ClinicalTrials.gg
Not yet recruitingNCT07904715Updated Oct 29, 2026

Tolerance and Acceptability of an Oral Nutrition Supplement

An interventional study of Oral nutritional supplementation in Disease Related Malnutrition, sponsored by Aymes International Limited. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Aymes International Limited · Not applicable, Interventional, and Other

Updated Oct 29, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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
02

Conditions studied

  • Disease Related Malnutrition

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03

In context

Malnutrition

1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.

This study's planned enrollment of 20 is below the median of 118 across 843 interventional studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Aymes International Limited is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 , or verbal consent countersigned by an independent witness if physically unable to sign

Exclusion criteria

Exclusion Criteria:

  • 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
  • Investigator concerns about the participant's ability or willingness to comply with study requirements
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Oral nutritional supplement

    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.

    Dietary Supplement: Oral nutritional supplementation

Interventions

  • Dietary supplementOral nutritional supplementation

    A Food for Special Medical Purposes taken orally, one or two servings a day as prescribed by the study dietitian, for 7 days.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and daily from Day 1 to Day 7

  2. 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.

    Time frame: Daily from Day 1 to Day 7

  3. 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).

    Time frame: 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.

    Time frame: Day 1 to Day 7

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07904715
Lead sponsor
Aymes International Limited
Responsible party
Sponsor
First posted
Oct 29, 2026
Start date
Nov 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Oct 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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