Acceptability and Tolerance Study of New Oral Nutritional Supplement PRAGUE

Tolerance and Acceptability of AYMES PRAGUE

Tolerance and Acceptability of new oral nutritional supplement - AYMES PRAGUE

Study Overview

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

Detailed Description

To evaluate tolerance and acceptability of AYMES PRAGUE 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 PRAGUE (to allow for prescription in the community at NHS expense).

• Study Type: Interventional
• Enrollment (Actual): 20
• 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: Other
• 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 PRAGUE for a period of 9 days.	Dietary supplement: AYMES PRAGUE; AYMES PRAGUE is a ready to drink, high energy, low volume oral nutritional supplement drink. It provides 300 kcal and 12g protein per 125ml serving. It is a Food for Special Medical Purposes (FSMP) and must therefore be used under medical supervision. It is not designed as a sole source of nutrition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GI side effects when using AYMES PRAGUE	Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES PRAGUE 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 PRAGUE	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 PRAGUE	Recording of amount of AYMES PRAGUE 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 PRAGUE	9 days
Bowel habits of subjects when using AYMES PRAGUE - frequency	Recording of bowel habits whilst subjects consuming AYMES PRAGUE, 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 PRAGUE - stool consistency	Recording of bowel habits whilst subjects consuming AYMES PRAGUE, 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: Eat Well Now

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 13, 2016

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: AY:AC1

Plan for Individual participant data (IPD)

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