Acceptability and Tolerance Study of a New Oral Nutritional Supplement (ONS)

Aymes International

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: AYMES PARIS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02898038

AY:SC1

Details and patient eligibility

About

Tolerance and Acceptability of new oral nutritional supplement - AYMES PARIS

Full description

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).

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

16 participants in 1 patient group

Experimental

Experimental group

Description:

Patients established on an oral nutritional supplement, being prescribed 1-2 oral nutritional supplement (ONS) providing at least 300 kcal/day will be changed onto an equivalent prescription of AYMES PARIS for a period of 9 days.

Treatment:

Dietary Supplement: AYMES PARIS