Acceptability and Tolerance Study of New Oral Nutritional Supplement PRAGUE

Malnutrition Clinical Trial

Official title:

Tolerance and Acceptability of AYMES PRAGUE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02831647
• Other study ID #: AY:AC1
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: December 1, 2016

Study information

• Verified date: January 2020
• Source: Aymes International Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tolerance and Acceptability of new oral nutritional supplement - AYMES PRAGUE

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aymes International Limited	Eat Well Now

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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