Tolerance and Acceptability Evaluation of AYMES AMSTERDAM

Aymes International

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: AYMES AMSTERDAM

Study type: Interventional

Funder types: Industry

Identifiers

NCT04700293

AY:AMS

Details and patient eligibility

About

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

Full description

To evaluate tolerance and acceptability of 'AMSTERDAM' 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 'AMSTERDAM' (to allow for prescription in the community at NHS expense).

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female participants.
• ≥ 18 years of age.
• Participants of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 7 days.
• Patient is able and willing to provide written informed consent.

Exclusion criteria

• Participants with medical or dietary contraindication to any feed ingredients.
• Participants requiring sole enteral tube feeding or parenteral nutrition.
• Participants with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis.)
• Participants with dysphagia requiring levels 1, 2, 3 or 4 thickened fluids.
• Participants with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
• Participants 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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18 participants in 1 patient group

AYMES AMSTERDAM

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 'AMSTERDAM' for a period of \> 7 days.

Treatment:

Dietary Supplement: AYMES AMSTERDAM