Tolerance and Acceptability Evaluation AYMES Cardiff

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: AYMES 'CARDIFF'

• Registration Number: NCT04703894
• Lead Sponsor: Aymes International Limited

Brief Summary

To evaluate tolerance and acceptability of 'CARDIFF' in patients requiring supplementary oral nutritional support compared with currently available alternatives.

Detailed Description

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).

Study Timeline

• Study Start: 2019-11-06
• Primary Completion: 2020-01-13
• Study Completion: 2020-01-13
• Status Verified: 2021-01
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-07
• Last Update Submitted: 2021-01-07
• Study First Posted: 2021-01-11
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Male and female patients.
• ≥ 18 years of age.
• Patients of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 30 days.
• Patient is able and willing to provide written informed consent.

Exclusion Criteria

• Patients with medical or dietary contraindication to any feed ingredients.
• Patients requiring sole enteral tube feeding or parenteral nutrition.
• Patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis.)
• Patients with dysphagia requiring levels 1, 2, 3 or 4 thickened fluids.
• Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
• Patients 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AYMES 'CARDIFF'	AYMES 'CARDIFF'	Patients established on an oral nutritional supplement (ONS), requiring nutritional supplementation of at least 300kcal/day will be changed onto an equivalent prescription of AYMES 'CARDIFF' for a period of 30 days.

Primary Outcome Measures

Name	Time	Method
Gastro-Intestinal Tolerance when consuming AYMES CARDIFF	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.

Secondary Outcome Measures

Name	Time	Method
Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire	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.
Compliance	30 days	To assess the compliance of patients to 'CARDIFF' by daily completion of a compliance diary, comparing consumed versus prescribed amount.

Trial Locations

Locations (1)

AYMES International Ltd.; 🇬🇧 Haywards Heath, United Kingdom