Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement
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
| Condition(s) | Disease Related Malnutrition |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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 appe |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Aymes International Limited |
| Locations | London, United Kingdom |
| Start date | 2022-09-30 |
| NCT ID | NCT07417514 |
| Official listing | https://clinicaltrials.gov/study/NCT07417514 |