Malnutrition
Conditions
Brief summary
Tolerance and Acceptability of new oral nutritional supplement - STOCKHOLM.
Detailed description
To evaluate tolerance and acceptability of 'STOCKHOLM' in patients requiring supplementary oral nutritional support compared with currently available alternatives. To obtain data to support an ACBS submissions for 'STOCKHOLM' (to allow for prescription in the community at NHS expense).
Interventions
DIETARY_SUPPLEMENTSTOCKHOLM
STOCKHOLM is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision.
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
* Patients who are able to communicate their views regarding acceptability. * Patients established on an oral nutritional supplement, being prescribed ONS providing approximately 300 kcal/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 dysphagia requiring stage 1,2 or 3 thickened fluids * Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GI Tolerance | 9 Days | To assess gastro-intestinal tolerance of 'STOCKHOLM' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number and consistency of bowel movements as assessed on the Bristol stool form scale, any episodes of nausea, vomiting, abdominal pain, bloating or diarrhoea. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability and Palatability of Consuming the Nutritional Supplement: Questionnaire | 9 days | To assess the acceptability of 'STOCKHOLM' 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. |
| Compliance with Prescription of STOCKHOLM | 9 days | Recording of amount of STOCKHOLM consumed by subjects compared to amount prescribed. Good compliance = \>80% of prescribed being consumed. Same data collected for baseline product and compared with that of STOCKHOLM. |
Countries
United Kingdom
Outcome results
None listed