Evaluation of Tolerance and Acceptability of AYMES 'LONDON' Product

Acceptability and Tolerance of New Oral Nutritional Supplement



Sponsors


Source

Aymes International Limited

Oversight Info

Authority

United Kingdom: Research Ethics Committee

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.

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.

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary Outcome

Measure

Time Frame

Safety Issue

GI Side Effects when using AYMES LONDON
9 days
No

Secondary Outcome

Measure

Time Frame

Safety Issue

Change to bodyweight of subjects when using AYMES LONDON
9 DAYS
No
Compliance with prescription of AYMES LONDON
9 days
No
Bowel habits of subjects when using AYMES LONDON
9 days
No

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.

Gender

Both

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

2015-12-21

Firstreceived Date

2015-12-18

Responsible Party

Responsible Party Type

Sponsor


Is Fda Regulated

No

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


ClinicalTrials.gov processed this data on September 13, 2016

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, 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.



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