Tolerance and Acceptability Evaluation AYMES ActaGain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aymes International Limited
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Gastro-Intestinal Tolerance when consuming AYMES ActaGain
Study Overview
Brief Summary
To evaluate tolerance and acceptability of 'AYMES ActaGain' in patients requiring supplementary oral nutritional support compared with currently available alternatives.
Detailed Description
To evaluate tolerance and acceptability of 'AYMES ActaGain' 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 'AYMES ActaGain' (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 patients.
- •≥ 18 years of age.
- •Patients of the intended target group (e.g. MUST score ≥ 1, with or at risk of disease related malnutrition) with an anticipated period of nutritional support ≥ 4 weeks.
- •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 chronic renal disease requiring dialysis.
- •Patients with liver failure.
- •Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements.
- •Patients assessed by a Speech and Language Therapist who require thickened fluids.
- •Participation in any other studies that may interfere with this study.
Arms & Interventions
AYMES ActaGain
Patients of the intended target group (e.g. MUST score ≥ 1, with or at risk of disease related malnutrition) with an anticipated period of nutritional support ≥ 4 weeks will be changed / started on an equivalent prescription of 'AYMES ActaGain' for a period of 30 days.
Intervention: AYMES ActaGain (Dietary Supplement)
Outcomes
Primary Outcomes
Gastro-Intestinal Tolerance when consuming AYMES ActaGain
Time Frame: 30 days
To assess gastro-intestinal tolerance of 'AYMES ActaGain' 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(30 days)
- Compliance(30 days)