Back to resultsTolerance and Acceptability Evaluation AYMES Cardiff
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
AYMES 'CARDIFF'
Sponsored by
About this trial
This is an interventional other trial for Malnutrition
Eligibility Criteria
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.
Sites / Locations
- AYMES International Ltd.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AYMES 'CARDIFF'
Arm Description
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.
Outcomes
Primary Outcome Measures
Gastro-Intestinal Tolerance when consuming AYMES CARDIFF
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
Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire
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
To assess the compliance of patients to 'CARDIFF' by daily completion of a compliance diary, comparing consumed versus prescribed amount.
Full Information
NCT ID
NCT04703894
First Posted
January 5, 2021
Last Updated
January 7, 2021
Sponsor
Aymes International Limited
1. Study Identification
Unique Protocol Identification Number
NCT04703894
Brief Title
Tolerance and Acceptability Evaluation AYMES Cardiff
Official Title
Tolerance and Acceptability Evaluation AYMES Cardiff
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 6, 2019 (Actual)
Primary Completion Date
January 13, 2020 (Actual)
Study Completion Date
January 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aymes International Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AYMES 'CARDIFF'
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
AYMES 'CARDIFF'
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gastro-Intestinal Tolerance when consuming AYMES CARDIFF
Description
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
Secondary Outcome Measure Information:
Title
Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire
Description
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
Title
Compliance
Description
To assess the compliance of patients to 'CARDIFF' by daily completion of a compliance diary, comparing consumed versus prescribed amount.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
AYMES International Ltd.
City
Haywards Heath
ZIP/Postal Code
RH16 9PL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Tolerance and Acceptability Evaluation AYMES Cardiff
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