Acceptability and Tolerance Study of New Oral Nutritional Supplement

Malnutrition Clinical Trial

Official title:

Tolerance and Acceptability of AYMES ROME

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02648451
• Other study ID #: AY:SJ1
• Status: Completed
• Phase: N/A
• First received: December 18, 2015
• Last updated: January 5, 2016
• Start date: January 2015
• Est. completion date: March 2015

Study information

• Verified date: January 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

• 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• 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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition

Intervention

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.

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 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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No