Status:
COMPLETED
Tolerance and Acceptability Evaluation of MONACO
Lead Sponsor:
Aymes International Limited
Conditions:
Malnutrition
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate tolerance and acceptability of 'MONACO' in patients requiring supplementary oral nutritional support compared with currently available alternatives.
Detailed 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, Compl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03836274
Start Date
November 1 2017
End Date
January 1 2020
Last Update
January 7 2020
Active Locations (1)
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1
AYMES International
Haywards Heath, United Kingdom, RH16 9PL