Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement
ConditionDisease Related Malnutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAymes International Limited
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Shot Style protein supplement
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov