Tolerance and Acceptability Evaluation of MONACO

Malnutrition Clinical Trial

Official title:

Tolerance and Acceptability Evaluation of MONACO

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836274
• Other study ID #: AY:ASK-SCH
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2020
• Source: Aymes International Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• AYMES MONACO
AYMES MONACO is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is not designed as a sole source of nutrition.

Locations

Country	Name	City	State
United Kingdom	AYMES International	Haywards Heath

Sponsors (1)

Lead Sponsor	Collaborator
Aymes International Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GI Tolerance	To assess gastro-intestinal tolerance of 'MONACO' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number and consistency of bowel movements, any episodes of nausea, vomiting, abdominal pain, bloating or diarrhoea.	9 Days
Secondary	Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire	To assess the acceptability of 'MONACO' 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.	9 days