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Tolerance and Acceptability of AYMES PARIS (NCT02898038)

Alison Clark Health and Nutrition
Tolerance and Acceptability of new oral nutritional supplement - AYMES PARIS
    AYMES PARIS is a powdered, high energy, oral nutritional supplement to be mixed with milk as a drink. It provides 320 kcal and 12.2 g protein per 139 ml serving. It 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.
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Accepts Healthy Volunteers
    Inclusion Criteria:
    • Adult patients (≥18 years) who are able to communicate their views regarding acceptability.
    • Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing approximately 300kcal/day
    • Patients expected to require oral nutritional supplementation for at least 2 further weeks.
    • Informed consent obtained.
    Exclusion Criteria:
    • Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
    • Patients requiring a milk-free diet
    • Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list)
    • Patients with significant renal or hepatic impairment
    • Patients with swallowing impairment requiring thickened fluids
    • Patients with inflammatory bowel disease or previous bowel resection.
    To evaluate tolerance and acceptability of AYMES PARIS in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference,convenience etc.

    To obtain data to support an ACBS submissions for AYMES PARIS (to allow for prescription in the community at NHS expense).
    31 October, 2015
    07 September, 2016
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