Acceptability and Tolerance Study of New Oral Nutritional Supplement PRAGUE

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: AYMES PRAGUE

• Registration Number: NCT02831647
• Lead Sponsor: Aymes International Limited

Brief Summary

Tolerance and Acceptability of new oral nutritional 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 Timeline

• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-13
• Study Start: 2016-09-01
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
intervention	AYMES PRAGUE	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.

Primary Outcome Measures

Name	Time	Method
GI side effects when using AYMES PRAGUE	9 DAYS	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

Secondary Outcome Measures

Name	Time	Method
Bowel habits of subjects when using AYMES PRAGUE - stool consistency	9 days	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
Change to bodyweight of subjects when using AYMES PRAGUE	9 days	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
Bowel habits of subjects when using AYMES PRAGUE - frequency	9 days	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
Compliance with prescription of AYMES PRAGUE	9 days	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