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Completed

NCT Number: NCT02831647

Acceptability and Tolerance Study of New Oral Nutritional Supplement PRAGUE

Tolerance and Acceptability of new oral nutritional supplement - AYMES PRAGUE

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AYMES PRAGUE

Dietary Supplement

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aymes International Limited

Industry

Collaborators

  • Eat Well Now

Registry information

Official study title

Tolerance and Acceptability of AYMES PRAGUE

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 13, 2016
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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