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Completed

NCT Number: NCT02648451

Acceptability and Tolerance Study of New Oral Nutritional Supplement

* 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).

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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 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).

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 ROME

Dietary Supplement

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.

Primary outcomes

  1. GI side effects when using AYMES Rome

    Time frame: 9 days

    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

Secondary outcomes

  1. Change to bodyweight of subjects when using AYMES Rome

    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 Rome

    Time frame: 9 days

    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

  3. Bowel habits of subjects when using AYMES Rome - frequency

    Time frame: 9 days

    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

  4. Bowel habits of subjects when using AYMES Rome - stool consistency

    Time frame: 9 days

    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

Sponsors and collaborators

Lead sponsor

Aymes International Limited

Industry

Collaborators

  • Alison Clark Health and Nutrition

Registry information

Official study title

Tolerance and Acceptability of AYMES ROME

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 7, 2016
Registry last updated
Jan 7, 2016

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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