Malnutrition
Conditions
Brief summary
To evaluate tolerance and acceptability of 'AMSTERDAM' in patients requiring supplementary oral nutritional support compared with currently available alternatives.
Detailed description
To evaluate tolerance and acceptability of 'AMSTERDAM' 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 'AMSTERDAM' (to allow for prescription in the community at NHS expense).
Interventions
DIETARY_SUPPLEMENTAYMES AMSTERDAM
AYMES AMSTERDAM 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.
Sponsors
Aymes International Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female participants. * ≥ 18 years of age. * Participants of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 7 days. * Patient is able and willing to provide written informed consent.
Exclusion criteria
* Participants with medical or dietary contraindication to any feed ingredients. * Participants requiring sole enteral tube feeding or parenteral nutrition. * Participants with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis.) * Participants with dysphagia requiring levels 1, 2, 3 or 4 thickened fluids. * Participants with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms. * Participants for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements. * Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastro-Intestinal Tolerance when consuming AYMES AMSTERDAM | 7 days | To assess gastro-intestinal tolerance of 'AMSTERDAM' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number of any GI complaints via a daily diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire | 7 days | To assess the acceptability of 'AMSTERDAM' 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. |
Countries
United Kingdom
Outcome results
None listed