Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-02 @ 1:07 PM
Study NCT ID:
NCT02639156
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2015-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptability and Tolerance of New Oral Nutritional Supplement
Sponsor:
Aymes International Limited
Organization:
Study Overview
Official Title:
Evaluation of Tolerance and Acceptability of AYMES 'LONDON' Product
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate tolerance and acceptability of AYMES LONDON in patients requiring supplementary oral nutritional support compared with currently available alternatives.
Detailed Description:
TITLE EVALUATION OF TOLERANCE AND ACCEPTABILITY OF AYMES LONDON STUDY OBJECTIVES
* To evaluate tolerance and acceptability of AYMES LONDON in patients requiring supplementary oral nutritional support compared with currently available alternatives.
* To obtain data to support an ACBS submissions for AYMES LONDON (to allow for prescription in the community at NHS expense).
STUDY DESIGN Interventional study. STUDY POPULATION 20 patients established on an oral nutritional supplement (ONS), requiring nutritional supplementation of at least 300kcal/day. Patients residing in community settings (e.g. own home, care home or community hospital) STUDY PRODUCTS AYMES LONDON Patients' current oral nutritional supplements STUDY GROUPS This is an observational study where the patient will act as their own control, there will be just one study group containing all patients STUDY OUTLINE Baseline: After recruitment patients will remain on their current oral nutritional supplement for 3 days, during which time baseline tolerance data will be recorded (number and consistency of bowel movements, daily, volume of ONS taken, any episodes of nausea, vomiting, burping, abdominal pain, bloating or diarrhoea). A three-day food diary will be kept to record total oral intake. Patients will also have anthropometric measurements carried out during this period (weight, height, body mass index (BMI)).
Intervention Period : Patients will then be changed onto an equivalent prescription of AYMES LONDON for a period of 9 days. Tolerance data will be recorded daily but the first 2 days on AYMES LONDON will be considered a 'transitional' period and data from these days will not be analysed. A further 3-day food diary will be kept during the intervention period. Weight of the patient will be recorded at the end of the period on AYMES LONDON, and an acceptability questionnaire will be completed.
Comparisons will be made between baseline and the end of each phase of the study using appropriate analysis methods.
* To evaluate tolerance and acceptability of AYMES LONDON in patients requiring supplementary oral nutritional support compared with currently available alternatives.
* To obtain data to support an ACBS submissions for AYMES LONDON (to allow for prescription in the community at NHS expense).
STUDY DESIGN Interventional study. STUDY POPULATION 20 patients established on an oral nutritional supplement (ONS), requiring nutritional supplementation of at least 300kcal/day. Patients residing in community settings (e.g. own home, care home or community hospital) STUDY PRODUCTS AYMES LONDON Patients' current oral nutritional supplements STUDY GROUPS This is an observational study where the patient will act as their own control, there will be just one study group containing all patients STUDY OUTLINE Baseline: After recruitment patients will remain on their current oral nutritional supplement for 3 days, during which time baseline tolerance data will be recorded (number and consistency of bowel movements, daily, volume of ONS taken, any episodes of nausea, vomiting, burping, abdominal pain, bloating or diarrhoea). A three-day food diary will be kept to record total oral intake. Patients will also have anthropometric measurements carried out during this period (weight, height, body mass index (BMI)).
Intervention Period : Patients will then be changed onto an equivalent prescription of AYMES LONDON for a period of 9 days. Tolerance data will be recorded daily but the first 2 days on AYMES LONDON will be considered a 'transitional' period and data from these days will not be analysed. A further 3-day food diary will be kept during the intervention period. Weight of the patient will be recorded at the end of the period on AYMES LONDON, and an acceptability questionnaire will be completed.
Comparisons will be made between baseline and the end of each phase of the study using appropriate analysis methods.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: