Acceptability and Tolerance of New Oral Nutritional Supplement

Evaluation of Tolerance and Acceptability of AYMES 'LONDON' Product

Sponsors

Lead Sponsor: Aymes International Limited

Collaborator: Alison Clark Health and Nutrition

Source Aymes International Limited
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 July 2015
Completion Date December 2015
Primary Completion Date December 2015
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: AYMES LONDON

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: 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

August 2015

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: intervention

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.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov