Tolerance and Acceptability Evaluation AYMES Cardiff
1 other identifier
interventional
17
1 country
1
Brief Summary
To evaluate tolerance and acceptability of 'CARDIFF' in patients requiring supplementary oral nutritional support compared with currently available alternatives.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2020
CompletedFirst Submitted
Initial submission to the registry
January 5, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2021
CompletedJanuary 11, 2021
January 1, 2021
2 months
January 5, 2021
January 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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.
30 days
Secondary Outcomes (2)
Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire
30 days
Compliance
30 days
Study Arms (1)
AYMES 'CARDIFF'
EXPERIMENTALPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AYMES International Ltd.
Haywards Heath, RH16 9PL, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2021
First Posted
January 11, 2021
Study Start
November 6, 2019
Primary Completion
January 13, 2020
Study Completion
January 13, 2020
Last Updated
January 11, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share