Tolerance and Acceptability Evaluation AYMES ActaGain

Malnutrition Clinical Trial

Official title:

Tolerance and Acceptability Evaluation AYMES ActaGain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04703881
• Other study ID #: AY-ActaGain
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: January 2021
• Source: Aymes International Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• AYMES ActaGain
AYMES ActaGain is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is designed as a supplement to the diet but can also be used as a sole source of nutrition.

Locations

Country	Name	City	State
United Kingdom	AYMES International Ltd.	Haywards Heath

Sponsors (1)

Lead Sponsor	Collaborator
Aymes International Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastro-Intestinal Tolerance when consuming AYMES ActaGain	To assess gastro-intestinal tolerance of 'AYMES ActaGain' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number of any GI complaints via a daily diary.	30 days
Secondary	Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire	To assess the acceptability of 'AYMES ActaGain' 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.	30 days
Secondary	Compliance	To assess the acceptability of 'AYMES ActaGain' in patients in the community requiring oral nutritional supplementation. A daily compliance diary will be kept detailing compliance to prescription versus prescribed amount.	30 days