Tolerance and Acceptability Evaluation 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).

Official Title
-----------------
Tolerance and Acceptability Evaluation AYMES ActaGain

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Dietary Supplement: AYMES ActaGain


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AYMES ActaGain<br>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. | Dietary Supplement: AYMES ActaGain<br>* AYMES ActaGain is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is designed as a supplement to the diet but can also be used as a sole source of nutrition.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastro-Intestinal Tolerance when consuming AYMES ActaGain | 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire | To assess the acceptability of 'AYMES ActaGain' 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. | 30 days | 
| Compliance | To assess the acceptability of 'AYMES ActaGain' in patients in the community requiring oral nutritional supplementation. A daily compliance diary will be kept detailing compliance to prescription versus prescribed amount. | 30 days |