Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement

NCT07417514 | Recruiting

• 1 other identifier: AY:PS01
• 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, taken either orally or via a feeding tube

Conditions

Disease Related Malnutrition

Outcome Measures

Primary Outcomes (3)

• Acceptability and Palatability of Oral Nutrition Supplement

  To assess the acceptability of the shot-style protein supplement in patients requiring oral nutritional supplementation. On day 7 and 28 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. A 5 point hedonic scale will be used.

  28 days

• Gastro-Intestinal (GI) Tolerance

  To assess the GI tolerance of the shot-style protein supplement in patients with or at risk of disease related malnutrition, requiring additional protein, either fed orally or with a feeding tube. Monitoring includes recording the number of any GI complaints and consistency of bowel movements via a diary for the first 7 days

  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.

  28 days

Secondary Outcomes (1)

• Safety of consumption of Study Product

  7 days

Study Arms (1)

Shot style protein supplement

EXPERIMENTAL

Patients with or at risk of DRM, who have been clinical identified as requiring additional protein will be prescribed the study product for a period of 7-28days. Study product can be taken either orally or via a feeding tube.

Dietary Supplement: Shot Style protein supplement

Interventions

Shot Style protein supplement DIETARY_SUPPLEMENT

The Study product 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.

Shot style protein supplement

Eligibility Criteria

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

You may qualify if:

• Adult patients (≥18 years) who are able to communicate clearly.
• Diagnosis of renal disease or confirmed requirement for protein supplementation by a suitably qualified health care professional (e.g. dietitian)
• Participants with or at risk of malnutrition as determined by the SGA nutritional screening tool, MUST and/or by professional clinical judgement.
• Participants expected to require an ONS for at least 28 days from baseline, to take flavour variants orally and neutral via feeding tube.
• Informed consent obtained.

You may not qualify if:

• Participation in any other studies involving investigational or marketed products concomitantly or within seven days prior to entry into the study
• Patients with medical or dietary contraindication to any ingredients (see appendix 2 of protocol for full list.)
• No feeding tube for any patient taking the neutral variant.
• Patients with significant hepatic impairment.
• Patients with dysphagia requiring IDDSI level 1 (or higher) fluids.
• Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
• Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
• Any participant unable to give consent i.e., those with dementia.
• Participants under 18 years of age.
• Individuals who do not have sufficient proficiency with English language
• Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.

Sponsors & Collaborators

• Aymes International Limited: lead

Study Sites (1)

UCLH NHS Foundation Trust

London, NW1 2PG, United Kingdom

RECRUITING

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 11, 2026
• First Posted: February 18, 2026
• Study Start: September 30, 2022
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)