Acceptability and Tolerance Study of New Oral Nutritional Supplement PRAGUE
Tolerance and Acceptability of AYMES PRAGUE
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
Tolerance and Acceptability of new oral nutritional supplement - AYMES PRAGUE
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2016
CompletedFirst Posted
Study publicly available on registry
July 13, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJanuary 9, 2020
January 1, 2020
3 months
July 11, 2016
January 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
GI side effects when using AYMES PRAGUE
Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES PRAGUE as assessed by presence / absence of side effect compared to baseline period
9 DAYS
Secondary Outcomes (4)
Change to bodyweight of subjects when using AYMES PRAGUE
9 days
Compliance with prescription of AYMES PRAGUE
9 days
Bowel habits of subjects when using AYMES PRAGUE - frequency
9 days
Bowel habits of subjects when using AYMES PRAGUE - stool consistency
9 days
Study Arms (1)
intervention
EXPERIMENTALPatients 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 PRAGUE for a period of 9 days.
Interventions
AYMES PRAGUE is a ready to drink, high energy, low volume oral nutritional supplement drink. It provides 300 kcal and 12g protein per 125ml serving. It 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aymes International Limitedlead
- Eat Well Nowcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2016
First Posted
July 13, 2016
Study Start
September 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
January 9, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share