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Tolerance and Acceptability Evaluation of AYMES AMSTERDAM

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
AYMES AMSTERDAM
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 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.

Sites / Locations

  • AYMES International Ltd.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AYMES AMSTERDAM

Arm 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.

Outcomes

Primary Outcome Measures

Gastro-Intestinal Tolerance when consuming AYMES AMSTERDAM
To assess gastro-intestinal tolerance of 'AMSTERDAM' 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 'AMSTERDAM' 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.

Full Information

First Posted
January 5, 2021
Last Updated
January 6, 2021
Sponsor
Aymes International Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04700293
Brief Title
Tolerance and Acceptability Evaluation of AYMES AMSTERDAM
Official Title
Tolerance and Acceptability Evaluation of AYMES AMSTERDAM
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (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 'AMSTERDAM' in patients requiring supplementary oral nutritional support compared with currently available alternatives.
Detailed 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).

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
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AYMES AMSTERDAM
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
AYMES AMSTERDAM
Intervention Description
AYMES AMSTERDAM is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is not designed as a sole source of nutrition.
Primary Outcome Measure Information:
Title
Gastro-Intestinal Tolerance when consuming AYMES AMSTERDAM
Description
To assess gastro-intestinal tolerance of 'AMSTERDAM' in patients in the community requiring oral nutritional supplementation. Monitoring includes recording the number of any GI complaints via a daily diary.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Acceptability and Palatability of Consuming the Nutritional Supplement: questionnaire
Description
To assess the acceptability of 'AMSTERDAM' 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
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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 of AYMES AMSTERDAM

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