Disease Related MalnutritionNCT07417514
Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement
A study testing Shot Style protein supplement 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, taken either orally or via a feeding tube 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?
- Shot Style protein supplement
- 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
- 30 Sep 2022to Apr 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
- Adult patients (≥18 years) who are able to communicate clearly.
- Diagnosis of renal disease or confirmed requirement for protein supplementation by a suitably qualified health care professional (e.g. dietitian)
- Participants with or at risk of malnutrition as determined by the SGA nutritional screening tool, MUST and/or by professional clinical judgement.
- Participants expected to require an ONS for at least 28 days from baseline, to take flavour variants orally and neutral via feeding tube.
- Informed consent obtained.
Who cannot join
- Participation in any other studies involving investigational or marketed products concomitantly or within seven days prior to entry into the study
- Patients with medical or dietary contraindication to any ingredients (see appendix 2 of protocol for full list.)
- No feeding tube for any patient taking the neutral variant.
- Patients with significant hepatic impairment.
- Patients with dysphagia requiring IDDSI level 1 (or higher) fluids.
- Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
Show all 11Show fewer
- Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
- Any participant unable to give consent i.e., those with dementia.
- Participants under 18 years of age.
- Individuals who do not have sufficient proficiency with English language
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol 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, 1 recruiting
- Recruiting
UCLH NHS Foundation Trust
London, NW1 2PG
James Evans, Dietetics, 0044 0203 447 9289, j.evans28@nhs.net
About this study
Official title: Tolerance and Acceptability Evaluation of AYMES Protein Shot
To evaluate the tolerance (gastrointestinal) and acceptability of a new Oral Nutrition Supplement in patients with or at risk of disease related malnutrition, taken either orally or via a feeding tube
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, either taken orally or with a feeding tube. Outcomes of GI effects, compliance, product preference, convenience etc. 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
- Shot Style protein supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shot Style protein supplementDietary supplement
The Study product 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 |
|---|---|---|
| Shot style protein supplement | Experimental | Patients with or at risk of DRM, who have been clinical identified as requiring additional protein will be prescribed the study product for a period of 7-28days. Study product can be taken either orally or via a feeding tube. Receives: Dietary Supplement: Shot Style protein supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability and Palatability of Oral Nutrition Supplement
To assess the acceptability of the shot-style protein supplement in patients requiring oral nutritional supplementation. On day 7 and 28 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. A 5 point hedonic scale will be used.
Measured: 28 days
Gastro-Intestinal (GI) Tolerance
To assess the GI tolerance of the shot-style protein supplement in patients with or at risk of disease related malnutrition, requiring additional protein, either fed orally or with a feeding tube. Monitoring includes recording the number of any GI complaints and consistency of bowel movements via a diary for the first 7 days
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: 28 days
Secondary outcomes (1)
Safety of consumption of Study Product
Daily assessment of GI symptoms
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 posted18 Feb 2026
- Study start30 Sep 2022
- Primary completionApr 2026 (estimated)
- Study completionApr 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
- NCT07417514
- Sponsor's protocol ID
- AY:PS01
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 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 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Acceptability Evaluation of AYMES Protein Shot
- ClinicalTrials.gov ID
- NCT07417514
- Acronym / sponsor ID
- AY:PS01
- Conditions
- Disease Related Malnutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aymes International LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 18 Feb 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, taken either orally or via a feeding tube
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, either taken orally or with a feeding tube. Outcomes of GI effects, compliance, product preference, convenience etc. 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 |
|---|---|---|
| Shot style protein supplement | Experimental | Dietary Supplement: Shot Style protein supplementPatients with or at risk of DRM, who have been clinical identified as requiring additional protein will be prescribed the study product for a period of 7-28days. Study product can be taken either orally or via a feeding tube. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (≥18 years) who are able to communicate clearly.
- Diagnosis of renal disease or confirmed requirement for protein supplementation by a suitably qualified health care professional (e.g. dietitian)
- Participants with or at risk of malnutrition as determined by the SGA nutritional screening tool, MUST and/or by professional clinical judgement.
- Participants expected to require an ONS for at least 28 days from baseline, to take flavour variants orally and neutral via feeding tube.
- Informed consent obtained.
Key exclusion criteria (11 listed)
- Participation in any other studies involving investigational or marketed products concomitantly or within seven days prior to entry into the study
- Patients with medical or dietary contraindication to any ingredients (see appendix 2 of protocol for full list.)
- No feeding tube for any patient taking the neutral variant.
- Patients with significant hepatic impairment.
- Patients with dysphagia requiring IDDSI level 1 (or higher) 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 |
|---|---|---|
| Shot Style protein supplementThe Study product 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 | Shot style protein supplement |
Primary outcome
Acceptability and Palatability of Oral Nutrition Supplement
Time frame: 28 days
To assess the acceptability of the shot-style protein supplement in patients requiring oral nutritional supplementation. On day 7 and 28 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. A 5 point hedonic scale will be used.
Gastro-Intestinal (GI) Tolerance
Time frame: 7 days
To assess the GI tolerance of the shot-style protein supplement in patients with or at risk of disease related malnutrition, requiring additional protein, either fed orally or with a feeding tube. Monitoring includes recording the number of any GI complaints and consistency of bowel movements via a diary for the first 7 days
Compliance
Time frame: 28 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.
1 secondary outcome
Safety of consumption of Study Product
Time frame: 7 days
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 18 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shot Style protein supplement 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 11 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: looking for participants now, as of the sponsor's last update on 18 Feb 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?
Acceptability and Palatability of Oral Nutrition Supplement (time frame: 28 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 18 Feb 2026.