacking mental capacity to consent
- Allergy to any study product ingredients (appendix 2)
- Investigator concern regarding ability or willingness of patient to comply with the study requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerance and Acceptability Evaluation of AYMES SWIFT
To evaluate the tolerance (gastrointestinal) and acceptability of a new Oral Nutrition Supplement in patients with or at risk of disease related malnutrition.
Read the detailed description
To evaluate tolerance and acceptability of a new Oral Nutrition Supplement in patients with or at risk of malnutrition, who require supplementary nutrition support. Outcomes of GI effects, compliance and palatability will be recorded.
To obtain data to support an ACBS submission (to allow for prescription in the community at NHS expense).
- Conditions
- Disease Related Malnutrition
- Being tested
- AYMES SWIFT oral nutritional supplement, AYMES SWIFT FIBRE, AYMES SWIFT PLANT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AYMES SWIFT oral nutritional supplementDietary supplement
Also called AYMES SWIFT Fibre
The study supplement is an oral nutritional supplement and food for special medical purposes.
AYMES SWIFT FIBREDietary supplement
An oral nutritional supplement and food for special medical purposes.
AYMES SWIFT PLANTDietary supplement
A plant based oral nutritional supplement and food for special medical purposes.
| Study group | Role | What they receive |
|---|---|---|
| AYMES SWIFT | Experimental | Patients with or at risk of disease related malnutrition (DRM), who have been clinically identified as requiring nutritional supplementation will be prescribed the study product for a period of 7 days. Receives: Dietary Supplement: AYMES SWIFT oral nutritional supplement; Dietary Supplement: AYMES SWIFT FIBRE; Dietary Supplement: AYMES SWIFT PLANT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and palatability of an oral nutriitonal supplement.
To assess the acceptability of the oral nutritional supplement in patients requiring oral nutritional supplementation. On day 7 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 oral nutrition supplement. Questions will be rated on a 7 point Likert scale (Strongly Agree, Somewhat agree, Neutral, Somewhat Disagree, Disagree, Disagree Strongly) and will relate to taste, smell, texure and overall liking.
Measured: 7 days
Gastro-intestinal Tolerance
To assess the GI tolerance of the oral nutritional supplement in patients with or at risk of disease related malnutrition. Monitoring includes recording the number of any GI complaints and consistency of bowel movements via a diary for the first 7 days.
A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea) will be recorded on day 1 (based on the 2 preceding days) and for the first 7 days during the intervention.
Information about bowel movements will also be collected using the Bristol Stool Chart© at the same time points.
Measured: 7 days
Compliance
To assess the compliance of patients taking the Study product as prescribed. This is measured by daily completion of a compliance diary, comparing consumed amount versus prescribed amount.
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 posted5 Mar 2026
- Study start1 Oct 2022
- Primary completion31 Dec 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease Related 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aymes International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452523
- Sponsor's protocol ID
- AY-SWIFT
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 5 Mar 2026
- 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 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Acceptability Evaluation of AYMES SWIFT
- ClinicalTrials.gov ID
- NCT07452523
- Acronym / sponsor ID
- AY-SWIFT
- Conditions
- Disease Related Malnutrition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aymes International LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Mar 2026 (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 the tolerance (gastrointestinal) and acceptability of a new Oral Nutrition Supplement in patients with or at risk of disease related malnutrition.
Detailed description
To evaluate tolerance and acceptability of a new Oral Nutrition Supplement in patients with or at risk of malnutrition, who require supplementary nutrition support. Outcomes of GI effects, compliance and palatability will be recorded.
To obtain data to support an ACBS submission (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 |
|---|---|---|
| AYMES SWIFT | Experimental | Dietary Supplement: AYMES SWIFT oral nutritional supplement, Dietary Supplement: AYMES SWIFT FIBRE, Dietary Supplement: AYMES SWIFT PLANTPatients with or at risk of disease related malnutrition (DRM), who have been clinically identified as requiring nutritional supplementation will be prescribed the study product for a period of 7 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)
- Male or female
- •≥ 18 years of age
- Identified as being malnourished/at risk of malnutrition-by-malnutrition screening tools [i.e., MUST score ≥1, and/or using or requiring ONS at least once daily as part of nutritional management plan]
- Expected to receive at least one bottle of ONS per day
- Written or electronic informed consent from patient, or verbally given consent countersigned by a witness for those physically unable to sign
Key exclusion criteria (9 listed)
- Participants receiving parenteral nutrition or ≥70% total energy requirements from enteral tube feeding
- Participants with major hepatic dysfunction (i.e., decompensated liver disease)
- Participants with major renal dysfunction [i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD)]
- Participants with active/chronic gastrointestinal disease or impaired gastrointestinal function
- Participants with significant dysphagia/high aspiration risk
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 SWIFT oral nutritional supplementAlso: AYMES SWIFT FibreThe study supplement is an oral nutritional supplement and food for special medical purposes. | Dietary supplement | AYMES SWIFT |
| AYMES SWIFT FIBREAn oral nutritional supplement and food for special medical purposes. | Dietary supplement | AYMES SWIFT |
| AYMES SWIFT PLANTA plant based oral nutritional supplement and food for special medical purposes. | Dietary supplement | AYMES SWIFT |
Primary outcome
Acceptability and palatability of an oral nutriitonal supplement.
Time frame: 7 days
To assess the acceptability of the oral nutritional supplement in patients requiring oral nutritional supplementation. On day 7 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 oral nutrition supplement. Questions will be rated on a 7 point Likert scale (Strongly Agree, Somewhat agree, Neutral, Somewhat Disagree, Disagree, Disagree Strongly) and will relate to taste, smell, texure and overall liking.
Gastro-intestinal Tolerance
Time frame: 7 days
To assess the GI tolerance of the oral nutritional supplement in patients with or at risk of disease related malnutrition. Monitoring includes recording the number of any GI complaints and consistency of bowel movements via a diary for the first 7 days. A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea) will be recorded on day 1 (based on the 2 preceding days) and for the first 7 days during the intervention. Information about bowel movements will also be collected using the Bristol Stool Chart© at the same time points.
Compliance
Time frame: 7 days
To assess the compliance of patients taking the Study product as prescribed. This is measured by daily completion of a compliance diary, comparing consumed amount versus prescribed amount.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- 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 SWIFT oral nutritional supplement, AYMES SWIFT FIBRE and AYMES SWIFT PLANT in people with Disease Related 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: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Acceptability and palatability of an oral nutriitonal supplement. (time frame: 7 days). The study lists 3 primary outcomes in all. 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 5 Mar 2026.