An interventional study of AYMES MONACO in Malnutrition, sponsored by Aymes International Limited. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-07.
Sponsored by Aymes International Limited · Not applicable, Interventional, and Other
To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral nutritional support compared with currently available alternatives.
To evaluate tolerance and acceptability of 'MONACO' 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 'MONACO' (to allow for prescription in the community at NHS expense).
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 15 is below the median of 90 across 1,134 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →Aymes International Limited is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients established on an oral nutritional supplement (ONS), requiring nutritional supplementation of at least 300kcal/day will be changed onto an equivalent prescription of AYMES 'MONACO' for a period of 9 days.
Dietary Supplement: AYMES MONACO
AYMES MONACO 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.
GI Tolerance
To assess gastro-intestinal tolerance of 'MONACO' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number and consistency of bowel movements, any episodes of nausea, vomiting, abdominal pain, bloating or diarrhoea.
Time frame: 9 Days
Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire
To assess the acceptability of 'MONACO' in patients in the community requiring oral nutritional supplementation. At the end of the intervention period an acceptability and preference questionnaire will be completed by the patient in order to seek their opinion on the taste, smell, texture and overall liking of the new supplement drink. A 5 point hedonic scale will be used.
Time frame: 9 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Aymes International Limited