NCT07417514 Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement
| NCT ID | NCT07417514 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aymes International Limited |
| Condition | Disease Related Malnutrition |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-09-30 |
| Primary Completion | 2026-04 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 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 h