Tolerance and Acceptability Evaluation AYMES ActaGain

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

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: AYMES ActaGain

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Haywards Heath, United Kingdom, RH16 9PL
    • AYMES International Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AYMES ActaGain; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Aymes International Limited

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: AY-ActaGain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No