Tolerance and Acceptability Evaluation AYMES ActaGain

Aymes International

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: AYMES ActaGain

Study type: Interventional

Funder types: Industry

Identifiers

NCT04703881

AY-ActaGain

Details and patient eligibility

About

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

Full description

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

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female patients.
• ≥ 18 years of age.
• Patients of the intended target group (e.g. MUST score ≥ 1, with or at risk of disease related malnutrition) with an anticipated period of nutritional support ≥ 4 weeks.
• Patient is able and willing to provide written informed consent.

Exclusion criteria

• Patients with medical or dietary contraindication to any feed ingredients.
• Patients requiring sole enteral tube feeding or parenteral nutrition.
• Patients with chronic renal disease requiring dialysis.
• Patients with liver failure.
• Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements.
• Patients assessed by a Speech and Language Therapist who require thickened fluids.
• Participation in any other studies that may interfere with this study.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

AYMES ActaGain

Experimental group

Description:

Patients of the intended target group (e.g. MUST score ≥ 1, with or at risk of disease related malnutrition) with an anticipated period of nutritional support ≥ 4 weeks will be changed / started on an equivalent prescription of 'AYMES ActaGain' for a period of 30 days.

Treatment:

Dietary Supplement: AYMES ActaGain