Disease Related MalnutritionNCT07904715
Tolerance and Acceptability of an Oral Nutrition Supplement
A study testing Oral nutritional supplementation in people with Disease Related Malnutrition, run by Aymes International Limited at 1 site in United Kingdom.
Trial summary
The goal of this study is to learn whether a new oral nutritional supplement is acceptable to adults who are malnourished, or at risk of malnutrition, and need nutritional support. 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?
- Oral nutritional supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2026to 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
- Aged 18 years or over
- Male or female
- Malnourished or at risk of malnutrition, identified using a validated screening tool (e.g. Malnutrition Universal Screening Tool (MUST) score of 1 or more), and/or currently using or requiring oral nutritional supplements as part of a nutritional management plan
- Expected to take at least one serving of the study product per day (some participants may be prescribed two servings per day, depending on individual nutritional requirements)
- Able to provide written or electronic informed consent, or verbal consent countersigned by an independent witness if physically unable to sign
Who cannot join
- Receiving exclusive enteral or parenteral nutrition (no oral intake)
- Known allergy or intolerance to any ingredient in the study product, including milk, or any dietary requirement or preference incompatible with its composition (e.g. vegan)
- Acute illness or unstable medical condition that may interfere with participation (e.g. major hepatic or renal dysfunction such as decompensated liver disease)
- Currently in intensive care
- Participation in another interventional clinical study within 2 weeks before this study
- Insufficient proficiency in the English language
- Lacking the mental capacity to provide informed consent
- Investigator concerns about the participant's ability or willingness to comply with study requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
Alison Head of Research Governance and Quality, 0115 924 9924 ext. 80755, nuhnt.researchsponsor@nhs.net
About this study
Official title: Evaluation of the Acceptability and Palatability of AYMES Essentials
The goal of this study is to learn whether a new oral nutritional supplement is acceptable to adults who are malnourished, or at risk of malnutrition, and need nutritional support.
The main questions it aims to answer are:
Read more
- Do participants tolerate the supplement without stomach or bowel problems?
- How much of the prescribed supplement do participants take each day?
- How do participants rate the taste, texture and overall experience of taking the supplement?
Researchers will also record any side effects.
Participants will:
- Take the supplement every day for 7 days, as prescribed by their dietitian
- Keep a daily diary of how much they take and any stomach or bowel symptoms
- Complete a short questionnaire about the supplement and have a review with the study team on Day 7
- Conditions
- Disease Related Malnutrition
- Being tested
- Oral nutritional supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritional supplementationDietary supplement
A Food for Special Medical Purposes taken orally, one or two servings a day as prescribed by the study dietitian, for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Oral nutritional supplement | Experimental | All participants take the oral nutritional supplement every day for 7 days, at one or two servings a day as prescribed by the study dietitian. Participants record their intake and any stomach or bowel symptoms in a daily diary, and complete a questionnaire and a review with the study team on Day 7. Receives: Dietary Supplement: Oral nutritional supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerance
Participants record gastrointestinal symptoms each day in a diary: nausea, vomiting, bloating, abdominal pain, constipation, diarrhoea, and burping or flatulence. Each symptom is rated none, mild, moderate or severe. Bowel movement frequency and stool type are recorded each day using the Bristol Stool Chart. Results are reported as how often each symptom occurs and how severe it is, compared with symptoms recorded at baseline.
Measured: Baseline and daily from Day 1 to Day 7
Compliance with the prescribed oral nutritional supplement
Participants record each day in a diary the number of servings prescribed and taken, and the reasons for any missed or partly taken servings. Compliance is reported as the percentage of prescribed servings each participant took over the study period.
Measured: Daily from Day 1 to Day 7
Palatability of the oral nutritional supplement
Participants complete a questionnaire rating appearance, smell, taste, texture, aftertaste, convenience and how pleasant the supplement is to take. Each item is scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Overall satisfaction is rated on a 5-point scale from 1 (very dissatisfied) to 5 (very satisfied).
Measured: Day 7
Secondary outcomes (1)
Adverse events
The investigator records all adverse events, including the number of participants with at least one adverse event, how severe each event was (mild, moderate or severe) and whether it was related to the study product (from not related to highly probably related). Serious adverse events are also reported.
Measured: Day 1 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 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
- 20 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
- NCT07904715
- Sponsor's protocol ID
- AY-ASE01
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Acceptability and Palatability of AYMES Essentials
- ClinicalTrials.gov ID
- NCT07904715
- Acronym / sponsor ID
- AY-ASE01
- Conditions
- Disease Related Malnutrition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aymes International LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Oct 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.
The goal of this study is to learn whether a new oral nutritional supplement is acceptable to adults who are malnourished, or at risk of malnutrition, and need nutritional support.
The main questions it aims to answer are:
- Do participants tolerate the supplement without stomach or bowel problems?
- How much of the prescribed supplement do participants take each day?
- How do participants rate the taste, texture and overall experience of taking the supplement?
Researchers will also record any side effects.
Participants will:
- Take the supplement every day for 7 days, as prescribed by their dietitian
- Keep a daily diary of how much they take and any stomach or bowel symptoms
- Complete a short questionnaire about the supplement and have a review with the study team on Day 7
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral nutritional supplement | Experimental | Dietary Supplement: Oral nutritional supplementationAll participants take the oral nutritional supplement every day for 7 days, at one or two servings a day as prescribed by the study dietitian. Participants record their intake and any stomach or bowel symptoms in a daily diary, and complete a questionnaire and a review with the study team on Day 7. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or over
- Male or female
- Malnourished or at risk of malnutrition, identified using a validated screening tool (e.g. Malnutrition Universal Screening Tool (MUST) score of 1 or more), and/or currently using or requiring oral nutritional supplements as part of a nutritional management plan
- Expected to take at least one serving of the study product per day (some participants may be prescribed two servings per day, depending on individual nutritional requirements)
- Able to provide written or electronic informed consent, or verbal consent countersigned by an independent witness if physically unable to sign
Key exclusion criteria (8 listed)
- Receiving exclusive enteral or parenteral nutrition (no oral intake)
- Known allergy or intolerance to any ingredient in the study product, including milk, or any dietary requirement or preference incompatible with its composition (e.g. vegan)
- Acute illness or unstable medical condition that may interfere with participation (e.g. major hepatic or renal dysfunction such as decompensated liver disease)
- Currently in intensive care
- Participation in another interventional clinical study within 2 weeks before this 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 |
|---|---|---|
| Oral nutritional supplementationA Food for Special Medical Purposes taken orally, one or two servings a day as prescribed by the study dietitian, for 7 days. | Dietary supplement | Oral nutritional supplement |
Primary outcome
Gastrointestinal tolerance
Time frame: Baseline and daily from Day 1 to Day 7
Participants record gastrointestinal symptoms each day in a diary: nausea, vomiting, bloating, abdominal pain, constipation, diarrhoea, and burping or flatulence. Each symptom is rated none, mild, moderate or severe. Bowel movement frequency and stool type are recorded each day using the Bristol Stool Chart. Results are reported as how often each symptom occurs and how severe it is, compared with symptoms recorded at baseline.
Compliance with the prescribed oral nutritional supplement
Time frame: Daily from Day 1 to Day 7
Participants record each day in a diary the number of servings prescribed and taken, and the reasons for any missed or partly taken servings. Compliance is reported as the percentage of prescribed servings each participant took over the study period.
Palatability of the oral nutritional supplement
Time frame: Day 7
Participants complete a questionnaire rating appearance, smell, taste, texture, aftertaste, convenience and how pleasant the supplement is to take. Each item is scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Overall satisfaction is rated on a 5-point scale from 1 (very dissatisfied) to 5 (very satisfied).
1 secondary outcome
Adverse events
Time frame: Day 1 to Day 7
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 29 Oct 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.
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral nutritional supplementation 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 8 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: opening soon, as of the sponsor's last update on 29 Oct 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal tolerance (time frame: Baseline and daily from Day 1 to Day 7). 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 29 Oct 2026.