← Back to all trials
Not Yet Recruiting
NCT07904715
Tolerance and Acceptability of an Oral Nutrition Supplement
Conditions: Disease Related Malnutrition
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Aymes International Limited
Location: Nottingham University Hospitals NHS Trust Nottingham
Summary
The goal of this study is to learn whether a new oral nutritional supplement is acceptable to adults who are malnourished, or at risk of malnutrition, and need nutritional support.
The main questions it aims to answer are:
* Do participants tolerate the supplement without stomach or bowel problems?
* How much of the prescribed supplement do participants take each day?
* How do participants rate the taste, texture and overall experience of taking the supplement?
Researchers will also record any side effects.
Participants will:
* Take the supplement every day for 7 days, as prescribed by their dietitian
* Keep a daily diary of how much they take and any stomach or bowel symptoms
* Complete a short questionnaire about the supplement and have a review with the study team on Day 7
Eligibility Criteria
Inclusion Criteria:
* Aged 18 years or over
* Male or female
* Malnourished or at risk of malnutrition, identified using a validated screening tool (e.g. Malnutrition Universal Screening Tool (MUST) score of 1 or more), and/or currently using or requiring oral nutritional supplements as part of a nutritional management plan
* Expected to take at least one serving of the study product per day (some participants may be prescribed two servings per day, depending on individual nutritional requirements)
* Able to provide written or electronic informed consent, or verbal consent countersigned by an independent witness if physically unable to sign
Exclusion Criteria:
* Receiving exclusive enteral or parenteral nutrition (no oral intake)
* Known allergy or intolerance to any ingredient in the study product, including milk, or any dietary requirement or preference incompatible with its composition (e.g. vegan)
* Acute illness or unstable medical condition that may interfere with participation (e.g. major hepatic or renal dysfunction such as decompensated liver disease)
* Currently in intensive care
* Participation in another interventional clinical study within 2 weeks before this study
* Insufficient proficiency in the English language
* Lacking the mental capacity to provide informed consent
* Investigator concerns about the participant's ability or willingness to comply with study requirements
Source: ClinicalTrials.gov (NCT07904715). StuddyBuddy aggregates publicly available trial information.