Tolerance and Acceptability Evaluation of MONACO
Tolerance and Acceptability Evaluation of MONACO
To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral
 nutritional support compared with currently available alternatives.
To evaluate tolerance and acceptability of 'MONACO' 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 'MONACO' (to allow for prescription in the
 community at NHS expense).
Inclusion Criteria:

 -  Patients (>18 years) who are able to communicate clearly.

 -  Patients with or at risk of malnutrition as determined by growth charts and/or by
 professional clinical judgement.

 -  Patients expected to require oral nutritional supplementation for at least 2 further
 weeks.

 -  Patients requiring supplementary intake approximately 300 kcal /day from an oral
 nutritional supplement

 -  Informed assent/consent obtained.

 Exclusion Criteria:

 -  Patients with cow's milk protein allergy requiring a milk free diet

 -  Patients with inherited metabolic conditions.

 -  Patients requiring enteral tube feeding or parenteral nutrition.

 -  Patients with medical or dietary contraindication to any feed ingredients (see
 appendix 2 for full ingredient list)

 -  Patients with significant renal (requiring dialysis) or hepatic impairment (e.g.
 hepatitis)

 -  Patients with dysphagia requiring stage 1, 2 or 3 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