RecruitingNot ApplicableNCT07417514

Tolerance and Acceptability Evaluation of an Oral Nutrition Supplement

Tolerance and Acceptability Evaluation of AYMES Protein Shot


Sponsor

Aymes International Limited

Enrollment

40 participants

Start Date

Sep 30, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral nutritional supplement designed to help adults who are malnourished or at risk of malnutrition, particularly those with kidney disease or who need extra protein. The supplement can be taken by mouth or delivered through a feeding tube, and researchers want to see how well patients tolerate it and whether they find it acceptable. Adults aged 18 and older who are expected to need this type of supplement for at least 28 days may be eligible, provided they can communicate clearly and do not have certain conditions such as severe liver disease, dysphagia requiring thickened fluids, or uncontrolled inflammatory bowel disease. Participants will consume different flavors of the supplement orally and a neutral version via feeding tube over 28 days, and will be asked about their digestive comfort, preferences, and convenience. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTShot 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.


Locations(1)

UCLH NHS Foundation Trust

London, United Kingdom

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NCT07417514


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