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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02898038
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : September 13, 2016
Alison Clark Health and Nutrition
Information provided by (Responsible Party):
Aymes International Limited

Brief Summary:
Tolerance and Acceptability of new oral nutritional supplement - AYMES PARIS

Condition or disease Intervention/treatment Phase
Malnutrition Dietary Supplement: AYMES PARIS Not Applicable

Detailed 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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Tolerance and Acceptability of AYMES PARIS
Study Start Date : November 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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.

Primary Outcome Measures :
  1. GI side effects when using AYMES PARIS [ Time Frame: 9 DAYS ]
    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

Secondary Outcome Measures :
  1. Change to bodyweight of subjects when using AYMES PARIS [ Time Frame: 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

  2. Compliance with prescription of AYMES PARIS [ Time Frame: 9 DAYS ]
    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

  3. Bowel habits of subjects when using AYMES PARIS - frequency [ Time Frame: 9 days ]
    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

  4. Bowel habits of subjects when using AYMES PARIS - stool consistency [ Time Frame: 9 days ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Responsible Party: Aymes International Limited Identifier: NCT02898038     History of Changes
Other Study ID Numbers: AY:SC1
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Nutrition Disorders