Tolerance, Palatability and Acceptability Evaluation of an Oral Nutrition Supplement (NCT07452523) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Tolerance, Palatability and Acceptability Evaluation of an Oral Nutrition Supplement
United Kingdom40 participantsStarted 2022-10-01
Plain-language summary
To evaluate the tolerance (gastrointestinal) and acceptability of a new Oral Nutrition Supplement in patients with or at risk of disease related malnutrition.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female
•≥ 18 years of age
* Identified as being malnourished/at risk of malnutrition-by-malnutrition screening tools \[i.e., MUST score ≥1, and/or using or requiring ONS at least once daily as part of nutritional management plan\]
* Expected to receive at least one bottle of ONS per day
* Written or electronic informed consent from patient, or verbally given consent countersigned by a witness for those physically unable to sign
Exclusion Criteria:
* Participants receiving parenteral nutrition or ≥70% total energy requirements from enteral tube feeding
* Participants with major hepatic dysfunction (i.e., decompensated liver disease)
* Participants with major renal dysfunction \[i.e., requiring filtration or stage 4/5 chronic kidney disease (CKD)\]
* Participants with active/chronic gastrointestinal disease or impaired gastrointestinal function
* Participants with significant dysphagia/high aspiration risk
* Participation in other clinical intervention studies within 1 month of this study
* Participants lacking mental capacity to consent
* Allergy to any study product ingredients (appendix 2)
* Investigator concern regarding ability or willingness of patient to comply with the study requirements.
What they're measuring
1
Acceptability and palatability of an oral nutriitonal supplement.