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Tolerance and Acceptability Evaluation AYMES ActaGain

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
AYMES ActaGain
Sponsored by
Aymes International Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Malnutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • AYMES International Ltd.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AYMES ActaGain

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 5, 2021
Last Updated
January 7, 2021
Sponsor
Aymes International Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04703881
Brief Title
Tolerance and Acceptability Evaluation AYMES ActaGain
Official Title
Tolerance and Acceptability Evaluation AYMES ActaGain
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aymes International Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AYMES ActaGain
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
AYMES ActaGain
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gastro-Intestinal Tolerance when consuming AYMES ActaGain
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire
Description
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.
Time Frame
30 days
Title
Compliance
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
AYMES International Ltd.
City
Haywards Heath
ZIP/Postal Code
RH16 9PL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tolerance and Acceptability Evaluation AYMES ActaGain

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