Tolerance, Palatability and Acceptability Evaluation of an Oral Nutrition Supplement

NCT07452523 | Active Not Recruiting

• 1 other identifier: AY-SWIFT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Disease Related Malnutrition

Outcome Measures

Primary Outcomes (3)

• Acceptability and palatability of an oral nutriitonal supplement.

  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.

  7 days

• Gastro-intestinal Tolerance

  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.

  7 days

• Compliance

  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.

  7 days

Study Arms (1)

AYMES SWIFT

EXPERIMENTAL

Patients with or at risk of disease related malnutrition (DRM), who have been clinically identified as requiring nutritional supplementation will be prescribed the study product for a period of 7 days.

Dietary Supplement: AYMES SWIFT oral nutritional supplement; Dietary Supplement: AYMES SWIFT FIBRE; Dietary Supplement: AYMES SWIFT PLANT

Interventions

AYMES SWIFT oral nutritional supplement DIETARY_SUPPLEMENT

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

Also known as: AYMES SWIFT Fibre

AYMES SWIFT

AYMES SWIFT FIBRE DIETARY_SUPPLEMENT

An oral nutritional supplement and food for special medical purposes.

AYMES SWIFT

AYMES SWIFT PLANT DIETARY_SUPPLEMENT

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

AYMES SWIFT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aymes International Limited: lead

Study Sites (1)

Preston Hill Surgery

Harrow, HA3 9SN, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: March 5, 2026
• Study Start: October 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)