Shot-style oral protein supplement for adults with or at risk of malnutrition
Tolerance and Acceptability Evaluation of AYMES Protein Shot
This project will test whether a new shot-style protein oral nutrition supplement is well tolerated and acceptable for adults with or at risk of disease-related malnutrition who take nutrition by mouth or via a feeding tube.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aymes International Limited Industry-sponsored |
| Locations | 1 site (London) |
| Trial ID | NCT07417514 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls adults (≥18) who are malnourished or at risk and who require supplementary nutrition for at least 28 days. Participants will take flavour variants orally and a neutral variant via feeding tube as appropriate. The study will record gastrointestinal tolerance, compliance, product preference, and convenience. Data collected are intended to support an ACBS submission to enable community prescription under the NHS.
Who should consider this trial
Good fit: Adults with or at risk of disease-related malnutrition who require supplemental nutrition for at least 28 days and who have a diagnosis of renal disease or a confirmed clinical need for protein supplementation are ideal candidates.
Not a fit: Patients with significant hepatic impairment, contraindications to any product ingredients, severe dysphagia requiring IDDSI level 1, or who cannot take the neutral variant via a feeding tube are unlikely to benefit from this product.
Why it matters
Potential benefit: If successful, the supplement could offer a more acceptable, easy-to-use protein option that improves intake and supports nutritional status for patients needing supplemental nutrition.
How similar studies have performed: Oral nutrition supplements have established use and prior acceptability/tolerance research, though this specific shot-style protein format is relatively new and needs direct tolerability data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
London
- UCLH NHS Foundation Trust — London, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.