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

NCT02898038 | Completed

• 1 other identifier: AY:SC1
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Tolerance and Acceptability of new oral nutritional supplement - AYMES PARIS

Conditions

Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change to bodyweight of subjects when using AYMES PARIS

  9 DAYS

• Compliance with prescription of AYMES PARIS

  9 DAYS

• Bowel habits of subjects when using AYMES PARIS - frequency

  9 days

• Bowel habits of subjects when using AYMES PARIS - stool consistency

  9 days

Study Arms (1)

Experimental

EXPERIMENTAL

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 PARIS for a period of 9 days.

Dietary Supplement: AYMES PARIS

Interventions

AYMES PARIS DIETARY_SUPPLEMENT

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aymes International Limited: lead
• Alison Clark Health and Nutrition: collaborator

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 13, 2016
• Study Start: November 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 13, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share