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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07904715). StuddyBuddy aggregates publicly available trial information.