Evaluation of Tolerance and Acceptability of AYMES 'LONDON' Product
Acceptability and Tolerance of New Oral Nutritional Supplement
Sponsors
Source
Aymes International Limited
Oversight Info
Has Dmc
No
Brief Summary
To evaluate tolerance and acceptability of AYMES LONDON in patients requiring supplementary
oral nutritional support compared with currently available alternatives.
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.
Overall Status
Completed
Start Date
2015-07-01
Completion Date
2015-12-01
Primary Completion Date
2015-12-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
GI Side Effects when using AYMES LONDON |
9 days |
Secondary Outcome
Measure |
Time Frame |
|
Change to bodyweight of subjects when using AYMES LONDON |
9 DAYS |
|
Compliance with prescription of AYMES LONDON |
9 days |
|
Bowel habits of subjects when using AYMES LONDON |
9 days |
Enrollment
22
Condition
Intervention
Intervention Type
Dietary Supplement
Intervention Name
Description
AYMES LONDON is a powder, designed to be mixed with 75ml whole milk to make a dessert style ONS. When made-up, AYMES LONDON provides 303kcal (2.2kcal/ml) and 11.2g 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.
Arm Group Label
intervention
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 at least 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
- 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 dysphagia requiring stage 1,2 or 3 thickened fluids
- Patients with uncontrolled inflammatory bowel disease or previous bowel resection with
ongoing gastrointestinal symptoms.
- 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 at least 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
- 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 dysphagia requiring stage 1,2 or 3 thickened fluids
- Patients with uncontrolled inflammatory bowel disease or previous bowel resection with
ongoing gastrointestinal symptoms.
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Alison Clark, BSc (Hons) |
Principal Investigator |
Alison Clark Health and Nutrition |
Verification Date
2015-08-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Arm Group
Arm Group Label
intervention
Arm Group Type
Experimental
Description
Patients established on an oral nutritional supplement, being prescribed 1-2 ONS providing at least 300kcal/day will be changed onto an equivalent prescription of AYMES LONDON for a period of 9 days.
Firstreceived Results Date
N/A
Reference
Citation
Stratton RJ, Green CJ, Elia M. Disease-related malnutrition: an evidence based approach to treatment. Wallingford: CABI Publishing; 2003.
Citation
National Institute for Health and Care Excellence (NICE). Nutrition support in adults: oral nutrition support, enteral tube feeding and parenteral nutrition (clinical guideline 32). 2006. London, National Institute for Health and Clinical Excellence (NICE).
Citation
Stratton RJ, Elia M. A review of reviews: A new look at the evidence for oral nutritional supplements in clinical practice. Clin Nutr 2007; 2(Suppl 1):5-23.
Citation
Gazzotti C, Arnaud-Battandier F, Parello M, Farine S, Seidel L, Albert A, Petermans J. Prevention of malnutrition in older people during and after hospitalisation: results from a randomised controlled clinical trial. Age Ageing. 2003 May;32(3):321-5.
PMID
12720620
Citation
Manders M, de Groot CP, Blauw YH, Dhonukshe-Rutten RA, van Hoeckel-Prüst L, Bindels JG, Siebelink E, van Staveren WA. Effect of a nutrient-enriched drink on dietary intake and nutritional status in institutionalised elderly. Eur J Clin Nutr. 2009 Oct;63(10):1241-50. doi: 10.1038/ejcn.2009.28. Epub 2009 May 20. Erratum in: Eur J Clin Nutr. 2009 Oct;63(10):1276.
PMID
19455176
Citation
Wouters-Wesseling W, Wouters AE, Kleijer CN, Bindels JG, de Groot CP, van Staveren WA. Study of the effect of a liquid nutrition supplement on the nutritional status of psycho-geriatric nursing home patients. Eur J Clin Nutr. 2002 Mar;56(3):245-51.
PMID
11960300
Citation
Hubbard GP, Elia M, Holdoway A, Stratton RJ. A systematic review of compliance to oral nutritional supplements. Clin Nutr. 2012 Jun;31(3):293-312. doi: 10.1016/j.clnu.2011.11.020. Epub 2012 Jan 17. Review.
PMID
22257636
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
December 18, 2015
Study First Submitted Qc
December 21, 2015
Study First Posted
December 24, 2015
Last Update Submitted
December 21, 2015
Last Update Submitted Qc
December 21, 2015
Last Update Posted
December 24, 2015
ClinicalTrials.gov processed this data on August 22, 2018
Conditions
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conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.