Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Tolerance and Acceptability of new oral nutritional supplement - STOCKHOLM.
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Patients established on an oral nutritional supplement, being prescribed oral nutritional supplement (ONS) providing at least 300 kcal/day will be changed onto an equivalent prescription of STOCKHOLM for a period of 9 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STOCKHOLM | Dietary Supplement | STOCKHOLM is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| GI Tolerance | 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. | 9 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability and Palatability of Consuming the Nutritional Supplement: Questionnaire | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gemma Fry | Haywards Heath | RH16 9PL | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C073583 | antithrombin III Stockholm |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 9 days |
| Compliance with Prescription of STOCKHOLM | 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. | 9 days |