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Acceptability and Tolerance Study of New Oral Nutritional Supplement PRAGUE

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ClinicalTrials.gov Identifier: NCT02831647
Recruitment Status : Not yet recruiting
First Posted : July 13, 2016
Last Update Posted : September 9, 2016
Sponsor:
Collaborator:
Eat Well Now
Information provided by (Responsible Party):
Aymes International Limited

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

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

Detailed 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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Tolerance and Acceptability of AYMES PRAGUE
Study Start Date : September 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention
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 PRAGUE for a period of 9 days.
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.




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


Secondary Outcome Measures :
  1. Change to bodyweight of subjects when using AYMES PRAGUE [ 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 PRAGUE [ Time Frame: 9 days ]
    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

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

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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
ClinicalTrials.gov Identifier: NCT02831647     History of Changes
Other Study ID Numbers: AY:AC1
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders