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OpenTrials
Completed

NCT Number: NCT03836274

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AYMES International

Haywards Heath, RH16 9PL, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. GI Tolerance

    Time frame: 9 Days

    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.

Secondary outcomes

  1. Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire

    Time frame: 9 days

    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.

Sponsors and collaborators

Lead sponsor

Aymes International Limited

Industry

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 11, 2019
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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