Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement

Tolerance and Acceptability Evaluation of AYMES Protein Shot

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

Study Overview

• Status: Recruiting
• Conditions: Disease Related Malnutrition
• Intervention / Treatment: Dietary supplement: Shot Style protein supplement

Detailed Description

To evaluate tolerance and acceptability of a new Oral Nutrition Supplement in patients with or at risk of malnutrition, who require supplementary nutrition support, either taken orally or with a feeding tube. Outcomes of GI effects, compliance, product preference, convenience etc. will be recorded.

To obtain data to support an ACBS submission (to allow for prescription in the community at NHS expense).

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2PG
    • Recruiting
    • UCLH NHS Foundation Trust
    • Contact: James Evans, Dietetics; Phone Number: 0044 0203 447 9289; Email: j.evans28@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shot style protein supplement; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of consumption of Study Product	Daily assessment of GI symptoms	7 days

Collaborators and Investigators

• Sponsor: Aymes International Limited

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: AY:PS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No