Acceptability and Tolerance Study of New Oral Nutritional Supplement

Tolerance and Acceptability of AYMES ROME

• To evaluate tolerance and acceptability of AYMES ROME in patients requiring supplementary oral nutritional support compared with currently available alternatives.
• To obtain data to support a submission to Advisory Committee on Borderline Substances (ACBS) for AYMES ROME (to allow for prescription in the community at National Health Service (NHS) expense).

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: Dietary supplement: AYMES ROME

Detailed Description

To evaluate tolerance and acceptability of AYMES ROME in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference,convenience etc.

To obtain data to support an ACBS submissions for AYMES ROME (to allow for prescription in the community at NHS expense).

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 approximately 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention; Patients 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 Rome for a period of 9 days	Dietary supplement: AYMES ROME; AYMES Rome is a powder, designed to be mixed with 250 ml water to make up a juice style ONS. When made up AYMES Rome provides 300 kcal (1 kcal / ml) and 10.7 g 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GI side effects when using AYMES Rome	Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES Rome as assessed by presence / absence of side effect compared to baseline period	9 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change to bodyweight of subjects when using AYMES Rome	Recording of bodyweight (in kg) at start of study, start of intervention and end of intervention for comparison to investigate any trend in weight change during the intervention period compared to baseline	9 days
Compliance with prescription of AYMES Rome	Recording of amount of AYMES Rome consumed by subjects compared to amount prescribed. Good compliance = >80% of prescribed being consumed. Same data collected for baseline product and compared with that of AYMES Rome	9 days
Bowel habits of subjects when using AYMES Rome - frequency	Recording of bowel habits whilst subjects consuming AYMES Rome, as assessed by frequency of bowel movements (number of stools per day) and compared to same data recorded during baseline period	9 days
Bowel habits of subjects when using AYMES Rome - stool consistency	Recording of bowel habits whilst subjects consuming AYMES Rome, as assessed by consistency of stools (assessed by Bristol Stool Chart) and compared to same data recorded during baseline period	9 days

Collaborators and Investigators

• Sponsor: Aymes International Limited
• Collaborators: Alison Clark Health and Nutrition
• Investigators: Principal Investigator: Alison Clarke, BSc (Hons), Alison Clark Health and Nutrition

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: December 18, 2015
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 7, 2016

Study Record Updates

• Last Update Posted (Estimate): January 7, 2016
• Last Update Submitted That Met QC Criteria: January 5, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: AY:SJ1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO