Tolerance and Acceptability Evaluation of AYMES AMSTERDAM
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aymes International Limited
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Gastro-Intestinal Tolerance when consuming AYMES AMSTERDAM
Study Overview
Brief Summary
To evaluate tolerance and acceptability of 'AMSTERDAM' in patients requiring supplementary oral nutritional support compared with currently available alternatives.
Detailed Description
To evaluate tolerance and acceptability of 'AMSTERDAM' 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 'AMSTERDAM' (to allow for prescription in the community at NHS expense).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female participants.
- •≥ 18 years of age.
- •Participants of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 7 days.
- •Patient is able and willing to provide written informed consent.
Exclusion Criteria
- •Participants with medical or dietary contraindication to any feed ingredients.
- •Participants requiring sole enteral tube feeding or parenteral nutrition.
- •Participants with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis.)
- •Participants with dysphagia requiring levels 1, 2, 3 or 4 thickened fluids.
- •Participants with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
- •Participants 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.
Outcomes
Primary Outcomes
Gastro-Intestinal Tolerance when consuming AYMES AMSTERDAM
Time Frame: 7 days
To assess gastro-intestinal tolerance of 'AMSTERDAM' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number of any GI complaints via a daily diary.
Secondary Outcomes
- Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire(7 days)