AYMES International Ltd.
Haywards Heath, RH16 9PL, United Kingdom
NCT Number: NCT04703894
To evaluate tolerance and acceptability of 'CARDIFF' in patients requiring supplementary oral nutritional support compared with currently available alternatives.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Haywards Heath, RH16 9PL, United Kingdom
To evaluate tolerance and acceptability of 'CARDIFF' 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 'CARDIFF' (to allow for prescription in the community at NHS expense).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AYMES CARDIFF 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.
Time frame: 30 days
To assess gastro-intestinal tolerance of 'CARDIFF' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number of any GI complaints via a daily diary.
Time frame: 30 days
To assess the acceptability of 'CARDIFF' 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: 30 days
To assess the compliance of patients to 'CARDIFF' by daily completion of a compliance diary, comparing consumed versus prescribed amount.
Aymes International Limited
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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