Tolerance and Acceptability Evaluation of MONACO

NCT03836274 | Completed

• 1 other identifier: AY:ASK-SCH
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire

  9 days

Study Arms (1)

Experimental

EXPERIMENTAL

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.

Dietary Supplement: AYMES MONACO

Interventions

AYMES MONACO DIETARY_SUPPLEMENT

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aymes International Limited: lead

Study Sites (1)

AYMES International

Haywards Heath, RH16 9PL, United Kingdom

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 11, 2019
• Study Start: November 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)