Tolerance and Acceptability Evaluation of MONACO

Aymes International

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: AYMES MONACO

Study type: Interventional

Funder types: Industry

Identifiers

NCT03836274

AY:ASK-SCH

Details and patient eligibility

About

To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral nutritional support compared with currently available alternatives.

Full description

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).

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Experimental

Experimental group

Description:

Patients established on an oral nutritional supplement (ONS), requiring nutritional supplementation of at least 300kcal/day will be changed onto an equivalent prescription of AYMES 'MONACO' for a period of 9 days.

Treatment:

Dietary Supplement: AYMES MONACO