Back to resultsAcceptability and Tolerance Study of New Oral Nutritional Supplement
Primary Purpose
Malnutrition
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AYMES ROME
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition
Eligibility Criteria
Inclusion Criteria:
- Adult patients (≥18 years) who are able to communicate their views regarding acceptability.
- Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing approximately 300kcal/day
- Patients expected to require oral nutritional supplementation for at least 2 further weeks.
- Informed consent obtained.
Exclusion Criteria:
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
- Patients requiring a milk free diet
- Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list)
- Patients with significant renal or hepatic impairment
- Patients with swallowing impairment requiring thickened fluids
- Patients with inflammatory bowel disease or previous bowel resection.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
intervention
Arm Description
Patients established on an oral nutritional supplement, being prescribed 1-2 oral nutritional supplement (ONS) providing at least 300 kcal/day will be changed onto an equivalent prescription of AYMES Rome for a period of 9 days
Outcomes
Primary Outcome Measures
GI side effects when using AYMES Rome
Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES Rome as assessed by presence / absence of side effect compared to baseline period
Secondary Outcome Measures
Change to bodyweight of subjects when using AYMES Rome
Recording of bodyweight (in kg) at start of study, start of intervention and end of intervention for comparison to investigate any trend in weight change during the intervention period compared to baseline
Compliance with prescription of AYMES Rome
Recording of amount of AYMES Rome consumed by subjects compared to amount prescribed. Good compliance = >80% of prescribed being consumed. Same data collected for baseline product and compared with that of AYMES Rome
Bowel habits of subjects when using AYMES Rome - frequency
Recording of bowel habits whilst subjects consuming AYMES Rome, as assessed by frequency of bowel movements (number of stools per day) and compared to same data recorded during baseline period
Bowel habits of subjects when using AYMES Rome - stool consistency
Recording of bowel habits whilst subjects consuming AYMES Rome, as assessed by consistency of stools (assessed by Bristol Stool Chart) and compared to same data recorded during baseline period
Full Information
NCT ID
NCT02648451
First Posted
December 18, 2015
Last Updated
January 5, 2016
Sponsor
Aymes International Limited
Collaborators
Alison Clark Health and Nutrition
1. Study Identification
Unique Protocol Identification Number
NCT02648451
Brief Title
Acceptability and Tolerance Study of New Oral Nutritional Supplement
Official Title
Tolerance and Acceptability of AYMES ROME
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aymes International Limited
Collaborators
Alison Clark Health and Nutrition
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate tolerance and acceptability of AYMES ROME in patients requiring supplementary oral nutritional support compared with currently available alternatives.
To obtain data to support a submission to Advisory Committee on Borderline Substances (ACBS) for AYMES ROME (to allow for prescription in the community at National Health Service (NHS) expense).
Detailed Description
To evaluate tolerance and acceptability of AYMES ROME 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 ROME (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
Treatment
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
intervention
Arm Type
Experimental
Arm Description
Patients established on an oral nutritional supplement, being prescribed 1-2 oral nutritional supplement (ONS) providing at least 300 kcal/day will be changed onto an equivalent prescription of AYMES Rome for a period of 9 days
Intervention Type
Dietary Supplement
Intervention Name(s)
AYMES ROME
Intervention Description
AYMES Rome is a powder, designed to be mixed with 250 ml water to make up a juice style ONS. When made up AYMES Rome provides 300 kcal (1 kcal / ml) and 10.7 g protein. It is not designed to be used as a sole source of nutrition. It is a Food for Special Medical Purposes (FSMP) and must therefore be used under medical supervision.
Primary Outcome Measure Information:
Title
GI side effects when using AYMES Rome
Description
Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES Rome as assessed by presence / absence of side effect compared to baseline period
Time Frame
9 days
Secondary Outcome Measure Information:
Title
Change to bodyweight of subjects when using AYMES Rome
Description
Recording of bodyweight (in kg) at start of study, start of intervention and end of intervention for comparison to investigate any trend in weight change during the intervention period compared to baseline
Time Frame
9 days
Title
Compliance with prescription of AYMES Rome
Description
Recording of amount of AYMES Rome consumed by subjects compared to amount prescribed. Good compliance = >80% of prescribed being consumed. Same data collected for baseline product and compared with that of AYMES Rome
Time Frame
9 days
Title
Bowel habits of subjects when using AYMES Rome - frequency
Description
Recording of bowel habits whilst subjects consuming AYMES Rome, as assessed by frequency of bowel movements (number of stools per day) and compared to same data recorded during baseline period
Time Frame
9 days
Title
Bowel habits of subjects when using AYMES Rome - stool consistency
Description
Recording of bowel habits whilst subjects consuming AYMES Rome, as assessed by consistency of stools (assessed by Bristol Stool Chart) and compared to same data recorded during baseline period
Time Frame
9 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients (≥18 years) who are able to communicate their views regarding acceptability.
Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing approximately 300kcal/day
Patients expected to require oral nutritional supplementation for at least 2 further weeks.
Informed consent obtained.
Exclusion Criteria:
Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Patients requiring a milk free diet
Patients with medical or dietary contraindication to any feed ingredients (see appendix 2 of protocol for full list)
Patients with significant renal or hepatic impairment
Patients with swallowing impairment requiring thickened fluids
Patients with inflammatory bowel disease or previous bowel resection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Clarke, BSc (Hons)
Organizational Affiliation
Alison Clark Health and Nutrition
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acceptability and Tolerance Study of New Oral Nutritional Supplement
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