Tolerance, Palatability and Acceptability Evaluation of an Oral Nutrition Supplement
Tolerance and Acceptability Evaluation of AYMES SWIFT
Study Overview
Status
Conditions
Detailed Description
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Harrow, United Kingdom, HA3 9SN
- Preston Hill Surgery
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- Participants receiving parenteral nutrition or ≥70% total energy requirements from enteral tube feeding
- Participants with major hepatic dysfunction (i.e., decompensated liver disease)
- Participants with major renal dysfunction [i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD)]
- Participants with active/chronic gastrointestinal disease or impaired gastrointestinal function
- Participants with significant dysphagia/high aspiration risk
- Participation in other clinical intervention studies within 1 month of this study
- Participants lacking mental capacity to consent
- Allergy to any study product ingredients (appendix 2)
- Investigator concern regarding ability or willingness of patient to comply with the study requirements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: AYMES SWIFT
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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The study supplement is an oral nutritional supplement and food for special medical purposes.
Other Names:
An oral nutritional supplement and food for special medical purposes.
A plant based oral nutritional supplement and food for special medical purposes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Acceptability and palatability of an oral nutriitonal supplement.
Time Frame: 7 days
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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.
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7 days
|
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Gastro-intestinal Tolerance
Time Frame: 7 days
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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
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Compliance
Time Frame: 7 days
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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.
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7 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AY-SWIFT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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