NCT02648451

Acceptability and Tolerance Study of New Oral Nutritional Supplement

Tolerance and Acceptability of AYMES ROME

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Aymes International Limited · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

* To evaluate tolerance and acceptability of AYMES ROME in patients requiring supplementary oral nutritional support compared with currently available alternatives. * To obtain data to support a submission to Advisory Committee on Borderline Substances (ACBS) for AYMES ROME (to allow for prescription in the community at National Health Service (NHS) expense).

Detailed description

To evaluate tolerance and acceptability of AYMES ROME 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 ROME (to allow for prescription in the community at NHS expense).

Conditions

• Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	AYMES ROME	AYMES Rome is a powder, designed to be mixed with 250 ml water to make up a juice style ONS. When made up AYMES Rome provides 300 kcal (1 kcal / ml) and 10.7 g protein. It is not designed to be used as a sole source of nutrition. It is a Food for Special Medical Purposes (FSMP) and must therefore be used under medical supervision.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2016-01-07
• Last updated: 2016-01-07