NCT07417514

Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement

Tolerance and Acceptability Evaluation of AYMES Protein Shot

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Aymes International Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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).

Conditions

• Disease Related Malnutrition

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-30
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: United Kingdom