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To evaluate the tolerance (gastrointestinal) and acceptability of a new Oral Nutrition Supplement in patients with or at risk of disease related malnutrition.
To evaluate tolerance and acceptability of a new Oral Nutrition Supplement in patients with or at risk of malnutrition, who require supplementary nutrition support. Outcomes of GI effects, compliance and palatability will be recorded.
To obtain data to support an ACBS submission (to allow for prescription in the community at NHS expense).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AYMES SWIFT | Experimental | Patients with or at risk of disease related malnutrition (DRM), who have been clinically identified as requiring nutritional supplementation will be prescribed the study product for a period of 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AYMES SWIFT oral nutritional supplement | Dietary Supplement | The study supplement is an oral nutritional supplement and food for special medical purposes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Acceptability and palatability of an oral nutriitonal supplement. | To assess the acceptability of the oral nutritional supplement in patients requiring oral nutritional supplementation. On day 7 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 oral nutrition supplement. Questions will be rated on a 7 point Likert scale (Strongly Agree, Somewhat agree, Neutral, Somewhat Disagree, Disagree, Disagree Strongly) and will relate to taste, smell, texure and overall liking. | 7 days |
| Gastro-intestinal Tolerance | To assess the GI tolerance of the oral nutritional supplement in patients with or at risk of disease related malnutrition. Monitoring includes recording the number of any GI complaints and consistency of bowel movements via a diary for the first 7 days. A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea) will be recorded on day 1 (based on the 2 preceding days) and for the first 7 days during the intervention. Information about bowel movements will also be collected using the Bristol Stool Chart© at the same time points. | 7 days |
| Compliance | To assess the compliance of patients taking the Study product as prescribed. This is measured by daily completion of a compliance diary, comparing consumed amount versus prescribed amount. | 7 days |
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Inclusion Criteria:
Male or female
•≥ 18 years of age
Identified as being malnourished/at risk of malnutrition-by-malnutrition screening tools [i.e., MUST score ≥1, and/or using or requiring ONS at least once daily as part of nutritional management plan]
Expected to receive at least one bottle of ONS per day
Written or electronic informed consent from patient, or verbally given consent countersigned by a witness for those physically unable to sign
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Preston Hill Surgery | Harrow | HA3 9SN | United Kingdom |
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| AYMES SWIFT FIBRE | Dietary Supplement | An oral nutritional supplement and food for special medical purposes. |
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| AYMES SWIFT PLANT | Dietary Supplement | A plant based oral nutritional supplement and food for special medical purposes. |
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