Clinical Trials in the UK / NCT07417514
Recruiting
Not applicable
Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement
NCT07417514 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Disease Related Malnutrition
Investigational drug(s) / intervention(s)
Shot Style protein supplement
Shot Style protein 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 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
Eligibility
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.
Primary outcome measure(s)
- Acceptability and Palatability of Oral Nutrition Supplement — 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 — 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 — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| UCLH NHS Foundation Trust | London | United Kingdom | Recruiting |
More Aymes International Limited trials in the UK
Tolerance, Palatability and Acceptability Evaluation of an Oral Nutrition Supplement
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Tolerance, Palatability and Acceptability Evaluation of an Oral Nutrition Supplement
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07417514 on ClinicalTrials.gov ↗ ← All trials in the UK