Evaluation of a High Protein, High Calorie Pudding in Adults With/or at Risk for Malnutrition (NCT04945083) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of a High Protein, High Calorie Pudding in Adults With/or at Risk for Malnutrition
United Kingdom25 participantsStarted 2021-01-13
Plain-language summary
This is a multi-center, prospective, non-randomized, non-blinded, single-arm, single treatment study to evaluate the tolerance of a nutritional pudding.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subject has voluntarily signed and dated an ICF approved by an IEC, and provided applicable privacy authorization prior to any participation
* Subject is considered by a dietitian or clinician as malnourished or at risk for malnutrition based on current use of an oral nutritional supplement (ONS), recently identified as malnourished or at risk of malnutrition based on validated malnutrition screening tool or has had weight loss within last two months as a result of a hospitalization or chronic illness
* Subject currently has normal GI function
* Subject requires ONS and is willing to comply with the study protocol
Exclusion Criteria:
* Subject has severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures
* Subject had a history of diabetes as evidenced by taking antihyperglycemic medications or by self-reported dietary modification
* Subject is currently taking or has taken antibiotics within 1 week prior to enrollment
* Subject has undergone major GI surgery less than 3 months prior to enrollment in the study
* Subject has current active malignant disease or was treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma, prior to enrollment
* Subject has an immunodeficiency disorder
* Subject…