Acceptability and Tolerance Study of a New Oral Nutritional Supplement (ONS)

Malnutrition Clinical Trial

Official title:

Tolerance and Acceptability of AYMES PARIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898038
• Other study ID #: AY:SC1
• Status: Completed
• Phase: N/A
• First received: September 8, 2016
• Last updated: September 8, 2016
• Start date: November 2015
• Est. completion date: November 2015

Study information

• Verified date: September 2016
• Source: Aymes International Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Tolerance and Acceptability of new oral nutritional supplement - AYMES PARIS

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• AYMES PARIS
AYMES PARIS is a powdered, high energy, oral nutritional supplement to be mixed with milk as a drink. It provides 320 kcal and 12.2 g protein per 139 ml 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	Alison Clark Health and Nutrition

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GI side effects when using AYMES PARIS	Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES PARIS as assessed by presence / absence of side effect compared to baseline period	9 DAYS	No
Secondary	Change to bodyweight of subjects when using AYMES PARIS	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	No
Secondary	Compliance with prescription of AYMES PARIS	Recording of amount of AYMES PARIS 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 PARIS	9 DAYS	No
Secondary	Bowel habits of subjects when using AYMES PARIS - frequency	Recording of bowel habits whilst subjects consuming AYMES PARIS, as assessed by frequency of bowel movements (number of stools per day) and compared to same data recorded during baseline period	9 days	No
Secondary	Bowel habits of subjects when using AYMES PARIS - stool consistency	Recording of bowel habits whilst subjects consuming AYMES PARIS, as assessed by consistency of stools (assessed by Bristol Stool Chart) and compared to same data recorded during baseline period	9 days	No