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New protein shot aims to help malnourished patients

NCT ID NCT07417514

Disease control Sponsor: Aymes International Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new protein drink (AYMES Protein Shot) in 40 adults with or at risk of malnutrition due to illness. The goal is to see if the drink is easy to take, tastes good, and causes any stomach issues. Participants will use the product for 28 days and report their experiences.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

kidney disorder nutritional deficiency disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Disease related malnutrition

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UCLH NHS Foundation Trust

    RECRUITING

    London, NW1 2PG, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.