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NCT Number: NCT07452523

Tolerance, Palatability and Acceptability Evaluation of an Oral Nutrition Supplement

To evaluate the tolerance (gastrointestinal) and acceptability of a new Oral Nutrition Supplement in patients with or at risk of disease related malnutrition.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Disease Related Malnutrition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Preston Hill Surgery

Harrow, HA3 9SN, United Kingdom

About this study

To evaluate tolerance and acceptability of a new Oral Nutrition Supplement in patients with or at risk of malnutrition, who require supplementary nutrition support. Outcomes of GI effects, compliance and palatability will be recorded.

To obtain data to support an ACBS submission (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

  • Male or female

•≥ 18 years of age

  • Identified as being malnourished/at risk of malnutrition-by-malnutrition screening tools [i.e., MUST score ≥1, and/or using or requiring ONS at least once daily as part of nutritional management plan]
  • Expected to receive at least one bottle of ONS per day
  • Written or electronic informed consent from patient, or verbally given consent countersigned by a witness for those physically unable to sign

Exclusion criteria

  • Participants receiving parenteral nutrition or ≥70% total energy requirements from enteral tube feeding
  • Participants with major hepatic dysfunction (i.e., decompensated liver disease)
  • Participants with major renal dysfunction [i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD)]
  • Participants with active/chronic gastrointestinal disease or impaired gastrointestinal function
  • Participants with significant dysphagia/high aspiration risk
  • Participation in other clinical intervention studies within 1 month of this study
  • Participants lacking mental capacity to consent
  • Allergy to any study product ingredients (appendix 2)
  • Investigator concern regarding ability or willingness of patient to comply with the study requirements.

Treatment and study plan

AYMES SWIFT oral nutritional supplement

Dietary Supplement

The study supplement is an oral nutritional supplement and food for special medical purposes.

Other names: AYMES SWIFT Fibre

AYMES SWIFT FIBRE

Dietary Supplement

An oral nutritional supplement and food for special medical purposes.

AYMES SWIFT PLANT

Dietary Supplement

A plant based oral nutritional supplement and food for special medical purposes.

Primary outcomes

  1. Acceptability and palatability of an oral nutriitonal supplement.

    Time frame: 7 days

    To assess the acceptability of the oral nutritional supplement in patients requiring oral nutritional supplementation. On day 7 of the intervention period an acceptability and preference questionnaire will be completed by the patient in order to seek their opinion on the taste, smell, texture and overall liking of the new oral nutrition supplement. Questions will be rated on a 7 point Likert scale (Strongly Agree, Somewhat agree, Neutral, Somewhat Disagree, Disagree, Disagree Strongly) and will relate to taste, smell, texure and overall liking.

  2. Gastro-intestinal Tolerance

    Time frame: 7 days

    To assess the GI tolerance of the oral nutritional supplement in patients with or at risk of disease related malnutrition. Monitoring includes recording the number of any GI complaints and consistency of bowel movements via a diary for the first 7 days.

    A standardised gastrointestinal (GI) tolerance questionnaire to capture perceived severity (none, mild, moderate or severe) of common gastrointestinal symptoms (diarrhoea, constipation, bloating, abdominal discomfort, vomiting and nausea) will be recorded on day 1 (based on the 2 preceding days) and for the first 7 days during the intervention.

    Information about bowel movements will also be collected using the Bristol Stool Chart© at the same time points.

  3. Compliance

    Time frame: 7 days

    To assess the compliance of patients taking the Study product as prescribed. This is measured by daily completion of a compliance diary, comparing consumed amount versus prescribed amount.

Sponsors and collaborators

Lead sponsor

Aymes International Limited

Industry

Registry information

Official study title

Tolerance and Acceptability Evaluation of AYMES SWIFT

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

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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